Label: ESIKA HYDRACOLOR 2 IN 1 HIGHLY MOISTURIZING AND COLORING SPF 25 (PIMIENTA CALIENTE) - BROWN- octinoxate and oxybenzone lipstick
ESIKA HYDRACOLOR 2 IN 1 HIGHLY MOISTURIZING AND COLORING SPF 25 (MARRON GLAMOUR) - BROWN- octinoxate and oxybenzone lipstick
ESIKA HYDRACOLOR 2 IN 1 HIGHLY MOISTURIZING AND COLORING SPF 25 (BORGONA SEXY) - PURPLE- octinoxate and oxybenzone lip .......
ESIKA HYDRACOLOR 2 IN 1 HIGHLY MOISTURIZING AND COLORING SPF 25 (BORGONA SEXY EXOTIC) - PURPLE- octinoxate and oxybenzone lipstick
ESIKA HYDRACOLOR 2 IN 1 HIGHLY MOISTURIZING AND COLORING SPF 25 (MARRON GLAMOUR EXOTIC) - BROWN- octinoxate and oxybenzone lipstick
ESIKA HYDRACOLOR 2 IN 1 HIGHLY MOISTURIZING AND COLORING SPF 25- octinoxate and oxybenzone kit

  • Contains inactivated NDC Code(s)
    NDC Code(s):     13537-475-01, 13537-475-02, 13537-476-01, 13537-476-02, view more
    13537-477-01, 13537-477-02, 13537-478-01, 13537-478-02, 13537-479-01, 13537-479-02, 13537-804-01, 13537-804-02, 13537-805-01, 13537-805-02, 13537-806-01, 13537-806-02, 13537-807-01, 13537-807-02, 13537-808-01, 13537-808-02, 13537-809-01, 13537-809-02, 13537-810-01, 13537-810-02, 13537-811-01, 13537-811-02, 13537-812-01, 13537-812-02, 13537-813-01, 13537-813-02, 13537-814-01, 13537-814-02, 13537-815-01, 13537-815-02, 13537-816-01, 13537-816-02, 13537-817-01, 13537-817-02, 13537-818-01, 13537-818-02, 13537-819-01, 13537-819-02, 13537-820-01, 13537-820-02, 13537-821-01, 13537-821-02, 13537-822-01, 13537-822-02, 13537-823-01, 13537-823-02, 13537-824-01, 13537-824-02, 13537-825-01, 13537-825-02, 13537-826-01, 13537-826-02, 13537-827-01, 13537-827-02, 13537-828-01, 13537-828-02, 13537-829-01, 13537-829-02, 13537-830-01, 13537-830-02, 13537-831-01, 13537-831-02, 13537-832-01, 13537-832-02, 13537-833-01, 13537-833-02, 13537-834-01, 13537-834-02, 13537-835-01, 13537-835-02, 13537-836-01, 13537-836-02, 13537-837-01, 13537-837-02, 13537-838-01, 13537-838-02, 13537-839-01, 13537-839-02, 13537-840-01, 13537-840-02, 13537-880-01, 13537-880-02
  • Packager: Ventura Corporation LTD
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated November 9, 2016

If you are a consumer or patient please visit this version.

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active Ingredients Purpose
    OCTINOXATE 6.64 %Sunscreen
    OXYBENZONE.. 1.51 %Sunscreen
  • Uses

    • Helps prevent sunburn.
  • Warnings

    • Skin Cancer / Skin Aging Alert: Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to help prevent sunburn, not skin cancer or early skin aging.
    • For external use only.

    • Do not use on damaged or broken skin.

    • When using this product keep out of eyes. Rinse with water to remove.

    • Stop use and ask a doctor if rash occurs.

    • Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
  • Directions

    • Apply liberally and evenly 15 minutes before sun exposure.
    • Reapply at least every 2 hours
    • Use a water resistant sunscreen if swimming or sweating.
    • Children under 6 months of age: Ask a doctor
  • Other information

    • Protect the product in this container from excessive heat and direct sun.
  • Inactive ingredients

    DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE, TRIDECYL TRIMELLITATE, ETHYLHEXYL PALMITATE, OZOKERITE, WATER, POLYETHYLENE, TRIDECYL STEARATE, POLYGLYCERYL-3 DIISOSTEARATE, POLYMETHYL METHACRYLATE, COPERNICIA CERIFERA (CARNAUBA) WAX, GLYCERIN, NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE, FRAGRANCE, CAPRYLIC/CAPRIC TRIGLYCERIDE, SODIUM STARCH OCTENYLSUCCINATE, TOCOPHERYL ACETATE, PHENOXYETHANOL, COCOS NUCIFERA (COCONUT) OIL, ALOE BARBADENSIS LEAF EXTRACT, CAPRYLYL GLYCOL, CERAMIDE 3, CHLORPHENESIN, PROPYLENE GLYCOL, LIMONIUM GERBERI EXTRACT, BUTYROSPERMUM PARKII (SHEA) BUTTER, GLYCINE SOJA (SOYBEAN) OIL, TOCOPHEROL, MAGNESIUM CHLORIDE, POTASSIUM CHLORIDE, SILICA, SODIUM CHLORIDE, VITIS VINIFERA (GRAPE) FRUIT EXTRACT, CITRONELLOL, d-LIMONENE, BENZYL ALCOHOL, ALPHA-ISOMETHYL IONONE, LINALOOL, AMYL CINNAMAL.

    MAY CONTAIN:
    MICA, RED 30 LAKE, TITANIUM DIOXIDE, IRON OXIDES, YELLOW 5 LAKE, RED 21 LAKE, RED 27 LAKE, RED 7 LAKE, TALC, BLUE 1 LAKE, PEG-8 METHYL ETHER TRIETHOXYSILANE, CARMINE.

  • SPL UNCLASSIFIED SECTION

    Dist. by Ventura
    Corp, Ltd., San Juan, Puerto Rico
    00926.

  • PRINCIPAL DISPLAY PANEL - 4 g Tube Box - (PIMIENTA CALIENTE) - BROWN

    ésika

    HYDRACOLOR 2 in 1
    Highly moisturizing and coloring
    LIPSTICK SPF 25

    Net Weight 0.14 oz. e (4 g)

    Principal Display Panel - 4 g Tube Box - (PIMIENTA CALIENTE) - BROWN
  • PRINCIPAL DISPLAY PANEL - 4 g Tube Box - (MARRON GLAMOUR) - BROWN

    ésika

    HYDRACOLOR 2 in 1
    Highly moisturizing and coloring
    LIPSTICK SPF 25

    Net Weight 0.14 oz. e (4 g)

    Principal Display Panel - 4 g Tube Box - (MARRON GLAMOUR) - BROWN
  • PRINCIPAL DISPLAY PANEL - 4 g Tube Box - (BORGONA SEXY) - PURPLE

    ésika

    HYDRACOLOR 2 in 1
    Highly moisturizing and coloring
    LIPSTICK SPF 25

    Net Weight 0.14 oz. e (4 g)

    Principal Display Panel - 4 g Tube Box - (BORGONA SEXY) - PURPLE
  • PRINCIPAL DISPLAY PANEL - 4 g Tube Box - (ROSA DULZURA) - PINK

    ésika

    HYDRACOLOR 2 in 1
    Highly moisturizing and coloring
    LIPSTICK SPF 25

    Net Weight 0.14 oz. e (4 g)

    Principal Display Panel - 4 g Tube Box - (ROSA DULZURA) - PINK
  • PRINCIPAL DISPLAY PANEL - 4 g Tube Box - (ROJO DESEO) - RED

    ésika

    HYDRACOLOR 2 in 1
    Highly moisturizing and coloring
    LIPSTICK SPF 25

    Net Weight 0.14 oz. e (4 g)

    Principal Display Panel - 4 g Tube Box - (ROJO DESEO) - RED
  • PRINCIPAL DISPLAY PANEL - 4 g Tube Box - (ROJO INTRIGANTE) - RED

    ésika

    HYDRACOLOR 2 in 1
    Highly moisturizing and coloring
    LIPSTICK SPF 25

    Net Weight 0.14 oz. e (4 g)

    Principal Display Panel - 4 g Tube Box - (ROJO INTRIGANTE) - RED
  • PRINCIPAL DISPLAY PANEL - 4 g Tube Box - (ROJO LUJURIA) - RED

    ésika

    HYDRACOLOR 2 in 1
    Highly moisturizing and coloring
    LIPSTICK SPF 25

    Net Weight 0.14 oz. e (4 g)

    Principal Display Panel - 4 g Tube Box - (ROJO LUJURIA) - RED
  • PRINCIPAL DISPLAY PANEL - 4 g Tube Box - (CORAL CHIC) - PINK

    ésika

    HYDRACOLOR 2 in 1
    Highly moisturizing and coloring
    LIPSTICK SPF 25

    Net Weight 0.14 oz. e (4 g)

    Principal Display Panel - 4 g Tube Box - (CORAL CHIC) - PINK
  • PRINCIPAL DISPLAY PANEL - 4 g Tube Box - (ROSA ENCANTO) - PINK

    ésika

    HYDRACOLOR 2 in 1
    Highly moisturizing and coloring
    LIPSTICK SPF 25

    Net Weight 0.14 oz. e (4 g)

    Principal Display Panel - 4 g Tube Box - (ROSA ENCANTO) - PINK
  • PRINCIPAL DISPLAY PANEL - 4 g Tube Box - (FUCSIA CAUTIVANTE) - PINK

    ésika

    HYDRACOLOR 2 in 1
    Highly moisturizing and coloring
    LIPSTICK SPF 25

    Net Weight 0.14 oz. e (4 g)

    Principal Display Panel - 4 g Tube Box - (FUCSIA CAUTIVANTE) - PINK
  • PRINCIPAL DISPLAY PANEL - 4 g Tube Box - (GRANATE SEDUCTOR) - PURPLE

    ésika

    HYDRACOLOR 2 in 1
    Highly moisturizing and coloring
    LIPSTICK SPF 25

    Net Weight 0.14 oz. e (4 g)

    Principal Display Panel - 4 g Tube Box - (GRANATE SEDUCTOR) - PURPLE
  • PRINCIPAL DISPLAY PANEL - 4 g Tube Box - (ROSA ROMANTICA) - PINK

    ésika

    HYDRACOLOR 2 in 1
    Highly moisturizing and coloring
    LIPSTICK SPF 25

    Net Weight 0.14 oz. e (4 g)

    Principal Display Panel - 4 g Tube Box - (ROSA ROMANTICA) - PINK
  • PRINCIPAL DISPLAY PANEL - 4 g Tube Box - (NARANJA PRIMAVERA) - ORANGE

    ésika

    HYDRACOLOR 2 in 1
    Highly moisturizing and coloring
    LIPSTICK SPF 25

    Net Weight 0.14 oz. e (4 g)

    Principal Display Panel - 4 g Tube Box - (NARANJA PRIMAVERA) - ORANGE
  • PRINCIPAL DISPLAY PANEL - 4 g Tube Box - (FRAMBUESA MANIA) - RED

    ésika

    HYDRACOLOR 2 in 1
    Highly moisturizing and coloring
    LIPSTICK SPF 25

    Net Weight 0.14 oz. e (4 g)

    Principal Display Panel - 4 g Tube Box - (FRAMBUESA MANIA) - RED
  • PRINCIPAL DISPLAY PANEL - 4 g Tube Box - (FRESA COQUETA) - RED

    ésika

    HYDRACOLOR 2 in 1
    Highly moisturizing and coloring
    LIPSTICK SPF 25

    Net Weight 0.14 oz. e (4 g)

    Principal Display Panel - 4 g Tube Box - (FRESA COQUETA) - RED
  • PRINCIPAL DISPLAY PANEL - 4 g Tube Box - (CANELA NUDE) - ORANGE

    ésika

    HYDRACOLOR 2 in 1
    Highly moisturizing and coloring
    LIPSTICK SPF 25

    Net Weight 0.14 oz. e (4 g)

    Principal Display Panel - 4 g Tube Box - (CANELA NUDE) - ORANGE
  • PRINCIPAL DISPLAY PANEL - 4 g Tube Box - (MORA GLAM) - BROWN

    ésika

    HYDRACOLOR 2 in 1
    Highly moisturizing and coloring
    LIPSTICK SPF 25

    Net Weight 0.14 oz. e (4 g)

    Principal Display Panel - 4 g Tube Box - (MORA GLAM) - BROWN
  • PRINCIPAL DISPLAY PANEL - 4 g Tube Box - (CORAL INTENSE) - RED

    ésika

    HYDRACOLOR 2 in 1
    Highly moisturizing and coloring
    LIPSTICK SPF 25

    Net Weight 0.14 oz. e (4 g)

    Principal Display Panel - 4 g Tube Box - (CORAL INTENSE) - RED
  • PRINCIPAL DISPLAY PANEL - 4 g Tube Box - (ROSA GEOMETRIC) - PINK

    ésika

    HYDRACOLOR 2 in 1
    Highly moisturizing and coloring
    LIPSTICK SPF 25

    Net Weight 0.14 oz. e (4 g)

    Principal Display Panel - 4 g Tube Box - (ROSA GEOMETRIC) - PINK
  • PRINCIPAL DISPLAY PANEL - 4 g Tube Box - (FUCSIA PRISMA) - RED

    ésika

    HYDRACOLOR 2 in 1
    Highly moisturizing and coloring
    LIPSTICK SPF 25

    Net Weight 0.14 oz. e (4 g)

    Principal Display Panel - 4 g Tube Box - (FUCSIA PRISMA) - RED
  • PRINCIPAL DISPLAY PANEL - 4 g Tube Box - (NARANJA ESFERA) - ORANGE

    ésika

    HYDRACOLOR 2 in 1
    Highly moisturizing and coloring
    LIPSTICK SPF 25

    Net Weight 0.14 oz. e (4 g)

    Principal Display Panel - 4 g Tube Box - (NARANJA ESFERA) - ORANGE
  • PRINCIPAL DISPLAY PANEL - 4 g Tube Box - (NUDE INFINITO) - BROWN

    ésika

    HYDRACOLOR 2 in 1
    Highly moisturizing and coloring
    LIPSTICK SPF 25

    Net Weight 0.14 oz. e (4 g)

    Principal Display Panel - 4 g Tube Box - (NUDE INFINITO) - BROWN
  • PRINCIPAL DISPLAY PANEL - 4 g Tube Box - (ROJO ESIKA) - RED

    ésika

    HYDRACOLOR 2 in 1
    Highly moisturizing and coloring
    LIPSTICK SPF 25

    Net Weight 0.14 oz. e (4 g)

    Principal Display Panel - 4 g Tube Box - (ROJO ESIKA) - RED
  • PRINCIPAL DISPLAY PANEL - 4 g Tube Box - (MARRON TOPACIO) - BROWN

    ésika

    HYDRACOLOR 2 in 1
    Highly moisturizing and coloring
    LIPSTICK SPF 25

    Net Weight 0.14 oz. e (4 g)

    Principal Display Panel - 4 g Tube Box - (MARRON TOPACIO) - BROWN
  • PRINCIPAL DISPLAY PANEL - 4 g Tube Box - (CORAL CUARZO) - ORANGE

    ésika

    HYDRACOLOR 2 in 1
    Highly moisturizing and coloring
    LIPSTICK SPF 25

    Net Weight 0.14 oz. e (4 g)

    Principal Display Panel - 4 g Tube Box - (CORAL CUARZO) - ORANGE
  • PRINCIPAL DISPLAY PANEL - 4 g Tube Box - (FUCSIA AMATISTA) - PINK

    ésika

    HYDRACOLOR 2 in 1
    Highly moisturizing and coloring
    LIPSTICK SPF 25

    Net Weight 0.14 oz. e (4 g)

    Principal Display Panel - 4 g Tube Box - (FUCSIA AMATISTA) - PINK
  • PRINCIPAL DISPLAY PANEL - 4 g Tube Box - (NUDE PRISMA) - ORANGE

    ésika

    HYDRACOLOR 2 in 1
    Highly moisturizing and coloring
    LIPSTICK SPF 25

    Net Weight 0.14 oz. e (4 g)

    Principal Display Panel - 4 g Tube Box - (NUDE PRISMA) - ORANGE
  • PRINCIPAL DISPLAY PANEL - 4 g Tube Box - (DORADO ESENCIAL) - YELLOW

    ésika

    HYDRACOLOR 2 in 1
    Highly moisturizing and coloring
    LIPSTICK SPF 25

    Net Weight 0.14 oz. e (4 g)

    Principal Display Panel - 4 g Tube Box - (DORADO ESENCIAL) - YELLOW
  • PRINCIPAL DISPLAY PANEL - 4 g Tube Box - (ROSA ENCANTO FEMME) - PINK

    ésika

    HYDRACOLOR 2 in 1
    Highly moisturizing and coloring
    LIPSTICK SPF 25

    Net Weight 0.14 oz. e (4 g)

    Principal Display Panel - 4 g Tube Box - (ROSA ENCANTO FEMME) - PINK
  • PRINCIPAL DISPLAY PANEL - 4 g Tube Box - (PIMIENTA CALIENTE FEMME) - RED

    ésika

    HYDRACOLOR 2 in 1
    Highly moisturizing and coloring
    LIPSTICK SPF 25

    Net Weight 0.14 oz. e (4 g)

    Principal Display Panel - 4 g Tube Box - (PIMIENTA CALIENTE FEMME) - RED
  • PRINCIPAL DISPLAY PANEL - 4 g Tube Box - (GRANATE SEDUCTOR FEMME) - PURPLE

    ésika

    HYDRACOLOR 2 in 1
    Highly moisturizing and coloring
    LIPSTICK SPF 25

    Net Weight 0.14 oz. e (4 g)

    Principal Display Panel - 4 g Tube Box - (GRANATE SEDUCTOR FEMME) - PURPLE
  • PRINCIPAL DISPLAY PANEL - 4 g Tube Box - (ROSA ROMANTICA FEMME) - PINK

    ésika

    HYDRACOLOR 2 in 1
    Highly moisturizing and coloring
    LIPSTICK SPF 25

    Net Weight 0.14 oz. e (4 g)

    Principal Display Panel - 4 g Tube Box - (ROSA ROMANTICA FEMME) - PINK
  • PRINCIPAL DISPLAY PANEL - 4 g Tube Box - (FUCSIA CAUTIVANTE FEMME) - PINK

    ésika

    HYDRACOLOR 2 in 1
    Highly moisturizing and coloring
    LIPSTICK SPF 25

    Net Weight 0.14 oz. e (4 g)

    Principal Display Panel - 4 g Tube Box - (FUCSIA CAUTIVANTE FEMME) - PINK
  • PRINCIPAL DISPLAY PANEL - 4 g Tube Box - (ROJO INTRIGANTE FEMME) - RED

    ésika

    HYDRACOLOR 2 in 1
    Highly moisturizing and coloring
    LIPSTICK SPF 25

    Net Weight 0.14 oz. e (4 g)

    Principal Display Panel - 4 g Tube Box - (ROJO INTRIGANTE FEMME) - RED
  • PRINCIPAL DISPLAY PANEL - 4 g Tube Box - (PIMIENTA CALIENTE EXOTIC) - RED

    ésika

    HYDRACOLOR 2 in 1
    Highly moisturizing and coloring
    LIPSTICK SPF 25

    Net Weight 0.14 oz. e (4 g)

    Principal Display Panel - 4 g Tube Box - (PIMIENTA CALIENTE EXOTIC) - RED
  • PRINCIPAL DISPLAY PANEL - 4 g Tube Box - (ROSA ENCANTO EXOTIC) - PINK

    ésika

    HYDRACOLOR 2 in 1
    Highly moisturizing and coloring
    LIPSTICK SPF 25

    Net Weight 0.14 oz. e (4 g)

    Principal Display Panel - 4 g Tube Box - (ROSA ENCANTO EXOTIC) - PINK
  • PRINCIPAL DISPLAY PANEL - 4 g Tube Box - (CORAL CHIC EXOTIC) - ORANGE

    ésika

    HYDRACOLOR 2 in 1
    Highly moisturizing and coloring
    LIPSTICK SPF 25

    Net Weight 0.14 oz. e (4 g)

    Principal Display Panel - 4 g Tube Box - (CORAL CHIC EXOTIC) - ORANGE
  • PRINCIPAL DISPLAY PANEL - 4 g Tube Box - (FUCSIA CAUTIVANTE EXOTIC) - PINK

    ésika

    HYDRACOLOR 2 in 1
    Highly moisturizing and coloring
    LIPSTICK SPF 25

    Net Weight 0.14 oz. e (4 g)

    Principal Display Panel - 4 g Tube Box - (FUCSIA CAUTIVANTE EXOTIC) - PINK
  • PRINCIPAL DISPLAY PANEL - 4 g Tube Box - (ROJO DESEO EXOTIC) - RED

    ésika

    HYDRACOLOR 2 in 1
    Highly moisturizing and coloring
    LIPSTICK SPF 25

    Net Weight 0.14 oz. e (4 g)

    Principal Display Panel - 4 g Tube Box - (ROJO DESEO EXOTIC) - RED
  • PRINCIPAL DISPLAY PANEL - 4 g Tube Box - (FRAMBUESA MANIA EXOTIC) - PINK

    ésika

    HYDRACOLOR 2 in 1
    Highly moisturizing and coloring
    LIPSTICK SPF 25

    Net Weight 0.14 oz. e (4 g)

    Principal Display Panel - 4 g Tube Box - (FRAMBUESA MANIA EXOTIC) - PINK
  • PRINCIPAL DISPLAY PANEL - 4 g Tube Box - (BORGONA SEXY EXOTIC) - PURPLE

    ésika

    HYDRACOLOR 2 in 1
    Highly moisturizing and coloring
    LIPSTICK SPF 25

    Net Weight 0.14 oz. e (4 g)

    Principal Display Panel - 4 g Tube Box - (BORGONA SEXY EXOTIC) - PURPLE
  • PRINCIPAL DISPLAY PANEL - 4 g Tube Box - (MARRON GLAMOUR EXOTIC) - BROWN

    ésika

    HYDRACOLOR 2 in 1
    Highly moisturizing and coloring
    LIPSTICK SPF 25

    Net Weight 0.14 oz. e (4 g)

    Principal Display Panel - 4 g Tube Box - (MARRON GLAMOUR EXOTIC) - BROWN
  • PRINCIPAL DISPLAY PANEL - Kit Carton

    HYDRACOLOR 2 in 1
    Highly moisturizing
    and coloring LIPSTICK SPF 25

    ésika

    Net Weight 0.28 oz. e (8g)

    Principal Display Panel - Kit Carton
  • INGREDIENTS AND APPEARANCE
    ESIKA HYDRACOLOR 2 IN 1 HIGHLY MOISTURIZING AND COLORING SPF 25   (PIMIENTA CALIENTE) - BROWN
    octinoxate and oxybenzone lipstick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13537-475
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE0.0664 g  in 1 g
    OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE0.0151 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW)  
    TRIDECYL TRIMELLITATE (UNII: FY36J270ES)  
    ETHYLHEXYL PALMITATE (UNII: 2865993309)  
    CERESIN (UNII: Q1LS2UJO3A)  
    WATER (UNII: 059QF0KO0R)  
    HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
    TRIDECYL STEARATE (UNII: A8OE252M6L)  
    POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)  
    POLY(METHYL METHACRYLATE; 450000 MW) (UNII: Z47NNT4J11)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    CERAMIDE NP (UNII: 4370DF050B)  
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    SOYBEAN OIL (UNII: 241ATL177A)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    MAGNESIUM CHLORIDE (UNII: 02F3473H9O)  
    POTASSIUM CHLORIDE (UNII: 660YQ98I10)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    WINE GRAPE (UNII: 3GOV20705G)  
    .BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)  
    LIMONENE, (+)- (UNII: GFD7C86Q1W)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)  
    LINALOOL, (+/-)- (UNII: D81QY6I88E)  
    .ALPHA.-AMYLCINNAMALDEHYDE (UNII: WC51CA3418)  
    MICA (UNII: V8A1AW0880)  
    D&C RED NO. 30 (UNII: 2S42T2808B)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    D&C RED NO. 21 (UNII: 08744Z6JNY)  
    D&C RED NO. 27 (UNII: 2LRS185U6K)  
    D&C RED NO. 7 (UNII: ECW0LZ41X8)  
    TALC (UNII: 7SEV7J4R1U)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:13537-475-021 in 1 BOX11/09/2016
    1NDC:13537-475-014 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35211/09/2016
    ESIKA HYDRACOLOR 2 IN 1 HIGHLY MOISTURIZING AND COLORING SPF 25   (MARRON GLAMOUR) - BROWN
    octinoxate and oxybenzone lipstick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13537-476
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE0.0664 g  in 1 g
    OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE0.0151 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW)  
    TRIDECYL TRIMELLITATE (UNII: FY36J270ES)  
    ETHYLHEXYL PALMITATE (UNII: 2865993309)  
    CERESIN (UNII: Q1LS2UJO3A)  
    WATER (UNII: 059QF0KO0R)  
    HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
    TRIDECYL STEARATE (UNII: A8OE252M6L)  
    POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)  
    POLY(METHYL METHACRYLATE; 450000 MW) (UNII: Z47NNT4J11)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    CERAMIDE NP (UNII: 4370DF050B)  
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    SOYBEAN OIL (UNII: 241ATL177A)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    MAGNESIUM CHLORIDE (UNII: 02F3473H9O)  
    POTASSIUM CHLORIDE (UNII: 660YQ98I10)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    WINE GRAPE (UNII: 3GOV20705G)  
    .BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)  
    LIMONENE, (+)- (UNII: GFD7C86Q1W)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)  
    LINALOOL, (+/-)- (UNII: D81QY6I88E)  
    .ALPHA.-AMYLCINNAMALDEHYDE (UNII: WC51CA3418)  
    MICA (UNII: V8A1AW0880)  
    D&C RED NO. 30 (UNII: 2S42T2808B)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    D&C RED NO. 21 (UNII: 08744Z6JNY)  
    D&C RED NO. 27 (UNII: 2LRS185U6K)  
    D&C RED NO. 7 (UNII: ECW0LZ41X8)  
    TALC (UNII: 7SEV7J4R1U)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:13537-476-021 in 1 BOX11/09/2016
    1NDC:13537-476-014 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35211/09/2016
    ESIKA HYDRACOLOR 2 IN 1 HIGHLY MOISTURIZING AND COLORING SPF 25   (BORGONA SEXY) - PURPLE
    octinoxate and oxybenzone lipstick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13537-477
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE0.0664 g  in 1 g
    OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE0.0151 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW)  
    TRIDECYL TRIMELLITATE (UNII: FY36J270ES)  
    ETHYLHEXYL PALMITATE (UNII: 2865993309)  
    CERESIN (UNII: Q1LS2UJO3A)  
    WATER (UNII: 059QF0KO0R)  
    HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
    TRIDECYL STEARATE (UNII: A8OE252M6L)  
    POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)  
    POLY(METHYL METHACRYLATE; 450000 MW) (UNII: Z47NNT4J11)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    CERAMIDE NP (UNII: 4370DF050B)  
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    SOYBEAN OIL (UNII: 241ATL177A)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    MAGNESIUM CHLORIDE (UNII: 02F3473H9O)  
    POTASSIUM CHLORIDE (UNII: 660YQ98I10)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    WINE GRAPE (UNII: 3GOV20705G)  
    .BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)  
    LIMONENE, (+)- (UNII: GFD7C86Q1W)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)  
    LINALOOL, (+/-)- (UNII: D81QY6I88E)  
    .ALPHA.-AMYLCINNAMALDEHYDE (UNII: WC51CA3418)  
    MICA (UNII: V8A1AW0880)  
    D&C RED NO. 30 (UNII: 2S42T2808B)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    D&C RED NO. 21 (UNII: 08744Z6JNY)  
    D&C RED NO. 27 (UNII: 2LRS185U6K)  
    D&C RED NO. 7 (UNII: ECW0LZ41X8)  
    TALC (UNII: 7SEV7J4R1U)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:13537-477-021 in 1 BOX11/09/2016
    1NDC:13537-477-014 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35211/09/2016
    ESIKA HYDRACOLOR 2 IN 1 HIGHLY MOISTURIZING AND COLORING SPF 25   (ROSA DULZURA) - PINK
    octinoxate and oxybenzone lipstick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13537-478
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE0.0664 g  in 1 g
    OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE0.0151 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW)  
    TRIDECYL TRIMELLITATE (UNII: FY36J270ES)  
    ETHYLHEXYL PALMITATE (UNII: 2865993309)  
    CERESIN (UNII: Q1LS2UJO3A)  
    WATER (UNII: 059QF0KO0R)  
    HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
    TRIDECYL STEARATE (UNII: A8OE252M6L)  
    POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)  
    POLY(METHYL METHACRYLATE; 450000 MW) (UNII: Z47NNT4J11)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    CERAMIDE NP (UNII: 4370DF050B)  
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    SOYBEAN OIL (UNII: 241ATL177A)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    MAGNESIUM CHLORIDE (UNII: 02F3473H9O)  
    POTASSIUM CHLORIDE (UNII: 660YQ98I10)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    WINE GRAPE (UNII: 3GOV20705G)  
    .BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)  
    LIMONENE, (+)- (UNII: GFD7C86Q1W)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)  
    LINALOOL, (+/-)- (UNII: D81QY6I88E)  
    .ALPHA.-AMYLCINNAMALDEHYDE (UNII: WC51CA3418)  
    MICA (UNII: V8A1AW0880)  
    D&C RED NO. 30 (UNII: 2S42T2808B)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    D&C RED NO. 21 (UNII: 08744Z6JNY)  
    D&C RED NO. 27 (UNII: 2LRS185U6K)  
    D&C RED NO. 7 (UNII: ECW0LZ41X8)  
    TALC (UNII: 7SEV7J4R1U)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:13537-478-021 in 1 BOX11/09/2016
    1NDC:13537-478-014 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35211/09/2016
    ESIKA HYDRACOLOR 2 IN 1 HIGHLY MOISTURIZING AND COLORING SPF 25   (ROJO DESEO) - RED
    octinoxate and oxybenzone lipstick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13537-479
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE0.0664 g  in 1 g
    OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE0.0151 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW)  
    TRIDECYL TRIMELLITATE (UNII: FY36J270ES)  
    ETHYLHEXYL PALMITATE (UNII: 2865993309)  
    CERESIN (UNII: Q1LS2UJO3A)  
    WATER (UNII: 059QF0KO0R)  
    HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
    TRIDECYL STEARATE (UNII: A8OE252M6L)  
    POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)  
    POLY(METHYL METHACRYLATE; 450000 MW) (UNII: Z47NNT4J11)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    CERAMIDE NP (UNII: 4370DF050B)  
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    SOYBEAN OIL (UNII: 241ATL177A)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    MAGNESIUM CHLORIDE (UNII: 02F3473H9O)  
    POTASSIUM CHLORIDE (UNII: 660YQ98I10)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    WINE GRAPE (UNII: 3GOV20705G)  
    .BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)  
    LIMONENE, (+)- (UNII: GFD7C86Q1W)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)  
    LINALOOL, (+/-)- (UNII: D81QY6I88E)  
    .ALPHA.-AMYLCINNAMALDEHYDE (UNII: WC51CA3418)  
    MICA (UNII: V8A1AW0880)  
    D&C RED NO. 30 (UNII: 2S42T2808B)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    D&C RED NO. 21 (UNII: 08744Z6JNY)  
    D&C RED NO. 27 (UNII: 2LRS185U6K)  
    D&C RED NO. 7 (UNII: ECW0LZ41X8)  
    TALC (UNII: 7SEV7J4R1U)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:13537-479-021 in 1 BOX11/09/2016
    1NDC:13537-479-014 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35211/09/2016
    ESIKA HYDRACOLOR 2 IN 1 HIGHLY MOISTURIZING AND COLORING SPF 25   (ROJO INTRIGANTE) - RED
    octinoxate and oxybenzone lipstick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13537-880
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE0.0664 g  in 1 g
    OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE0.0151 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW)  
    TRIDECYL TRIMELLITATE (UNII: FY36J270ES)  
    ETHYLHEXYL PALMITATE (UNII: 2865993309)  
    CERESIN (UNII: Q1LS2UJO3A)  
    WATER (UNII: 059QF0KO0R)  
    HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
    TRIDECYL STEARATE (UNII: A8OE252M6L)  
    POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)  
    POLY(METHYL METHACRYLATE; 450000 MW) (UNII: Z47NNT4J11)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    CERAMIDE NP (UNII: 4370DF050B)  
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    SOYBEAN OIL (UNII: 241ATL177A)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    MAGNESIUM CHLORIDE (UNII: 02F3473H9O)  
    POTASSIUM CHLORIDE (UNII: 660YQ98I10)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    WINE GRAPE (UNII: 3GOV20705G)  
    .BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)  
    LIMONENE, (+)- (UNII: GFD7C86Q1W)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)  
    LINALOOL, (+/-)- (UNII: D81QY6I88E)  
    .ALPHA.-AMYLCINNAMALDEHYDE (UNII: WC51CA3418)  
    MICA (UNII: V8A1AW0880)  
    D&C RED NO. 30 (UNII: 2S42T2808B)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    D&C RED NO. 21 (UNII: 08744Z6JNY)  
    D&C RED NO. 27 (UNII: 2LRS185U6K)  
    D&C RED NO. 7 (UNII: ECW0LZ41X8)  
    TALC (UNII: 7SEV7J4R1U)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:13537-880-021 in 1 BOX11/09/2016
    1NDC:13537-880-014 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35211/09/2016
    ESIKA HYDRACOLOR 2 IN 1 HIGHLY MOISTURIZING AND COLORING SPF 25   (ROJO LUJURIA) - RED
    octinoxate and oxybenzone lipstick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13537-804
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE0.0664 g  in 1 g
    OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE0.0151 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW)  
    TRIDECYL TRIMELLITATE (UNII: FY36J270ES)  
    ETHYLHEXYL PALMITATE (UNII: 2865993309)  
    CERESIN (UNII: Q1LS2UJO3A)  
    WATER (UNII: 059QF0KO0R)  
    HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
    TRIDECYL STEARATE (UNII: A8OE252M6L)  
    POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)  
    POLY(METHYL METHACRYLATE; 450000 MW) (UNII: Z47NNT4J11)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    CERAMIDE NP (UNII: 4370DF050B)  
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    SOYBEAN OIL (UNII: 241ATL177A)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    MAGNESIUM CHLORIDE (UNII: 02F3473H9O)  
    POTASSIUM CHLORIDE (UNII: 660YQ98I10)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    WINE GRAPE (UNII: 3GOV20705G)  
    .BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)  
    LIMONENE, (+)- (UNII: GFD7C86Q1W)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)  
    LINALOOL, (+/-)- (UNII: D81QY6I88E)  
    .ALPHA.-AMYLCINNAMALDEHYDE (UNII: WC51CA3418)  
    MICA (UNII: V8A1AW0880)  
    D&C RED NO. 30 (UNII: 2S42T2808B)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    D&C RED NO. 21 (UNII: 08744Z6JNY)  
    D&C RED NO. 27 (UNII: 2LRS185U6K)  
    D&C RED NO. 7 (UNII: ECW0LZ41X8)  
    TALC (UNII: 7SEV7J4R1U)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:13537-804-021 in 1 BOX11/09/2016
    1NDC:13537-804-014 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35211/09/2016
    ESIKA HYDRACOLOR 2 IN 1 HIGHLY MOISTURIZING AND COLORING SPF 25   (CORAL CHIC) - PINK
    octinoxate and oxybenzone lipstick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13537-805
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE0.0664 g  in 1 g
    OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE0.0151 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW)  
    TRIDECYL TRIMELLITATE (UNII: FY36J270ES)  
    ETHYLHEXYL PALMITATE (UNII: 2865993309)  
    CERESIN (UNII: Q1LS2UJO3A)  
    WATER (UNII: 059QF0KO0R)  
    HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
    TRIDECYL STEARATE (UNII: A8OE252M6L)  
    POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)  
    POLY(METHYL METHACRYLATE; 450000 MW) (UNII: Z47NNT4J11)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    CERAMIDE NP (UNII: 4370DF050B)  
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    SOYBEAN OIL (UNII: 241ATL177A)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    MAGNESIUM CHLORIDE (UNII: 02F3473H9O)  
    POTASSIUM CHLORIDE (UNII: 660YQ98I10)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    WINE GRAPE (UNII: 3GOV20705G)  
    .BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)  
    LIMONENE, (+)- (UNII: GFD7C86Q1W)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)  
    LINALOOL, (+/-)- (UNII: D81QY6I88E)  
    .ALPHA.-AMYLCINNAMALDEHYDE (UNII: WC51CA3418)  
    MICA (UNII: V8A1AW0880)  
    D&C RED NO. 30 (UNII: 2S42T2808B)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    D&C RED NO. 21 (UNII: 08744Z6JNY)  
    D&C RED NO. 27 (UNII: 2LRS185U6K)  
    D&C RED NO. 7 (UNII: ECW0LZ41X8)  
    TALC (UNII: 7SEV7J4R1U)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:13537-805-021 in 1 BOX11/09/2016
    1NDC:13537-805-014 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35211/09/2016
    ESIKA HYDRACOLOR 2 IN 1 HIGHLY MOISTURIZING AND COLORING SPF 25   (ROSA ENCANTO) - PINK
    octinoxate and oxybenzone lipstick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13537-806
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE0.0664 g  in 1 g
    OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE0.0151 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW)  
    TRIDECYL TRIMELLITATE (UNII: FY36J270ES)  
    ETHYLHEXYL PALMITATE (UNII: 2865993309)  
    CERESIN (UNII: Q1LS2UJO3A)  
    WATER (UNII: 059QF0KO0R)  
    HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
    TRIDECYL STEARATE (UNII: A8OE252M6L)  
    POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)  
    POLY(METHYL METHACRYLATE; 450000 MW) (UNII: Z47NNT4J11)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    CERAMIDE NP (UNII: 4370DF050B)  
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    SOYBEAN OIL (UNII: 241ATL177A)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    MAGNESIUM CHLORIDE (UNII: 02F3473H9O)  
    POTASSIUM CHLORIDE (UNII: 660YQ98I10)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    WINE GRAPE (UNII: 3GOV20705G)  
    .BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)  
    LIMONENE, (+)- (UNII: GFD7C86Q1W)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)  
    LINALOOL, (+/-)- (UNII: D81QY6I88E)  
    .ALPHA.-AMYLCINNAMALDEHYDE (UNII: WC51CA3418)  
    MICA (UNII: V8A1AW0880)  
    D&C RED NO. 30 (UNII: 2S42T2808B)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    D&C RED NO. 21 (UNII: 08744Z6JNY)  
    D&C RED NO. 27 (UNII: 2LRS185U6K)  
    D&C RED NO. 7 (UNII: ECW0LZ41X8)  
    TALC (UNII: 7SEV7J4R1U)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:13537-806-021 in 1 BOX11/09/2016
    1NDC:13537-806-014 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35211/09/2016
    ESIKA HYDRACOLOR 2 IN 1 HIGHLY MOISTURIZING AND COLORING SPF 25   (FUCSIA CAUTIVANTE) - PINK
    octinoxate and oxybenzone lipstick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13537-807
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE0.0664 g  in 1 g
    OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE0.0151 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW)  
    TRIDECYL TRIMELLITATE (UNII: FY36J270ES)  
    ETHYLHEXYL PALMITATE (UNII: 2865993309)  
    CERESIN (UNII: Q1LS2UJO3A)  
    WATER (UNII: 059QF0KO0R)  
    HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
    TRIDECYL STEARATE (UNII: A8OE252M6L)  
    POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)  
    POLY(METHYL METHACRYLATE; 450000 MW) (UNII: Z47NNT4J11)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    CERAMIDE NP (UNII: 4370DF050B)  
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    SOYBEAN OIL (UNII: 241ATL177A)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    MAGNESIUM CHLORIDE (UNII: 02F3473H9O)  
    POTASSIUM CHLORIDE (UNII: 660YQ98I10)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    WINE GRAPE (UNII: 3GOV20705G)  
    .BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)  
    LIMONENE, (+)- (UNII: GFD7C86Q1W)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)  
    LINALOOL, (+/-)- (UNII: D81QY6I88E)  
    .ALPHA.-AMYLCINNAMALDEHYDE (UNII: WC51CA3418)  
    MICA (UNII: V8A1AW0880)  
    D&C RED NO. 30 (UNII: 2S42T2808B)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    D&C RED NO. 21 (UNII: 08744Z6JNY)  
    D&C RED NO. 27 (UNII: 2LRS185U6K)  
    D&C RED NO. 7 (UNII: ECW0LZ41X8)  
    TALC (UNII: 7SEV7J4R1U)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:13537-807-021 in 1 BOX11/09/2016
    1NDC:13537-807-014 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35211/09/2016
    ESIKA HYDRACOLOR 2 IN 1 HIGHLY MOISTURIZING AND COLORING SPF 25   (GRANATE SEDUCTOR) - PURPLE
    octinoxate and oxybenzone lipstick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13537-808
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE0.0664 g  in 1 g
    OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE0.0151 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW)  
    TRIDECYL TRIMELLITATE (UNII: FY36J270ES)  
    ETHYLHEXYL PALMITATE (UNII: 2865993309)  
    CERESIN (UNII: Q1LS2UJO3A)  
    WATER (UNII: 059QF0KO0R)  
    HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
    TRIDECYL STEARATE (UNII: A8OE252M6L)  
    POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)  
    POLY(METHYL METHACRYLATE; 450000 MW) (UNII: Z47NNT4J11)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    CERAMIDE NP (UNII: 4370DF050B)  
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    SOYBEAN OIL (UNII: 241ATL177A)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    MAGNESIUM CHLORIDE (UNII: 02F3473H9O)  
    POTASSIUM CHLORIDE (UNII: 660YQ98I10)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    WINE GRAPE (UNII: 3GOV20705G)  
    .BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)  
    LIMONENE, (+)- (UNII: GFD7C86Q1W)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)  
    LINALOOL, (+/-)- (UNII: D81QY6I88E)  
    .ALPHA.-AMYLCINNAMALDEHYDE (UNII: WC51CA3418)  
    MICA (UNII: V8A1AW0880)  
    D&C RED NO. 30 (UNII: 2S42T2808B)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    D&C RED NO. 21 (UNII: 08744Z6JNY)  
    D&C RED NO. 27 (UNII: 2LRS185U6K)  
    D&C RED NO. 7 (UNII: ECW0LZ41X8)  
    TALC (UNII: 7SEV7J4R1U)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:13537-808-021 in 1 BOX11/09/2016
    1NDC:13537-808-014 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35211/09/2016
    ESIKA HYDRACOLOR 2 IN 1 HIGHLY MOISTURIZING AND COLORING SPF 25   (ROSA ROMANTICA) - PINK
    octinoxate and oxybenzone lipstick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13537-809
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE0.0664 g  in 1 g
    OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE0.0151 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW)  
    TRIDECYL TRIMELLITATE (UNII: FY36J270ES)  
    ETHYLHEXYL PALMITATE (UNII: 2865993309)  
    CERESIN (UNII: Q1LS2UJO3A)  
    WATER (UNII: 059QF0KO0R)  
    HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
    TRIDECYL STEARATE (UNII: A8OE252M6L)  
    POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)  
    POLY(METHYL METHACRYLATE; 450000 MW) (UNII: Z47NNT4J11)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    CERAMIDE NP (UNII: 4370DF050B)  
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    SOYBEAN OIL (UNII: 241ATL177A)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    MAGNESIUM CHLORIDE (UNII: 02F3473H9O)  
    POTASSIUM CHLORIDE (UNII: 660YQ98I10)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    WINE GRAPE (UNII: 3GOV20705G)  
    .BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)  
    LIMONENE, (+)- (UNII: GFD7C86Q1W)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)  
    LINALOOL, (+/-)- (UNII: D81QY6I88E)  
    .ALPHA.-AMYLCINNAMALDEHYDE (UNII: WC51CA3418)  
    MICA (UNII: V8A1AW0880)  
    D&C RED NO. 30 (UNII: 2S42T2808B)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    D&C RED NO. 21 (UNII: 08744Z6JNY)  
    D&C RED NO. 27 (UNII: 2LRS185U6K)  
    D&C RED NO. 7 (UNII: ECW0LZ41X8)  
    TALC (UNII: 7SEV7J4R1U)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:13537-809-021 in 1 BOX11/09/2016
    1NDC:13537-809-014 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35211/09/2016
    ESIKA HYDRACOLOR 2 IN 1 HIGHLY MOISTURIZING AND COLORING SPF 25   (NARANJA PRIMAVERA) - ORANGE
    octinoxate and oxybenzone lipstick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13537-810
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE0.0664 g  in 1 g
    OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE0.0151 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW)  
    TRIDECYL TRIMELLITATE (UNII: FY36J270ES)  
    ETHYLHEXYL PALMITATE (UNII: 2865993309)  
    CERESIN (UNII: Q1LS2UJO3A)  
    WATER (UNII: 059QF0KO0R)  
    HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
    TRIDECYL STEARATE (UNII: A8OE252M6L)  
    POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)  
    POLY(METHYL METHACRYLATE; 450000 MW) (UNII: Z47NNT4J11)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    CERAMIDE NP (UNII: 4370DF050B)  
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    SOYBEAN OIL (UNII: 241ATL177A)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    MAGNESIUM CHLORIDE (UNII: 02F3473H9O)  
    POTASSIUM CHLORIDE (UNII: 660YQ98I10)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    WINE GRAPE (UNII: 3GOV20705G)  
    .BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)  
    LIMONENE, (+)- (UNII: GFD7C86Q1W)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)  
    LINALOOL, (+/-)- (UNII: D81QY6I88E)  
    .ALPHA.-AMYLCINNAMALDEHYDE (UNII: WC51CA3418)  
    MICA (UNII: V8A1AW0880)  
    D&C RED NO. 30 (UNII: 2S42T2808B)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    D&C RED NO. 21 (UNII: 08744Z6JNY)  
    D&C RED NO. 27 (UNII: 2LRS185U6K)  
    D&C RED NO. 7 (UNII: ECW0LZ41X8)  
    TALC (UNII: 7SEV7J4R1U)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:13537-810-021 in 1 BOX11/09/2016
    1NDC:13537-810-014 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35211/09/2016
    ESIKA HYDRACOLOR 2 IN 1 HIGHLY MOISTURIZING AND COLORING SPF 25   (FRAMBUESA MANIA) - RED
    octinoxate and oxybenzone lipstick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13537-811
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE0.0664 g  in 1 g
    OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE0.0151 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW)  
    TRIDECYL TRIMELLITATE (UNII: FY36J270ES)  
    ETHYLHEXYL PALMITATE (UNII: 2865993309)  
    CERESIN (UNII: Q1LS2UJO3A)  
    WATER (UNII: 059QF0KO0R)  
    HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
    TRIDECYL STEARATE (UNII: A8OE252M6L)  
    POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)  
    POLY(METHYL METHACRYLATE; 450000 MW) (UNII: Z47NNT4J11)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    CERAMIDE NP (UNII: 4370DF050B)  
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    SOYBEAN OIL (UNII: 241ATL177A)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    MAGNESIUM CHLORIDE (UNII: 02F3473H9O)  
    POTASSIUM CHLORIDE (UNII: 660YQ98I10)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    WINE GRAPE (UNII: 3GOV20705G)  
    .BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)  
    LIMONENE, (+)- (UNII: GFD7C86Q1W)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)  
    LINALOOL, (+/-)- (UNII: D81QY6I88E)  
    .ALPHA.-AMYLCINNAMALDEHYDE (UNII: WC51CA3418)  
    MICA (UNII: V8A1AW0880)  
    D&C RED NO. 30 (UNII: 2S42T2808B)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    D&C RED NO. 21 (UNII: 08744Z6JNY)  
    D&C RED NO. 27 (UNII: 2LRS185U6K)  
    D&C RED NO. 7 (UNII: ECW0LZ41X8)  
    TALC (UNII: 7SEV7J4R1U)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:13537-811-021 in 1 BOX11/09/2016
    1NDC:13537-811-014 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35211/09/2016
    ESIKA HYDRACOLOR 2 IN 1 HIGHLY MOISTURIZING AND COLORING SPF 25   (FRESA COQUETA) - RED
    octinoxate and oxybenzone lipstick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13537-812
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE0.0664 g  in 1 g
    OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE0.0151 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW)  
    TRIDECYL TRIMELLITATE (UNII: FY36J270ES)  
    ETHYLHEXYL PALMITATE (UNII: 2865993309)  
    CERESIN (UNII: Q1LS2UJO3A)  
    WATER (UNII: 059QF0KO0R)  
    HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
    TRIDECYL STEARATE (UNII: A8OE252M6L)  
    POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)  
    POLY(METHYL METHACRYLATE; 450000 MW) (UNII: Z47NNT4J11)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    CERAMIDE NP (UNII: 4370DF050B)  
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    SOYBEAN OIL (UNII: 241ATL177A)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    MAGNESIUM CHLORIDE (UNII: 02F3473H9O)  
    POTASSIUM CHLORIDE (UNII: 660YQ98I10)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    WINE GRAPE (UNII: 3GOV20705G)  
    .BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)  
    LIMONENE, (+)- (UNII: GFD7C86Q1W)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)  
    LINALOOL, (+/-)- (UNII: D81QY6I88E)  
    .ALPHA.-AMYLCINNAMALDEHYDE (UNII: WC51CA3418)  
    MICA (UNII: V8A1AW0880)  
    D&C RED NO. 30 (UNII: 2S42T2808B)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    D&C RED NO. 21 (UNII: 08744Z6JNY)  
    D&C RED NO. 27 (UNII: 2LRS185U6K)  
    D&C RED NO. 7 (UNII: ECW0LZ41X8)  
    TALC (UNII: 7SEV7J4R1U)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:13537-812-021 in 1 BOX11/09/2016
    1NDC:13537-812-014 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35211/09/2016
    ESIKA HYDRACOLOR 2 IN 1 HIGHLY MOISTURIZING AND COLORING SPF 25   (CANELA NUDE) - ORANGE
    octinoxate and oxybenzone lipstick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13537-813
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE0.0664 g  in 1 g
    OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE0.0151 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW)  
    TRIDECYL TRIMELLITATE (UNII: FY36J270ES)  
    ETHYLHEXYL PALMITATE (UNII: 2865993309)  
    CERESIN (UNII: Q1LS2UJO3A)  
    WATER (UNII: 059QF0KO0R)  
    HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
    TRIDECYL STEARATE (UNII: A8OE252M6L)  
    POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)  
    POLY(METHYL METHACRYLATE; 450000 MW) (UNII: Z47NNT4J11)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    CERAMIDE NP (UNII: 4370DF050B)  
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    SOYBEAN OIL (UNII: 241ATL177A)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    MAGNESIUM CHLORIDE (UNII: 02F3473H9O)  
    POTASSIUM CHLORIDE (UNII: 660YQ98I10)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    WINE GRAPE (UNII: 3GOV20705G)  
    .BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)  
    LIMONENE, (+)- (UNII: GFD7C86Q1W)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)  
    LINALOOL, (+/-)- (UNII: D81QY6I88E)  
    .ALPHA.-AMYLCINNAMALDEHYDE (UNII: WC51CA3418)  
    MICA (UNII: V8A1AW0880)  
    D&C RED NO. 30 (UNII: 2S42T2808B)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    D&C RED NO. 21 (UNII: 08744Z6JNY)  
    D&C RED NO. 27 (UNII: 2LRS185U6K)  
    D&C RED NO. 7 (UNII: ECW0LZ41X8)  
    TALC (UNII: 7SEV7J4R1U)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:13537-813-021 in 1 BOX11/09/2016
    1NDC:13537-813-014 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35211/09/2016
    ESIKA HYDRACOLOR 2 IN 1 HIGHLY MOISTURIZING AND COLORING SPF 25   (MORA GLAM) - BROWN
    octinoxate and oxybenzone lipstick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13537-814
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE0.0664 g  in 1 g
    OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE0.0151 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW)  
    TRIDECYL TRIMELLITATE (UNII: FY36J270ES)  
    ETHYLHEXYL PALMITATE (UNII: 2865993309)  
    CERESIN (UNII: Q1LS2UJO3A)  
    WATER (UNII: 059QF0KO0R)  
    HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
    TRIDECYL STEARATE (UNII: A8OE252M6L)  
    POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)  
    POLY(METHYL METHACRYLATE; 450000 MW) (UNII: Z47NNT4J11)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    CERAMIDE NP (UNII: 4370DF050B)  
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    SOYBEAN OIL (UNII: 241ATL177A)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    MAGNESIUM CHLORIDE (UNII: 02F3473H9O)  
    POTASSIUM CHLORIDE (UNII: 660YQ98I10)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    WINE GRAPE (UNII: 3GOV20705G)  
    .BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)  
    LIMONENE, (+)- (UNII: GFD7C86Q1W)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)  
    LINALOOL, (+/-)- (UNII: D81QY6I88E)  
    .ALPHA.-AMYLCINNAMALDEHYDE (UNII: WC51CA3418)  
    MICA (UNII: V8A1AW0880)  
    D&C RED NO. 30 (UNII: 2S42T2808B)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    D&C RED NO. 21 (UNII: 08744Z6JNY)  
    D&C RED NO. 27 (UNII: 2LRS185U6K)  
    D&C RED NO. 7 (UNII: ECW0LZ41X8)  
    TALC (UNII: 7SEV7J4R1U)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:13537-814-021 in 1 BOX11/09/2016
    1NDC:13537-814-014 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35211/09/2016
    ESIKA HYDRACOLOR 2 IN 1 HIGHLY MOISTURIZING AND COLORING SPF 25   (CORAL INTENSE) - RED
    octinoxate and oxybenzone lipstick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13537-815
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE0.0664 g  in 1 g
    OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE0.0151 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW)  
    TRIDECYL TRIMELLITATE (UNII: FY36J270ES)  
    ETHYLHEXYL PALMITATE (UNII: 2865993309)  
    CERESIN (UNII: Q1LS2UJO3A)  
    WATER (UNII: 059QF0KO0R)  
    HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
    TRIDECYL STEARATE (UNII: A8OE252M6L)  
    POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)  
    POLY(METHYL METHACRYLATE; 450000 MW) (UNII: Z47NNT4J11)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    CERAMIDE NP (UNII: 4370DF050B)  
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    SOYBEAN OIL (UNII: 241ATL177A)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    MAGNESIUM CHLORIDE (UNII: 02F3473H9O)  
    POTASSIUM CHLORIDE (UNII: 660YQ98I10)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    WINE GRAPE (UNII: 3GOV20705G)  
    .BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)  
    LIMONENE, (+)- (UNII: GFD7C86Q1W)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)  
    LINALOOL, (+/-)- (UNII: D81QY6I88E)  
    .ALPHA.-AMYLCINNAMALDEHYDE (UNII: WC51CA3418)  
    MICA (UNII: V8A1AW0880)  
    D&C RED NO. 30 (UNII: 2S42T2808B)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    D&C RED NO. 21 (UNII: 08744Z6JNY)  
    D&C RED NO. 27 (UNII: 2LRS185U6K)  
    D&C RED NO. 7 (UNII: ECW0LZ41X8)  
    TALC (UNII: 7SEV7J4R1U)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:13537-815-021 in 1 BOX11/09/2016
    1NDC:13537-815-014 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35211/09/2016
    ESIKA HYDRACOLOR 2 IN 1 HIGHLY MOISTURIZING AND COLORING SPF 25   (ROSA GEOMETRIC) - PINK
    octinoxate and oxybenzone lipstick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13537-816
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE0.0664 g  in 1 g
    OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE0.0151 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW)  
    TRIDECYL TRIMELLITATE (UNII: FY36J270ES)  
    ETHYLHEXYL PALMITATE (UNII: 2865993309)  
    CERESIN (UNII: Q1LS2UJO3A)  
    WATER (UNII: 059QF0KO0R)  
    HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
    TRIDECYL STEARATE (UNII: A8OE252M6L)  
    POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)  
    POLY(METHYL METHACRYLATE; 450000 MW) (UNII: Z47NNT4J11)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    CERAMIDE NP (UNII: 4370DF050B)  
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    SOYBEAN OIL (UNII: 241ATL177A)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    MAGNESIUM CHLORIDE (UNII: 02F3473H9O)  
    POTASSIUM CHLORIDE (UNII: 660YQ98I10)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    WINE GRAPE (UNII: 3GOV20705G)  
    .BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)  
    LIMONENE, (+)- (UNII: GFD7C86Q1W)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)  
    LINALOOL, (+/-)- (UNII: D81QY6I88E)  
    .ALPHA.-AMYLCINNAMALDEHYDE (UNII: WC51CA3418)  
    MICA (UNII: V8A1AW0880)  
    D&C RED NO. 30 (UNII: 2S42T2808B)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    D&C RED NO. 21 (UNII: 08744Z6JNY)  
    D&C RED NO. 27 (UNII: 2LRS185U6K)  
    D&C RED NO. 7 (UNII: ECW0LZ41X8)  
    TALC (UNII: 7SEV7J4R1U)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:13537-816-021 in 1 BOX11/09/2016
    1NDC:13537-816-014 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35211/09/2016
    ESIKA HYDRACOLOR 2 IN 1 HIGHLY MOISTURIZING AND COLORING SPF 25   (FUCSIA PRISMA) - RED
    octinoxate and oxybenzone lipstick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13537-817
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE0.0664 g  in 1 g
    OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE0.0151 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW)  
    TRIDECYL TRIMELLITATE (UNII: FY36J270ES)  
    ETHYLHEXYL PALMITATE (UNII: 2865993309)  
    CERESIN (UNII: Q1LS2UJO3A)  
    WATER (UNII: 059QF0KO0R)  
    HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
    TRIDECYL STEARATE (UNII: A8OE252M6L)  
    POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)  
    POLY(METHYL METHACRYLATE; 450000 MW) (UNII: Z47NNT4J11)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    CERAMIDE NP (UNII: 4370DF050B)  
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    SOYBEAN OIL (UNII: 241ATL177A)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    MAGNESIUM CHLORIDE (UNII: 02F3473H9O)  
    POTASSIUM CHLORIDE (UNII: 660YQ98I10)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    WINE GRAPE (UNII: 3GOV20705G)  
    .BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)  
    LIMONENE, (+)- (UNII: GFD7C86Q1W)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)  
    LINALOOL, (+/-)- (UNII: D81QY6I88E)  
    .ALPHA.-AMYLCINNAMALDEHYDE (UNII: WC51CA3418)  
    MICA (UNII: V8A1AW0880)  
    D&C RED NO. 30 (UNII: 2S42T2808B)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    D&C RED NO. 21 (UNII: 08744Z6JNY)  
    D&C RED NO. 27 (UNII: 2LRS185U6K)  
    D&C RED NO. 7 (UNII: ECW0LZ41X8)  
    TALC (UNII: 7SEV7J4R1U)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:13537-817-021 in 1 BOX11/09/2016
    1NDC:13537-817-014 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35211/09/2016
    ESIKA HYDRACOLOR 2 IN 1 HIGHLY MOISTURIZING AND COLORING SPF 25   (NARANJA ESFERA) - ORANGE
    octinoxate and oxybenzone lipstick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13537-818
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE0.0664 g  in 1 g
    OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE0.0151 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW)  
    TRIDECYL TRIMELLITATE (UNII: FY36J270ES)  
    ETHYLHEXYL PALMITATE (UNII: 2865993309)  
    CERESIN (UNII: Q1LS2UJO3A)  
    WATER (UNII: 059QF0KO0R)  
    HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
    TRIDECYL STEARATE (UNII: A8OE252M6L)  
    POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)  
    POLY(METHYL METHACRYLATE; 450000 MW) (UNII: Z47NNT4J11)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    CERAMIDE NP (UNII: 4370DF050B)  
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    SOYBEAN OIL (UNII: 241ATL177A)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    MAGNESIUM CHLORIDE (UNII: 02F3473H9O)  
    POTASSIUM CHLORIDE (UNII: 660YQ98I10)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    WINE GRAPE (UNII: 3GOV20705G)  
    .BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)  
    LIMONENE, (+)- (UNII: GFD7C86Q1W)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)  
    LINALOOL, (+/-)- (UNII: D81QY6I88E)  
    .ALPHA.-AMYLCINNAMALDEHYDE (UNII: WC51CA3418)  
    MICA (UNII: V8A1AW0880)  
    D&C RED NO. 30 (UNII: 2S42T2808B)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    D&C RED NO. 21 (UNII: 08744Z6JNY)  
    D&C RED NO. 27 (UNII: 2LRS185U6K)  
    D&C RED NO. 7 (UNII: ECW0LZ41X8)  
    TALC (UNII: 7SEV7J4R1U)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:13537-818-021 in 1 BOX11/09/2016
    1NDC:13537-818-014 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35211/09/2016
    ESIKA HYDRACOLOR 2 IN 1 HIGHLY MOISTURIZING AND COLORING SPF 25   (NUDE INFINITO) - BROWN
    octinoxate and oxybenzone lipstick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13537-819
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE0.0664 g  in 1 g
    OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE0.0151 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW)  
    TRIDECYL TRIMELLITATE (UNII: FY36J270ES)  
    ETHYLHEXYL PALMITATE (UNII: 2865993309)  
    CERESIN (UNII: Q1LS2UJO3A)  
    WATER (UNII: 059QF0KO0R)  
    HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
    TRIDECYL STEARATE (UNII: A8OE252M6L)  
    POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)  
    POLY(METHYL METHACRYLATE; 450000 MW) (UNII: Z47NNT4J11)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    CERAMIDE NP (UNII: 4370DF050B)  
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    SOYBEAN OIL (UNII: 241ATL177A)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    MAGNESIUM CHLORIDE (UNII: 02F3473H9O)  
    POTASSIUM CHLORIDE (UNII: 660YQ98I10)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    WINE GRAPE (UNII: 3GOV20705G)  
    .BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)  
    LIMONENE, (+)- (UNII: GFD7C86Q1W)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)  
    LINALOOL, (+/-)- (UNII: D81QY6I88E)  
    .ALPHA.-AMYLCINNAMALDEHYDE (UNII: WC51CA3418)  
    MICA (UNII: V8A1AW0880)  
    D&C RED NO. 30 (UNII: 2S42T2808B)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    D&C RED NO. 21 (UNII: 08744Z6JNY)  
    D&C RED NO. 27 (UNII: 2LRS185U6K)  
    D&C RED NO. 7 (UNII: ECW0LZ41X8)  
    TALC (UNII: 7SEV7J4R1U)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:13537-819-021 in 1 BOX11/09/2016
    1NDC:13537-819-014 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35211/09/2016
    ESIKA HYDRACOLOR 2 IN 1 HIGHLY MOISTURIZING AND COLORING SPF 25   (ROJO ESIKA) - RED
    octinoxate and oxybenzone lipstick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13537-820
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE0.0664 g  in 1 g
    OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE0.0151 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW)  
    TRIDECYL TRIMELLITATE (UNII: FY36J270ES)  
    ETHYLHEXYL PALMITATE (UNII: 2865993309)  
    CERESIN (UNII: Q1LS2UJO3A)  
    WATER (UNII: 059QF0KO0R)  
    HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
    TRIDECYL STEARATE (UNII: A8OE252M6L)  
    POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)  
    POLY(METHYL METHACRYLATE; 450000 MW) (UNII: Z47NNT4J11)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    CERAMIDE NP (UNII: 4370DF050B)  
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    SOYBEAN OIL (UNII: 241ATL177A)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    MAGNESIUM CHLORIDE (UNII: 02F3473H9O)  
    POTASSIUM CHLORIDE (UNII: 660YQ98I10)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    WINE GRAPE (UNII: 3GOV20705G)  
    .BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)  
    LIMONENE, (+)- (UNII: GFD7C86Q1W)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)  
    LINALOOL, (+/-)- (UNII: D81QY6I88E)  
    .ALPHA.-AMYLCINNAMALDEHYDE (UNII: WC51CA3418)  
    MICA (UNII: V8A1AW0880)  
    D&C RED NO. 30 (UNII: 2S42T2808B)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    D&C RED NO. 21 (UNII: 08744Z6JNY)  
    D&C RED NO. 27 (UNII: 2LRS185U6K)  
    D&C RED NO. 7 (UNII: ECW0LZ41X8)  
    TALC (UNII: 7SEV7J4R1U)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:13537-820-021 in 1 BOX11/09/2016
    1NDC:13537-820-014 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35211/09/2016
    ESIKA HYDRACOLOR 2 IN 1 HIGHLY MOISTURIZING AND COLORING SPF 25   (MARRON TOPACIO) - BROWN
    octinoxate and oxybenzone lipstick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13537-821
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE0.0664 g  in 1 g
    OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE0.0151 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW)  
    TRIDECYL TRIMELLITATE (UNII: FY36J270ES)  
    ETHYLHEXYL PALMITATE (UNII: 2865993309)  
    CERESIN (UNII: Q1LS2UJO3A)  
    WATER (UNII: 059QF0KO0R)  
    HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
    TRIDECYL STEARATE (UNII: A8OE252M6L)  
    POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)  
    POLY(METHYL METHACRYLATE; 450000 MW) (UNII: Z47NNT4J11)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    CERAMIDE NP (UNII: 4370DF050B)  
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    SOYBEAN OIL (UNII: 241ATL177A)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    MAGNESIUM CHLORIDE (UNII: 02F3473H9O)  
    POTASSIUM CHLORIDE (UNII: 660YQ98I10)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    WINE GRAPE (UNII: 3GOV20705G)  
    .BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)  
    LIMONENE, (+)- (UNII: GFD7C86Q1W)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)  
    LINALOOL, (+/-)- (UNII: D81QY6I88E)  
    .ALPHA.-AMYLCINNAMALDEHYDE (UNII: WC51CA3418)  
    MICA (UNII: V8A1AW0880)  
    D&C RED NO. 30 (UNII: 2S42T2808B)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    D&C RED NO. 21 (UNII: 08744Z6JNY)  
    D&C RED NO. 27 (UNII: 2LRS185U6K)  
    D&C RED NO. 7 (UNII: ECW0LZ41X8)  
    TALC (UNII: 7SEV7J4R1U)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:13537-821-021 in 1 BOX11/09/2016
    1NDC:13537-821-014 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35211/09/2016
    ESIKA HYDRACOLOR 2 IN 1 HIGHLY MOISTURIZING AND COLORING SPF 25   (CORAL CUARZO) - ORANGE
    octinoxate and oxybenzone lipstick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13537-822
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE0.0664 g  in 1 g
    OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE0.0151 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW)  
    TRIDECYL TRIMELLITATE (UNII: FY36J270ES)  
    ETHYLHEXYL PALMITATE (UNII: 2865993309)  
    CERESIN (UNII: Q1LS2UJO3A)  
    WATER (UNII: 059QF0KO0R)  
    HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
    TRIDECYL STEARATE (UNII: A8OE252M6L)  
    POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)  
    POLY(METHYL METHACRYLATE; 450000 MW) (UNII: Z47NNT4J11)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    CERAMIDE NP (UNII: 4370DF050B)  
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    SOYBEAN OIL (UNII: 241ATL177A)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    MAGNESIUM CHLORIDE (UNII: 02F3473H9O)  
    POTASSIUM CHLORIDE (UNII: 660YQ98I10)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    WINE GRAPE (UNII: 3GOV20705G)  
    .BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)  
    LIMONENE, (+)- (UNII: GFD7C86Q1W)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)  
    LINALOOL, (+/-)- (UNII: D81QY6I88E)  
    .ALPHA.-AMYLCINNAMALDEHYDE (UNII: WC51CA3418)  
    MICA (UNII: V8A1AW0880)  
    D&C RED NO. 30 (UNII: 2S42T2808B)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    D&C RED NO. 21 (UNII: 08744Z6JNY)  
    D&C RED NO. 27 (UNII: 2LRS185U6K)  
    D&C RED NO. 7 (UNII: ECW0LZ41X8)  
    TALC (UNII: 7SEV7J4R1U)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:13537-822-021 in 1 BOX11/09/2016
    1NDC:13537-822-014 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35211/09/2016
    ESIKA HYDRACOLOR 2 IN 1 HIGHLY MOISTURIZING AND COLORING SPF 25   (FUCSIA AMATISTA) - PINK
    octinoxate and oxybenzone lipstick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13537-823
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE0.0664 g  in 1 g
    OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE0.0151 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW)  
    TRIDECYL TRIMELLITATE (UNII: FY36J270ES)  
    ETHYLHEXYL PALMITATE (UNII: 2865993309)  
    CERESIN (UNII: Q1LS2UJO3A)  
    WATER (UNII: 059QF0KO0R)  
    HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
    TRIDECYL STEARATE (UNII: A8OE252M6L)  
    POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)  
    POLY(METHYL METHACRYLATE; 450000 MW) (UNII: Z47NNT4J11)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    CERAMIDE NP (UNII: 4370DF050B)  
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    SOYBEAN OIL (UNII: 241ATL177A)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    MAGNESIUM CHLORIDE (UNII: 02F3473H9O)  
    POTASSIUM CHLORIDE (UNII: 660YQ98I10)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    WINE GRAPE (UNII: 3GOV20705G)  
    .BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)  
    LIMONENE, (+)- (UNII: GFD7C86Q1W)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)  
    LINALOOL, (+/-)- (UNII: D81QY6I88E)  
    .ALPHA.-AMYLCINNAMALDEHYDE (UNII: WC51CA3418)  
    MICA (UNII: V8A1AW0880)  
    D&C RED NO. 30 (UNII: 2S42T2808B)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    D&C RED NO. 21 (UNII: 08744Z6JNY)  
    D&C RED NO. 27 (UNII: 2LRS185U6K)  
    D&C RED NO. 7 (UNII: ECW0LZ41X8)  
    TALC (UNII: 7SEV7J4R1U)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:13537-823-021 in 1 BOX11/09/2016
    1NDC:13537-823-014 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35211/09/2016
    ESIKA HYDRACOLOR 2 IN 1 HIGHLY MOISTURIZING AND COLORING SPF 25   (NUDE PRISMA) - ORANGE
    octinoxate and oxybenzone lipstick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13537-824
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE0.0664 g  in 1 g
    OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE0.0151 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW)  
    TRIDECYL TRIMELLITATE (UNII: FY36J270ES)  
    ETHYLHEXYL PALMITATE (UNII: 2865993309)  
    CERESIN (UNII: Q1LS2UJO3A)  
    WATER (UNII: 059QF0KO0R)  
    HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
    TRIDECYL STEARATE (UNII: A8OE252M6L)  
    POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)  
    POLY(METHYL METHACRYLATE; 450000 MW) (UNII: Z47NNT4J11)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    CERAMIDE NP (UNII: 4370DF050B)  
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    SOYBEAN OIL (UNII: 241ATL177A)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    MAGNESIUM CHLORIDE (UNII: 02F3473H9O)  
    POTASSIUM CHLORIDE (UNII: 660YQ98I10)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    WINE GRAPE (UNII: 3GOV20705G)  
    .BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)  
    LIMONENE, (+)- (UNII: GFD7C86Q1W)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)  
    LINALOOL, (+/-)- (UNII: D81QY6I88E)  
    .ALPHA.-AMYLCINNAMALDEHYDE (UNII: WC51CA3418)  
    MICA (UNII: V8A1AW0880)  
    D&C RED NO. 30 (UNII: 2S42T2808B)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    D&C RED NO. 21 (UNII: 08744Z6JNY)  
    D&C RED NO. 27 (UNII: 2LRS185U6K)  
    D&C RED NO. 7 (UNII: ECW0LZ41X8)  
    TALC (UNII: 7SEV7J4R1U)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:13537-824-021 in 1 BOX11/09/2016
    1NDC:13537-824-014 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35211/09/2016
    ESIKA HYDRACOLOR 2 IN 1 HIGHLY MOISTURIZING AND COLORING SPF 25   (DORADO ESENCIAL) - YELLOW
    octinoxate and oxybenzone lipstick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13537-825
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE0.0664 g  in 1 g
    OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE0.0151 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW)  
    TRIDECYL TRIMELLITATE (UNII: FY36J270ES)  
    ETHYLHEXYL PALMITATE (UNII: 2865993309)  
    CERESIN (UNII: Q1LS2UJO3A)  
    WATER (UNII: 059QF0KO0R)  
    HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
    TRIDECYL STEARATE (UNII: A8OE252M6L)  
    POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)  
    POLY(METHYL METHACRYLATE; 450000 MW) (UNII: Z47NNT4J11)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    CERAMIDE NP (UNII: 4370DF050B)  
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    SOYBEAN OIL (UNII: 241ATL177A)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    MAGNESIUM CHLORIDE (UNII: 02F3473H9O)  
    POTASSIUM CHLORIDE (UNII: 660YQ98I10)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    WINE GRAPE (UNII: 3GOV20705G)  
    .BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)  
    LIMONENE, (+)- (UNII: GFD7C86Q1W)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)  
    LINALOOL, (+/-)- (UNII: D81QY6I88E)  
    .ALPHA.-AMYLCINNAMALDEHYDE (UNII: WC51CA3418)  
    MICA (UNII: V8A1AW0880)  
    D&C RED NO. 30 (UNII: 2S42T2808B)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    D&C RED NO. 21 (UNII: 08744Z6JNY)  
    D&C RED NO. 27 (UNII: 2LRS185U6K)  
    D&C RED NO. 7 (UNII: ECW0LZ41X8)  
    TALC (UNII: 7SEV7J4R1U)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:13537-825-021 in 1 BOX11/09/2016
    1NDC:13537-825-014 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35211/09/2016
    ESIKA HYDRACOLOR 2 IN 1 HIGHLY MOISTURIZING AND COLORING SPF 25   (ROSA ENCANTO FEMME) - PINK
    octinoxate and oxybenzone lipstick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13537-826
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE0.0664 g  in 1 g
    OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE0.0151 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW)  
    TRIDECYL TRIMELLITATE (UNII: FY36J270ES)  
    ETHYLHEXYL PALMITATE (UNII: 2865993309)  
    CERESIN (UNII: Q1LS2UJO3A)  
    WATER (UNII: 059QF0KO0R)  
    HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
    TRIDECYL STEARATE (UNII: A8OE252M6L)  
    POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)  
    POLY(METHYL METHACRYLATE; 450000 MW) (UNII: Z47NNT4J11)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    CERAMIDE NP (UNII: 4370DF050B)  
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    SOYBEAN OIL (UNII: 241ATL177A)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    MAGNESIUM CHLORIDE (UNII: 02F3473H9O)  
    POTASSIUM CHLORIDE (UNII: 660YQ98I10)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    WINE GRAPE (UNII: 3GOV20705G)  
    .BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)  
    LIMONENE, (+)- (UNII: GFD7C86Q1W)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)  
    LINALOOL, (+/-)- (UNII: D81QY6I88E)  
    .ALPHA.-AMYLCINNAMALDEHYDE (UNII: WC51CA3418)  
    MICA (UNII: V8A1AW0880)  
    D&C RED NO. 30 (UNII: 2S42T2808B)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    D&C RED NO. 21 (UNII: 08744Z6JNY)  
    D&C RED NO. 27 (UNII: 2LRS185U6K)  
    D&C RED NO. 7 (UNII: ECW0LZ41X8)  
    TALC (UNII: 7SEV7J4R1U)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:13537-826-021 in 1 BOX11/09/2016
    1NDC:13537-826-014 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35211/09/2016
    ESIKA HYDRACOLOR 2 IN 1 HIGHLY MOISTURIZING AND COLORING SPF 25   (PIMIENTA CALIENTE FEMME) - RED
    octinoxate and oxybenzone lipstick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13537-827
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE0.0664 g  in 1 g
    OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE0.0151 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW)  
    TRIDECYL TRIMELLITATE (UNII: FY36J270ES)  
    ETHYLHEXYL PALMITATE (UNII: 2865993309)  
    CERESIN (UNII: Q1LS2UJO3A)  
    WATER (UNII: 059QF0KO0R)  
    HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
    TRIDECYL STEARATE (UNII: A8OE252M6L)  
    POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)  
    POLY(METHYL METHACRYLATE; 450000 MW) (UNII: Z47NNT4J11)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    CERAMIDE NP (UNII: 4370DF050B)  
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    SOYBEAN OIL (UNII: 241ATL177A)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    MAGNESIUM CHLORIDE (UNII: 02F3473H9O)  
    POTASSIUM CHLORIDE (UNII: 660YQ98I10)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    WINE GRAPE (UNII: 3GOV20705G)  
    .BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)  
    LIMONENE, (+)- (UNII: GFD7C86Q1W)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)  
    LINALOOL, (+/-)- (UNII: D81QY6I88E)  
    .ALPHA.-AMYLCINNAMALDEHYDE (UNII: WC51CA3418)  
    MICA (UNII: V8A1AW0880)  
    D&C RED NO. 30 (UNII: 2S42T2808B)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    D&C RED NO. 21 (UNII: 08744Z6JNY)  
    D&C RED NO. 27 (UNII: 2LRS185U6K)  
    D&C RED NO. 7 (UNII: ECW0LZ41X8)  
    TALC (UNII: 7SEV7J4R1U)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:13537-827-021 in 1 BOX11/09/2016
    1NDC:13537-827-014 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35211/09/2016
    ESIKA HYDRACOLOR 2 IN 1 HIGHLY MOISTURIZING AND COLORING SPF 25   (GRANATE SEDUCTOR FEMME) - PURPLE
    octinoxate and oxybenzone lipstick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13537-828
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE0.0664 g  in 1 g
    OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE0.0151 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW)  
    TRIDECYL TRIMELLITATE (UNII: FY36J270ES)  
    ETHYLHEXYL PALMITATE (UNII: 2865993309)  
    CERESIN (UNII: Q1LS2UJO3A)  
    WATER (UNII: 059QF0KO0R)  
    HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
    TRIDECYL STEARATE (UNII: A8OE252M6L)  
    POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)  
    POLY(METHYL METHACRYLATE; 450000 MW) (UNII: Z47NNT4J11)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    CERAMIDE NP (UNII: 4370DF050B)  
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    SOYBEAN OIL (UNII: 241ATL177A)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    MAGNESIUM CHLORIDE (UNII: 02F3473H9O)  
    POTASSIUM CHLORIDE (UNII: 660YQ98I10)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    WINE GRAPE (UNII: 3GOV20705G)  
    .BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)  
    LIMONENE, (+)- (UNII: GFD7C86Q1W)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)  
    LINALOOL, (+/-)- (UNII: D81QY6I88E)  
    .ALPHA.-AMYLCINNAMALDEHYDE (UNII: WC51CA3418)  
    MICA (UNII: V8A1AW0880)  
    D&C RED NO. 30 (UNII: 2S42T2808B)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    D&C RED NO. 21 (UNII: 08744Z6JNY)  
    D&C RED NO. 27 (UNII: 2LRS185U6K)  
    D&C RED NO. 7 (UNII: ECW0LZ41X8)  
    TALC (UNII: 7SEV7J4R1U)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:13537-828-021 in 1 BOX11/09/2016
    1NDC:13537-828-014 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35211/09/2016
    ESIKA HYDRACOLOR 2 IN 1 HIGHLY MOISTURIZING AND COLORING SPF 25   (ROSA ROMANTICA FEMME) - PINK
    octinoxate and oxybenzone lipstick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13537-829
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE0.0664 g  in 1 g
    OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE0.0151 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW)  
    TRIDECYL TRIMELLITATE (UNII: FY36J270ES)  
    ETHYLHEXYL PALMITATE (UNII: 2865993309)  
    CERESIN (UNII: Q1LS2UJO3A)  
    WATER (UNII: 059QF0KO0R)  
    HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
    TRIDECYL STEARATE (UNII: A8OE252M6L)  
    POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)  
    POLY(METHYL METHACRYLATE; 450000 MW) (UNII: Z47NNT4J11)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    CERAMIDE NP (UNII: 4370DF050B)  
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    SOYBEAN OIL (UNII: 241ATL177A)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    MAGNESIUM CHLORIDE (UNII: 02F3473H9O)  
    POTASSIUM CHLORIDE (UNII: 660YQ98I10)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    WINE GRAPE (UNII: 3GOV20705G)  
    .BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)  
    LIMONENE, (+)- (UNII: GFD7C86Q1W)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)  
    LINALOOL, (+/-)- (UNII: D81QY6I88E)  
    .ALPHA.-AMYLCINNAMALDEHYDE (UNII: WC51CA3418)  
    MICA (UNII: V8A1AW0880)  
    D&C RED NO. 30 (UNII: 2S42T2808B)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    D&C RED NO. 21 (UNII: 08744Z6JNY)  
    D&C RED NO. 27 (UNII: 2LRS185U6K)  
    D&C RED NO. 7 (UNII: ECW0LZ41X8)  
    TALC (UNII: 7SEV7J4R1U)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:13537-829-021 in 1 BOX11/09/2016
    1NDC:13537-829-014 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35211/09/2016
    ESIKA HYDRACOLOR 2 IN 1 HIGHLY MOISTURIZING AND COLORING SPF 25   (FUCSIA CAUTIVANTE FEMME) - PINK
    octinoxate and oxybenzone lipstick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13537-830
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE0.0664 g  in 1 g
    OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE0.0151 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW)  
    TRIDECYL TRIMELLITATE (UNII: FY36J270ES)  
    ETHYLHEXYL PALMITATE (UNII: 2865993309)  
    CERESIN (UNII: Q1LS2UJO3A)  
    WATER (UNII: 059QF0KO0R)  
    HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
    TRIDECYL STEARATE (UNII: A8OE252M6L)  
    POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)  
    POLY(METHYL METHACRYLATE; 450000 MW) (UNII: Z47NNT4J11)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    CERAMIDE NP (UNII: 4370DF050B)  
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    SOYBEAN OIL (UNII: 241ATL177A)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    MAGNESIUM CHLORIDE (UNII: 02F3473H9O)  
    POTASSIUM CHLORIDE (UNII: 660YQ98I10)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    WINE GRAPE (UNII: 3GOV20705G)  
    .BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)  
    LIMONENE, (+)- (UNII: GFD7C86Q1W)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)  
    LINALOOL, (+/-)- (UNII: D81QY6I88E)  
    .ALPHA.-AMYLCINNAMALDEHYDE (UNII: WC51CA3418)  
    MICA (UNII: V8A1AW0880)  
    D&C RED NO. 30 (UNII: 2S42T2808B)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    D&C RED NO. 21 (UNII: 08744Z6JNY)  
    D&C RED NO. 27 (UNII: 2LRS185U6K)  
    D&C RED NO. 7 (UNII: ECW0LZ41X8)  
    TALC (UNII: 7SEV7J4R1U)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:13537-830-021 in 1 BOX11/09/2016
    1NDC:13537-830-014 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35211/09/2016
    ESIKA HYDRACOLOR 2 IN 1 HIGHLY MOISTURIZING AND COLORING SPF 25   (ROJO INTRIGANTE FEMME) - RED
    octinoxate and oxybenzone lipstick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13537-831
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE0.0664 g  in 1 g
    OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE0.0151 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW)  
    TRIDECYL TRIMELLITATE (UNII: FY36J270ES)  
    ETHYLHEXYL PALMITATE (UNII: 2865993309)  
    CERESIN (UNII: Q1LS2UJO3A)  
    WATER (UNII: 059QF0KO0R)  
    HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
    TRIDECYL STEARATE (UNII: A8OE252M6L)  
    POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)  
    POLY(METHYL METHACRYLATE; 450000 MW) (UNII: Z47NNT4J11)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    CERAMIDE NP (UNII: 4370DF050B)  
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    SOYBEAN OIL (UNII: 241ATL177A)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    MAGNESIUM CHLORIDE (UNII: 02F3473H9O)  
    POTASSIUM CHLORIDE (UNII: 660YQ98I10)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    WINE GRAPE (UNII: 3GOV20705G)  
    .BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)  
    LIMONENE, (+)- (UNII: GFD7C86Q1W)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)  
    LINALOOL, (+/-)- (UNII: D81QY6I88E)  
    .ALPHA.-AMYLCINNAMALDEHYDE (UNII: WC51CA3418)  
    MICA (UNII: V8A1AW0880)  
    D&C RED NO. 30 (UNII: 2S42T2808B)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    D&C RED NO. 21 (UNII: 08744Z6JNY)  
    D&C RED NO. 27 (UNII: 2LRS185U6K)  
    D&C RED NO. 7 (UNII: ECW0LZ41X8)  
    TALC (UNII: 7SEV7J4R1U)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:13537-831-021 in 1 BOX11/09/2016
    1NDC:13537-831-014 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35211/09/2016
    ESIKA HYDRACOLOR 2 IN 1 HIGHLY MOISTURIZING AND COLORING SPF 25   (PIMIENTA CALIENTE EXOTIC) - RED
    octinoxate and oxybenzone lipstick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13537-832
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE0.0664 g  in 1 g
    OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE0.0151 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW)  
    TRIDECYL TRIMELLITATE (UNII: FY36J270ES)  
    ETHYLHEXYL PALMITATE (UNII: 2865993309)  
    CERESIN (UNII: Q1LS2UJO3A)  
    WATER (UNII: 059QF0KO0R)  
    HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
    TRIDECYL STEARATE (UNII: A8OE252M6L)  
    POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)  
    POLY(METHYL METHACRYLATE; 450000 MW) (UNII: Z47NNT4J11)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    CERAMIDE NP (UNII: 4370DF050B)  
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    SOYBEAN OIL (UNII: 241ATL177A)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    MAGNESIUM CHLORIDE (UNII: 02F3473H9O)  
    POTASSIUM CHLORIDE (UNII: 660YQ98I10)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    WINE GRAPE (UNII: 3GOV20705G)  
    .BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)  
    LIMONENE, (+)- (UNII: GFD7C86Q1W)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)  
    LINALOOL, (+/-)- (UNII: D81QY6I88E)  
    .ALPHA.-AMYLCINNAMALDEHYDE (UNII: WC51CA3418)  
    MICA (UNII: V8A1AW0880)  
    D&C RED NO. 30 (UNII: 2S42T2808B)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    D&C RED NO. 21 (UNII: 08744Z6JNY)  
    D&C RED NO. 27 (UNII: 2LRS185U6K)  
    D&C RED NO. 7 (UNII: ECW0LZ41X8)  
    TALC (UNII: 7SEV7J4R1U)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:13537-832-021 in 1 BOX11/09/2016
    1NDC:13537-832-014 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35211/09/2016
    ESIKA HYDRACOLOR 2 IN 1 HIGHLY MOISTURIZING AND COLORING SPF 25   (ROSA ENCANTO EXOTIC) - PINK
    octinoxate and oxybenzone lipstick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13537-833
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE0.0664 g  in 1 g
    OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE0.0151 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW)  
    TRIDECYL TRIMELLITATE (UNII: FY36J270ES)  
    ETHYLHEXYL PALMITATE (UNII: 2865993309)  
    CERESIN (UNII: Q1LS2UJO3A)  
    WATER (UNII: 059QF0KO0R)  
    HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
    TRIDECYL STEARATE (UNII: A8OE252M6L)  
    POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)  
    POLY(METHYL METHACRYLATE; 450000 MW) (UNII: Z47NNT4J11)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    CERAMIDE NP (UNII: 4370DF050B)  
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    SOYBEAN OIL (UNII: 241ATL177A)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    MAGNESIUM CHLORIDE (UNII: 02F3473H9O)  
    POTASSIUM CHLORIDE (UNII: 660YQ98I10)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    WINE GRAPE (UNII: 3GOV20705G)  
    .BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)  
    LIMONENE, (+)- (UNII: GFD7C86Q1W)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)  
    LINALOOL, (+/-)- (UNII: D81QY6I88E)  
    .ALPHA.-AMYLCINNAMALDEHYDE (UNII: WC51CA3418)  
    MICA (UNII: V8A1AW0880)  
    D&C RED NO. 30 (UNII: 2S42T2808B)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    D&C RED NO. 21 (UNII: 08744Z6JNY)  
    D&C RED NO. 27 (UNII: 2LRS185U6K)  
    D&C RED NO. 7 (UNII: ECW0LZ41X8)  
    TALC (UNII: 7SEV7J4R1U)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:13537-833-021 in 1 BOX11/09/2016
    1NDC:13537-833-014 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35211/09/2016
    ESIKA HYDRACOLOR 2 IN 1 HIGHLY MOISTURIZING AND COLORING SPF 25   (CORAL CHIC EXOTIC) - ORANGE
    octinoxate and oxybenzone lipstick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13537-834
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE0.0664 g  in 1 g
    OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE0.0151 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW)  
    TRIDECYL TRIMELLITATE (UNII: FY36J270ES)  
    ETHYLHEXYL PALMITATE (UNII: 2865993309)  
    CERESIN (UNII: Q1LS2UJO3A)  
    WATER (UNII: 059QF0KO0R)  
    HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
    TRIDECYL STEARATE (UNII: A8OE252M6L)  
    POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)  
    POLY(METHYL METHACRYLATE; 450000 MW) (UNII: Z47NNT4J11)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    CERAMIDE NP (UNII: 4370DF050B)  
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    SOYBEAN OIL (UNII: 241ATL177A)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    MAGNESIUM CHLORIDE (UNII: 02F3473H9O)  
    POTASSIUM CHLORIDE (UNII: 660YQ98I10)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    WINE GRAPE (UNII: 3GOV20705G)  
    .BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)  
    LIMONENE, (+)- (UNII: GFD7C86Q1W)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)  
    LINALOOL, (+/-)- (UNII: D81QY6I88E)  
    .ALPHA.-AMYLCINNAMALDEHYDE (UNII: WC51CA3418)  
    MICA (UNII: V8A1AW0880)  
    D&C RED NO. 30 (UNII: 2S42T2808B)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    D&C RED NO. 21 (UNII: 08744Z6JNY)  
    D&C RED NO. 27 (UNII: 2LRS185U6K)  
    D&C RED NO. 7 (UNII: ECW0LZ41X8)  
    TALC (UNII: 7SEV7J4R1U)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:13537-834-021 in 1 BOX11/09/2016
    1NDC:13537-834-014 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35211/09/2016
    ESIKA HYDRACOLOR 2 IN 1 HIGHLY MOISTURIZING AND COLORING SPF 25   (FUCSIA CAUTIVANTE EXOTIC) - PINK
    octinoxate and oxybenzone lipstick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13537-835
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE0.0664 g  in 1 g
    OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE0.0151 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW)  
    TRIDECYL TRIMELLITATE (UNII: FY36J270ES)  
    ETHYLHEXYL PALMITATE (UNII: 2865993309)  
    CERESIN (UNII: Q1LS2UJO3A)  
    WATER (UNII: 059QF0KO0R)  
    HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
    TRIDECYL STEARATE (UNII: A8OE252M6L)  
    POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)  
    POLY(METHYL METHACRYLATE; 450000 MW) (UNII: Z47NNT4J11)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    CERAMIDE NP (UNII: 4370DF050B)  
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    SOYBEAN OIL (UNII: 241ATL177A)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    MAGNESIUM CHLORIDE (UNII: 02F3473H9O)  
    POTASSIUM CHLORIDE (UNII: 660YQ98I10)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    WINE GRAPE (UNII: 3GOV20705G)  
    .BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)  
    LIMONENE, (+)- (UNII: GFD7C86Q1W)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)  
    LINALOOL, (+/-)- (UNII: D81QY6I88E)  
    .ALPHA.-AMYLCINNAMALDEHYDE (UNII: WC51CA3418)  
    MICA (UNII: V8A1AW0880)  
    D&C RED NO. 30 (UNII: 2S42T2808B)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    D&C RED NO. 21 (UNII: 08744Z6JNY)  
    D&C RED NO. 27 (UNII: 2LRS185U6K)  
    D&C RED NO. 7 (UNII: ECW0LZ41X8)  
    TALC (UNII: 7SEV7J4R1U)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:13537-835-021 in 1 BOX11/09/2016
    1NDC:13537-835-014 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35211/09/2016
    ESIKA HYDRACOLOR 2 IN 1 HIGHLY MOISTURIZING AND COLORING SPF 25   (ROJO DESEO EXOTIC) - RED
    octinoxate and oxybenzone lipstick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13537-836
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE0.0664 g  in 1 g
    OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE0.0151 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW)  
    TRIDECYL TRIMELLITATE (UNII: FY36J270ES)  
    ETHYLHEXYL PALMITATE (UNII: 2865993309)  
    CERESIN (UNII: Q1LS2UJO3A)  
    WATER (UNII: 059QF0KO0R)  
    HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
    TRIDECYL STEARATE (UNII: A8OE252M6L)  
    POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)  
    POLY(METHYL METHACRYLATE; 450000 MW) (UNII: Z47NNT4J11)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    CERAMIDE NP (UNII: 4370DF050B)  
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    SOYBEAN OIL (UNII: 241ATL177A)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    MAGNESIUM CHLORIDE (UNII: 02F3473H9O)  
    POTASSIUM CHLORIDE (UNII: 660YQ98I10)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    WINE GRAPE (UNII: 3GOV20705G)  
    .BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)  
    LIMONENE, (+)- (UNII: GFD7C86Q1W)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)  
    LINALOOL, (+/-)- (UNII: D81QY6I88E)  
    .ALPHA.-AMYLCINNAMALDEHYDE (UNII: WC51CA3418)  
    MICA (UNII: V8A1AW0880)  
    D&C RED NO. 30 (UNII: 2S42T2808B)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    D&C RED NO. 21 (UNII: 08744Z6JNY)  
    D&C RED NO. 27 (UNII: 2LRS185U6K)  
    D&C RED NO. 7 (UNII: ECW0LZ41X8)  
    TALC (UNII: 7SEV7J4R1U)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:13537-836-021 in 1 BOX11/09/2016
    1NDC:13537-836-014 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35211/09/2016
    ESIKA HYDRACOLOR 2 IN 1 HIGHLY MOISTURIZING AND COLORING SPF 25   (FRAMBUESA MANIA EXOTIC) - PINK
    octinoxate and oxybenzone lipstick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13537-837
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE0.0664 g  in 1 g
    OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE0.0151 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW)  
    TRIDECYL TRIMELLITATE (UNII: FY36J270ES)  
    ETHYLHEXYL PALMITATE (UNII: 2865993309)  
    CERESIN (UNII: Q1LS2UJO3A)  
    WATER (UNII: 059QF0KO0R)  
    HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
    TRIDECYL STEARATE (UNII: A8OE252M6L)  
    POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)  
    POLY(METHYL METHACRYLATE; 450000 MW) (UNII: Z47NNT4J11)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    CERAMIDE NP (UNII: 4370DF050B)  
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    SOYBEAN OIL (UNII: 241ATL177A)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    MAGNESIUM CHLORIDE (UNII: 02F3473H9O)  
    POTASSIUM CHLORIDE (UNII: 660YQ98I10)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    WINE GRAPE (UNII: 3GOV20705G)  
    .BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)  
    LIMONENE, (+)- (UNII: GFD7C86Q1W)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)  
    LINALOOL, (+/-)- (UNII: D81QY6I88E)  
    .ALPHA.-AMYLCINNAMALDEHYDE (UNII: WC51CA3418)  
    MICA (UNII: V8A1AW0880)  
    D&C RED NO. 30 (UNII: 2S42T2808B)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    D&C RED NO. 21 (UNII: 08744Z6JNY)  
    D&C RED NO. 27 (UNII: 2LRS185U6K)  
    D&C RED NO. 7 (UNII: ECW0LZ41X8)  
    TALC (UNII: 7SEV7J4R1U)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:13537-837-021 in 1 BOX11/09/2016
    1NDC:13537-837-014 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35211/09/2016
    ESIKA HYDRACOLOR 2 IN 1 HIGHLY MOISTURIZING AND COLORING SPF 25   (BORGONA SEXY EXOTIC) - PURPLE
    octinoxate and oxybenzone lipstick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13537-838
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE0.0664 g  in 1 g
    OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE0.0151 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW)  
    TRIDECYL TRIMELLITATE (UNII: FY36J270ES)  
    ETHYLHEXYL PALMITATE (UNII: 2865993309)  
    CERESIN (UNII: Q1LS2UJO3A)  
    WATER (UNII: 059QF0KO0R)  
    HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
    TRIDECYL STEARATE (UNII: A8OE252M6L)  
    POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)  
    POLY(METHYL METHACRYLATE; 450000 MW) (UNII: Z47NNT4J11)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    CERAMIDE NP (UNII: 4370DF050B)  
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    SOYBEAN OIL (UNII: 241ATL177A)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    MAGNESIUM CHLORIDE (UNII: 02F3473H9O)  
    POTASSIUM CHLORIDE (UNII: 660YQ98I10)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    WINE GRAPE (UNII: 3GOV20705G)  
    .BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)  
    LIMONENE, (+)- (UNII: GFD7C86Q1W)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)  
    LINALOOL, (+/-)- (UNII: D81QY6I88E)  
    .ALPHA.-AMYLCINNAMALDEHYDE (UNII: WC51CA3418)  
    MICA (UNII: V8A1AW0880)  
    D&C RED NO. 30 (UNII: 2S42T2808B)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    D&C RED NO. 21 (UNII: 08744Z6JNY)  
    D&C RED NO. 27 (UNII: 2LRS185U6K)  
    D&C RED NO. 7 (UNII: ECW0LZ41X8)  
    TALC (UNII: 7SEV7J4R1U)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:13537-838-021 in 1 BOX11/09/2016
    1NDC:13537-838-014 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35211/09/2016
    ESIKA HYDRACOLOR 2 IN 1 HIGHLY MOISTURIZING AND COLORING SPF 25   (MARRON GLAMOUR EXOTIC) - BROWN
    octinoxate and oxybenzone lipstick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13537-839
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE0.0664 g  in 1 g
    OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE0.0151 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW)  
    TRIDECYL TRIMELLITATE (UNII: FY36J270ES)  
    ETHYLHEXYL PALMITATE (UNII: 2865993309)  
    CERESIN (UNII: Q1LS2UJO3A)  
    WATER (UNII: 059QF0KO0R)  
    HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
    TRIDECYL STEARATE (UNII: A8OE252M6L)  
    POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)  
    POLY(METHYL METHACRYLATE; 450000 MW) (UNII: Z47NNT4J11)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    CERAMIDE NP (UNII: 4370DF050B)  
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    SOYBEAN OIL (UNII: 241ATL177A)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    MAGNESIUM CHLORIDE (UNII: 02F3473H9O)  
    POTASSIUM CHLORIDE (UNII: 660YQ98I10)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    WINE GRAPE (UNII: 3GOV20705G)  
    .BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)  
    LIMONENE, (+)- (UNII: GFD7C86Q1W)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)  
    LINALOOL, (+/-)- (UNII: D81QY6I88E)  
    .ALPHA.-AMYLCINNAMALDEHYDE (UNII: WC51CA3418)  
    MICA (UNII: V8A1AW0880)  
    D&C RED NO. 30 (UNII: 2S42T2808B)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    D&C RED NO. 21 (UNII: 08744Z6JNY)  
    D&C RED NO. 27 (UNII: 2LRS185U6K)  
    D&C RED NO. 7 (UNII: ECW0LZ41X8)  
    TALC (UNII: 7SEV7J4R1U)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:13537-839-021 in 1 BOX11/09/2016
    1NDC:13537-839-014 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35211/09/2016
    ESIKA HYDRACOLOR 2 IN 1 HIGHLY MOISTURIZING AND COLORING SPF 25 
    octinoxate and oxybenzone kit
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13537-840
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:13537-840-022 in 1 BOX11/09/2016
    1NDC:13537-840-011 in 1 TUBE
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 11 TUBE 8 g
    Part 21 TUBE 8 g
    Part 31 TUBE 8 g
    Part 41 TUBE 8 g
    Part 51 TUBE 8 g
    Part 61 TUBE 8 g
    Part 71 TUBE 8 g
    Part 81 TUBE 8 g
    Part 91 TUBE 8 g
    Part 101 TUBE 8 g
    Part 111 TUBE 8 g
    Part 121 TUBE 8 g
    Part 131 TUBE 8 g
    Part 141 TUBE 8 g
    Part 151 TUBE 8 g
    Part 161 TUBE 8 g
    Part 171 TUBE 8 g
    Part 181 TUBE 8 g
    Part 191 TUBE 8 g
    Part 201 TUBE 8 g
    Part 211 TUBE 8 g
    Part 221 TUBE 8 g
    Part 231 TUBE 8 g
    Part 241 TUBE 8 g
    Part 251 TUBE 8 g
    Part 261 TUBE 8 g
    Part 271 TUBE 8 g
    Part 281 TUBE 8 g
    Part 291 TUBE 8 g
    Part 301 TUBE 8 g
    Part 311 TUBE 8 g
    Part 321 TUBE 8 g
    Part 331 TUBE 8 g
    Part 341 TUBE 8 g
    Part 351 TUBE 8 g
    Part 361 TUBE 8 g
    Part 371 TUBE 8 g
    Part 381 TUBE 8 g
    Part 391 TUBE 8 g
    Part 401 TUBE 8 g
    Part 411 TUBE 8 g
    Part 421 TUBE 8 g
    Part 1 of 42
    ESIKA HYDRACOLOR 2 IN 1 HIGHLY MOISTURIZING AND COLORING SPF 25  (PIMIENTA CALIENTE) - BROWN
    octinoxate and oxybenzone lipstick
    Product Information
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE0.0664 g  in 1 g
    OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE0.0151 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW)  
    TRIDECYL TRIMELLITATE (UNII: FY36J270ES)  
    ETHYLHEXYL PALMITATE (UNII: 2865993309)  
    CERESIN (UNII: Q1LS2UJO3A)  
    WATER (UNII: 059QF0KO0R)  
    HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
    TRIDECYL STEARATE (UNII: A8OE252M6L)  
    POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)  
    POLY(METHYL METHACRYLATE; 450000 MW) (UNII: Z47NNT4J11)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    CERAMIDE NP (UNII: 4370DF050B)  
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    SOYBEAN OIL (UNII: 241ATL177A)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    MAGNESIUM CHLORIDE (UNII: 02F3473H9O)  
    POTASSIUM CHLORIDE (UNII: 660YQ98I10)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    WINE GRAPE (UNII: 3GOV20705G)  
    .BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)  
    LIMONENE, (+)- (UNII: GFD7C86Q1W)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)  
    LINALOOL, (+/-)- (UNII: D81QY6I88E)  
    .ALPHA.-AMYLCINNAMALDEHYDE (UNII: WC51CA3418)  
    MICA (UNII: V8A1AW0880)  
    D&C RED NO. 30 (UNII: 2S42T2808B)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    D&C RED NO. 21 (UNII: 08744Z6JNY)  
    D&C RED NO. 27 (UNII: 2LRS185U6K)  
    D&C RED NO. 7 (UNII: ECW0LZ41X8)  
    TALC (UNII: 7SEV7J4R1U)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    18 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35211/09/2016
    Part 2 of 42
    ESIKA HYDRACOLOR 2 IN 1 HIGHLY MOISTURIZING AND COLORING SPF 25  (MARRON GLAMOUR) - BROWN
    octinoxate and oxybenzone lipstick
    Product Information
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE0.0664 g  in 1 g
    OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE0.0151 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW)  
    TRIDECYL TRIMELLITATE (UNII: FY36J270ES)  
    ETHYLHEXYL PALMITATE (UNII: 2865993309)  
    CERESIN (UNII: Q1LS2UJO3A)  
    WATER (UNII: 059QF0KO0R)  
    HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
    TRIDECYL STEARATE (UNII: A8OE252M6L)  
    POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)  
    POLY(METHYL METHACRYLATE; 450000 MW) (UNII: Z47NNT4J11)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    CERAMIDE NP (UNII: 4370DF050B)  
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    SOYBEAN OIL (UNII: 241ATL177A)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    MAGNESIUM CHLORIDE (UNII: 02F3473H9O)  
    POTASSIUM CHLORIDE (UNII: 660YQ98I10)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    WINE GRAPE (UNII: 3GOV20705G)  
    .BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)  
    LIMONENE, (+)- (UNII: GFD7C86Q1W)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)  
    LINALOOL, (+/-)- (UNII: D81QY6I88E)  
    .ALPHA.-AMYLCINNAMALDEHYDE (UNII: WC51CA3418)  
    MICA (UNII: V8A1AW0880)  
    D&C RED NO. 30 (UNII: 2S42T2808B)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    D&C RED NO. 21 (UNII: 08744Z6JNY)  
    D&C RED NO. 27 (UNII: 2LRS185U6K)  
    D&C RED NO. 7 (UNII: ECW0LZ41X8)  
    TALC (UNII: 7SEV7J4R1U)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    18 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35211/09/2016
    Part 3 of 42
    ESIKA HYDRACOLOR 2 IN 1 HIGHLY MOISTURIZING AND COLORING SPF 25  (BORGONA SEXY) - PURPLE
    octinoxate and oxybenzone lipstick
    Product Information
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE0.0664 g  in 1 g
    OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE0.0151 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW)  
    TRIDECYL TRIMELLITATE (UNII: FY36J270ES)  
    ETHYLHEXYL PALMITATE (UNII: 2865993309)  
    CERESIN (UNII: Q1LS2UJO3A)  
    WATER (UNII: 059QF0KO0R)  
    HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
    TRIDECYL STEARATE (UNII: A8OE252M6L)  
    POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)  
    POLY(METHYL METHACRYLATE; 450000 MW) (UNII: Z47NNT4J11)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    CERAMIDE NP (UNII: 4370DF050B)  
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    SOYBEAN OIL (UNII: 241ATL177A)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    MAGNESIUM CHLORIDE (UNII: 02F3473H9O)  
    POTASSIUM CHLORIDE (UNII: 660YQ98I10)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    WINE GRAPE (UNII: 3GOV20705G)  
    .BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)  
    LIMONENE, (+)- (UNII: GFD7C86Q1W)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)  
    LINALOOL, (+/-)- (UNII: D81QY6I88E)  
    .ALPHA.-AMYLCINNAMALDEHYDE (UNII: WC51CA3418)  
    MICA (UNII: V8A1AW0880)  
    D&C RED NO. 30 (UNII: 2S42T2808B)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    D&C RED NO. 21 (UNII: 08744Z6JNY)  
    D&C RED NO. 27 (UNII: 2LRS185U6K)  
    D&C RED NO. 7 (UNII: ECW0LZ41X8)  
    TALC (UNII: 7SEV7J4R1U)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    18 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35211/09/2016
    Part 4 of 42
    ESIKA HYDRACOLOR 2 IN 1 HIGHLY MOISTURIZING AND COLORING SPF 25  (ROSA DULZURA) - PINK
    octinoxate and oxybenzone lipstick
    Product Information
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE0.0664 g  in 1 g
    OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE0.0151 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW)  
    TRIDECYL TRIMELLITATE (UNII: FY36J270ES)  
    ETHYLHEXYL PALMITATE (UNII: 2865993309)  
    CERESIN (UNII: Q1LS2UJO3A)  
    WATER (UNII: 059QF0KO0R)  
    HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
    TRIDECYL STEARATE (UNII: A8OE252M6L)  
    POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)  
    POLY(METHYL METHACRYLATE; 450000 MW) (UNII: Z47NNT4J11)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    CERAMIDE NP (UNII: 4370DF050B)  
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    SOYBEAN OIL (UNII: 241ATL177A)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    MAGNESIUM CHLORIDE (UNII: 02F3473H9O)  
    POTASSIUM CHLORIDE (UNII: 660YQ98I10)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    WINE GRAPE (UNII: 3GOV20705G)  
    .BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)  
    LIMONENE, (+)- (UNII: GFD7C86Q1W)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)  
    LINALOOL, (+/-)- (UNII: D81QY6I88E)  
    .ALPHA.-AMYLCINNAMALDEHYDE (UNII: WC51CA3418)  
    MICA (UNII: V8A1AW0880)  
    D&C RED NO. 30 (UNII: 2S42T2808B)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    D&C RED NO. 21 (UNII: 08744Z6JNY)  
    D&C RED NO. 27 (UNII: 2LRS185U6K)  
    D&C RED NO. 7 (UNII: ECW0LZ41X8)  
    TALC (UNII: 7SEV7J4R1U)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    18 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35211/09/2016
    Part 5 of 42
    ESIKA HYDRACOLOR 2 IN 1 HIGHLY MOISTURIZING AND COLORING SPF 25  (ROJO DESEO) - RED
    octinoxate and oxybenzone lipstick
    Product Information
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE0.0664 g  in 1 g
    OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE0.0151 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW)  
    TRIDECYL TRIMELLITATE (UNII: FY36J270ES)  
    ETHYLHEXYL PALMITATE (UNII: 2865993309)  
    CERESIN (UNII: Q1LS2UJO3A)  
    WATER (UNII: 059QF0KO0R)  
    HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
    TRIDECYL STEARATE (UNII: A8OE252M6L)  
    POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)  
    POLY(METHYL METHACRYLATE; 450000 MW) (UNII: Z47NNT4J11)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    CERAMIDE NP (UNII: 4370DF050B)  
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    SOYBEAN OIL (UNII: 241ATL177A)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    MAGNESIUM CHLORIDE (UNII: 02F3473H9O)  
    POTASSIUM CHLORIDE (UNII: 660YQ98I10)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    WINE GRAPE (UNII: 3GOV20705G)  
    .BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)  
    LIMONENE, (+)- (UNII: GFD7C86Q1W)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)  
    LINALOOL, (+/-)- (UNII: D81QY6I88E)  
    .ALPHA.-AMYLCINNAMALDEHYDE (UNII: WC51CA3418)  
    MICA (UNII: V8A1AW0880)  
    D&C RED NO. 30 (UNII: 2S42T2808B)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    D&C RED NO. 21 (UNII: 08744Z6JNY)  
    D&C RED NO. 27 (UNII: 2LRS185U6K)  
    D&C RED NO. 7 (UNII: ECW0LZ41X8)  
    TALC (UNII: 7SEV7J4R1U)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    18 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35211/09/2016
    Part 6 of 42
    ESIKA HYDRACOLOR 2 IN 1 HIGHLY MOISTURIZING AND COLORING SPF 25  (ROJO INTRIGANTE) - RED
    octinoxate and oxybenzone lipstick
    Product Information
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE0.0664 g  in 1 g
    OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE0.0151 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW)  
    TRIDECYL TRIMELLITATE (UNII: FY36J270ES)  
    ETHYLHEXYL PALMITATE (UNII: 2865993309)  
    CERESIN (UNII: Q1LS2UJO3A)  
    WATER (UNII: 059QF0KO0R)  
    HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
    TRIDECYL STEARATE (UNII: A8OE252M6L)  
    POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)  
    POLY(METHYL METHACRYLATE; 450000 MW) (UNII: Z47NNT4J11)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    CERAMIDE NP (UNII: 4370DF050B)  
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    SOYBEAN OIL (UNII: 241ATL177A)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    MAGNESIUM CHLORIDE (UNII: 02F3473H9O)  
    POTASSIUM CHLORIDE (UNII: 660YQ98I10)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    WINE GRAPE (UNII: 3GOV20705G)  
    .BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)  
    LIMONENE, (+)- (UNII: GFD7C86Q1W)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)  
    LINALOOL, (+/-)- (UNII: D81QY6I88E)  
    .ALPHA.-AMYLCINNAMALDEHYDE (UNII: WC51CA3418)  
    MICA (UNII: V8A1AW0880)  
    D&C RED NO. 30 (UNII: 2S42T2808B)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    D&C RED NO. 21 (UNII: 08744Z6JNY)  
    D&C RED NO. 27 (UNII: 2LRS185U6K)  
    D&C RED NO. 7 (UNII: ECW0LZ41X8)  
    TALC (UNII: 7SEV7J4R1U)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    18 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35211/09/2016
    Part 7 of 42
    ESIKA HYDRACOLOR 2 IN 1 HIGHLY MOISTURIZING AND COLORING SPF 25  (ROJO LUJURIA) - RED
    octinoxate and oxybenzone lipstick
    Product Information
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE0.0664 g  in 1 g
    OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE0.0151 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW)  
    TRIDECYL TRIMELLITATE (UNII: FY36J270ES)  
    ETHYLHEXYL PALMITATE (UNII: 2865993309)  
    CERESIN (UNII: Q1LS2UJO3A)  
    WATER (UNII: 059QF0KO0R)  
    HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
    TRIDECYL STEARATE (UNII: A8OE252M6L)  
    POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)  
    POLY(METHYL METHACRYLATE; 450000 MW) (UNII: Z47NNT4J11)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    CERAMIDE NP (UNII: 4370DF050B)  
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    SOYBEAN OIL (UNII: 241ATL177A)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    MAGNESIUM CHLORIDE (UNII: 02F3473H9O)  
    POTASSIUM CHLORIDE (UNII: 660YQ98I10)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    WINE GRAPE (UNII: 3GOV20705G)  
    .BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)  
    LIMONENE, (+)- (UNII: GFD7C86Q1W)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)  
    LINALOOL, (+/-)- (UNII: D81QY6I88E)  
    .ALPHA.-AMYLCINNAMALDEHYDE (UNII: WC51CA3418)  
    MICA (UNII: V8A1AW0880)  
    D&C RED NO. 30 (UNII: 2S42T2808B)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    D&C RED NO. 21 (UNII: 08744Z6JNY)  
    D&C RED NO. 27 (UNII: 2LRS185U6K)  
    D&C RED NO. 7 (UNII: ECW0LZ41X8)  
    TALC (UNII: 7SEV7J4R1U)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    18 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35211/09/2016
    Part 8 of 42
    ESIKA HYDRACOLOR 2 IN 1 HIGHLY MOISTURIZING AND COLORING SPF 25  (CORAL CHIC) - PINK
    octinoxate and oxybenzone lipstick
    Product Information
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE0.0664 g  in 1 g
    OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE0.0151 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW)  
    TRIDECYL TRIMELLITATE (UNII: FY36J270ES)  
    ETHYLHEXYL PALMITATE (UNII: 2865993309)  
    CERESIN (UNII: Q1LS2UJO3A)  
    WATER (UNII: 059QF0KO0R)  
    HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
    TRIDECYL STEARATE (UNII: A8OE252M6L)  
    POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)  
    POLY(METHYL METHACRYLATE; 450000 MW) (UNII: Z47NNT4J11)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    CERAMIDE NP (UNII: 4370DF050B)  
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    SOYBEAN OIL (UNII: 241ATL177A)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    MAGNESIUM CHLORIDE (UNII: 02F3473H9O)  
    POTASSIUM CHLORIDE (UNII: 660YQ98I10)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    WINE GRAPE (UNII: 3GOV20705G)  
    .BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)  
    LIMONENE, (+)- (UNII: GFD7C86Q1W)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)  
    LINALOOL, (+/-)- (UNII: D81QY6I88E)  
    .ALPHA.-AMYLCINNAMALDEHYDE (UNII: WC51CA3418)  
    MICA (UNII: V8A1AW0880)  
    D&C RED NO. 30 (UNII: 2S42T2808B)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    D&C RED NO. 21 (UNII: 08744Z6JNY)  
    D&C RED NO. 27 (UNII: 2LRS185U6K)  
    D&C RED NO. 7 (UNII: ECW0LZ41X8)  
    TALC (UNII: 7SEV7J4R1U)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    18 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35211/09/2016
    Part 9 of 42
    ESIKA HYDRACOLOR 2 IN 1 HIGHLY MOISTURIZING AND COLORING SPF 25  (ROSA ENCANTO) - PINK
    octinoxate and oxybenzone lipstick
    Product Information
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE0.0664 g  in 1 g
    OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE0.0151 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW)  
    TRIDECYL TRIMELLITATE (UNII: FY36J270ES)  
    ETHYLHEXYL PALMITATE (UNII: 2865993309)  
    CERESIN (UNII: Q1LS2UJO3A)  
    WATER (UNII: 059QF0KO0R)  
    HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
    TRIDECYL STEARATE (UNII: A8OE252M6L)  
    POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)  
    POLY(METHYL METHACRYLATE; 450000 MW) (UNII: Z47NNT4J11)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    CERAMIDE NP (UNII: 4370DF050B)  
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    SOYBEAN OIL (UNII: 241ATL177A)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    MAGNESIUM CHLORIDE (UNII: 02F3473H9O)  
    POTASSIUM CHLORIDE (UNII: 660YQ98I10)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    WINE GRAPE (UNII: 3GOV20705G)  
    .BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)  
    LIMONENE, (+)- (UNII: GFD7C86Q1W)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)  
    LINALOOL, (+/-)- (UNII: D81QY6I88E)  
    .ALPHA.-AMYLCINNAMALDEHYDE (UNII: WC51CA3418)  
    MICA (UNII: V8A1AW0880)  
    D&C RED NO. 30 (UNII: 2S42T2808B)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    D&C RED NO. 21 (UNII: 08744Z6JNY)  
    D&C RED NO. 27 (UNII: 2LRS185U6K)  
    D&C RED NO. 7 (UNII: ECW0LZ41X8)  
    TALC (UNII: 7SEV7J4R1U)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    18 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35211/09/2016
    Part 10 of 42
    ESIKA HYDRACOLOR 2 IN 1 HIGHLY MOISTURIZING AND COLORING SPF 25  (FUCSIA CAUTIVANTE) - PINK
    octinoxate and oxybenzone lipstick
    Product Information
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE0.0664 g  in 1 g
    OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE0.0151 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW)  
    TRIDECYL TRIMELLITATE (UNII: FY36J270ES)  
    ETHYLHEXYL PALMITATE (UNII: 2865993309)  
    CERESIN (UNII: Q1LS2UJO3A)  
    WATER (UNII: 059QF0KO0R)  
    HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
    TRIDECYL STEARATE (UNII: A8OE252M6L)  
    POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)  
    POLY(METHYL METHACRYLATE; 450000 MW) (UNII: Z47NNT4J11)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    CERAMIDE NP (UNII: 4370DF050B)  
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    SOYBEAN OIL (UNII: 241ATL177A)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    MAGNESIUM CHLORIDE (UNII: 02F3473H9O)  
    POTASSIUM CHLORIDE (UNII: 660YQ98I10)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    WINE GRAPE (UNII: 3GOV20705G)  
    .BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)  
    LIMONENE, (+)- (UNII: GFD7C86Q1W)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)  
    LINALOOL, (+/-)- (UNII: D81QY6I88E)  
    .ALPHA.-AMYLCINNAMALDEHYDE (UNII: WC51CA3418)  
    MICA (UNII: V8A1AW0880)  
    D&C RED NO. 30 (UNII: 2S42T2808B)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    D&C RED NO. 21 (UNII: 08744Z6JNY)  
    D&C RED NO. 27 (UNII: 2LRS185U6K)  
    D&C RED NO. 7 (UNII: ECW0LZ41X8)  
    TALC (UNII: 7SEV7J4R1U)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    18 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35211/09/2016
    Part 11 of 42
    ESIKA HYDRACOLOR 2 IN 1 HIGHLY MOISTURIZING AND COLORING SPF 25  (GRANATE SEDUCTOR) - PURPLE
    octinoxate and oxybenzone lipstick
    Product Information
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE0.0664 g  in 1 g
    OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE0.0151 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW)  
    TRIDECYL TRIMELLITATE (UNII: FY36J270ES)  
    ETHYLHEXYL PALMITATE (UNII: 2865993309)  
    CERESIN (UNII: Q1LS2UJO3A)  
    WATER (UNII: 059QF0KO0R)  
    HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
    TRIDECYL STEARATE (UNII: A8OE252M6L)  
    POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)  
    POLY(METHYL METHACRYLATE; 450000 MW) (UNII: Z47NNT4J11)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    CERAMIDE NP (UNII: 4370DF050B)  
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    SOYBEAN OIL (UNII: 241ATL177A)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    MAGNESIUM CHLORIDE (UNII: 02F3473H9O)  
    POTASSIUM CHLORIDE (UNII: 660YQ98I10)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    WINE GRAPE (UNII: 3GOV20705G)  
    .BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)  
    LIMONENE, (+)- (UNII: GFD7C86Q1W)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)  
    LINALOOL, (+/-)- (UNII: D81QY6I88E)  
    .ALPHA.-AMYLCINNAMALDEHYDE (UNII: WC51CA3418)  
    MICA (UNII: V8A1AW0880)  
    D&C RED NO. 30 (UNII: 2S42T2808B)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    D&C RED NO. 21 (UNII: 08744Z6JNY)  
    D&C RED NO. 27 (UNII: 2LRS185U6K)  
    D&C RED NO. 7 (UNII: ECW0LZ41X8)  
    TALC (UNII: 7SEV7J4R1U)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    18 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35211/09/2016
    Part 12 of 42
    ESIKA HYDRACOLOR 2 IN 1 HIGHLY MOISTURIZING AND COLORING SPF 25  (ROSA ROMANTICA) - PINK
    octinoxate and oxybenzone lipstick
    Product Information
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE0.0664 g  in 1 g
    OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE0.0151 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW)  
    TRIDECYL TRIMELLITATE (UNII: FY36J270ES)  
    ETHYLHEXYL PALMITATE (UNII: 2865993309)  
    CERESIN (UNII: Q1LS2UJO3A)  
    WATER (UNII: 059QF0KO0R)  
    HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
    TRIDECYL STEARATE (UNII: A8OE252M6L)  
    POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)  
    POLY(METHYL METHACRYLATE; 450000 MW) (UNII: Z47NNT4J11)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    CERAMIDE NP (UNII: 4370DF050B)  
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    SOYBEAN OIL (UNII: 241ATL177A)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    MAGNESIUM CHLORIDE (UNII: 02F3473H9O)  
    POTASSIUM CHLORIDE (UNII: 660YQ98I10)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    WINE GRAPE (UNII: 3GOV20705G)  
    .BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)  
    LIMONENE, (+)- (UNII: GFD7C86Q1W)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)  
    LINALOOL, (+/-)- (UNII: D81QY6I88E)  
    .ALPHA.-AMYLCINNAMALDEHYDE (UNII: WC51CA3418)  
    MICA (UNII: V8A1AW0880)  
    D&C RED NO. 30 (UNII: 2S42T2808B)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    D&C RED NO. 21 (UNII: 08744Z6JNY)  
    D&C RED NO. 27 (UNII: 2LRS185U6K)  
    D&C RED NO. 7 (UNII: ECW0LZ41X8)  
    TALC (UNII: 7SEV7J4R1U)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    18 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35211/09/2016
    Part 13 of 42
    ESIKA HYDRACOLOR 2 IN 1 HIGHLY MOISTURIZING AND COLORING SPF 25  (NARANJA PRIMAVERA) - ORANGE
    octinoxate and oxybenzone lipstick
    Product Information
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE0.0664 g  in 1 g
    OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE0.0151 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW)  
    TRIDECYL TRIMELLITATE (UNII: FY36J270ES)  
    ETHYLHEXYL PALMITATE (UNII: 2865993309)  
    CERESIN (UNII: Q1LS2UJO3A)  
    WATER (UNII: 059QF0KO0R)  
    HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
    TRIDECYL STEARATE (UNII: A8OE252M6L)  
    POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)  
    POLY(METHYL METHACRYLATE; 450000 MW) (UNII: Z47NNT4J11)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    CERAMIDE NP (UNII: 4370DF050B)  
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    SOYBEAN OIL (UNII: 241ATL177A)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    MAGNESIUM CHLORIDE (UNII: 02F3473H9O)  
    POTASSIUM CHLORIDE (UNII: 660YQ98I10)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    WINE GRAPE (UNII: 3GOV20705G)  
    .BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)  
    LIMONENE, (+)- (UNII: GFD7C86Q1W)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)  
    LINALOOL, (+/-)- (UNII: D81QY6I88E)  
    .ALPHA.-AMYLCINNAMALDEHYDE (UNII: WC51CA3418)  
    MICA (UNII: V8A1AW0880)  
    D&C RED NO. 30 (UNII: 2S42T2808B)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    D&C RED NO. 21 (UNII: 08744Z6JNY)  
    D&C RED NO. 27 (UNII: 2LRS185U6K)  
    D&C RED NO. 7 (UNII: ECW0LZ41X8)  
    TALC (UNII: 7SEV7J4R1U)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    18 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35211/09/2016
    Part 14 of 42
    ESIKA HYDRACOLOR 2 IN 1 HIGHLY MOISTURIZING AND COLORING SPF 25  (FRAMBUESA MANIA) - RED
    octinoxate and oxybenzone lipstick
    Product Information
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE0.0664 g  in 1 g
    OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE0.0151 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW)  
    TRIDECYL TRIMELLITATE (UNII: FY36J270ES)  
    ETHYLHEXYL PALMITATE (UNII: 2865993309)  
    CERESIN (UNII: Q1LS2UJO3A)  
    WATER (UNII: 059QF0KO0R)  
    HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
    TRIDECYL STEARATE (UNII: A8OE252M6L)  
    POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)  
    POLY(METHYL METHACRYLATE; 450000 MW) (UNII: Z47NNT4J11)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    CERAMIDE NP (UNII: 4370DF050B)  
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    SOYBEAN OIL (UNII: 241ATL177A)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    MAGNESIUM CHLORIDE (UNII: 02F3473H9O)  
    POTASSIUM CHLORIDE (UNII: 660YQ98I10)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    WINE GRAPE (UNII: 3GOV20705G)  
    .BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)  
    LIMONENE, (+)- (UNII: GFD7C86Q1W)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)  
    LINALOOL, (+/-)- (UNII: D81QY6I88E)  
    .ALPHA.-AMYLCINNAMALDEHYDE (UNII: WC51CA3418)  
    MICA (UNII: V8A1AW0880)  
    D&C RED NO. 30 (UNII: 2S42T2808B)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    D&C RED NO. 21 (UNII: 08744Z6JNY)  
    D&C RED NO. 27 (UNII: 2LRS185U6K)  
    D&C RED NO. 7 (UNII: ECW0LZ41X8)  
    TALC (UNII: 7SEV7J4R1U)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    18 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35211/09/2016
    Part 15 of 42
    ESIKA HYDRACOLOR 2 IN 1 HIGHLY MOISTURIZING AND COLORING SPF 25  (FRESA COQUETA) - RED
    octinoxate and oxybenzone lipstick
    Product Information
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE0.0664 g  in 1 g
    OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE0.0151 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW)  
    TRIDECYL TRIMELLITATE (UNII: FY36J270ES)  
    ETHYLHEXYL PALMITATE (UNII: 2865993309)  
    CERESIN (UNII: Q1LS2UJO3A)  
    WATER (UNII: 059QF0KO0R)  
    HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
    TRIDECYL STEARATE (UNII: A8OE252M6L)  
    POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)  
    POLY(METHYL METHACRYLATE; 450000 MW) (UNII: Z47NNT4J11)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    CERAMIDE NP (UNII: 4370DF050B)  
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    SOYBEAN OIL (UNII: 241ATL177A)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    MAGNESIUM CHLORIDE (UNII: 02F3473H9O)  
    POTASSIUM CHLORIDE (UNII: 660YQ98I10)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    WINE GRAPE (UNII: 3GOV20705G)  
    .BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)  
    LIMONENE, (+)- (UNII: GFD7C86Q1W)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)  
    LINALOOL, (+/-)- (UNII: D81QY6I88E)  
    .ALPHA.-AMYLCINNAMALDEHYDE (UNII: WC51CA3418)  
    MICA (UNII: V8A1AW0880)  
    D&C RED NO. 30 (UNII: 2S42T2808B)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    D&C RED NO. 21 (UNII: 08744Z6JNY)  
    D&C RED NO. 27 (UNII: 2LRS185U6K)  
    D&C RED NO. 7 (UNII: ECW0LZ41X8)  
    TALC (UNII: 7SEV7J4R1U)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    18 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35211/09/2016
    Part 16 of 42
    ESIKA HYDRACOLOR 2 IN 1 HIGHLY MOISTURIZING AND COLORING SPF 25  (CANELA NUDE) - ORANGE
    octinoxate and oxybenzone lipstick
    Product Information
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE0.0664 g  in 1 g
    OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE0.0151 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW)  
    TRIDECYL TRIMELLITATE (UNII: FY36J270ES)  
    ETHYLHEXYL PALMITATE (UNII: 2865993309)  
    CERESIN (UNII: Q1LS2UJO3A)  
    WATER (UNII: 059QF0KO0R)  
    HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
    TRIDECYL STEARATE (UNII: A8OE252M6L)  
    POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)  
    POLY(METHYL METHACRYLATE; 450000 MW) (UNII: Z47NNT4J11)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    CERAMIDE NP (UNII: 4370DF050B)  
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    SOYBEAN OIL (UNII: 241ATL177A)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    MAGNESIUM CHLORIDE (UNII: 02F3473H9O)  
    POTASSIUM CHLORIDE (UNII: 660YQ98I10)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    WINE GRAPE (UNII: 3GOV20705G)  
    .BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)  
    LIMONENE, (+)- (UNII: GFD7C86Q1W)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)  
    LINALOOL, (+/-)- (UNII: D81QY6I88E)  
    .ALPHA.-AMYLCINNAMALDEHYDE (UNII: WC51CA3418)  
    MICA (UNII: V8A1AW0880)  
    D&C RED NO. 30 (UNII: 2S42T2808B)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    D&C RED NO. 21 (UNII: 08744Z6JNY)  
    D&C RED NO. 27 (UNII: 2LRS185U6K)  
    D&C RED NO. 7 (UNII: ECW0LZ41X8)  
    TALC (UNII: 7SEV7J4R1U)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    18 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35211/09/2016
    Part 17 of 42
    ESIKA HYDRACOLOR 2 IN 1 HIGHLY MOISTURIZING AND COLORING SPF 25  (MORA GLAM) - BROWN
    octinoxate and oxybenzone lipstick
    Product Information
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE0.0664 g  in 1 g
    OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE0.0151 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW)  
    TRIDECYL TRIMELLITATE (UNII: FY36J270ES)  
    ETHYLHEXYL PALMITATE (UNII: 2865993309)  
    CERESIN (UNII: Q1LS2UJO3A)  
    WATER (UNII: 059QF0KO0R)  
    HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
    TRIDECYL STEARATE (UNII: A8OE252M6L)  
    POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)  
    POLY(METHYL METHACRYLATE; 450000 MW) (UNII: Z47NNT4J11)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    CERAMIDE NP (UNII: 4370DF050B)  
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    SOYBEAN OIL (UNII: 241ATL177A)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    MAGNESIUM CHLORIDE (UNII: 02F3473H9O)  
    POTASSIUM CHLORIDE (UNII: 660YQ98I10)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    WINE GRAPE (UNII: 3GOV20705G)  
    .BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)  
    LIMONENE, (+)- (UNII: GFD7C86Q1W)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)  
    LINALOOL, (+/-)- (UNII: D81QY6I88E)  
    .ALPHA.-AMYLCINNAMALDEHYDE (UNII: WC51CA3418)  
    MICA (UNII: V8A1AW0880)  
    D&C RED NO. 30 (UNII: 2S42T2808B)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    D&C RED NO. 21 (UNII: 08744Z6JNY)  
    D&C RED NO. 27 (UNII: 2LRS185U6K)  
    D&C RED NO. 7 (UNII: ECW0LZ41X8)  
    TALC (UNII: 7SEV7J4R1U)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    18 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35211/09/2016
    Part 18 of 42
    ESIKA HYDRACOLOR 2 IN 1 HIGHLY MOISTURIZING AND COLORING SPF 25  (CORAL INTENSE) - RED
    octinoxate and oxybenzone lipstick
    Product Information
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE0.0664 g  in 1 g
    OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE0.0151 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW)  
    TRIDECYL TRIMELLITATE (UNII: FY36J270ES)  
    ETHYLHEXYL PALMITATE (UNII: 2865993309)  
    CERESIN (UNII: Q1LS2UJO3A)  
    WATER (UNII: 059QF0KO0R)  
    HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
    TRIDECYL STEARATE (UNII: A8OE252M6L)  
    POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)  
    POLY(METHYL METHACRYLATE; 450000 MW) (UNII: Z47NNT4J11)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    CERAMIDE NP (UNII: 4370DF050B)  
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    SOYBEAN OIL (UNII: 241ATL177A)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    MAGNESIUM CHLORIDE (UNII: 02F3473H9O)  
    POTASSIUM CHLORIDE (UNII: 660YQ98I10)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    WINE GRAPE (UNII: 3GOV20705G)  
    .BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)  
    LIMONENE, (+)- (UNII: GFD7C86Q1W)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)  
    LINALOOL, (+/-)- (UNII: D81QY6I88E)  
    .ALPHA.-AMYLCINNAMALDEHYDE (UNII: WC51CA3418)  
    MICA (UNII: V8A1AW0880)  
    D&C RED NO. 30 (UNII: 2S42T2808B)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    D&C RED NO. 21 (UNII: 08744Z6JNY)  
    D&C RED NO. 27 (UNII: 2LRS185U6K)  
    D&C RED NO. 7 (UNII: ECW0LZ41X8)  
    TALC (UNII: 7SEV7J4R1U)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    18 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35211/09/2016
    Part 19 of 42
    ESIKA HYDRACOLOR 2 IN 1 HIGHLY MOISTURIZING AND COLORING SPF 25  (ROSA GEOMETRIC) - PINK
    octinoxate and oxybenzone lipstick
    Product Information
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE0.0664 g  in 1 g
    OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE0.0151 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW)  
    TRIDECYL TRIMELLITATE (UNII: FY36J270ES)  
    ETHYLHEXYL PALMITATE (UNII: 2865993309)  
    CERESIN (UNII: Q1LS2UJO3A)  
    WATER (UNII: 059QF0KO0R)  
    HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
    TRIDECYL STEARATE (UNII: A8OE252M6L)  
    POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)  
    POLY(METHYL METHACRYLATE; 450000 MW) (UNII: Z47NNT4J11)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    CERAMIDE NP (UNII: 4370DF050B)  
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    SOYBEAN OIL (UNII: 241ATL177A)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    MAGNESIUM CHLORIDE (UNII: 02F3473H9O)  
    POTASSIUM CHLORIDE (UNII: 660YQ98I10)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    WINE GRAPE (UNII: 3GOV20705G)  
    .BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)  
    LIMONENE, (+)- (UNII: GFD7C86Q1W)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)  
    LINALOOL, (+/-)- (UNII: D81QY6I88E)  
    .ALPHA.-AMYLCINNAMALDEHYDE (UNII: WC51CA3418)  
    MICA (UNII: V8A1AW0880)  
    D&C RED NO. 30 (UNII: 2S42T2808B)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    D&C RED NO. 21 (UNII: 08744Z6JNY)  
    D&C RED NO. 27 (UNII: 2LRS185U6K)  
    D&C RED NO. 7 (UNII: ECW0LZ41X8)  
    TALC (UNII: 7SEV7J4R1U)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    18 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35211/09/2016
    Part 20 of 42
    ESIKA HYDRACOLOR 2 IN 1 HIGHLY MOISTURIZING AND COLORING SPF 25  (FUCSIA PRISMA) - RED
    octinoxate and oxybenzone lipstick
    Product Information
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE0.0664 g  in 1 g
    OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE0.0151 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW)  
    TRIDECYL TRIMELLITATE (UNII: FY36J270ES)  
    ETHYLHEXYL PALMITATE (UNII: 2865993309)  
    CERESIN (UNII: Q1LS2UJO3A)  
    WATER (UNII: 059QF0KO0R)  
    HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
    TRIDECYL STEARATE (UNII: A8OE252M6L)  
    POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)  
    POLY(METHYL METHACRYLATE; 450000 MW) (UNII: Z47NNT4J11)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    CERAMIDE NP (UNII: 4370DF050B)  
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    SOYBEAN OIL (UNII: 241ATL177A)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    MAGNESIUM CHLORIDE (UNII: 02F3473H9O)  
    POTASSIUM CHLORIDE (UNII: 660YQ98I10)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    WINE GRAPE (UNII: 3GOV20705G)  
    .BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)  
    LIMONENE, (+)- (UNII: GFD7C86Q1W)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)  
    LINALOOL, (+/-)- (UNII: D81QY6I88E)  
    .ALPHA.-AMYLCINNAMALDEHYDE (UNII: WC51CA3418)  
    MICA (UNII: V8A1AW0880)  
    D&C RED NO. 30 (UNII: 2S42T2808B)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    D&C RED NO. 21 (UNII: 08744Z6JNY)  
    D&C RED NO. 27 (UNII: 2LRS185U6K)  
    D&C RED NO. 7 (UNII: ECW0LZ41X8)  
    TALC (UNII: 7SEV7J4R1U)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    18 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35211/09/2016
    Part 21 of 42
    ESIKA HYDRACOLOR 2 IN 1 HIGHLY MOISTURIZING AND COLORING SPF 25  (NARANJA ESFERA) - ORANGE
    octinoxate and oxybenzone lipstick
    Product Information
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE0.0664 g  in 1 g
    OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE0.0151 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW)  
    TRIDECYL TRIMELLITATE (UNII: FY36J270ES)  
    ETHYLHEXYL PALMITATE (UNII: 2865993309)  
    CERESIN (UNII: Q1LS2UJO3A)  
    WATER (UNII: 059QF0KO0R)  
    HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
    TRIDECYL STEARATE (UNII: A8OE252M6L)  
    POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)  
    POLY(METHYL METHACRYLATE; 450000 MW) (UNII: Z47NNT4J11)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    CERAMIDE NP (UNII: 4370DF050B)  
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    SOYBEAN OIL (UNII: 241ATL177A)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    MAGNESIUM CHLORIDE (UNII: 02F3473H9O)  
    POTASSIUM CHLORIDE (UNII: 660YQ98I10)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    WINE GRAPE (UNII: 3GOV20705G)  
    .BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)  
    LIMONENE, (+)- (UNII: GFD7C86Q1W)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)  
    LINALOOL, (+/-)- (UNII: D81QY6I88E)  
    .ALPHA.-AMYLCINNAMALDEHYDE (UNII: WC51CA3418)  
    MICA (UNII: V8A1AW0880)  
    D&C RED NO. 30 (UNII: 2S42T2808B)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    D&C RED NO. 21 (UNII: 08744Z6JNY)  
    D&C RED NO. 27 (UNII: 2LRS185U6K)  
    D&C RED NO. 7 (UNII: ECW0LZ41X8)  
    TALC (UNII: 7SEV7J4R1U)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    18 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35211/09/2016
    Part 22 of 42
    ESIKA HYDRACOLOR 2 IN 1 HIGHLY MOISTURIZING AND COLORING SPF 25  (NUDE INFINITO) - BROWN
    octinoxate and oxybenzone lipstick
    Product Information
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE0.0664 g  in 1 g
    OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE0.0151 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW)  
    TRIDECYL TRIMELLITATE (UNII: FY36J270ES)  
    ETHYLHEXYL PALMITATE (UNII: 2865993309)  
    CERESIN (UNII: Q1LS2UJO3A)  
    WATER (UNII: 059QF0KO0R)  
    HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
    TRIDECYL STEARATE (UNII: A8OE252M6L)  
    POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)  
    POLY(METHYL METHACRYLATE; 450000 MW) (UNII: Z47NNT4J11)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    CERAMIDE NP (UNII: 4370DF050B)  
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    SOYBEAN OIL (UNII: 241ATL177A)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    MAGNESIUM CHLORIDE (UNII: 02F3473H9O)  
    POTASSIUM CHLORIDE (UNII: 660YQ98I10)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    WINE GRAPE (UNII: 3GOV20705G)  
    .BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)  
    LIMONENE, (+)- (UNII: GFD7C86Q1W)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)  
    LINALOOL, (+/-)- (UNII: D81QY6I88E)  
    .ALPHA.-AMYLCINNAMALDEHYDE (UNII: WC51CA3418)  
    MICA (UNII: V8A1AW0880)  
    D&C RED NO. 30 (UNII: 2S42T2808B)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    D&C RED NO. 21 (UNII: 08744Z6JNY)  
    D&C RED NO. 27 (UNII: 2LRS185U6K)  
    D&C RED NO. 7 (UNII: ECW0LZ41X8)  
    TALC (UNII: 7SEV7J4R1U)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    18 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35211/09/2016
    Part 23 of 42
    ESIKA HYDRACOLOR 2 IN 1 HIGHLY MOISTURIZING AND COLORING SPF 25  (ROJO ESIKA) - RED
    octinoxate and oxybenzone lipstick
    Product Information
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE0.0664 g  in 1 g
    OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE0.0151 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW)  
    TRIDECYL TRIMELLITATE (UNII: FY36J270ES)  
    ETHYLHEXYL PALMITATE (UNII: 2865993309)  
    CERESIN (UNII: Q1LS2UJO3A)  
    WATER (UNII: 059QF0KO0R)  
    HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
    TRIDECYL STEARATE (UNII: A8OE252M6L)  
    POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)  
    POLY(METHYL METHACRYLATE; 450000 MW) (UNII: Z47NNT4J11)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    CERAMIDE NP (UNII: 4370DF050B)  
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    SOYBEAN OIL (UNII: 241ATL177A)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    MAGNESIUM CHLORIDE (UNII: 02F3473H9O)  
    POTASSIUM CHLORIDE (UNII: 660YQ98I10)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    WINE GRAPE (UNII: 3GOV20705G)  
    .BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)  
    LIMONENE, (+)- (UNII: GFD7C86Q1W)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)  
    LINALOOL, (+/-)- (UNII: D81QY6I88E)  
    .ALPHA.-AMYLCINNAMALDEHYDE (UNII: WC51CA3418)  
    MICA (UNII: V8A1AW0880)  
    D&C RED NO. 30 (UNII: 2S42T2808B)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    D&C RED NO. 21 (UNII: 08744Z6JNY)  
    D&C RED NO. 27 (UNII: 2LRS185U6K)  
    D&C RED NO. 7 (UNII: ECW0LZ41X8)  
    TALC (UNII: 7SEV7J4R1U)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    18 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35211/09/2016
    Part 24 of 42
    ESIKA HYDRACOLOR 2 IN 1 HIGHLY MOISTURIZING AND COLORING SPF 25  (MARRON TOPACIO) - BROWN
    octinoxate and oxybenzone lipstick
    Product Information
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE0.0664 g  in 1 g
    OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE0.0151 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW)  
    TRIDECYL TRIMELLITATE (UNII: FY36J270ES)  
    ETHYLHEXYL PALMITATE (UNII: 2865993309)  
    CERESIN (UNII: Q1LS2UJO3A)  
    WATER (UNII: 059QF0KO0R)  
    HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
    TRIDECYL STEARATE (UNII: A8OE252M6L)  
    POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)  
    POLY(METHYL METHACRYLATE; 450000 MW) (UNII: Z47NNT4J11)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    CERAMIDE NP (UNII: 4370DF050B)  
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    SOYBEAN OIL (UNII: 241ATL177A)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    MAGNESIUM CHLORIDE (UNII: 02F3473H9O)  
    POTASSIUM CHLORIDE (UNII: 660YQ98I10)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    WINE GRAPE (UNII: 3GOV20705G)  
    .BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)  
    LIMONENE, (+)- (UNII: GFD7C86Q1W)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)  
    LINALOOL, (+/-)- (UNII: D81QY6I88E)  
    .ALPHA.-AMYLCINNAMALDEHYDE (UNII: WC51CA3418)  
    MICA (UNII: V8A1AW0880)  
    D&C RED NO. 30 (UNII: 2S42T2808B)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    D&C RED NO. 21 (UNII: 08744Z6JNY)  
    D&C RED NO. 27 (UNII: 2LRS185U6K)  
    D&C RED NO. 7 (UNII: ECW0LZ41X8)  
    TALC (UNII: 7SEV7J4R1U)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    18 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35211/09/2016
    Part 25 of 42
    ESIKA HYDRACOLOR 2 IN 1 HIGHLY MOISTURIZING AND COLORING SPF 25  (CORAL CUARZO) - ORANGE
    octinoxate and oxybenzone lipstick
    Product Information
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE0.0664 g  in 1 g
    OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE0.0151 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW)  
    TRIDECYL TRIMELLITATE (UNII: FY36J270ES)  
    ETHYLHEXYL PALMITATE (UNII: 2865993309)  
    CERESIN (UNII: Q1LS2UJO3A)  
    WATER (UNII: 059QF0KO0R)  
    HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
    TRIDECYL STEARATE (UNII: A8OE252M6L)  
    POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)  
    POLY(METHYL METHACRYLATE; 450000 MW) (UNII: Z47NNT4J11)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    CERAMIDE NP (UNII: 4370DF050B)  
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    SOYBEAN OIL (UNII: 241ATL177A)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    MAGNESIUM CHLORIDE (UNII: 02F3473H9O)  
    POTASSIUM CHLORIDE (UNII: 660YQ98I10)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    WINE GRAPE (UNII: 3GOV20705G)  
    .BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)  
    LIMONENE, (+)- (UNII: GFD7C86Q1W)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)  
    LINALOOL, (+/-)- (UNII: D81QY6I88E)  
    .ALPHA.-AMYLCINNAMALDEHYDE (UNII: WC51CA3418)  
    MICA (UNII: V8A1AW0880)  
    D&C RED NO. 30 (UNII: 2S42T2808B)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    D&C RED NO. 21 (UNII: 08744Z6JNY)  
    D&C RED NO. 27 (UNII: 2LRS185U6K)  
    D&C RED NO. 7 (UNII: ECW0LZ41X8)  
    TALC (UNII: 7SEV7J4R1U)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    18 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35211/09/2016
    Part 26 of 42
    ESIKA HYDRACOLOR 2 IN 1 HIGHLY MOISTURIZING AND COLORING SPF 25  (FUCSIA AMATISTA) - PINK
    octinoxate and oxybenzone lipstick
    Product Information
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE0.0664 g  in 1 g
    OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE0.0151 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW)  
    TRIDECYL TRIMELLITATE (UNII: FY36J270ES)  
    ETHYLHEXYL PALMITATE (UNII: 2865993309)  
    CERESIN (UNII: Q1LS2UJO3A)  
    WATER (UNII: 059QF0KO0R)  
    HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
    TRIDECYL STEARATE (UNII: A8OE252M6L)  
    POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)  
    POLY(METHYL METHACRYLATE; 450000 MW) (UNII: Z47NNT4J11)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    CERAMIDE NP (UNII: 4370DF050B)  
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    SOYBEAN OIL (UNII: 241ATL177A)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    MAGNESIUM CHLORIDE (UNII: 02F3473H9O)  
    POTASSIUM CHLORIDE (UNII: 660YQ98I10)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    WINE GRAPE (UNII: 3GOV20705G)  
    .BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)  
    LIMONENE, (+)- (UNII: GFD7C86Q1W)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)  
    LINALOOL, (+/-)- (UNII: D81QY6I88E)  
    .ALPHA.-AMYLCINNAMALDEHYDE (UNII: WC51CA3418)  
    MICA (UNII: V8A1AW0880)  
    D&C RED NO. 30 (UNII: 2S42T2808B)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    D&C RED NO. 21 (UNII: 08744Z6JNY)  
    D&C RED NO. 27 (UNII: 2LRS185U6K)  
    D&C RED NO. 7 (UNII: ECW0LZ41X8)  
    TALC (UNII: 7SEV7J4R1U)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    18 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35211/09/2016
    Part 27 of 42
    ESIKA HYDRACOLOR 2 IN 1 HIGHLY MOISTURIZING AND COLORING SPF 25  (NUDE PRISMA) - ORANGE
    octinoxate and oxybenzone lipstick
    Product Information
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE0.0664 g  in 1 g
    OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE0.0151 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW)  
    TRIDECYL TRIMELLITATE (UNII: FY36J270ES)  
    ETHYLHEXYL PALMITATE (UNII: 2865993309)  
    CERESIN (UNII: Q1LS2UJO3A)  
    WATER (UNII: 059QF0KO0R)  
    HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
    TRIDECYL STEARATE (UNII: A8OE252M6L)  
    POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)  
    POLY(METHYL METHACRYLATE; 450000 MW) (UNII: Z47NNT4J11)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    CERAMIDE NP (UNII: 4370DF050B)  
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    SOYBEAN OIL (UNII: 241ATL177A)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    MAGNESIUM CHLORIDE (UNII: 02F3473H9O)  
    POTASSIUM CHLORIDE (UNII: 660YQ98I10)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    WINE GRAPE (UNII: 3GOV20705G)  
    .BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)  
    LIMONENE, (+)- (UNII: GFD7C86Q1W)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)  
    LINALOOL, (+/-)- (UNII: D81QY6I88E)  
    .ALPHA.-AMYLCINNAMALDEHYDE (UNII: WC51CA3418)  
    MICA (UNII: V8A1AW0880)  
    D&C RED NO. 30 (UNII: 2S42T2808B)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    D&C RED NO. 21 (UNII: 08744Z6JNY)  
    D&C RED NO. 27 (UNII: 2LRS185U6K)  
    D&C RED NO. 7 (UNII: ECW0LZ41X8)  
    TALC (UNII: 7SEV7J4R1U)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    18 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35211/09/2016
    Part 28 of 42
    ESIKA HYDRACOLOR 2 IN 1 HIGHLY MOISTURIZING AND COLORING SPF 25  (DORADO ESENCIAL) - YELLOW
    octinoxate and oxybenzone lipstick
    Product Information
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE0.0664 g  in 1 g
    OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE0.0151 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW)  
    TRIDECYL TRIMELLITATE (UNII: FY36J270ES)  
    ETHYLHEXYL PALMITATE (UNII: 2865993309)  
    CERESIN (UNII: Q1LS2UJO3A)  
    WATER (UNII: 059QF0KO0R)  
    HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
    TRIDECYL STEARATE (UNII: A8OE252M6L)  
    POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)  
    POLY(METHYL METHACRYLATE; 450000 MW) (UNII: Z47NNT4J11)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    CERAMIDE NP (UNII: 4370DF050B)  
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    SOYBEAN OIL (UNII: 241ATL177A)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    MAGNESIUM CHLORIDE (UNII: 02F3473H9O)  
    POTASSIUM CHLORIDE (UNII: 660YQ98I10)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    WINE GRAPE (UNII: 3GOV20705G)  
    .BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)  
    LIMONENE, (+)- (UNII: GFD7C86Q1W)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)  
    LINALOOL, (+/-)- (UNII: D81QY6I88E)  
    .ALPHA.-AMYLCINNAMALDEHYDE (UNII: WC51CA3418)  
    MICA (UNII: V8A1AW0880)  
    D&C RED NO. 30 (UNII: 2S42T2808B)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    D&C RED NO. 21 (UNII: 08744Z6JNY)  
    D&C RED NO. 27 (UNII: 2LRS185U6K)  
    D&C RED NO. 7 (UNII: ECW0LZ41X8)  
    TALC (UNII: 7SEV7J4R1U)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    18 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35211/09/2016
    Part 29 of 42
    ESIKA HYDRACOLOR 2 IN 1 HIGHLY MOISTURIZING AND COLORING SPF 25  (ROSA ENCANTO FEMME) - PINK
    octinoxate and oxybenzone lipstick
    Product Information
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE0.0664 g  in 1 g
    OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE0.0151 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW)  
    TRIDECYL TRIMELLITATE (UNII: FY36J270ES)  
    ETHYLHEXYL PALMITATE (UNII: 2865993309)  
    CERESIN (UNII: Q1LS2UJO3A)  
    WATER (UNII: 059QF0KO0R)  
    HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
    TRIDECYL STEARATE (UNII: A8OE252M6L)  
    POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)  
    POLY(METHYL METHACRYLATE; 450000 MW) (UNII: Z47NNT4J11)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    CERAMIDE NP (UNII: 4370DF050B)  
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    SOYBEAN OIL (UNII: 241ATL177A)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    MAGNESIUM CHLORIDE (UNII: 02F3473H9O)  
    POTASSIUM CHLORIDE (UNII: 660YQ98I10)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    WINE GRAPE (UNII: 3GOV20705G)  
    .BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)  
    LIMONENE, (+)- (UNII: GFD7C86Q1W)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)  
    LINALOOL, (+/-)- (UNII: D81QY6I88E)  
    .ALPHA.-AMYLCINNAMALDEHYDE (UNII: WC51CA3418)  
    MICA (UNII: V8A1AW0880)  
    D&C RED NO. 30 (UNII: 2S42T2808B)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    D&C RED NO. 21 (UNII: 08744Z6JNY)  
    D&C RED NO. 27 (UNII: 2LRS185U6K)  
    D&C RED NO. 7 (UNII: ECW0LZ41X8)  
    TALC (UNII: 7SEV7J4R1U)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    18 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35211/09/2016
    Part 30 of 42
    ESIKA HYDRACOLOR 2 IN 1 HIGHLY MOISTURIZING AND COLORING SPF 25  (PIMIENTA CALIENTE FEMME) - RED
    octinoxate and oxybenzone lipstick
    Product Information
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE0.0664 g  in 1 g
    OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE0.0151 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW)  
    TRIDECYL TRIMELLITATE (UNII: FY36J270ES)  
    ETHYLHEXYL PALMITATE (UNII: 2865993309)  
    CERESIN (UNII: Q1LS2UJO3A)  
    WATER (UNII: 059QF0KO0R)  
    HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
    TRIDECYL STEARATE (UNII: A8OE252M6L)  
    POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)  
    POLY(METHYL METHACRYLATE; 450000 MW) (UNII: Z47NNT4J11)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    CERAMIDE NP (UNII: 4370DF050B)  
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    SOYBEAN OIL (UNII: 241ATL177A)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    MAGNESIUM CHLORIDE (UNII: 02F3473H9O)  
    POTASSIUM CHLORIDE (UNII: 660YQ98I10)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    WINE GRAPE (UNII: 3GOV20705G)  
    .BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)  
    LIMONENE, (+)- (UNII: GFD7C86Q1W)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)  
    LINALOOL, (+/-)- (UNII: D81QY6I88E)  
    .ALPHA.-AMYLCINNAMALDEHYDE (UNII: WC51CA3418)  
    MICA (UNII: V8A1AW0880)  
    D&C RED NO. 30 (UNII: 2S42T2808B)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    D&C RED NO. 21 (UNII: 08744Z6JNY)  
    D&C RED NO. 27 (UNII: 2LRS185U6K)  
    D&C RED NO. 7 (UNII: ECW0LZ41X8)  
    TALC (UNII: 7SEV7J4R1U)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    18 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35211/09/2016
    Part 31 of 42
    ESIKA HYDRACOLOR 2 IN 1 HIGHLY MOISTURIZING AND COLORING SPF 25  (GRANATE SEDUCTOR FEMME) - PURPLE
    octinoxate and oxybenzone lipstick
    Product Information
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE0.0664 g  in 1 g
    OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE0.0151 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW)  
    TRIDECYL TRIMELLITATE (UNII: FY36J270ES)  
    ETHYLHEXYL PALMITATE (UNII: 2865993309)  
    CERESIN (UNII: Q1LS2UJO3A)  
    WATER (UNII: 059QF0KO0R)  
    HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
    TRIDECYL STEARATE (UNII: A8OE252M6L)  
    POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)  
    POLY(METHYL METHACRYLATE; 450000 MW) (UNII: Z47NNT4J11)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    CERAMIDE NP (UNII: 4370DF050B)  
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    SOYBEAN OIL (UNII: 241ATL177A)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    MAGNESIUM CHLORIDE (UNII: 02F3473H9O)  
    POTASSIUM CHLORIDE (UNII: 660YQ98I10)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    WINE GRAPE (UNII: 3GOV20705G)  
    .BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)  
    LIMONENE, (+)- (UNII: GFD7C86Q1W)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)  
    LINALOOL, (+/-)- (UNII: D81QY6I88E)  
    .ALPHA.-AMYLCINNAMALDEHYDE (UNII: WC51CA3418)  
    MICA (UNII: V8A1AW0880)  
    D&C RED NO. 30 (UNII: 2S42T2808B)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    D&C RED NO. 21 (UNII: 08744Z6JNY)  
    D&C RED NO. 27 (UNII: 2LRS185U6K)  
    D&C RED NO. 7 (UNII: ECW0LZ41X8)  
    TALC (UNII: 7SEV7J4R1U)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    18 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35211/09/2016
    Part 32 of 42
    ESIKA HYDRACOLOR 2 IN 1 HIGHLY MOISTURIZING AND COLORING SPF 25  (ROSA ROMANTICA FEMME) - PINK
    octinoxate and oxybenzone lipstick
    Product Information
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE0.0664 g  in 1 g
    OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE0.0151 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW)  
    TRIDECYL TRIMELLITATE (UNII: FY36J270ES)  
    ETHYLHEXYL PALMITATE (UNII: 2865993309)  
    CERESIN (UNII: Q1LS2UJO3A)  
    WATER (UNII: 059QF0KO0R)  
    HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
    TRIDECYL STEARATE (UNII: A8OE252M6L)  
    POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)  
    POLY(METHYL METHACRYLATE; 450000 MW) (UNII: Z47NNT4J11)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    CERAMIDE NP (UNII: 4370DF050B)  
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    SOYBEAN OIL (UNII: 241ATL177A)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    MAGNESIUM CHLORIDE (UNII: 02F3473H9O)  
    POTASSIUM CHLORIDE (UNII: 660YQ98I10)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    WINE GRAPE (UNII: 3GOV20705G)  
    .BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)  
    LIMONENE, (+)- (UNII: GFD7C86Q1W)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)  
    LINALOOL, (+/-)- (UNII: D81QY6I88E)  
    .ALPHA.-AMYLCINNAMALDEHYDE (UNII: WC51CA3418)  
    MICA (UNII: V8A1AW0880)  
    D&C RED NO. 30 (UNII: 2S42T2808B)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    D&C RED NO. 21 (UNII: 08744Z6JNY)  
    D&C RED NO. 27 (UNII: 2LRS185U6K)  
    D&C RED NO. 7 (UNII: ECW0LZ41X8)  
    TALC (UNII: 7SEV7J4R1U)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    18 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35211/09/2016
    Part 33 of 42
    ESIKA HYDRACOLOR 2 IN 1 HIGHLY MOISTURIZING AND COLORING SPF 25  (FUCSIA CAUTIVANTE FEMME) - PINK
    octinoxate and oxybenzone lipstick
    Product Information
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE0.0664 g  in 1 g
    OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE0.0151 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW)  
    TRIDECYL TRIMELLITATE (UNII: FY36J270ES)  
    ETHYLHEXYL PALMITATE (UNII: 2865993309)  
    CERESIN (UNII: Q1LS2UJO3A)  
    WATER (UNII: 059QF0KO0R)  
    HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
    TRIDECYL STEARATE (UNII: A8OE252M6L)  
    POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)  
    POLY(METHYL METHACRYLATE; 450000 MW) (UNII: Z47NNT4J11)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    CERAMIDE NP (UNII: 4370DF050B)  
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    SOYBEAN OIL (UNII: 241ATL177A)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    MAGNESIUM CHLORIDE (UNII: 02F3473H9O)  
    POTASSIUM CHLORIDE (UNII: 660YQ98I10)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    WINE GRAPE (UNII: 3GOV20705G)  
    .BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)  
    LIMONENE, (+)- (UNII: GFD7C86Q1W)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)  
    LINALOOL, (+/-)- (UNII: D81QY6I88E)  
    .ALPHA.-AMYLCINNAMALDEHYDE (UNII: WC51CA3418)  
    MICA (UNII: V8A1AW0880)  
    D&C RED NO. 30 (UNII: 2S42T2808B)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    D&C RED NO. 21 (UNII: 08744Z6JNY)  
    D&C RED NO. 27 (UNII: 2LRS185U6K)  
    D&C RED NO. 7 (UNII: ECW0LZ41X8)  
    TALC (UNII: 7SEV7J4R1U)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    18 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35211/09/2016
    Part 34 of 42
    ESIKA HYDRACOLOR 2 IN 1 HIGHLY MOISTURIZING AND COLORING SPF 25  (ROJO INTRIGANTE FEMME) - RED
    octinoxate and oxybenzone lipstick
    Product Information
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE0.0664 g  in 1 g
    OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE0.0151 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW)  
    TRIDECYL TRIMELLITATE (UNII: FY36J270ES)  
    ETHYLHEXYL PALMITATE (UNII: 2865993309)  
    CERESIN (UNII: Q1LS2UJO3A)  
    WATER (UNII: 059QF0KO0R)  
    HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
    TRIDECYL STEARATE (UNII: A8OE252M6L)  
    POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)  
    POLY(METHYL METHACRYLATE; 450000 MW) (UNII: Z47NNT4J11)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    CERAMIDE NP (UNII: 4370DF050B)  
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    SOYBEAN OIL (UNII: 241ATL177A)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    MAGNESIUM CHLORIDE (UNII: 02F3473H9O)  
    POTASSIUM CHLORIDE (UNII: 660YQ98I10)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    WINE GRAPE (UNII: 3GOV20705G)  
    .BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)  
    LIMONENE, (+)- (UNII: GFD7C86Q1W)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)  
    LINALOOL, (+/-)- (UNII: D81QY6I88E)  
    .ALPHA.-AMYLCINNAMALDEHYDE (UNII: WC51CA3418)  
    MICA (UNII: V8A1AW0880)  
    D&C RED NO. 30 (UNII: 2S42T2808B)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    D&C RED NO. 21 (UNII: 08744Z6JNY)  
    D&C RED NO. 27 (UNII: 2LRS185U6K)  
    D&C RED NO. 7 (UNII: ECW0LZ41X8)  
    TALC (UNII: 7SEV7J4R1U)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    18 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35211/09/2016
    Part 35 of 42
    ESIKA HYDRACOLOR 2 IN 1 HIGHLY MOISTURIZING AND COLORING SPF 25  (PIMIENTA CALIENTE EXOTIC) - RED
    octinoxate and oxybenzone lipstick
    Product Information
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE0.0664 g  in 1 g
    OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE0.0151 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW)  
    TRIDECYL TRIMELLITATE (UNII: FY36J270ES)  
    ETHYLHEXYL PALMITATE (UNII: 2865993309)  
    CERESIN (UNII: Q1LS2UJO3A)  
    WATER (UNII: 059QF0KO0R)  
    HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
    TRIDECYL STEARATE (UNII: A8OE252M6L)  
    POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)  
    POLY(METHYL METHACRYLATE; 450000 MW) (UNII: Z47NNT4J11)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    CERAMIDE NP (UNII: 4370DF050B)  
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    SOYBEAN OIL (UNII: 241ATL177A)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    MAGNESIUM CHLORIDE (UNII: 02F3473H9O)  
    POTASSIUM CHLORIDE (UNII: 660YQ98I10)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    WINE GRAPE (UNII: 3GOV20705G)  
    .BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)  
    LIMONENE, (+)- (UNII: GFD7C86Q1W)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)  
    LINALOOL, (+/-)- (UNII: D81QY6I88E)  
    .ALPHA.-AMYLCINNAMALDEHYDE (UNII: WC51CA3418)  
    MICA (UNII: V8A1AW0880)  
    D&C RED NO. 30 (UNII: 2S42T2808B)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    D&C RED NO. 21 (UNII: 08744Z6JNY)  
    D&C RED NO. 27 (UNII: 2LRS185U6K)  
    D&C RED NO. 7 (UNII: ECW0LZ41X8)  
    TALC (UNII: 7SEV7J4R1U)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    18 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35211/09/2016
    Part 36 of 42
    ESIKA HYDRACOLOR 2 IN 1 HIGHLY MOISTURIZING AND COLORING SPF 25  (ROSA ENCANTO EXOTIC) - PINK
    octinoxate and oxybenzone lipstick
    Product Information
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE0.0664 g  in 1 g
    OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE0.0151 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW)  
    TRIDECYL TRIMELLITATE (UNII: FY36J270ES)  
    ETHYLHEXYL PALMITATE (UNII: 2865993309)  
    CERESIN (UNII: Q1LS2UJO3A)  
    WATER (UNII: 059QF0KO0R)  
    HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
    TRIDECYL STEARATE (UNII: A8OE252M6L)  
    POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)  
    POLY(METHYL METHACRYLATE; 450000 MW) (UNII: Z47NNT4J11)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    CERAMIDE NP (UNII: 4370DF050B)  
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    SOYBEAN OIL (UNII: 241ATL177A)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    MAGNESIUM CHLORIDE (UNII: 02F3473H9O)  
    POTASSIUM CHLORIDE (UNII: 660YQ98I10)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    WINE GRAPE (UNII: 3GOV20705G)  
    .BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)  
    LIMONENE, (+)- (UNII: GFD7C86Q1W)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)  
    LINALOOL, (+/-)- (UNII: D81QY6I88E)  
    .ALPHA.-AMYLCINNAMALDEHYDE (UNII: WC51CA3418)  
    MICA (UNII: V8A1AW0880)  
    D&C RED NO. 30 (UNII: 2S42T2808B)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    D&C RED NO. 21 (UNII: 08744Z6JNY)  
    D&C RED NO. 27 (UNII: 2LRS185U6K)  
    D&C RED NO. 7 (UNII: ECW0LZ41X8)  
    TALC (UNII: 7SEV7J4R1U)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    18 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35211/09/2016
    Part 37 of 42
    ESIKA HYDRACOLOR 2 IN 1 HIGHLY MOISTURIZING AND COLORING SPF 25  (CORAL CHIC EXOTIC) - ORANGE
    octinoxate and oxybenzone lipstick
    Product Information
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE0.0664 g  in 1 g
    OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE0.0151 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW)  
    TRIDECYL TRIMELLITATE (UNII: FY36J270ES)  
    ETHYLHEXYL PALMITATE (UNII: 2865993309)  
    CERESIN (UNII: Q1LS2UJO3A)  
    WATER (UNII: 059QF0KO0R)  
    HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
    TRIDECYL STEARATE (UNII: A8OE252M6L)  
    POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)  
    POLY(METHYL METHACRYLATE; 450000 MW) (UNII: Z47NNT4J11)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    CERAMIDE NP (UNII: 4370DF050B)  
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    SOYBEAN OIL (UNII: 241ATL177A)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    MAGNESIUM CHLORIDE (UNII: 02F3473H9O)  
    POTASSIUM CHLORIDE (UNII: 660YQ98I10)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    WINE GRAPE (UNII: 3GOV20705G)  
    .BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)  
    LIMONENE, (+)- (UNII: GFD7C86Q1W)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)  
    LINALOOL, (+/-)- (UNII: D81QY6I88E)  
    .ALPHA.-AMYLCINNAMALDEHYDE (UNII: WC51CA3418)  
    MICA (UNII: V8A1AW0880)  
    D&C RED NO. 30 (UNII: 2S42T2808B)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    D&C RED NO. 21 (UNII: 08744Z6JNY)  
    D&C RED NO. 27 (UNII: 2LRS185U6K)  
    D&C RED NO. 7 (UNII: ECW0LZ41X8)  
    TALC (UNII: 7SEV7J4R1U)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    18 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35211/09/2016
    Part 38 of 42
    ESIKA HYDRACOLOR 2 IN 1 HIGHLY MOISTURIZING AND COLORING SPF 25  (FUCSIA CAUTIVANTE EXOTIC) - PINK
    octinoxate and oxybenzone lipstick
    Product Information
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE0.0664 g  in 1 g
    OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE0.0151 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW)  
    TRIDECYL TRIMELLITATE (UNII: FY36J270ES)  
    ETHYLHEXYL PALMITATE (UNII: 2865993309)  
    CERESIN (UNII: Q1LS2UJO3A)  
    WATER (UNII: 059QF0KO0R)  
    HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
    TRIDECYL STEARATE (UNII: A8OE252M6L)  
    POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)  
    POLY(METHYL METHACRYLATE; 450000 MW) (UNII: Z47NNT4J11)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    CERAMIDE NP (UNII: 4370DF050B)  
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    SOYBEAN OIL (UNII: 241ATL177A)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    MAGNESIUM CHLORIDE (UNII: 02F3473H9O)  
    POTASSIUM CHLORIDE (UNII: 660YQ98I10)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    WINE GRAPE (UNII: 3GOV20705G)  
    .BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)  
    LIMONENE, (+)- (UNII: GFD7C86Q1W)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)  
    LINALOOL, (+/-)- (UNII: D81QY6I88E)  
    .ALPHA.-AMYLCINNAMALDEHYDE (UNII: WC51CA3418)  
    MICA (UNII: V8A1AW0880)  
    D&C RED NO. 30 (UNII: 2S42T2808B)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    D&C RED NO. 21 (UNII: 08744Z6JNY)  
    D&C RED NO. 27 (UNII: 2LRS185U6K)  
    D&C RED NO. 7 (UNII: ECW0LZ41X8)  
    TALC (UNII: 7SEV7J4R1U)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    18 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35211/09/2016
    Part 39 of 42
    ESIKA HYDRACOLOR 2 IN 1 HIGHLY MOISTURIZING AND COLORING SPF 25  (ROJO DESEO EXOTIC) - RED
    octinoxate and oxybenzone lipstick
    Product Information
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE0.0664 g  in 1 g
    OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE0.0151 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW)  
    TRIDECYL TRIMELLITATE (UNII: FY36J270ES)  
    ETHYLHEXYL PALMITATE (UNII: 2865993309)  
    CERESIN (UNII: Q1LS2UJO3A)  
    WATER (UNII: 059QF0KO0R)  
    HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
    TRIDECYL STEARATE (UNII: A8OE252M6L)  
    POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)  
    POLY(METHYL METHACRYLATE; 450000 MW) (UNII: Z47NNT4J11)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    CERAMIDE NP (UNII: 4370DF050B)  
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    SOYBEAN OIL (UNII: 241ATL177A)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    MAGNESIUM CHLORIDE (UNII: 02F3473H9O)  
    POTASSIUM CHLORIDE (UNII: 660YQ98I10)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    WINE GRAPE (UNII: 3GOV20705G)  
    .BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)  
    LIMONENE, (+)- (UNII: GFD7C86Q1W)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)  
    LINALOOL, (+/-)- (UNII: D81QY6I88E)  
    .ALPHA.-AMYLCINNAMALDEHYDE (UNII: WC51CA3418)  
    MICA (UNII: V8A1AW0880)  
    D&C RED NO. 30 (UNII: 2S42T2808B)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    D&C RED NO. 21 (UNII: 08744Z6JNY)  
    D&C RED NO. 27 (UNII: 2LRS185U6K)  
    D&C RED NO. 7 (UNII: ECW0LZ41X8)  
    TALC (UNII: 7SEV7J4R1U)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    18 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35211/09/2016
    Part 40 of 42
    ESIKA HYDRACOLOR 2 IN 1 HIGHLY MOISTURIZING AND COLORING SPF 25  (FRAMBUESA MANIA EXOTIC) - PINK
    octinoxate and oxybenzone lipstick
    Product Information
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE0.0664 g  in 1 g
    OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE0.0151 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW)  
    TRIDECYL TRIMELLITATE (UNII: FY36J270ES)  
    ETHYLHEXYL PALMITATE (UNII: 2865993309)  
    CERESIN (UNII: Q1LS2UJO3A)  
    WATER (UNII: 059QF0KO0R)  
    HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
    TRIDECYL STEARATE (UNII: A8OE252M6L)  
    POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)  
    POLY(METHYL METHACRYLATE; 450000 MW) (UNII: Z47NNT4J11)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    CERAMIDE NP (UNII: 4370DF050B)  
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    SOYBEAN OIL (UNII: 241ATL177A)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    MAGNESIUM CHLORIDE (UNII: 02F3473H9O)  
    POTASSIUM CHLORIDE (UNII: 660YQ98I10)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    WINE GRAPE (UNII: 3GOV20705G)  
    .BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)  
    LIMONENE, (+)- (UNII: GFD7C86Q1W)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)  
    LINALOOL, (+/-)- (UNII: D81QY6I88E)  
    .ALPHA.-AMYLCINNAMALDEHYDE (UNII: WC51CA3418)  
    MICA (UNII: V8A1AW0880)  
    D&C RED NO. 30 (UNII: 2S42T2808B)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    D&C RED NO. 21 (UNII: 08744Z6JNY)  
    D&C RED NO. 27 (UNII: 2LRS185U6K)  
    D&C RED NO. 7 (UNII: ECW0LZ41X8)  
    TALC (UNII: 7SEV7J4R1U)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    18 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35211/09/2016
    Part 41 of 42
    ESIKA HYDRACOLOR 2 IN 1 HIGHLY MOISTURIZING AND COLORING SPF 25  (BORGONA SEXY EXOTIC) - PURPLE
    octinoxate and oxybenzone lipstick
    Product Information
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE0.0664 g  in 1 g
    OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE0.0151 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW)  
    TRIDECYL TRIMELLITATE (UNII: FY36J270ES)  
    ETHYLHEXYL PALMITATE (UNII: 2865993309)  
    CERESIN (UNII: Q1LS2UJO3A)  
    WATER (UNII: 059QF0KO0R)  
    HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
    TRIDECYL STEARATE (UNII: A8OE252M6L)  
    POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)  
    POLY(METHYL METHACRYLATE; 450000 MW) (UNII: Z47NNT4J11)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    CERAMIDE NP (UNII: 4370DF050B)  
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    SOYBEAN OIL (UNII: 241ATL177A)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    MAGNESIUM CHLORIDE (UNII: 02F3473H9O)  
    POTASSIUM CHLORIDE (UNII: 660YQ98I10)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    WINE GRAPE (UNII: 3GOV20705G)  
    .BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)  
    LIMONENE, (+)- (UNII: GFD7C86Q1W)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)  
    LINALOOL, (+/-)- (UNII: D81QY6I88E)  
    .ALPHA.-AMYLCINNAMALDEHYDE (UNII: WC51CA3418)  
    MICA (UNII: V8A1AW0880)  
    D&C RED NO. 30 (UNII: 2S42T2808B)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    D&C RED NO. 21 (UNII: 08744Z6JNY)  
    D&C RED NO. 27 (UNII: 2LRS185U6K)  
    D&C RED NO. 7 (UNII: ECW0LZ41X8)  
    TALC (UNII: 7SEV7J4R1U)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    18 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35211/09/2016
    Part 42 of 42
    ESIKA HYDRACOLOR 2 IN 1 HIGHLY MOISTURIZING AND COLORING SPF 25  (MARRON GLAMOUR EXOTIC) - BROWN
    octinoxate and oxybenzone lipstick
    Product Information
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE0.0664 g  in 1 g
    OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE0.0151 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW)  
    TRIDECYL TRIMELLITATE (UNII: FY36J270ES)  
    ETHYLHEXYL PALMITATE (UNII: 2865993309)  
    CERESIN (UNII: Q1LS2UJO3A)  
    WATER (UNII: 059QF0KO0R)  
    HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
    TRIDECYL STEARATE (UNII: A8OE252M6L)  
    POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)  
    POLY(METHYL METHACRYLATE; 450000 MW) (UNII: Z47NNT4J11)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    CERAMIDE NP (UNII: 4370DF050B)  
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    SOYBEAN OIL (UNII: 241ATL177A)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    MAGNESIUM CHLORIDE (UNII: 02F3473H9O)  
    POTASSIUM CHLORIDE (UNII: 660YQ98I10)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    WINE GRAPE (UNII: 3GOV20705G)  
    .BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)  
    LIMONENE, (+)- (UNII: GFD7C86Q1W)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)  
    LINALOOL, (+/-)- (UNII: D81QY6I88E)  
    .ALPHA.-AMYLCINNAMALDEHYDE (UNII: WC51CA3418)  
    MICA (UNII: V8A1AW0880)  
    D&C RED NO. 30 (UNII: 2S42T2808B)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    D&C RED NO. 21 (UNII: 08744Z6JNY)  
    D&C RED NO. 27 (UNII: 2LRS185U6K)  
    D&C RED NO. 7 (UNII: ECW0LZ41X8)  
    TALC (UNII: 7SEV7J4R1U)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    18 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35211/09/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35211/09/2016
    Labeler - Ventura Corporation LTD (602751344)
    Establishment
    NameAddressID/FEIBusiness Operations
    Bel Star S.A. (Colombia)880160197MANUFACTURE(13537-475, 13537-476, 13537-477, 13537-478, 13537-479, 13537-880, 13537-804, 13537-805, 13537-806, 13537-807, 13537-808, 13537-809, 13537-810, 13537-811, 13537-812, 13537-813, 13537-814, 13537-815, 13537-816, 13537-817, 13537-818, 13537-819, 13537-820, 13537-821, 13537-822, 13537-823, 13537-824, 13537-825, 13537-826, 13537-827, 13537-828, 13537-829, 13537-830, 13537-831, 13537-832, 13537-833, 13537-834, 13537-835, 13537-836, 13537-837, 13537-838, 13537-839, 13537-840)
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