Label: ESIKA PRO HIDRACOLOR 3 IN 1 MOISTURIZING, COLOR AND PERFECTING EFFECT SPF 25 (PIMIENTA CALIENTE) - BROWN- octinoxate and zinc oxide lipstick
ESIKA PRO HIDRACOLOR 3 IN 1 MOISTURIZING, COLOR AND PERFECTING EFFECT SPF 25 (ROJO DESEO) - RED- octinoxate and zinc oxide lipstick
ESIKA PRO HIDRACOLOR 3 IN 1 MOISTURIZING, COLOR AND PERFECTING EFFECT SPF 25 (ROJO ESIKA) - RED (octino .......RO HIDRACOLOR 3 IN 1 MOISTURIZING, COLOR AND PERFECTING EFFECT SPF 25 (NUDE MOCCHA) - ORANGE- octinoxate and zinc oxide lipstick
ESIKA PRO HIDRACOLOR 3 IN 1 MOISTURIZING, COLOR AND PERFECTING EFFECT SPF 25 (BRONCE METALLIC) - BROWN- octinoxate and zinc oxide lipstick
ESIKA PRO HIDRACOLOR 3 IN 1 MOISTURIZING, COLOR AND PERFECTING EFFECT SPF 25- octinoxate and zinc oxide kit

  • Contains inactivated NDC Code(s)
    NDC Code(s):
    13537-958-01, 13537-958-02, 13537-959-03, 13537-959-04, view more
    13537-960-05, 13537-960-06, 13537-966-07, 13537-966-08, 13537-967-09, 13537-967-10, 13537-968-11, 13537-968-12, 13537-969-13, 13537-969-14, 13537-970-17, 13537-970-18, 13537-971-19, 13537-971-20, 13537-972-21, 13537-972-22, 13537-973-23, 13537-973-24, 13537-974-23, 13537-974-24, 13537-975-23, 13537-975-24, 13537-976-23, 13537-976-24, 13537-977-23, 13537-977-24, 13537-978-23, 13537-978-24, 13537-979-23, 13537-979-24, 13537-980-23, 13537-980-24, 13537-981-23, 13537-981-24, 13537-982-23, 13537-982-24, 13537-983-23, 13537-983-24, 13537-984-23, 13537-984-24, 13537-985-23, 13537-985-24, 13537-986-23, 13537-986-24, 13537-987-27, 13537-987-28
  • Packager: Ventura Corporation LTD DUNS
  • Category: HUMAN OTC DRUG LABEL

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 26, 2018

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active IngredientsPurpose
    OCTINOXATE 7.5%Sunscreen
    ZINC OXIDE 3.92%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, ISONONYL ISONONANOATE, OZOKERITE, WATER, POLYGLYCERYL-3 DIISOSTEARATE, TRIDECYL STEARATE, POLYETHYLENE, COPERNICIA CERIFERA (CARNAUBA) WAX, GLYCERIN, NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE, BUTYROSPERMUM PARKII (SHEA) BUTTER, PTFE, SODIUM STARCH OCTENYLSUCCINATE, TOCOPHERYL ACETATE, CAPRYLIC/CAPRIC TRIGLYCERIDE, PHENOXYETHANOL, COCOS NUCIFERA (COCONUT) OIL, ALOE BARBADENSIS LEAF EXTRACT, FRAGRANCE, CERAMIDE 3, CAPRYLYL GLYCOL, CHLORPHENESIN, DIMETHICONE, TRIETHOXYCAPRYLYLSILANE, GLYCINE SOJA (SOYBEAN) OIL, LIMONIUM GERBERI EXTRACT, TRIMETHYLSILOXYSILICATE, TOCOPHEROL, MAGNESIUM CHLORIDE, POTASSIUM CHLORIDE, SILICA, SODIUM CHLORIDE, CRAMBE MARITIMA EXTRACT, ALPHA-ISOMETHYL IONONE, d-LIMONENE, LINALOOL, AMYL CINNAMAL, CITRONELLOL.

    MAY CONTAIN: RED 30 LAKE, TITANIUM DIOXIDE, IRON OXIDES, MICA, RED 27 LAKE, YELLOW 5 LAKE, RED 7 LAKE, RED 21 LAKE, TALC, BLUE 1 LAKE, 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
    PRO

    HIDRACOLOR
    3 IN 1

    Moisturizing Lipstick,
    Color and Perfecting
    Effect 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 - (ROJO DESEO) - RED

    ésika
    PRO

    HIDRACOLOR
    3 IN 1

    Moisturizing Lipstick,
    Color and Perfecting
    Effect 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 ESIKA) - RED

    ésika
    PRO

    HIDRACOLOR
    3 IN 1

    Moisturizing Lipstick,
    Color and Perfecting
    Effect 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
    PRO

    HIDRACOLOR
    3 IN 1

    Moisturizing Lipstick,
    Color and Perfecting
    Effect 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 - (ROSA GEOMETRIC) - PINK

    ésika
    PRO

    HIDRACOLOR
    3 IN 1

    Moisturizing Lipstick,
    Color and Perfecting
    Effect 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 - (ROSA ENCANTO) - PINK

    ésika
    PRO

    HIDRACOLOR
    3 IN 1

    Moisturizing Lipstick,
    Color and Perfecting
    Effect 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 - (MORA GLAM) - PURPLE

    ésika
    PRO

    HIDRACOLOR
    3 IN 1

    Moisturizing Lipstick,
    Color and Perfecting
    Effect SPF 25

    Net Weight
    0.14 oz. e (4 g)

    PRINCIPAL DISPLAY PANEL - 4 g Tube Box - (MORA GLAM) - PURPLE
  • PRINCIPAL DISPLAY PANEL - 4 g Tube Box - (GRANATE SEDUCTOR) - PURPLE

    ésika
    PRO

    HIDRACOLOR
    3 IN 1

    Moisturizing Lipstick,
    Color and Perfecting
    Effect 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 - (BORGONA SEXY) - PURPLE

    ésika
    PRO

    HIDRACOLOR
    3 IN 1

    Moisturizing Lipstick,
    Color and Perfecting
    Effect 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 - (FRESA HOT) - PINK

    ésika
    PRO

    HIDRACOLOR
    3 IN 1

    Moisturizing Lipstick,
    Color and Perfecting
    Effect SPF 25

    Net Weight
    0.14 oz. e (4 g)

    PRINCIPAL DISPLAY PANEL - 4 g Tube Box - (FRESA HOT) - PINK
  • PRINCIPAL DISPLAY PANEL - 4 g Tube Box - (FUCSIA CAUTIVANTE) - PINK

    ésika
    PRO

    HIDRACOLOR
    3 IN 1

    Moisturizing Lipstick,
    Color and Perfecting
    Effect 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 - (FUCSIA INTENSE) - PINK

    ésika
    PRO

    HIDRACOLOR
    3 IN 1

    Moisturizing Lipstick,
    Color and Perfecting
    Effect SPF 25

    Net Weight
    0.14 oz. e (4 g)

    PRINCIPAL DISPLAY PANEL - 4 g Tube Box - (FUCSIA INTENSE) - PINK
  • PRINCIPAL DISPLAY PANEL - 4 g Tube Box - (NARANJA ESFERA) - ORANGE

    ésika
    PRO

    HIDRACOLOR
    3 IN 1

    Moisturizing Lipstick,
    Color and Perfecting
    Effect 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 - (ROSA NUDE) - PINK

    ésika
    PRO

    HIDRACOLOR
    3 IN 1

    Moisturizing Lipstick,
    Color and Perfecting
    Effect SPF 25

    Net Weight
    0.14 oz. e (4 g)

    PRINCIPAL DISPLAY PANEL - 4 g Tube Box - (ROSA NUDE) - PINK
  • PRINCIPAL DISPLAY PANEL - 4 g Tube Box - (PEACH NUDE) - BROWN

    ésika
    PRO

    HIDRACOLOR
    3 IN 1

    Moisturizing Lipstick,
    Color and Perfecting
    Effect SPF 25

    Net Weight
    0.14 oz. e (4 g)

    PRINCIPAL DISPLAY PANEL - 4 g Tube Box - (PEACH NUDE) - BROWN
  • PRINCIPAL DISPLAY PANEL - 4 g Tube Box - (CORAL CHIC) - PINK

    ésika
    PRO

    HIDRACOLOR
    3 IN 1

    Moisturizing Lipstick,
    Color and Perfecting
    Effect 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 - (ROJO TROPICAL) - RED

    ésika
    PRO

    HIDRACOLOR
    3 IN 1

    Moisturizing Lipstick,
    Color and Perfecting
    Effect SPF 25

    Net Weight
    0.14 oz. e (4 g)

    PRINCIPAL DISPLAY PANEL - 4 g Tube Box - (ROJO TROPICAL) - RED
  • PRINCIPAL DISPLAY PANEL - 4 g Tube Box - (NARANJA CITRICO) - ORANGE

    ésika
    PRO

    HIDRACOLOR
    3 IN 1

    Moisturizing Lipstick,
    Color and Perfecting
    Effect SPF 25

    Net Weight
    0.14 oz. e (4 g)

    PRINCIPAL DISPLAY PANEL - 4 g Tube Box - (NARANJA CITRICO) - ORANGE
  • PRINCIPAL DISPLAY PANEL - 4 g Tube Box - (NUDE PUNCH) - ORANGE

    ésika
    PRO

    HIDRACOLOR
    3 IN 1

    Moisturizing Lipstick,
    Color and Perfecting
    Effect SPF 25

    Net Weight
    0.14 oz. e (4 g)

    PRINCIPAL DISPLAY PANEL - 4 g Tube Box - (NUDE PUNCH) - ORANGE
  • PRINCIPAL DISPLAY PANEL - 4 g Tube Box - (MORA ATREVIDA) - PURPLE

    ésika
    PRO

    HIDRACOLOR
    3 IN 1

    Moisturizing Lipstick,
    Color and Perfecting
    Effect SPF 25

    Net Weight
    0.14 oz. e (4 g)

    PRINCIPAL DISPLAY PANEL - 4 g Tube Box - (MORA ATREVIDA) - PURPLE
  • PRINCIPAL DISPLAY PANEL - 4 g Tube Box - (NUDE SAVANNA) - ORANGE

    ésika
    PRO

    HIDRACOLOR
    3 IN 1

    Moisturizing Lipstick,
    Color and Perfecting
    Effect SPF 25

    Net Weight
    0.14 oz. e (4 g)

    PRINCIPAL DISPLAY PANEL - 4 g Tube Box - (NUDE SAVANNA) - ORANGE
  • PRINCIPAL DISPLAY PANEL - 4 g Tube Box - (ROJO SENSUAL) - RED

    ésika
    PRO

    HIDRACOLOR
    3 IN 1

    Moisturizing Lipstick,
    Color and Perfecting
    Effect SPF 25

    Net Weight
    0.14 oz. e (4 g)

    PRINCIPAL DISPLAY PANEL - 4 g Tube Box - (ROJO SENSUAL) - RED
  • PRINCIPAL DISPLAY PANEL - 4 g Tube Box - (NUDE MOCCHA) - ORANGE

    ésika
    PRO

    HIDRACOLOR
    3 IN 1

    Moisturizing Lipstick,
    Color and Perfecting
    Effect SPF 25

    Net Weight
    0.14 oz. e (4 g)

    PRINCIPAL DISPLAY PANEL - 4 g Tube Box - (NUDE MOCCHA) - ORANGE
  • PRINCIPAL DISPLAY PANEL - 4 g Tube Box - (BRONCE METALLIC) - BROWN

    ésika
    PRO

    HIDRACOLOR
    3 IN 1

    Moisturizing Lipstick,
    Color and Perfecting
    Effect SPF 25

    Net Weight
    0.14 oz. e (4 g)

    PRINCIPAL DISPLAY PANEL - 4 g Tube Box - (BRONCE METALLIC) - BROWN
  • PRINCIPAL DISPLAY PANEL - Kit Carton

    HIDRACOLOR 3 IN 1

    Moisturizing Lipstick,
    Color and Perfecting Effect SPF 25

    ésika
    PRO

    Net Wt. 0.28 oz. e (8 g)

    PRINCIPAL DISPLAY PANEL - Kit Carton
  • INGREDIENTS AND APPEARANCE
    ESIKA PRO HIDRACOLOR 3 IN 1 MOISTURIZING, COLOR AND PERFECTING EFFECT SPF 25   (PIMIENTA CALIENTE) - BROWN
    octinoxate and zinc oxide lipstick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13537-958
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE0.075 g  in 1 g
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE0.0392 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW)  
    TRIDECYL TRIMELLITATE (UNII: FY36J270ES)  
    ISONONYL ISONONANOATE (UNII: S4V5BS6GCX)  
    CERESIN (UNII: Q1LS2UJO3A)  
    WATER (UNII: 059QF0KO0R)  
    POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)  
    TRIDECYL STEARATE (UNII: A8OE252M6L)  
    HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    POLYTETRAFLUOROETHYLENE (UNII: E1NC1JVS3O)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    CERAMIDE NP (UNII: 4370DF050B)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    SOYBEAN OIL (UNII: 241ATL177A)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    MAGNESIUM CHLORIDE (UNII: 02F3473H9O)  
    POTASSIUM CHLORIDE (UNII: 660YQ98I10)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)  
    LIMONENE, (+)- (UNII: GFD7C86Q1W)  
    LINALOOL, (+/-)- (UNII: D81QY6I88E)  
    .ALPHA.-AMYLCINNAMALDEHYDE (UNII: WC51CA3418)  
    .BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)  
    D&C RED NO. 30 (UNII: 2S42T2808B)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    MICA (UNII: V8A1AW0880)  
    D&C RED NO. 27 (UNII: 2LRS185U6K)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    D&C RED NO. 7 (UNII: ECW0LZ41X8)  
    D&C RED NO. 21 (UNII: 08744Z6JNY)  
    TALC (UNII: 7SEV7J4R1U)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:13537-958-021 in 1 BOX07/12/2016
    1NDC:13537-958-014 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35207/12/2016
    ESIKA PRO HIDRACOLOR 3 IN 1 MOISTURIZING, COLOR AND PERFECTING EFFECT SPF 25   (ROJO DESEO) - RED
    octinoxate and zinc oxide lipstick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13537-959
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE0.075 g  in 1 g
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE0.0392 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW)  
    TRIDECYL TRIMELLITATE (UNII: FY36J270ES)  
    ISONONYL ISONONANOATE (UNII: S4V5BS6GCX)  
    CERESIN (UNII: Q1LS2UJO3A)  
    WATER (UNII: 059QF0KO0R)  
    POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)  
    TRIDECYL STEARATE (UNII: A8OE252M6L)  
    HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    POLYTETRAFLUOROETHYLENE (UNII: E1NC1JVS3O)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    CERAMIDE NP (UNII: 4370DF050B)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    SOYBEAN OIL (UNII: 241ATL177A)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    MAGNESIUM CHLORIDE (UNII: 02F3473H9O)  
    POTASSIUM CHLORIDE (UNII: 660YQ98I10)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)  
    LIMONENE, (+)- (UNII: GFD7C86Q1W)  
    LINALOOL, (+/-)- (UNII: D81QY6I88E)  
    .ALPHA.-AMYLCINNAMALDEHYDE (UNII: WC51CA3418)  
    .BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)  
    D&C RED NO. 30 (UNII: 2S42T2808B)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    MICA (UNII: V8A1AW0880)  
    D&C RED NO. 27 (UNII: 2LRS185U6K)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    D&C RED NO. 7 (UNII: ECW0LZ41X8)  
    D&C RED NO. 21 (UNII: 08744Z6JNY)  
    TALC (UNII: 7SEV7J4R1U)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:13537-959-041 in 1 BOX07/12/2016
    1NDC:13537-959-034 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35207/12/2016
    ESIKA PRO HIDRACOLOR 3 IN 1 MOISTURIZING, COLOR AND PERFECTING EFFECT SPF 25   (ROJO ESIKA) - RED
    octinoxate and zinc oxide lipstick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13537-960
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE0.075 g  in 1 g
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE0.0392 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW)  
    TRIDECYL TRIMELLITATE (UNII: FY36J270ES)  
    ISONONYL ISONONANOATE (UNII: S4V5BS6GCX)  
    CERESIN (UNII: Q1LS2UJO3A)  
    WATER (UNII: 059QF0KO0R)  
    POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)  
    TRIDECYL STEARATE (UNII: A8OE252M6L)  
    HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    POLYTETRAFLUOROETHYLENE (UNII: E1NC1JVS3O)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    CERAMIDE NP (UNII: 4370DF050B)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    SOYBEAN OIL (UNII: 241ATL177A)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    MAGNESIUM CHLORIDE (UNII: 02F3473H9O)  
    POTASSIUM CHLORIDE (UNII: 660YQ98I10)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)  
    LIMONENE, (+)- (UNII: GFD7C86Q1W)  
    LINALOOL, (+/-)- (UNII: D81QY6I88E)  
    .ALPHA.-AMYLCINNAMALDEHYDE (UNII: WC51CA3418)  
    .BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)  
    D&C RED NO. 30 (UNII: 2S42T2808B)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    MICA (UNII: V8A1AW0880)  
    D&C RED NO. 27 (UNII: 2LRS185U6K)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    D&C RED NO. 7 (UNII: ECW0LZ41X8)  
    D&C RED NO. 21 (UNII: 08744Z6JNY)  
    TALC (UNII: 7SEV7J4R1U)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:13537-960-061 in 1 BOX07/12/2016
    1NDC:13537-960-054 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35207/12/2016
    ESIKA PRO HIDRACOLOR 3 IN 1 MOISTURIZING, COLOR AND PERFECTING EFFECT SPF 25   (MARRON TOPACIO) - BROWN
    octinoxate and zinc oxide lipstick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13537-966
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE0.075 g  in 1 g
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE0.0392 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW)  
    TRIDECYL TRIMELLITATE (UNII: FY36J270ES)  
    ISONONYL ISONONANOATE (UNII: S4V5BS6GCX)  
    CERESIN (UNII: Q1LS2UJO3A)  
    WATER (UNII: 059QF0KO0R)  
    POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)  
    TRIDECYL STEARATE (UNII: A8OE252M6L)  
    HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    POLYTETRAFLUOROETHYLENE (UNII: E1NC1JVS3O)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    CERAMIDE NP (UNII: 4370DF050B)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    SOYBEAN OIL (UNII: 241ATL177A)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    MAGNESIUM CHLORIDE (UNII: 02F3473H9O)  
    POTASSIUM CHLORIDE (UNII: 660YQ98I10)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)  
    LIMONENE, (+)- (UNII: GFD7C86Q1W)  
    LINALOOL, (+/-)- (UNII: D81QY6I88E)  
    .ALPHA.-AMYLCINNAMALDEHYDE (UNII: WC51CA3418)  
    .BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)  
    D&C RED NO. 30 (UNII: 2S42T2808B)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    MICA (UNII: V8A1AW0880)  
    D&C RED NO. 27 (UNII: 2LRS185U6K)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    D&C RED NO. 7 (UNII: ECW0LZ41X8)  
    D&C RED NO. 21 (UNII: 08744Z6JNY)  
    TALC (UNII: 7SEV7J4R1U)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:13537-966-081 in 1 BOX07/12/2016
    1NDC:13537-966-074 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35207/12/2016
    ESIKA PRO HIDRACOLOR 3 IN 1 MOISTURIZING, COLOR AND PERFECTING EFFECT SPF 25   (ROSA GEOMETRIC) - PINK
    octinoxate and zinc oxide lipstick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13537-967
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE0.075 g  in 1 g
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE0.0392 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW)  
    TRIDECYL TRIMELLITATE (UNII: FY36J270ES)  
    ISONONYL ISONONANOATE (UNII: S4V5BS6GCX)  
    CERESIN (UNII: Q1LS2UJO3A)  
    WATER (UNII: 059QF0KO0R)  
    POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)  
    TRIDECYL STEARATE (UNII: A8OE252M6L)  
    HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    POLYTETRAFLUOROETHYLENE (UNII: E1NC1JVS3O)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    CERAMIDE NP (UNII: 4370DF050B)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    SOYBEAN OIL (UNII: 241ATL177A)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    MAGNESIUM CHLORIDE (UNII: 02F3473H9O)  
    POTASSIUM CHLORIDE (UNII: 660YQ98I10)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)  
    LIMONENE, (+)- (UNII: GFD7C86Q1W)  
    LINALOOL, (+/-)- (UNII: D81QY6I88E)  
    .ALPHA.-AMYLCINNAMALDEHYDE (UNII: WC51CA3418)  
    .BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)  
    D&C RED NO. 30 (UNII: 2S42T2808B)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    MICA (UNII: V8A1AW0880)  
    D&C RED NO. 27 (UNII: 2LRS185U6K)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    D&C RED NO. 7 (UNII: ECW0LZ41X8)  
    D&C RED NO. 21 (UNII: 08744Z6JNY)  
    TALC (UNII: 7SEV7J4R1U)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:13537-967-101 in 1 BOX07/12/2016
    1NDC:13537-967-094 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35207/12/2016
    ESIKA PRO HIDRACOLOR 3 IN 1 MOISTURIZING, COLOR AND PERFECTING EFFECT SPF 25   (ROSA ENCANTO) - PINK
    octinoxate and zinc oxide lipstick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13537-968
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE0.075 g  in 1 g
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE0.0392 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW)  
    TRIDECYL TRIMELLITATE (UNII: FY36J270ES)  
    ISONONYL ISONONANOATE (UNII: S4V5BS6GCX)  
    CERESIN (UNII: Q1LS2UJO3A)  
    WATER (UNII: 059QF0KO0R)  
    POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)  
    TRIDECYL STEARATE (UNII: A8OE252M6L)  
    HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    POLYTETRAFLUOROETHYLENE (UNII: E1NC1JVS3O)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    CERAMIDE NP (UNII: 4370DF050B)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    SOYBEAN OIL (UNII: 241ATL177A)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    MAGNESIUM CHLORIDE (UNII: 02F3473H9O)  
    POTASSIUM CHLORIDE (UNII: 660YQ98I10)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)  
    LIMONENE, (+)- (UNII: GFD7C86Q1W)  
    LINALOOL, (+/-)- (UNII: D81QY6I88E)  
    .ALPHA.-AMYLCINNAMALDEHYDE (UNII: WC51CA3418)  
    .BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)  
    D&C RED NO. 30 (UNII: 2S42T2808B)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    MICA (UNII: V8A1AW0880)  
    D&C RED NO. 27 (UNII: 2LRS185U6K)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    D&C RED NO. 7 (UNII: ECW0LZ41X8)  
    D&C RED NO. 21 (UNII: 08744Z6JNY)  
    TALC (UNII: 7SEV7J4R1U)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:13537-968-121 in 1 BOX07/12/2016
    1NDC:13537-968-114 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35207/12/2016
    ESIKA PRO HIDRACOLOR 3 IN 1 MOISTURIZING, COLOR AND PERFECTING EFFECT SPF 25   (MORA GLAM) - PURPLE
    octinoxate and zinc oxide lipstick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13537-969
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE0.075 g  in 1 g
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE0.0392 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW)  
    TRIDECYL TRIMELLITATE (UNII: FY36J270ES)  
    ISONONYL ISONONANOATE (UNII: S4V5BS6GCX)  
    CERESIN (UNII: Q1LS2UJO3A)  
    WATER (UNII: 059QF0KO0R)  
    POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)  
    TRIDECYL STEARATE (UNII: A8OE252M6L)  
    HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    POLYTETRAFLUOROETHYLENE (UNII: E1NC1JVS3O)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    CERAMIDE NP (UNII: 4370DF050B)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    SOYBEAN OIL (UNII: 241ATL177A)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    MAGNESIUM CHLORIDE (UNII: 02F3473H9O)  
    POTASSIUM CHLORIDE (UNII: 660YQ98I10)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)  
    LIMONENE, (+)- (UNII: GFD7C86Q1W)  
    LINALOOL, (+/-)- (UNII: D81QY6I88E)  
    .ALPHA.-AMYLCINNAMALDEHYDE (UNII: WC51CA3418)  
    .BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)  
    D&C RED NO. 30 (UNII: 2S42T2808B)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    MICA (UNII: V8A1AW0880)  
    D&C RED NO. 27 (UNII: 2LRS185U6K)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    D&C RED NO. 7 (UNII: ECW0LZ41X8)  
    D&C RED NO. 21 (UNII: 08744Z6JNY)  
    TALC (UNII: 7SEV7J4R1U)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:13537-969-141 in 1 BOX07/12/2016
    1NDC:13537-969-134 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35207/12/2016
    ESIKA PRO HIDRACOLOR 3 IN 1 MOISTURIZING, COLOR AND PERFECTING EFFECT SPF 25   (GRANATE SEDUCTOR) - PURPLE
    octinoxate and zinc oxide lipstick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13537-970
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE0.075 g  in 1 g
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE0.0392 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW)  
    TRIDECYL TRIMELLITATE (UNII: FY36J270ES)  
    ISONONYL ISONONANOATE (UNII: S4V5BS6GCX)  
    CERESIN (UNII: Q1LS2UJO3A)  
    WATER (UNII: 059QF0KO0R)  
    POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)  
    TRIDECYL STEARATE (UNII: A8OE252M6L)  
    HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    POLYTETRAFLUOROETHYLENE (UNII: E1NC1JVS3O)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    CERAMIDE NP (UNII: 4370DF050B)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    SOYBEAN OIL (UNII: 241ATL177A)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    MAGNESIUM CHLORIDE (UNII: 02F3473H9O)  
    POTASSIUM CHLORIDE (UNII: 660YQ98I10)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)  
    LIMONENE, (+)- (UNII: GFD7C86Q1W)  
    LINALOOL, (+/-)- (UNII: D81QY6I88E)  
    .ALPHA.-AMYLCINNAMALDEHYDE (UNII: WC51CA3418)  
    .BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)  
    D&C RED NO. 30 (UNII: 2S42T2808B)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    MICA (UNII: V8A1AW0880)  
    D&C RED NO. 27 (UNII: 2LRS185U6K)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    D&C RED NO. 7 (UNII: ECW0LZ41X8)  
    D&C RED NO. 21 (UNII: 08744Z6JNY)  
    TALC (UNII: 7SEV7J4R1U)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:13537-970-181 in 1 BOX07/12/2016
    1NDC:13537-970-174 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35207/12/2016
    ESIKA PRO HIDRACOLOR 3 IN 1 MOISTURIZING, COLOR AND PERFECTING EFFECT SPF 25   (BORGONA SEXY) - PURPLE
    octinoxate and zinc oxide lipstick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13537-971
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE0.075 g  in 1 g
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE0.0392 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW)  
    TRIDECYL TRIMELLITATE (UNII: FY36J270ES)  
    ISONONYL ISONONANOATE (UNII: S4V5BS6GCX)  
    CERESIN (UNII: Q1LS2UJO3A)  
    WATER (UNII: 059QF0KO0R)  
    POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)  
    TRIDECYL STEARATE (UNII: A8OE252M6L)  
    HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    POLYTETRAFLUOROETHYLENE (UNII: E1NC1JVS3O)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    CERAMIDE NP (UNII: 4370DF050B)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    SOYBEAN OIL (UNII: 241ATL177A)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    MAGNESIUM CHLORIDE (UNII: 02F3473H9O)  
    POTASSIUM CHLORIDE (UNII: 660YQ98I10)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)  
    LIMONENE, (+)- (UNII: GFD7C86Q1W)  
    LINALOOL, (+/-)- (UNII: D81QY6I88E)  
    .ALPHA.-AMYLCINNAMALDEHYDE (UNII: WC51CA3418)  
    .BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)  
    D&C RED NO. 30 (UNII: 2S42T2808B)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    MICA (UNII: V8A1AW0880)  
    D&C RED NO. 27 (UNII: 2LRS185U6K)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    D&C RED NO. 7 (UNII: ECW0LZ41X8)  
    D&C RED NO. 21 (UNII: 08744Z6JNY)  
    TALC (UNII: 7SEV7J4R1U)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:13537-971-201 in 1 BOX07/12/2016
    1NDC:13537-971-194 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35207/12/2016
    ESIKA PRO HIDRACOLOR 3 IN 1 MOISTURIZING, COLOR AND PERFECTING EFFECT SPF 25   (FRESA HOT) - PINK
    octinoxate and zinc oxide lipstick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13537-972
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE0.075 g  in 1 g
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE0.0392 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW)  
    TRIDECYL TRIMELLITATE (UNII: FY36J270ES)  
    ISONONYL ISONONANOATE (UNII: S4V5BS6GCX)  
    CERESIN (UNII: Q1LS2UJO3A)  
    WATER (UNII: 059QF0KO0R)  
    POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)  
    TRIDECYL STEARATE (UNII: A8OE252M6L)  
    HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    POLYTETRAFLUOROETHYLENE (UNII: E1NC1JVS3O)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    CERAMIDE NP (UNII: 4370DF050B)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    SOYBEAN OIL (UNII: 241ATL177A)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    MAGNESIUM CHLORIDE (UNII: 02F3473H9O)  
    POTASSIUM CHLORIDE (UNII: 660YQ98I10)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)  
    LIMONENE, (+)- (UNII: GFD7C86Q1W)  
    LINALOOL, (+/-)- (UNII: D81QY6I88E)  
    .ALPHA.-AMYLCINNAMALDEHYDE (UNII: WC51CA3418)  
    .BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)  
    D&C RED NO. 30 (UNII: 2S42T2808B)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    MICA (UNII: V8A1AW0880)  
    D&C RED NO. 27 (UNII: 2LRS185U6K)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    D&C RED NO. 7 (UNII: ECW0LZ41X8)  
    D&C RED NO. 21 (UNII: 08744Z6JNY)  
    TALC (UNII: 7SEV7J4R1U)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:13537-972-221 in 1 BOX07/12/2016
    1NDC:13537-972-214 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35207/12/2016
    ESIKA PRO HIDRACOLOR 3 IN 1 MOISTURIZING, COLOR AND PERFECTING EFFECT SPF 25   (FUCSIA CAUTIVANTE) - PINK
    octinoxate and zinc oxide lipstick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13537-973
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE0.075 g  in 1 g
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE0.0392 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW)  
    TRIDECYL TRIMELLITATE (UNII: FY36J270ES)  
    ISONONYL ISONONANOATE (UNII: S4V5BS6GCX)  
    CERESIN (UNII: Q1LS2UJO3A)  
    WATER (UNII: 059QF0KO0R)  
    POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)  
    TRIDECYL STEARATE (UNII: A8OE252M6L)  
    HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    POLYTETRAFLUOROETHYLENE (UNII: E1NC1JVS3O)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    CERAMIDE NP (UNII: 4370DF050B)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    SOYBEAN OIL (UNII: 241ATL177A)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    MAGNESIUM CHLORIDE (UNII: 02F3473H9O)  
    POTASSIUM CHLORIDE (UNII: 660YQ98I10)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)  
    LIMONENE, (+)- (UNII: GFD7C86Q1W)  
    LINALOOL, (+/-)- (UNII: D81QY6I88E)  
    .ALPHA.-AMYLCINNAMALDEHYDE (UNII: WC51CA3418)  
    .BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)  
    D&C RED NO. 30 (UNII: 2S42T2808B)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    MICA (UNII: V8A1AW0880)  
    D&C RED NO. 27 (UNII: 2LRS185U6K)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    D&C RED NO. 7 (UNII: ECW0LZ41X8)  
    D&C RED NO. 21 (UNII: 08744Z6JNY)  
    TALC (UNII: 7SEV7J4R1U)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:13537-973-241 in 1 BOX07/12/2016
    1NDC:13537-973-234 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35207/12/2016
    ESIKA PRO HIDRACOLOR 3 IN 1 MOISTURIZING, COLOR AND PERFECTING EFFECT SPF 25   (FUCSIA INTENSE) - PINK
    octinoxate and zinc oxide lipstick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13537-974
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE0.075 g  in 1 g
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE0.0392 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW)  
    TRIDECYL TRIMELLITATE (UNII: FY36J270ES)  
    ISONONYL ISONONANOATE (UNII: S4V5BS6GCX)  
    CERESIN (UNII: Q1LS2UJO3A)  
    WATER (UNII: 059QF0KO0R)  
    POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)  
    TRIDECYL STEARATE (UNII: A8OE252M6L)  
    HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    POLYTETRAFLUOROETHYLENE (UNII: E1NC1JVS3O)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    CERAMIDE NP (UNII: 4370DF050B)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    SOYBEAN OIL (UNII: 241ATL177A)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    MAGNESIUM CHLORIDE (UNII: 02F3473H9O)  
    POTASSIUM CHLORIDE (UNII: 660YQ98I10)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)  
    LIMONENE, (+)- (UNII: GFD7C86Q1W)  
    LINALOOL, (+/-)- (UNII: D81QY6I88E)  
    .ALPHA.-AMYLCINNAMALDEHYDE (UNII: WC51CA3418)  
    .BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)  
    D&C RED NO. 30 (UNII: 2S42T2808B)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    MICA (UNII: V8A1AW0880)  
    D&C RED NO. 27 (UNII: 2LRS185U6K)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    D&C RED NO. 7 (UNII: ECW0LZ41X8)  
    D&C RED NO. 21 (UNII: 08744Z6JNY)  
    TALC (UNII: 7SEV7J4R1U)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:13537-974-241 in 1 BOX07/12/2016
    1NDC:13537-974-234 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35207/12/2016
    ESIKA PRO HIDRACOLOR 3 IN 1 MOISTURIZING, COLOR AND PERFECTING EFFECT SPF 25   (NARANJA ESFERA) - ORANGE
    octinoxate and zinc oxide lipstick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13537-975
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE0.075 g  in 1 g
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE0.0392 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW)  
    TRIDECYL TRIMELLITATE (UNII: FY36J270ES)  
    ISONONYL ISONONANOATE (UNII: S4V5BS6GCX)  
    CERESIN (UNII: Q1LS2UJO3A)  
    WATER (UNII: 059QF0KO0R)  
    POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)  
    TRIDECYL STEARATE (UNII: A8OE252M6L)  
    HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    POLYTETRAFLUOROETHYLENE (UNII: E1NC1JVS3O)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    CERAMIDE NP (UNII: 4370DF050B)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    SOYBEAN OIL (UNII: 241ATL177A)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    MAGNESIUM CHLORIDE (UNII: 02F3473H9O)  
    POTASSIUM CHLORIDE (UNII: 660YQ98I10)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)  
    LIMONENE, (+)- (UNII: GFD7C86Q1W)  
    LINALOOL, (+/-)- (UNII: D81QY6I88E)  
    .ALPHA.-AMYLCINNAMALDEHYDE (UNII: WC51CA3418)  
    .BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)  
    D&C RED NO. 30 (UNII: 2S42T2808B)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    MICA (UNII: V8A1AW0880)  
    D&C RED NO. 27 (UNII: 2LRS185U6K)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    D&C RED NO. 7 (UNII: ECW0LZ41X8)  
    D&C RED NO. 21 (UNII: 08744Z6JNY)  
    TALC (UNII: 7SEV7J4R1U)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:13537-975-241 in 1 BOX07/12/2016
    1NDC:13537-975-234 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35207/12/2016
    ESIKA PRO HIDRACOLOR 3 IN 1 MOISTURIZING, COLOR AND PERFECTING EFFECT SPF 25   (ROSA NUDE) - PINK
    octinoxate and zinc oxide lipstick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13537-976
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE0.075 g  in 1 g
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE0.0392 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW)  
    TRIDECYL TRIMELLITATE (UNII: FY36J270ES)  
    ISONONYL ISONONANOATE (UNII: S4V5BS6GCX)  
    CERESIN (UNII: Q1LS2UJO3A)  
    WATER (UNII: 059QF0KO0R)  
    POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)  
    TRIDECYL STEARATE (UNII: A8OE252M6L)  
    HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    POLYTETRAFLUOROETHYLENE (UNII: E1NC1JVS3O)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    CERAMIDE NP (UNII: 4370DF050B)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    SOYBEAN OIL (UNII: 241ATL177A)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    MAGNESIUM CHLORIDE (UNII: 02F3473H9O)  
    POTASSIUM CHLORIDE (UNII: 660YQ98I10)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)  
    LIMONENE, (+)- (UNII: GFD7C86Q1W)  
    LINALOOL, (+/-)- (UNII: D81QY6I88E)  
    .ALPHA.-AMYLCINNAMALDEHYDE (UNII: WC51CA3418)  
    .BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)  
    D&C RED NO. 30 (UNII: 2S42T2808B)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    MICA (UNII: V8A1AW0880)  
    D&C RED NO. 27 (UNII: 2LRS185U6K)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    D&C RED NO. 7 (UNII: ECW0LZ41X8)  
    D&C RED NO. 21 (UNII: 08744Z6JNY)  
    TALC (UNII: 7SEV7J4R1U)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:13537-976-241 in 1 BOX07/12/2016
    1NDC:13537-976-234 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35207/12/2016
    ESIKA PRO HIDRACOLOR 3 IN 1 MOISTURIZING, COLOR AND PERFECTING EFFECT SPF 25   (PEACH NUDE) - BROWN
    octinoxate and zinc oxide lipstick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13537-977
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE0.075 g  in 1 g
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE0.0392 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW)  
    TRIDECYL TRIMELLITATE (UNII: FY36J270ES)  
    ISONONYL ISONONANOATE (UNII: S4V5BS6GCX)  
    CERESIN (UNII: Q1LS2UJO3A)  
    WATER (UNII: 059QF0KO0R)  
    POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)  
    TRIDECYL STEARATE (UNII: A8OE252M6L)  
    HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    POLYTETRAFLUOROETHYLENE (UNII: E1NC1JVS3O)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    CERAMIDE NP (UNII: 4370DF050B)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    SOYBEAN OIL (UNII: 241ATL177A)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    MAGNESIUM CHLORIDE (UNII: 02F3473H9O)  
    POTASSIUM CHLORIDE (UNII: 660YQ98I10)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)  
    LIMONENE, (+)- (UNII: GFD7C86Q1W)  
    LINALOOL, (+/-)- (UNII: D81QY6I88E)  
    .ALPHA.-AMYLCINNAMALDEHYDE (UNII: WC51CA3418)  
    .BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)  
    D&C RED NO. 30 (UNII: 2S42T2808B)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    MICA (UNII: V8A1AW0880)  
    D&C RED NO. 27 (UNII: 2LRS185U6K)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    D&C RED NO. 7 (UNII: ECW0LZ41X8)  
    D&C RED NO. 21 (UNII: 08744Z6JNY)  
    TALC (UNII: 7SEV7J4R1U)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:13537-977-241 in 1 BOX07/12/2016
    1NDC:13537-977-234 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35207/12/2016
    ESIKA PRO HIDRACOLOR 3 IN 1 MOISTURIZING, COLOR AND PERFECTING EFFECT SPF 25   (CORAL CHIC) - PINK
    octinoxate and zinc oxide lipstick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13537-978
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE0.075 g  in 1 g
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE0.0392 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW)  
    TRIDECYL TRIMELLITATE (UNII: FY36J270ES)  
    ISONONYL ISONONANOATE (UNII: S4V5BS6GCX)  
    CERESIN (UNII: Q1LS2UJO3A)  
    WATER (UNII: 059QF0KO0R)  
    POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)  
    TRIDECYL STEARATE (UNII: A8OE252M6L)  
    HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    POLYTETRAFLUOROETHYLENE (UNII: E1NC1JVS3O)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    CERAMIDE NP (UNII: 4370DF050B)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    SOYBEAN OIL (UNII: 241ATL177A)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    MAGNESIUM CHLORIDE (UNII: 02F3473H9O)  
    POTASSIUM CHLORIDE (UNII: 660YQ98I10)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)  
    LIMONENE, (+)- (UNII: GFD7C86Q1W)  
    LINALOOL, (+/-)- (UNII: D81QY6I88E)  
    .ALPHA.-AMYLCINNAMALDEHYDE (UNII: WC51CA3418)  
    .BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)  
    D&C RED NO. 30 (UNII: 2S42T2808B)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    MICA (UNII: V8A1AW0880)  
    D&C RED NO. 27 (UNII: 2LRS185U6K)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    D&C RED NO. 7 (UNII: ECW0LZ41X8)  
    D&C RED NO. 21 (UNII: 08744Z6JNY)  
    TALC (UNII: 7SEV7J4R1U)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:13537-978-241 in 1 BOX07/12/2016
    1NDC:13537-978-234 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35207/12/2016
    ESIKA PRO HIDRACOLOR 3 IN 1 MOISTURIZING, COLOR AND PERFECTING EFFECT SPF 25   (ROJO TROPICAL) - RED
    octinoxate and zinc oxide lipstick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13537-979
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE0.075 g  in 1 g
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE0.0392 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW)  
    TRIDECYL TRIMELLITATE (UNII: FY36J270ES)  
    ISONONYL ISONONANOATE (UNII: S4V5BS6GCX)  
    CERESIN (UNII: Q1LS2UJO3A)  
    WATER (UNII: 059QF0KO0R)  
    POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)  
    TRIDECYL STEARATE (UNII: A8OE252M6L)  
    HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    POLYTETRAFLUOROETHYLENE (UNII: E1NC1JVS3O)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    CERAMIDE NP (UNII: 4370DF050B)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    SOYBEAN OIL (UNII: 241ATL177A)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    MAGNESIUM CHLORIDE (UNII: 02F3473H9O)  
    POTASSIUM CHLORIDE (UNII: 660YQ98I10)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)  
    LIMONENE, (+)- (UNII: GFD7C86Q1W)  
    LINALOOL, (+/-)- (UNII: D81QY6I88E)  
    .ALPHA.-AMYLCINNAMALDEHYDE (UNII: WC51CA3418)  
    .BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)  
    D&C RED NO. 30 (UNII: 2S42T2808B)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    MICA (UNII: V8A1AW0880)  
    D&C RED NO. 27 (UNII: 2LRS185U6K)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    D&C RED NO. 7 (UNII: ECW0LZ41X8)  
    D&C RED NO. 21 (UNII: 08744Z6JNY)  
    TALC (UNII: 7SEV7J4R1U)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:13537-979-241 in 1 BOX07/12/2016
    1NDC:13537-979-234 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35207/12/2016
    ESIKA PRO HIDRACOLOR 3 IN 1 MOISTURIZING, COLOR AND PERFECTING EFFECT SPF 25   (NARANJA CITRICO) - ORANGE
    octinoxate and zinc oxide lipstick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13537-980
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE0.075 g  in 1 g
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE0.0392 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW)  
    TRIDECYL TRIMELLITATE (UNII: FY36J270ES)  
    ISONONYL ISONONANOATE (UNII: S4V5BS6GCX)  
    CERESIN (UNII: Q1LS2UJO3A)  
    WATER (UNII: 059QF0KO0R)  
    POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)  
    TRIDECYL STEARATE (UNII: A8OE252M6L)  
    HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    POLYTETRAFLUOROETHYLENE (UNII: E1NC1JVS3O)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    CERAMIDE NP (UNII: 4370DF050B)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    SOYBEAN OIL (UNII: 241ATL177A)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    MAGNESIUM CHLORIDE (UNII: 02F3473H9O)  
    POTASSIUM CHLORIDE (UNII: 660YQ98I10)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)  
    LIMONENE, (+)- (UNII: GFD7C86Q1W)  
    LINALOOL, (+/-)- (UNII: D81QY6I88E)  
    .ALPHA.-AMYLCINNAMALDEHYDE (UNII: WC51CA3418)  
    .BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)  
    D&C RED NO. 30 (UNII: 2S42T2808B)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    MICA (UNII: V8A1AW0880)  
    D&C RED NO. 27 (UNII: 2LRS185U6K)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    D&C RED NO. 7 (UNII: ECW0LZ41X8)  
    D&C RED NO. 21 (UNII: 08744Z6JNY)  
    TALC (UNII: 7SEV7J4R1U)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:13537-980-241 in 1 BOX07/12/2016
    1NDC:13537-980-234 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35207/12/2016
    ESIKA PRO HIDRACOLOR 3 IN 1 MOISTURIZING, COLOR AND PERFECTING EFFECT SPF 25   (NUDE PUNCH) - ORANGE
    octinoxate and zinc oxide lipstick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13537-981
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE0.075 g  in 1 g
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE0.0392 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW)  
    TRIDECYL TRIMELLITATE (UNII: FY36J270ES)  
    ISONONYL ISONONANOATE (UNII: S4V5BS6GCX)  
    CERESIN (UNII: Q1LS2UJO3A)  
    WATER (UNII: 059QF0KO0R)  
    POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)  
    TRIDECYL STEARATE (UNII: A8OE252M6L)  
    HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    POLYTETRAFLUOROETHYLENE (UNII: E1NC1JVS3O)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    CERAMIDE NP (UNII: 4370DF050B)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    SOYBEAN OIL (UNII: 241ATL177A)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    MAGNESIUM CHLORIDE (UNII: 02F3473H9O)  
    POTASSIUM CHLORIDE (UNII: 660YQ98I10)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)  
    LIMONENE, (+)- (UNII: GFD7C86Q1W)  
    LINALOOL, (+/-)- (UNII: D81QY6I88E)  
    .ALPHA.-AMYLCINNAMALDEHYDE (UNII: WC51CA3418)  
    .BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)  
    D&C RED NO. 30 (UNII: 2S42T2808B)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    MICA (UNII: V8A1AW0880)  
    D&C RED NO. 27 (UNII: 2LRS185U6K)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    D&C RED NO. 7 (UNII: ECW0LZ41X8)  
    D&C RED NO. 21 (UNII: 08744Z6JNY)  
    TALC (UNII: 7SEV7J4R1U)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:13537-981-241 in 1 BOX07/12/2016
    1NDC:13537-981-234 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35207/12/2016
    ESIKA PRO HIDRACOLOR 3 IN 1 MOISTURIZING, COLOR AND PERFECTING EFFECT SPF 25   (MORA ATREVIDA) - PURPLE
    octinoxate and zinc oxide lipstick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13537-982
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE0.075 g  in 1 g
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE0.0392 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW)  
    TRIDECYL TRIMELLITATE (UNII: FY36J270ES)  
    ISONONYL ISONONANOATE (UNII: S4V5BS6GCX)  
    CERESIN (UNII: Q1LS2UJO3A)  
    WATER (UNII: 059QF0KO0R)  
    POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)  
    TRIDECYL STEARATE (UNII: A8OE252M6L)  
    HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    POLYTETRAFLUOROETHYLENE (UNII: E1NC1JVS3O)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    CERAMIDE NP (UNII: 4370DF050B)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    SOYBEAN OIL (UNII: 241ATL177A)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    MAGNESIUM CHLORIDE (UNII: 02F3473H9O)  
    POTASSIUM CHLORIDE (UNII: 660YQ98I10)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)  
    LIMONENE, (+)- (UNII: GFD7C86Q1W)  
    LINALOOL, (+/-)- (UNII: D81QY6I88E)  
    .ALPHA.-AMYLCINNAMALDEHYDE (UNII: WC51CA3418)  
    .BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)  
    D&C RED NO. 30 (UNII: 2S42T2808B)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    MICA (UNII: V8A1AW0880)  
    D&C RED NO. 27 (UNII: 2LRS185U6K)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    D&C RED NO. 7 (UNII: ECW0LZ41X8)  
    D&C RED NO. 21 (UNII: 08744Z6JNY)  
    TALC (UNII: 7SEV7J4R1U)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:13537-982-241 in 1 BOX07/12/2016
    1NDC:13537-982-234 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35207/12/2016
    ESIKA PRO HIDRACOLOR 3 IN 1 MOISTURIZING, COLOR AND PERFECTING EFFECT SPF 25   (NUDE SAVANNA) - ORANGE
    octinoxate and zinc oxide lipstick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13537-983
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE0.075 g  in 1 g
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE0.0392 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW)  
    TRIDECYL TRIMELLITATE (UNII: FY36J270ES)  
    ISONONYL ISONONANOATE (UNII: S4V5BS6GCX)  
    CERESIN (UNII: Q1LS2UJO3A)  
    WATER (UNII: 059QF0KO0R)  
    POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)  
    TRIDECYL STEARATE (UNII: A8OE252M6L)  
    HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    POLYTETRAFLUOROETHYLENE (UNII: E1NC1JVS3O)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    CERAMIDE NP (UNII: 4370DF050B)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    SOYBEAN OIL (UNII: 241ATL177A)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    MAGNESIUM CHLORIDE (UNII: 02F3473H9O)  
    POTASSIUM CHLORIDE (UNII: 660YQ98I10)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)  
    LIMONENE, (+)- (UNII: GFD7C86Q1W)  
    LINALOOL, (+/-)- (UNII: D81QY6I88E)  
    .ALPHA.-AMYLCINNAMALDEHYDE (UNII: WC51CA3418)  
    .BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)  
    D&C RED NO. 30 (UNII: 2S42T2808B)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    MICA (UNII: V8A1AW0880)  
    D&C RED NO. 27 (UNII: 2LRS185U6K)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    D&C RED NO. 7 (UNII: ECW0LZ41X8)  
    D&C RED NO. 21 (UNII: 08744Z6JNY)  
    TALC (UNII: 7SEV7J4R1U)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:13537-983-241 in 1 BOX07/12/2016
    1NDC:13537-983-234 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35207/12/2016
    ESIKA PRO HIDRACOLOR 3 IN 1 MOISTURIZING, COLOR AND PERFECTING EFFECT SPF 25   (ROJO SENSUAL) - RED
    octinoxate and zinc oxide lipstick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13537-984
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE0.075 g  in 1 g
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE0.0392 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW)  
    TRIDECYL TRIMELLITATE (UNII: FY36J270ES)  
    ISONONYL ISONONANOATE (UNII: S4V5BS6GCX)  
    CERESIN (UNII: Q1LS2UJO3A)  
    WATER (UNII: 059QF0KO0R)  
    POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)  
    TRIDECYL STEARATE (UNII: A8OE252M6L)  
    HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    POLYTETRAFLUOROETHYLENE (UNII: E1NC1JVS3O)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    CERAMIDE NP (UNII: 4370DF050B)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    SOYBEAN OIL (UNII: 241ATL177A)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    MAGNESIUM CHLORIDE (UNII: 02F3473H9O)  
    POTASSIUM CHLORIDE (UNII: 660YQ98I10)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)  
    LIMONENE, (+)- (UNII: GFD7C86Q1W)  
    LINALOOL, (+/-)- (UNII: D81QY6I88E)  
    .ALPHA.-AMYLCINNAMALDEHYDE (UNII: WC51CA3418)  
    .BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)  
    D&C RED NO. 30 (UNII: 2S42T2808B)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    MICA (UNII: V8A1AW0880)  
    D&C RED NO. 27 (UNII: 2LRS185U6K)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    D&C RED NO. 7 (UNII: ECW0LZ41X8)  
    D&C RED NO. 21 (UNII: 08744Z6JNY)  
    TALC (UNII: 7SEV7J4R1U)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:13537-984-241 in 1 BOX07/12/2016
    1NDC:13537-984-234 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35207/12/2016
    ESIKA PRO HIDRACOLOR 3 IN 1 MOISTURIZING, COLOR AND PERFECTING EFFECT SPF 25   (NUDE MOCCHA) - ORANGE
    octinoxate and zinc oxide lipstick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13537-985
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE0.075 g  in 1 g
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE0.0392 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW)  
    TRIDECYL TRIMELLITATE (UNII: FY36J270ES)  
    ISONONYL ISONONANOATE (UNII: S4V5BS6GCX)  
    CERESIN (UNII: Q1LS2UJO3A)  
    WATER (UNII: 059QF0KO0R)  
    POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)  
    TRIDECYL STEARATE (UNII: A8OE252M6L)  
    HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    POLYTETRAFLUOROETHYLENE (UNII: E1NC1JVS3O)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    CERAMIDE NP (UNII: 4370DF050B)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    SOYBEAN OIL (UNII: 241ATL177A)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    MAGNESIUM CHLORIDE (UNII: 02F3473H9O)  
    POTASSIUM CHLORIDE (UNII: 660YQ98I10)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)  
    LIMONENE, (+)- (UNII: GFD7C86Q1W)  
    LINALOOL, (+/-)- (UNII: D81QY6I88E)  
    .ALPHA.-AMYLCINNAMALDEHYDE (UNII: WC51CA3418)  
    .BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)  
    D&C RED NO. 30 (UNII: 2S42T2808B)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    MICA (UNII: V8A1AW0880)  
    D&C RED NO. 27 (UNII: 2LRS185U6K)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    D&C RED NO. 7 (UNII: ECW0LZ41X8)  
    D&C RED NO. 21 (UNII: 08744Z6JNY)  
    TALC (UNII: 7SEV7J4R1U)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:13537-985-241 in 1 BOX07/12/2016
    1NDC:13537-985-234 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35207/12/2016
    ESIKA PRO HIDRACOLOR 3 IN 1 MOISTURIZING, COLOR AND PERFECTING EFFECT SPF 25   (BRONCE METALLIC) - BROWN
    octinoxate and zinc oxide lipstick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13537-986
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE0.075 g  in 1 g
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE0.0392 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW)  
    TRIDECYL TRIMELLITATE (UNII: FY36J270ES)  
    ISONONYL ISONONANOATE (UNII: S4V5BS6GCX)  
    CERESIN (UNII: Q1LS2UJO3A)  
    WATER (UNII: 059QF0KO0R)  
    POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)  
    TRIDECYL STEARATE (UNII: A8OE252M6L)  
    HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    POLYTETRAFLUOROETHYLENE (UNII: E1NC1JVS3O)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    CERAMIDE NP (UNII: 4370DF050B)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    SOYBEAN OIL (UNII: 241ATL177A)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    MAGNESIUM CHLORIDE (UNII: 02F3473H9O)  
    POTASSIUM CHLORIDE (UNII: 660YQ98I10)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)  
    LIMONENE, (+)- (UNII: GFD7C86Q1W)  
    LINALOOL, (+/-)- (UNII: D81QY6I88E)  
    .ALPHA.-AMYLCINNAMALDEHYDE (UNII: WC51CA3418)  
    .BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)  
    D&C RED NO. 30 (UNII: 2S42T2808B)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    MICA (UNII: V8A1AW0880)  
    D&C RED NO. 27 (UNII: 2LRS185U6K)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    D&C RED NO. 7 (UNII: ECW0LZ41X8)  
    D&C RED NO. 21 (UNII: 08744Z6JNY)  
    TALC (UNII: 7SEV7J4R1U)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:13537-986-241 in 1 BOX07/12/2016
    1NDC:13537-986-234 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35207/12/2016
    ESIKA PRO HIDRACOLOR 3 IN 1 MOISTURIZING, COLOR AND PERFECTING EFFECT SPF 25 
    octinoxate and zinc oxide kit
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13537-987
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:13537-987-283 in 1 BOX07/12/2016
    1NDC:13537-987-271 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 1 of 24
    ESIKA PRO HIDRACOLOR 3 IN 1 MOISTURIZING, COLOR AND PERFECTING EFFECT SPF 25   (PIMIENTA CALIENTE) - BROWN
    octinoxate and zinc oxide lipstick
    Product Information
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE0.075 g  in 1 g
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE0.0392 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW)  
    TRIDECYL TRIMELLITATE (UNII: FY36J270ES)  
    ISONONYL ISONONANOATE (UNII: S4V5BS6GCX)  
    CERESIN (UNII: Q1LS2UJO3A)  
    WATER (UNII: 059QF0KO0R)  
    POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)  
    TRIDECYL STEARATE (UNII: A8OE252M6L)  
    HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    POLYTETRAFLUOROETHYLENE (UNII: E1NC1JVS3O)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    CERAMIDE NP (UNII: 4370DF050B)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    SOYBEAN OIL (UNII: 241ATL177A)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    MAGNESIUM CHLORIDE (UNII: 02F3473H9O)  
    POTASSIUM CHLORIDE (UNII: 660YQ98I10)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)  
    LIMONENE, (+)- (UNII: GFD7C86Q1W)  
    LINALOOL, (+/-)- (UNII: D81QY6I88E)  
    .ALPHA.-AMYLCINNAMALDEHYDE (UNII: WC51CA3418)  
    .BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)  
    D&C RED NO. 30 (UNII: 2S42T2808B)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    MICA (UNII: V8A1AW0880)  
    D&C RED NO. 27 (UNII: 2LRS185U6K)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    D&C RED NO. 7 (UNII: ECW0LZ41X8)  
    D&C RED NO. 21 (UNII: 08744Z6JNY)  
    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 FINALpart35207/12/2016
    Part 2 of 24
    ESIKA PRO HIDRACOLOR 3 IN 1 MOISTURIZING, COLOR AND PERFECTING EFFECT SPF 25   (ROJO DESEO) - RED
    octinoxate and zinc oxide lipstick
    Product Information
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE0.075 g  in 1 g
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE0.0392 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW)  
    TRIDECYL TRIMELLITATE (UNII: FY36J270ES)  
    ISONONYL ISONONANOATE (UNII: S4V5BS6GCX)  
    CERESIN (UNII: Q1LS2UJO3A)  
    WATER (UNII: 059QF0KO0R)  
    POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)  
    TRIDECYL STEARATE (UNII: A8OE252M6L)  
    HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    POLYTETRAFLUOROETHYLENE (UNII: E1NC1JVS3O)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    CERAMIDE NP (UNII: 4370DF050B)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    SOYBEAN OIL (UNII: 241ATL177A)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    MAGNESIUM CHLORIDE (UNII: 02F3473H9O)  
    POTASSIUM CHLORIDE (UNII: 660YQ98I10)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)  
    LIMONENE, (+)- (UNII: GFD7C86Q1W)  
    LINALOOL, (+/-)- (UNII: D81QY6I88E)  
    .ALPHA.-AMYLCINNAMALDEHYDE (UNII: WC51CA3418)  
    .BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)  
    D&C RED NO. 30 (UNII: 2S42T2808B)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    MICA (UNII: V8A1AW0880)  
    D&C RED NO. 27 (UNII: 2LRS185U6K)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    D&C RED NO. 7 (UNII: ECW0LZ41X8)  
    D&C RED NO. 21 (UNII: 08744Z6JNY)  
    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 FINALpart35207/12/2016
    Part 3 of 24
    ESIKA PRO HIDRACOLOR 3 IN 1 MOISTURIZING, COLOR AND PERFECTING EFFECT SPF 25   (ROJO ESIKA) - RED
    octinoxate and zinc oxide lipstick
    Product Information
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE0.075 g  in 1 g
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE0.0392 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW)  
    TRIDECYL TRIMELLITATE (UNII: FY36J270ES)  
    ISONONYL ISONONANOATE (UNII: S4V5BS6GCX)  
    CERESIN (UNII: Q1LS2UJO3A)  
    WATER (UNII: 059QF0KO0R)  
    POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)  
    TRIDECYL STEARATE (UNII: A8OE252M6L)  
    HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    POLYTETRAFLUOROETHYLENE (UNII: E1NC1JVS3O)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    CERAMIDE NP (UNII: 4370DF050B)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    SOYBEAN OIL (UNII: 241ATL177A)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    MAGNESIUM CHLORIDE (UNII: 02F3473H9O)  
    POTASSIUM CHLORIDE (UNII: 660YQ98I10)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)  
    LIMONENE, (+)- (UNII: GFD7C86Q1W)  
    LINALOOL, (+/-)- (UNII: D81QY6I88E)  
    .ALPHA.-AMYLCINNAMALDEHYDE (UNII: WC51CA3418)  
    .BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)  
    D&C RED NO. 30 (UNII: 2S42T2808B)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    MICA (UNII: V8A1AW0880)  
    D&C RED NO. 27 (UNII: 2LRS185U6K)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    D&C RED NO. 7 (UNII: ECW0LZ41X8)  
    D&C RED NO. 21 (UNII: 08744Z6JNY)  
    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 FINALpart35207/12/2016
    Part 4 of 24
    ESIKA PRO HIDRACOLOR 3 IN 1 MOISTURIZING, COLOR AND PERFECTING EFFECT SPF 25   (MARRON TOPACIO) - BROWN
    octinoxate and zinc oxide lipstick
    Product Information
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE0.075 g  in 1 g
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE0.0392 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW)  
    TRIDECYL TRIMELLITATE (UNII: FY36J270ES)  
    ISONONYL ISONONANOATE (UNII: S4V5BS6GCX)  
    CERESIN (UNII: Q1LS2UJO3A)  
    WATER (UNII: 059QF0KO0R)  
    POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)  
    TRIDECYL STEARATE (UNII: A8OE252M6L)  
    HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    POLYTETRAFLUOROETHYLENE (UNII: E1NC1JVS3O)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    CERAMIDE NP (UNII: 4370DF050B)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    SOYBEAN OIL (UNII: 241ATL177A)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    MAGNESIUM CHLORIDE (UNII: 02F3473H9O)  
    POTASSIUM CHLORIDE (UNII: 660YQ98I10)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)  
    LIMONENE, (+)- (UNII: GFD7C86Q1W)  
    LINALOOL, (+/-)- (UNII: D81QY6I88E)  
    .ALPHA.-AMYLCINNAMALDEHYDE (UNII: WC51CA3418)  
    .BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)  
    D&C RED NO. 30 (UNII: 2S42T2808B)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    MICA (UNII: V8A1AW0880)  
    D&C RED NO. 27 (UNII: 2LRS185U6K)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    D&C RED NO. 7 (UNII: ECW0LZ41X8)  
    D&C RED NO. 21 (UNII: 08744Z6JNY)  
    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 FINALpart35207/12/2016
    Part 5 of 24
    ESIKA PRO HIDRACOLOR 3 IN 1 MOISTURIZING, COLOR AND PERFECTING EFFECT SPF 25   (ROSA GEOMETRIC) - PINK
    octinoxate and zinc oxide lipstick
    Product Information
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE0.075 g  in 1 g
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE0.0392 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW)  
    TRIDECYL TRIMELLITATE (UNII: FY36J270ES)  
    ISONONYL ISONONANOATE (UNII: S4V5BS6GCX)  
    CERESIN (UNII: Q1LS2UJO3A)  
    WATER (UNII: 059QF0KO0R)  
    POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)  
    TRIDECYL STEARATE (UNII: A8OE252M6L)  
    HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    POLYTETRAFLUOROETHYLENE (UNII: E1NC1JVS3O)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    CERAMIDE NP (UNII: 4370DF050B)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    SOYBEAN OIL (UNII: 241ATL177A)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    MAGNESIUM CHLORIDE (UNII: 02F3473H9O)  
    POTASSIUM CHLORIDE (UNII: 660YQ98I10)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)  
    LIMONENE, (+)- (UNII: GFD7C86Q1W)  
    LINALOOL, (+/-)- (UNII: D81QY6I88E)  
    .ALPHA.-AMYLCINNAMALDEHYDE (UNII: WC51CA3418)  
    .BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)  
    D&C RED NO. 30 (UNII: 2S42T2808B)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    MICA (UNII: V8A1AW0880)  
    D&C RED NO. 27 (UNII: 2LRS185U6K)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    D&C RED NO. 7 (UNII: ECW0LZ41X8)  
    D&C RED NO. 21 (UNII: 08744Z6JNY)  
    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 FINALpart35207/12/2016
    Part 6 of 24
    ESIKA PRO HIDRACOLOR 3 IN 1 MOISTURIZING, COLOR AND PERFECTING EFFECT SPF 25   (ROSA ENCANTO) - PINK
    octinoxate and zinc oxide lipstick
    Product Information
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE0.075 g  in 1 g
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE0.0392 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW)  
    TRIDECYL TRIMELLITATE (UNII: FY36J270ES)  
    ISONONYL ISONONANOATE (UNII: S4V5BS6GCX)  
    CERESIN (UNII: Q1LS2UJO3A)  
    WATER (UNII: 059QF0KO0R)  
    POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)  
    TRIDECYL STEARATE (UNII: A8OE252M6L)  
    HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    POLYTETRAFLUOROETHYLENE (UNII: E1NC1JVS3O)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    CERAMIDE NP (UNII: 4370DF050B)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    SOYBEAN OIL (UNII: 241ATL177A)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    MAGNESIUM CHLORIDE (UNII: 02F3473H9O)  
    POTASSIUM CHLORIDE (UNII: 660YQ98I10)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)  
    LIMONENE, (+)- (UNII: GFD7C86Q1W)  
    LINALOOL, (+/-)- (UNII: D81QY6I88E)  
    .ALPHA.-AMYLCINNAMALDEHYDE (UNII: WC51CA3418)  
    .BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)  
    D&C RED NO. 30 (UNII: 2S42T2808B)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    MICA (UNII: V8A1AW0880)  
    D&C RED NO. 27 (UNII: 2LRS185U6K)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    D&C RED NO. 7 (UNII: ECW0LZ41X8)  
    D&C RED NO. 21 (UNII: 08744Z6JNY)  
    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 FINALpart35207/12/2016
    Part 7 of 24
    ESIKA PRO HIDRACOLOR 3 IN 1 MOISTURIZING, COLOR AND PERFECTING EFFECT SPF 25   (MORA GLAM) - PURPLE
    octinoxate and zinc oxide lipstick
    Product Information
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE0.075 g  in 1 g
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE0.0392 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW)  
    TRIDECYL TRIMELLITATE (UNII: FY36J270ES)  
    ISONONYL ISONONANOATE (UNII: S4V5BS6GCX)  
    CERESIN (UNII: Q1LS2UJO3A)  
    WATER (UNII: 059QF0KO0R)  
    POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)  
    TRIDECYL STEARATE (UNII: A8OE252M6L)  
    HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    POLYTETRAFLUOROETHYLENE (UNII: E1NC1JVS3O)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    CERAMIDE NP (UNII: 4370DF050B)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    SOYBEAN OIL (UNII: 241ATL177A)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    MAGNESIUM CHLORIDE (UNII: 02F3473H9O)  
    POTASSIUM CHLORIDE (UNII: 660YQ98I10)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)  
    LIMONENE, (+)- (UNII: GFD7C86Q1W)  
    LINALOOL, (+/-)- (UNII: D81QY6I88E)  
    .ALPHA.-AMYLCINNAMALDEHYDE (UNII: WC51CA3418)  
    .BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)  
    D&C RED NO. 30 (UNII: 2S42T2808B)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    MICA (UNII: V8A1AW0880)  
    D&C RED NO. 27 (UNII: 2LRS185U6K)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    D&C RED NO. 7 (UNII: ECW0LZ41X8)  
    D&C RED NO. 21 (UNII: 08744Z6JNY)  
    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 FINALpart35207/12/2016
    Part 8 of 24
    ESIKA PRO HIDRACOLOR 3 IN 1 MOISTURIZING, COLOR AND PERFECTING EFFECT SPF 25   (GRANATE SEDUCTOR) - PURPLE
    octinoxate and zinc oxide lipstick
    Product Information
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE0.075 g  in 1 g
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE0.0392 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW)  
    TRIDECYL TRIMELLITATE (UNII: FY36J270ES)  
    ISONONYL ISONONANOATE (UNII: S4V5BS6GCX)  
    CERESIN (UNII: Q1LS2UJO3A)  
    WATER (UNII: 059QF0KO0R)  
    POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)  
    TRIDECYL STEARATE (UNII: A8OE252M6L)  
    HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    POLYTETRAFLUOROETHYLENE (UNII: E1NC1JVS3O)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    CERAMIDE NP (UNII: 4370DF050B)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    SOYBEAN OIL (UNII: 241ATL177A)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    MAGNESIUM CHLORIDE (UNII: 02F3473H9O)  
    POTASSIUM CHLORIDE (UNII: 660YQ98I10)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)  
    LIMONENE, (+)- (UNII: GFD7C86Q1W)  
    LINALOOL, (+/-)- (UNII: D81QY6I88E)  
    .ALPHA.-AMYLCINNAMALDEHYDE (UNII: WC51CA3418)  
    .BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)  
    D&C RED NO. 30 (UNII: 2S42T2808B)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    MICA (UNII: V8A1AW0880)  
    D&C RED NO. 27 (UNII: 2LRS185U6K)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    D&C RED NO. 7 (UNII: ECW0LZ41X8)  
    D&C RED NO. 21 (UNII: 08744Z6JNY)  
    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 FINALpart35207/12/2016
    Part 9 of 24
    ESIKA PRO HIDRACOLOR 3 IN 1 MOISTURIZING, COLOR AND PERFECTING EFFECT SPF 25   (BORGONA SEXY) - PURPLE
    octinoxate and zinc oxide lipstick
    Product Information
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE0.075 g  in 1 g
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE0.0392 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW)  
    TRIDECYL TRIMELLITATE (UNII: FY36J270ES)  
    ISONONYL ISONONANOATE (UNII: S4V5BS6GCX)  
    CERESIN (UNII: Q1LS2UJO3A)  
    WATER (UNII: 059QF0KO0R)  
    POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)  
    TRIDECYL STEARATE (UNII: A8OE252M6L)  
    HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    POLYTETRAFLUOROETHYLENE (UNII: E1NC1JVS3O)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    CERAMIDE NP (UNII: 4370DF050B)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    SOYBEAN OIL (UNII: 241ATL177A)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    MAGNESIUM CHLORIDE (UNII: 02F3473H9O)  
    POTASSIUM CHLORIDE (UNII: 660YQ98I10)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)  
    LIMONENE, (+)- (UNII: GFD7C86Q1W)  
    LINALOOL, (+/-)- (UNII: D81QY6I88E)  
    .ALPHA.-AMYLCINNAMALDEHYDE (UNII: WC51CA3418)  
    .BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)  
    D&C RED NO. 30 (UNII: 2S42T2808B)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    MICA (UNII: V8A1AW0880)  
    D&C RED NO. 27 (UNII: 2LRS185U6K)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    D&C RED NO. 7 (UNII: ECW0LZ41X8)  
    D&C RED NO. 21 (UNII: 08744Z6JNY)  
    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 FINALpart35207/12/2016
    Part 10 of 24
    ESIKA PRO HIDRACOLOR 3 IN 1 MOISTURIZING, COLOR AND PERFECTING EFFECT SPF 25   (FRESA HOT) - PINK
    octinoxate and zinc oxide lipstick
    Product Information
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE0.075 g  in 1 g
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE0.0392 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW)  
    TRIDECYL TRIMELLITATE (UNII: FY36J270ES)  
    ISONONYL ISONONANOATE (UNII: S4V5BS6GCX)  
    CERESIN (UNII: Q1LS2UJO3A)  
    WATER (UNII: 059QF0KO0R)  
    POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)  
    TRIDECYL STEARATE (UNII: A8OE252M6L)  
    HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    POLYTETRAFLUOROETHYLENE (UNII: E1NC1JVS3O)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    CERAMIDE NP (UNII: 4370DF050B)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    SOYBEAN OIL (UNII: 241ATL177A)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    MAGNESIUM CHLORIDE (UNII: 02F3473H9O)  
    POTASSIUM CHLORIDE (UNII: 660YQ98I10)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)  
    LIMONENE, (+)- (UNII: GFD7C86Q1W)  
    LINALOOL, (+/-)- (UNII: D81QY6I88E)  
    .ALPHA.-AMYLCINNAMALDEHYDE (UNII: WC51CA3418)  
    .BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)  
    D&C RED NO. 30 (UNII: 2S42T2808B)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    MICA (UNII: V8A1AW0880)  
    D&C RED NO. 27 (UNII: 2LRS185U6K)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    D&C RED NO. 7 (UNII: ECW0LZ41X8)  
    D&C RED NO. 21 (UNII: 08744Z6JNY)  
    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 FINALpart35207/12/2016
    Part 11 of 24
    ESIKA PRO HIDRACOLOR 3 IN 1 MOISTURIZING, COLOR AND PERFECTING EFFECT SPF 25   (FUCSIA CAUTIVANTE) - PINK
    octinoxate and zinc oxide lipstick
    Product Information
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE0.075 g  in 1 g
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE0.0392 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW)  
    TRIDECYL TRIMELLITATE (UNII: FY36J270ES)  
    ISONONYL ISONONANOATE (UNII: S4V5BS6GCX)  
    CERESIN (UNII: Q1LS2UJO3A)  
    WATER (UNII: 059QF0KO0R)  
    POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)  
    TRIDECYL STEARATE (UNII: A8OE252M6L)  
    HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    POLYTETRAFLUOROETHYLENE (UNII: E1NC1JVS3O)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    CERAMIDE NP (UNII: 4370DF050B)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    SOYBEAN OIL (UNII: 241ATL177A)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    MAGNESIUM CHLORIDE (UNII: 02F3473H9O)  
    POTASSIUM CHLORIDE (UNII: 660YQ98I10)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)  
    LIMONENE, (+)- (UNII: GFD7C86Q1W)  
    LINALOOL, (+/-)- (UNII: D81QY6I88E)  
    .ALPHA.-AMYLCINNAMALDEHYDE (UNII: WC51CA3418)  
    .BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)  
    D&C RED NO. 30 (UNII: 2S42T2808B)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    MICA (UNII: V8A1AW0880)  
    D&C RED NO. 27 (UNII: 2LRS185U6K)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    D&C RED NO. 7 (UNII: ECW0LZ41X8)  
    D&C RED NO. 21 (UNII: 08744Z6JNY)  
    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 FINALpart35207/12/2016
    Part 12 of 24
    ESIKA PRO HIDRACOLOR 3 IN 1 MOISTURIZING, COLOR AND PERFECTING EFFECT SPF 25   (FUCSIA INTENSE) - PINK
    octinoxate and zinc oxide lipstick
    Product Information
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE0.075 g  in 1 g
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE0.0392 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW)  
    TRIDECYL TRIMELLITATE (UNII: FY36J270ES)  
    ISONONYL ISONONANOATE (UNII: S4V5BS6GCX)  
    CERESIN (UNII: Q1LS2UJO3A)  
    WATER (UNII: 059QF0KO0R)  
    POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)  
    TRIDECYL STEARATE (UNII: A8OE252M6L)  
    HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    POLYTETRAFLUOROETHYLENE (UNII: E1NC1JVS3O)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    CERAMIDE NP (UNII: 4370DF050B)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    SOYBEAN OIL (UNII: 241ATL177A)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    MAGNESIUM CHLORIDE (UNII: 02F3473H9O)  
    POTASSIUM CHLORIDE (UNII: 660YQ98I10)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)  
    LIMONENE, (+)- (UNII: GFD7C86Q1W)  
    LINALOOL, (+/-)- (UNII: D81QY6I88E)  
    .ALPHA.-AMYLCINNAMALDEHYDE (UNII: WC51CA3418)  
    .BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)  
    D&C RED NO. 30 (UNII: 2S42T2808B)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    MICA (UNII: V8A1AW0880)  
    D&C RED NO. 27 (UNII: 2LRS185U6K)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    D&C RED NO. 7 (UNII: ECW0LZ41X8)  
    D&C RED NO. 21 (UNII: 08744Z6JNY)  
    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 FINALpart35207/12/2016
    Part 13 of 24
    ESIKA PRO HIDRACOLOR 3 IN 1 MOISTURIZING, COLOR AND PERFECTING EFFECT SPF 25   (NARANJA ESFERA) - ORANGE
    octinoxate and zinc oxide lipstick
    Product Information
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE0.075 g  in 1 g
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE0.0392 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW)  
    TRIDECYL TRIMELLITATE (UNII: FY36J270ES)  
    ISONONYL ISONONANOATE (UNII: S4V5BS6GCX)  
    CERESIN (UNII: Q1LS2UJO3A)  
    WATER (UNII: 059QF0KO0R)  
    POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)  
    TRIDECYL STEARATE (UNII: A8OE252M6L)  
    HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    POLYTETRAFLUOROETHYLENE (UNII: E1NC1JVS3O)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    CERAMIDE NP (UNII: 4370DF050B)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    SOYBEAN OIL (UNII: 241ATL177A)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    MAGNESIUM CHLORIDE (UNII: 02F3473H9O)  
    POTASSIUM CHLORIDE (UNII: 660YQ98I10)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)  
    LIMONENE, (+)- (UNII: GFD7C86Q1W)  
    LINALOOL, (+/-)- (UNII: D81QY6I88E)  
    .ALPHA.-AMYLCINNAMALDEHYDE (UNII: WC51CA3418)  
    .BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)  
    D&C RED NO. 30 (UNII: 2S42T2808B)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    MICA (UNII: V8A1AW0880)  
    D&C RED NO. 27 (UNII: 2LRS185U6K)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    D&C RED NO. 7 (UNII: ECW0LZ41X8)  
    D&C RED NO. 21 (UNII: 08744Z6JNY)  
    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 FINALpart35207/12/2016
    Part 14 of 24
    ESIKA PRO HIDRACOLOR 3 IN 1 MOISTURIZING, COLOR AND PERFECTING EFFECT SPF 25   (ROSA NUDE) - PINK
    octinoxate and zinc oxide lipstick
    Product Information
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE0.075 g  in 1 g
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE0.0392 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW)  
    TRIDECYL TRIMELLITATE (UNII: FY36J270ES)  
    ISONONYL ISONONANOATE (UNII: S4V5BS6GCX)  
    CERESIN (UNII: Q1LS2UJO3A)  
    WATER (UNII: 059QF0KO0R)  
    POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)  
    TRIDECYL STEARATE (UNII: A8OE252M6L)  
    HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    POLYTETRAFLUOROETHYLENE (UNII: E1NC1JVS3O)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    CERAMIDE NP (UNII: 4370DF050B)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    SOYBEAN OIL (UNII: 241ATL177A)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    MAGNESIUM CHLORIDE (UNII: 02F3473H9O)  
    POTASSIUM CHLORIDE (UNII: 660YQ98I10)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)  
    LIMONENE, (+)- (UNII: GFD7C86Q1W)  
    LINALOOL, (+/-)- (UNII: D81QY6I88E)  
    .ALPHA.-AMYLCINNAMALDEHYDE (UNII: WC51CA3418)  
    .BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)  
    D&C RED NO. 30 (UNII: 2S42T2808B)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    MICA (UNII: V8A1AW0880)  
    D&C RED NO. 27 (UNII: 2LRS185U6K)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    D&C RED NO. 7 (UNII: ECW0LZ41X8)  
    D&C RED NO. 21 (UNII: 08744Z6JNY)  
    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 FINALpart35207/12/2016
    Part 15 of 24
    ESIKA PRO HIDRACOLOR 3 IN 1 MOISTURIZING, COLOR AND PERFECTING EFFECT SPF 25   (PEACH NUDE) - BROWN
    octinoxate and zinc oxide lipstick
    Product Information
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE0.075 g  in 1 g
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE0.0392 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW)  
    TRIDECYL TRIMELLITATE (UNII: FY36J270ES)  
    ISONONYL ISONONANOATE (UNII: S4V5BS6GCX)  
    CERESIN (UNII: Q1LS2UJO3A)  
    WATER (UNII: 059QF0KO0R)  
    POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)  
    TRIDECYL STEARATE (UNII: A8OE252M6L)  
    HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    POLYTETRAFLUOROETHYLENE (UNII: E1NC1JVS3O)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    CERAMIDE NP (UNII: 4370DF050B)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    SOYBEAN OIL (UNII: 241ATL177A)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    MAGNESIUM CHLORIDE (UNII: 02F3473H9O)  
    POTASSIUM CHLORIDE (UNII: 660YQ98I10)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)  
    LIMONENE, (+)- (UNII: GFD7C86Q1W)  
    LINALOOL, (+/-)- (UNII: D81QY6I88E)  
    .ALPHA.-AMYLCINNAMALDEHYDE (UNII: WC51CA3418)  
    .BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)  
    D&C RED NO. 30 (UNII: 2S42T2808B)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    MICA (UNII: V8A1AW0880)  
    D&C RED NO. 27 (UNII: 2LRS185U6K)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    D&C RED NO. 7 (UNII: ECW0LZ41X8)  
    D&C RED NO. 21 (UNII: 08744Z6JNY)  
    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 FINALpart35207/12/2016
    Part 16 of 24
    ESIKA PRO HIDRACOLOR 3 IN 1 MOISTURIZING, COLOR AND PERFECTING EFFECT SPF 25   (CORAL CHIC) - PINK
    octinoxate and zinc oxide lipstick
    Product Information
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE0.075 g  in 1 g
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE0.0392 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW)  
    TRIDECYL TRIMELLITATE (UNII: FY36J270ES)  
    ISONONYL ISONONANOATE (UNII: S4V5BS6GCX)  
    CERESIN (UNII: Q1LS2UJO3A)  
    WATER (UNII: 059QF0KO0R)  
    POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)  
    TRIDECYL STEARATE (UNII: A8OE252M6L)  
    HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    POLYTETRAFLUOROETHYLENE (UNII: E1NC1JVS3O)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    CERAMIDE NP (UNII: 4370DF050B)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    SOYBEAN OIL (UNII: 241ATL177A)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    MAGNESIUM CHLORIDE (UNII: 02F3473H9O)  
    POTASSIUM CHLORIDE (UNII: 660YQ98I10)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)  
    LIMONENE, (+)- (UNII: GFD7C86Q1W)  
    LINALOOL, (+/-)- (UNII: D81QY6I88E)  
    .ALPHA.-AMYLCINNAMALDEHYDE (UNII: WC51CA3418)  
    .BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)  
    D&C RED NO. 30 (UNII: 2S42T2808B)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    MICA (UNII: V8A1AW0880)  
    D&C RED NO. 27 (UNII: 2LRS185U6K)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    D&C RED NO. 7 (UNII: ECW0LZ41X8)  
    D&C RED NO. 21 (UNII: 08744Z6JNY)  
    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 FINALpart35207/12/2016
    Part 17 of 24
    ESIKA PRO HIDRACOLOR 3 IN 1 MOISTURIZING, COLOR AND PERFECTING EFFECT SPF 25   (ROJO TROPICAL) - RED
    octinoxate and zinc oxide lipstick
    Product Information
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE0.075 g  in 1 g
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE0.0392 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW)  
    TRIDECYL TRIMELLITATE (UNII: FY36J270ES)  
    ISONONYL ISONONANOATE (UNII: S4V5BS6GCX)  
    CERESIN (UNII: Q1LS2UJO3A)  
    WATER (UNII: 059QF0KO0R)  
    POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)  
    TRIDECYL STEARATE (UNII: A8OE252M6L)  
    HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    POLYTETRAFLUOROETHYLENE (UNII: E1NC1JVS3O)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    CERAMIDE NP (UNII: 4370DF050B)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    SOYBEAN OIL (UNII: 241ATL177A)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    MAGNESIUM CHLORIDE (UNII: 02F3473H9O)  
    POTASSIUM CHLORIDE (UNII: 660YQ98I10)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)  
    LIMONENE, (+)- (UNII: GFD7C86Q1W)  
    LINALOOL, (+/-)- (UNII: D81QY6I88E)  
    .ALPHA.-AMYLCINNAMALDEHYDE (UNII: WC51CA3418)  
    .BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)  
    D&C RED NO. 30 (UNII: 2S42T2808B)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    MICA (UNII: V8A1AW0880)  
    D&C RED NO. 27 (UNII: 2LRS185U6K)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    D&C RED NO. 7 (UNII: ECW0LZ41X8)  
    D&C RED NO. 21 (UNII: 08744Z6JNY)  
    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 FINALpart35207/12/2016
    Part 18 of 24
    ESIKA PRO HIDRACOLOR 3 IN 1 MOISTURIZING, COLOR AND PERFECTING EFFECT SPF 25   (NARANJA CITRICO) - ORANGE
    octinoxate and zinc oxide lipstick
    Product Information
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE0.075 g  in 1 g
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE0.0392 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW)  
    TRIDECYL TRIMELLITATE (UNII: FY36J270ES)  
    ISONONYL ISONONANOATE (UNII: S4V5BS6GCX)  
    CERESIN (UNII: Q1LS2UJO3A)  
    WATER (UNII: 059QF0KO0R)  
    POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)  
    TRIDECYL STEARATE (UNII: A8OE252M6L)  
    HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    POLYTETRAFLUOROETHYLENE (UNII: E1NC1JVS3O)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    CERAMIDE NP (UNII: 4370DF050B)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    SOYBEAN OIL (UNII: 241ATL177A)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    MAGNESIUM CHLORIDE (UNII: 02F3473H9O)  
    POTASSIUM CHLORIDE (UNII: 660YQ98I10)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)  
    LIMONENE, (+)- (UNII: GFD7C86Q1W)  
    LINALOOL, (+/-)- (UNII: D81QY6I88E)  
    .ALPHA.-AMYLCINNAMALDEHYDE (UNII: WC51CA3418)  
    .BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)  
    D&C RED NO. 30 (UNII: 2S42T2808B)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    MICA (UNII: V8A1AW0880)  
    D&C RED NO. 27 (UNII: 2LRS185U6K)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    D&C RED NO. 7 (UNII: ECW0LZ41X8)  
    D&C RED NO. 21 (UNII: 08744Z6JNY)  
    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 FINALpart35207/12/2016
    Part 19 of 24
    ESIKA PRO HIDRACOLOR 3 IN 1 MOISTURIZING, COLOR AND PERFECTING EFFECT SPF 25   (NUDE PUNCH) - ORANGE
    octinoxate and zinc oxide lipstick
    Product Information
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE0.075 g  in 1 g
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE0.0392 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW)  
    TRIDECYL TRIMELLITATE (UNII: FY36J270ES)  
    ISONONYL ISONONANOATE (UNII: S4V5BS6GCX)  
    CERESIN (UNII: Q1LS2UJO3A)  
    WATER (UNII: 059QF0KO0R)  
    POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)  
    TRIDECYL STEARATE (UNII: A8OE252M6L)  
    HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    POLYTETRAFLUOROETHYLENE (UNII: E1NC1JVS3O)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    CERAMIDE NP (UNII: 4370DF050B)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    SOYBEAN OIL (UNII: 241ATL177A)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    MAGNESIUM CHLORIDE (UNII: 02F3473H9O)  
    POTASSIUM CHLORIDE (UNII: 660YQ98I10)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)  
    LIMONENE, (+)- (UNII: GFD7C86Q1W)  
    LINALOOL, (+/-)- (UNII: D81QY6I88E)  
    .ALPHA.-AMYLCINNAMALDEHYDE (UNII: WC51CA3418)  
    .BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)  
    D&C RED NO. 30 (UNII: 2S42T2808B)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    MICA (UNII: V8A1AW0880)  
    D&C RED NO. 27 (UNII: 2LRS185U6K)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    D&C RED NO. 7 (UNII: ECW0LZ41X8)  
    D&C RED NO. 21 (UNII: 08744Z6JNY)  
    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 FINALpart35207/12/2016
    Part 20 of 24
    ESIKA PRO HIDRACOLOR 3 IN 1 MOISTURIZING, COLOR AND PERFECTING EFFECT SPF 25   (MORA ATREVIDA) - PURPLE
    octinoxate and zinc oxide lipstick
    Product Information
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE0.075 g  in 1 g
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE0.0392 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW)  
    TRIDECYL TRIMELLITATE (UNII: FY36J270ES)  
    ISONONYL ISONONANOATE (UNII: S4V5BS6GCX)  
    CERESIN (UNII: Q1LS2UJO3A)  
    WATER (UNII: 059QF0KO0R)  
    POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)  
    TRIDECYL STEARATE (UNII: A8OE252M6L)  
    HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    POLYTETRAFLUOROETHYLENE (UNII: E1NC1JVS3O)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    CERAMIDE NP (UNII: 4370DF050B)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    SOYBEAN OIL (UNII: 241ATL177A)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    MAGNESIUM CHLORIDE (UNII: 02F3473H9O)  
    POTASSIUM CHLORIDE (UNII: 660YQ98I10)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)  
    LIMONENE, (+)- (UNII: GFD7C86Q1W)  
    LINALOOL, (+/-)- (UNII: D81QY6I88E)  
    .ALPHA.-AMYLCINNAMALDEHYDE (UNII: WC51CA3418)  
    .BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)  
    D&C RED NO. 30 (UNII: 2S42T2808B)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    MICA (UNII: V8A1AW0880)  
    D&C RED NO. 27 (UNII: 2LRS185U6K)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    D&C RED NO. 7 (UNII: ECW0LZ41X8)  
    D&C RED NO. 21 (UNII: 08744Z6JNY)  
    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 FINALpart35207/12/2016
    Part 21 of 24
    ESIKA PRO HIDRACOLOR 3 IN 1 MOISTURIZING, COLOR AND PERFECTING EFFECT SPF 25   (NUDE SAVANNA) - ORANGE
    octinoxate and zinc oxide lipstick
    Product Information
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE0.075 g  in 1 g
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE0.0392 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW)  
    TRIDECYL TRIMELLITATE (UNII: FY36J270ES)  
    ISONONYL ISONONANOATE (UNII: S4V5BS6GCX)  
    CERESIN (UNII: Q1LS2UJO3A)  
    WATER (UNII: 059QF0KO0R)  
    POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)  
    TRIDECYL STEARATE (UNII: A8OE252M6L)  
    HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    POLYTETRAFLUOROETHYLENE (UNII: E1NC1JVS3O)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    CERAMIDE NP (UNII: 4370DF050B)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    SOYBEAN OIL (UNII: 241ATL177A)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    MAGNESIUM CHLORIDE (UNII: 02F3473H9O)  
    POTASSIUM CHLORIDE (UNII: 660YQ98I10)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)  
    LIMONENE, (+)- (UNII: GFD7C86Q1W)  
    LINALOOL, (+/-)- (UNII: D81QY6I88E)  
    .ALPHA.-AMYLCINNAMALDEHYDE (UNII: WC51CA3418)  
    .BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)  
    D&C RED NO. 30 (UNII: 2S42T2808B)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    MICA (UNII: V8A1AW0880)  
    D&C RED NO. 27 (UNII: 2LRS185U6K)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    D&C RED NO. 7 (UNII: ECW0LZ41X8)  
    D&C RED NO. 21 (UNII: 08744Z6JNY)  
    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 FINALpart35207/12/2016
    Part 22 of 24
    ESIKA PRO HIDRACOLOR 3 IN 1 MOISTURIZING, COLOR AND PERFECTING EFFECT SPF 25   (ROJO SENSUAL) - RED
    octinoxate and zinc oxide lipstick
    Product Information
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE0.075 g  in 1 g
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE0.0392 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW)  
    TRIDECYL TRIMELLITATE (UNII: FY36J270ES)  
    ISONONYL ISONONANOATE (UNII: S4V5BS6GCX)  
    CERESIN (UNII: Q1LS2UJO3A)  
    WATER (UNII: 059QF0KO0R)  
    POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)  
    TRIDECYL STEARATE (UNII: A8OE252M6L)  
    HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    POLYTETRAFLUOROETHYLENE (UNII: E1NC1JVS3O)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    CERAMIDE NP (UNII: 4370DF050B)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    SOYBEAN OIL (UNII: 241ATL177A)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    MAGNESIUM CHLORIDE (UNII: 02F3473H9O)  
    POTASSIUM CHLORIDE (UNII: 660YQ98I10)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)  
    LIMONENE, (+)- (UNII: GFD7C86Q1W)  
    LINALOOL, (+/-)- (UNII: D81QY6I88E)  
    .ALPHA.-AMYLCINNAMALDEHYDE (UNII: WC51CA3418)  
    .BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)  
    D&C RED NO. 30 (UNII: 2S42T2808B)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    MICA (UNII: V8A1AW0880)  
    D&C RED NO. 27 (UNII: 2LRS185U6K)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    D&C RED NO. 7 (UNII: ECW0LZ41X8)  
    D&C RED NO. 21 (UNII: 08744Z6JNY)  
    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 FINALpart35207/12/2016
    Part 23 of 24
    ESIKA PRO HIDRACOLOR 3 IN 1 MOISTURIZING, COLOR AND PERFECTING EFFECT SPF 25   (NUDE MOCCHA) - ORANGE
    octinoxate and zinc oxide lipstick
    Product Information
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE0.075 g  in 1 g
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE0.0392 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW)  
    TRIDECYL TRIMELLITATE (UNII: FY36J270ES)  
    ISONONYL ISONONANOATE (UNII: S4V5BS6GCX)  
    CERESIN (UNII: Q1LS2UJO3A)  
    WATER (UNII: 059QF0KO0R)  
    POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)  
    TRIDECYL STEARATE (UNII: A8OE252M6L)  
    HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    POLYTETRAFLUOROETHYLENE (UNII: E1NC1JVS3O)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    CERAMIDE NP (UNII: 4370DF050B)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    SOYBEAN OIL (UNII: 241ATL177A)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    MAGNESIUM CHLORIDE (UNII: 02F3473H9O)  
    POTASSIUM CHLORIDE (UNII: 660YQ98I10)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)  
    LIMONENE, (+)- (UNII: GFD7C86Q1W)  
    LINALOOL, (+/-)- (UNII: D81QY6I88E)  
    .ALPHA.-AMYLCINNAMALDEHYDE (UNII: WC51CA3418)  
    .BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)  
    D&C RED NO. 30 (UNII: 2S42T2808B)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    MICA (UNII: V8A1AW0880)  
    D&C RED NO. 27 (UNII: 2LRS185U6K)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    D&C RED NO. 7 (UNII: ECW0LZ41X8)  
    D&C RED NO. 21 (UNII: 08744Z6JNY)  
    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 FINALpart35207/12/2016
    Part 24 of 24
    ESIKA PRO HIDRACOLOR 3 IN 1 MOISTURIZING, COLOR AND PERFECTING EFFECT SPF 25   (BRONCE METALLIC) - BROWN
    octinoxate and zinc oxide lipstick
    Product Information
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE0.075 g  in 1 g
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE0.0392 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW)  
    TRIDECYL TRIMELLITATE (UNII: FY36J270ES)  
    ISONONYL ISONONANOATE (UNII: S4V5BS6GCX)  
    CERESIN (UNII: Q1LS2UJO3A)  
    WATER (UNII: 059QF0KO0R)  
    POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)  
    TRIDECYL STEARATE (UNII: A8OE252M6L)  
    HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    POLYTETRAFLUOROETHYLENE (UNII: E1NC1JVS3O)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    CERAMIDE NP (UNII: 4370DF050B)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    SOYBEAN OIL (UNII: 241ATL177A)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    MAGNESIUM CHLORIDE (UNII: 02F3473H9O)  
    POTASSIUM CHLORIDE (UNII: 660YQ98I10)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)  
    LIMONENE, (+)- (UNII: GFD7C86Q1W)  
    LINALOOL, (+/-)- (UNII: D81QY6I88E)  
    .ALPHA.-AMYLCINNAMALDEHYDE (UNII: WC51CA3418)  
    .BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)  
    D&C RED NO. 30 (UNII: 2S42T2808B)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    MICA (UNII: V8A1AW0880)  
    D&C RED NO. 27 (UNII: 2LRS185U6K)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    D&C RED NO. 7 (UNII: ECW0LZ41X8)  
    D&C RED NO. 21 (UNII: 08744Z6JNY)  
    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 FINALpart35207/12/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35207/12/2016
    Labeler - Ventura Corporation LTD DUNS (602751344)
    Establishment
    NameAddressID/FEIBusiness Operations
    Bel Star S.A. (Colombia)880160197MANUFACTURE(13537-958, 13537-959, 13537-960, 13537-966, 13537-967, 13537-968, 13537-969, 13537-970, 13537-971, 13537-972, 13537-973, 13537-974, 13537-975, 13537-976, 13537-977, 13537-978, 13537-979, 13537-980, 13537-981, 13537-982, 13537-983, 13537-984, 13537-985, 13537-986, 13537-987)