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- octinoxate and zinc oxide lipstick 
ESIKA PRO HIDRACOLOR 3 IN 1 MOISTURIZING, COLOR AND PERFECTING EFFECT SPF 25  (MARRON TOPACIO) - BROWN- octinoxate and zinc oxide lipstick 
ESIKA PRO HIDRACOLOR 3 IN 1 MOISTURIZING, COLOR AND PERFECTING EFFECT SPF 25  (ROSA GEOMETRIC) - PINK- octinoxate and zinc oxide lipstick 
ESIKA PRO HIDRACOLOR 3 IN 1 MOISTURIZING, COLOR AND PERFECTING EFFECT SPF 25  (ROSA ENCANTO) - PINK- octinoxate and zinc oxide lipstick 
ESIKA PRO HIDRACOLOR 3 IN 1 MOISTURIZING, COLOR AND PERFECTING EFFECT SPF 25  (MORA GLAM) - PURPLE- octinoxate and zinc oxide lipstick 
ESIKA PRO HIDRACOLOR 3 IN 1 MOISTURIZING, COLOR AND PERFECTING EFFECT SPF 25  (GRANATE SEDUCTOR) - PURPLE- octinoxate and zinc oxide lipstick 
ESIKA PRO HIDRACOLOR 3 IN 1 MOISTURIZING, COLOR AND PERFECTING EFFECT SPF 25  (BORGONA SEXY) - PURPLE- octinoxate and zinc oxide lipstick 
ESIKA PRO HIDRACOLOR 3 IN 1 MOISTURIZING, COLOR AND PERFECTING EFFECT SPF 25  (FRESA HOT) - PINK- octinoxate and zinc oxide lipstick 
ESIKA PRO HIDRACOLOR 3 IN 1 MOISTURIZING, COLOR AND PERFECTING EFFECT SPF 25  (FUCSIA CAUTIVANTE) - PINK- octinoxate and zinc oxide lipstick 
ESIKA PRO HIDRACOLOR 3 IN 1 MOISTURIZING, COLOR AND PERFECTING EFFECT SPF 25  (FUCSIA INTENSE) - PINK- octinoxate and zinc oxide lipstick 
ESIKA PRO HIDRACOLOR 3 IN 1 MOISTURIZING, COLOR AND PERFECTING EFFECT SPF 25  (NARANJA ESFERA) - ORANGE- octinoxate and zinc oxide lipstick 
ESIKA PRO HIDRACOLOR 3 IN 1 MOISTURIZING, COLOR AND PERFECTING EFFECT SPF 25  (ROSA NUDE) - PINK- octinoxate and zinc oxide lipstick 
ESIKA PRO HIDRACOLOR 3 IN 1 MOISTURIZING, COLOR AND PERFECTING EFFECT SPF 25  (PEACH NUDE) - BROWN- octinoxate and zinc oxide lipstick 
ESIKA PRO HIDRACOLOR 3 IN 1 MOISTURIZING, COLOR AND PERFECTING EFFECT SPF 25  (CORAL CHIC) - PINK- octinoxate and zinc oxide lipstick 
ESIKA PRO HIDRACOLOR 3 IN 1 MOISTURIZING, COLOR AND PERFECTING EFFECT SPF 25  (ROJO TROPICAL) - RED- octinoxate and zinc oxide lipstick 
ESIKA PRO HIDRACOLOR 3 IN 1 MOISTURIZING, COLOR AND PERFECTING EFFECT SPF 25  (NARANJA CITRICO) - ORANGE- octinoxate and zinc oxide lipstick 
ESIKA PRO HIDRACOLOR 3 IN 1 MOISTURIZING, COLOR AND PERFECTING EFFECT SPF 25  (NUDE PUNCH) - ORANGE- octinoxate and zinc oxide lipstick 
ESIKA PRO HIDRACOLOR 3 IN 1 MOISTURIZING, COLOR AND PERFECTING EFFECT SPF 25  (MORA ATREVIDA) - PURPLE- octinoxate and zinc oxide lipstick 
ESIKA PRO HIDRACOLOR 3 IN 1 MOISTURIZING, COLOR AND PERFECTING EFFECT SPF 25  (NUDE SAVANNA) - ORANGE- octinoxate and zinc oxide lipstick 
ESIKA PRO HIDRACOLOR 3 IN 1 MOISTURIZING, COLOR AND PERFECTING EFFECT SPF 25  (ROJO SENSUAL) - RED- octinoxate and zinc oxide lipstick 
ESIKA PRO 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 
Ventura Corporation LTD DUNS

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.

----------

ÉSIKA PRO HIDRACOLOR 3 IN 1 Moisturizing lipstick, color and perfecting effect SPF 25

Drug Facts

Active IngredientsPurpose
OCTINOXATE 7.5%Sunscreen
ZINC OXIDE 3.92%Sunscreen

Uses

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

Other information

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.

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
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)

Revised: 11/2018
Document Id: 31695d5d-af4a-4306-aef9-db95a1b75a1a
Set id: bb76db06-ff79-4581-a1d7-186129e3c1b2
Version: 2
Effective Time: 20181126
 
Ventura Corporation LTD DUNS