ESIKA HYDRACOLOR 2 IN 1 HIGHLY MOISTURIZING AND COLORING SPF 25 (MARRON GLAMOUR) - BROWN- octinoxate and oxybenzone lipstick
ESIKA HYDRACOLOR 2 IN 1 HIGHLY MOISTURIZING AND COLORING SPF 25 (ROJO DESEO) - RED- octinoxate and oxybenzone lipstick
ESIKA HYDRACOLOR 2 IN 1 HIGHLY MOISTURIZING AND COLORING SPF 25 (ROJO INTRIGANTE) - RED- octinoxate and oxybenzone lipstick
ESIKA HYDRACOLOR 2 IN 1 HIGHLY MOISTURIZING AND COLORING SPF 25 (ROJO LUJURIA) - RED- octinoxate and oxybenzone lipstick
ESIKA HYDRACOLOR 2 IN 1 HIGHLY MOISTURIZING AND COLORING SPF 25 (CORAL CHIC) - PINK- octinoxate and oxybenzone lipstick
ESIKA HYDRACOLOR 2 IN 1 HIGHLY MOISTURIZING AND COLORING SPF 25 (ROSA ENCANTO) - PINK- octinoxate and oxybenzone lipstick
ESIKA HYDRACOLOR 2 IN 1 HIGHLY MOISTURIZING AND COLORING SPF 25 (BORGONA SEXY) - PURPLE- octinoxate and oxybenzone lipstick
ESIKA HYDRACOLOR 2 IN 1 HIGHLY MOISTURIZING AND COLORING SPF 25 (FUCSIA CAUTIVANTE) - PINK- octinoxate and oxybenzone lipstick
ESIKA HYDRACOLOR 2 IN 1 HIGHLY MOISTURIZING AND COLORING SPF 25 (GRANATE SEDUCTOR) - PURPLE- octinoxate and oxybenzone lipstick
ESIKA HYDRACOLOR 2 IN 1 HIGHLY MOISTURIZING AND COLORING SPF 25 (ROSA ROMANTICA) - PINK- octinoxate and oxybenzone lipstick
ESIKA HYDRACOLOR 2 IN 1 HIGHLY MOISTURIZING AND COLORING SPF 25 (NARANJA PRIMAVERA) - ORANGE- octinoxate and oxybenzone lipstick
ESIKA HYDRACOLOR 2 IN 1 HIGHLY MOISTURIZING AND COLORING SPF 25 (FRAMBUESA MANIA) - RED- octinoxate and oxybenzone lipstick
ESIKA HYDRACOLOR 2 IN 1 HIGHLY MOISTURIZING AND COLORING SPF 25 (ROSA DULZURA) - PINK- octinoxate and oxybenzone lipstick
ESIKA HYDRACOLOR 2 IN 1 HIGHLY MOISTURIZING AND COLORING SPF 25 (PIMIENTA CALIENTE) - BROWN- octinoxate and oxybenzone lipstick
ESIKA HYDRACOLOR 2 IN 1 HIGHLY MOISTURIZING AND COLORING SPF 25 (CANELA NUDE) - ORANGE- octinoxate and oxybenzone lipstick
ESIKA HYDRACOLOR 2 IN 1 HIGHLY MOISTURIZING AND COLORING SPF 25 (MORA GLAM) - BROWN- octinoxate and oxybenzone lipstick
ESIKA HYDRACOLOR 2 IN 1 HIGHLY MOISTURIZING AND COLORING SPF 25 (CORAL INTENSE) - RED- octinoxate and oxybenzone lipstick
ESIKA HYDRACOLOR 2 IN 1 HIGHLY MOISTURIZING AND COLORING SPF 25 (FRESA COQUETA) - RED- octinoxate and oxybenzone lipstick
ESIKA HYDRACOLOR 2 IN 1 HIGHLY MOISTURIZING AND COLORING SPF 25 (PIMIENTA CALIENTE FEMME) - RED- octinoxate and oxybenzone lipstick
ESIKA HYDRACOLOR 2 IN 1 HIGHLY MOISTURIZING AND COLORING SPF 25 (GRANATE SEDUCTOR FEMME) - PURPLE- octinoxate and oxybenzone lipstick
ESIKA HYDRACOLOR 2 IN 1 HIGHLY MOISTURIZING AND COLORING SPF 25 (FUCSIA CAUTIVANTE FEMME) - PINK- octinoxate and oxybenzone lipstick
ESIKA HYDRACOLOR 2 IN 1 HIGHLY MOISTURIZING AND COLORING SPF 25 (ROSA ROMANTICA FEMME) - PINK- octinoxate and oxybenzone lipstick
ESIKA HYDRACOLOR 2 IN 1 HIGHLY MOISTURIZING AND COLORING SPF 25 (ROJO INTRIGANTE FEMME) - RED- octinoxate and oxybenzone lipstick
ESIKA HYDRACOLOR 2 IN 1 HIGHLY MOISTURIZING AND COLORING SPF 25 (ROSA ENCANTO FEMME) - PINK- octinoxate and oxybenzone lipstick
Ventura Corporation LTD

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 HYDRACOLOR 2 IN 1 Highly Moisturizing and coloring SPF 25

Drug Facts

Active Ingredients	Purpose
OCTINOXATE: 6.6%	Sunscreen
OXYBENZONE: 1.5%	Sunscreen

Uses

Helps prevent sunburn.

Warnings

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

Do not use on damaged or broken skin.

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

Stop use and ask a doctor if rash occurs.

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

Directions

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

Other information

Protect this product in this container form excesive heat and direct sun. Keep away from heat sources and direct sunlight. Store well and under 50°C (112°F).

Inactive ingredients

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

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

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

PRINCIPAL DISPLAY PANEL - 4 g Tube Box - (MARRON GLAMOUR) - BROWN

ésika

HYDRACOLOR 2 in 1
Highly moisturizing and coloring
LIPSTICK SPF 25

Net Weight 0.14 oz. e (4 g)

PRINCIPAL DISPLAY PANEL - 4 g Tube Box - (MARRON GLAMOUR) - BROWN

PRINCIPAL DISPLAY PANEL - 4 g Tube Box - (ROJO DESEO) - RED

ésika

HYDRACOLOR 2 in 1
Highly moisturizing and coloring
LIPSTICK SPF 25

Net Weight 0.14 oz. e (4 g)

PRINCIPAL DISPLAY PANEL - 4 g Tube Box - (ROJO DESEO) - RED

PRINCIPAL DISPLAY PANEL - 4 g Tube Box - (ROJO INTRIGANTE) - RED

ésika

HYDRACOLOR 2 in 1
Highly moisturizing and coloring
LIPSTICK SPF 25

Net Weight 0.14 oz. e (4 g)

PRINCIPAL DISPLAY PANEL - 4 g Tube Box - (ROJO INTRIGANTE) - RED

PRINCIPAL DISPLAY PANEL - 4 g Tube Box - (ROJO LUJURIA) - RED

ésika

HYDRACOLOR 2 in 1
Highly moisturizing and coloring
LIPSTICK SPF 25

Net Weight 0.14 oz. e (4 g)

PRINCIPAL DISPLAY PANEL - 4 g Tube Box - (ROJO LUJURIA) - RED

PRINCIPAL DISPLAY PANEL - 4 g Tube Box - (CORAL CHIC) - PINK

ésika

HYDRACOLOR 2 in 1
Highly moisturizing and coloring
LIPSTICK SPF 25

Net Weight 0.14 oz. e (4 g)

PRINCIPAL DISPLAY PANEL - 4 g Tube Box - (CORAL CHIC) - PINK

PRINCIPAL DISPLAY PANEL - 4 g Tube Box - (ROSA ENCANTO) - PINK

ésika

HYDRACOLOR 2 in 1
Highly moisturizing and coloring
LIPSTICK SPF 25

Net Weight 0.14 oz. e (4 g)

PRINCIPAL DISPLAY PANEL - 4 g Tube Box - (ROSA ENCANTO) - PINK

PRINCIPAL DISPLAY PANEL - 4 g Tube Box - (BORGONA SEXY) - PURPLE

ésika

HYDRACOLOR 2 in 1
Highly moisturizing and coloring
LIPSTICK SPF 25

Net Weight 0.14 oz. e (4 g)

PRINCIPAL DISPLAY PANEL - 4 g Tube Box - (BORGONA SEXY) - PURPLE

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

ésika

HYDRACOLOR 2 in 1
Highly moisturizing and coloring
LIPSTICK SPF 25

Net Weight 0.14 oz. e (4 g)

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

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

ésika

HYDRACOLOR 2 in 1
Highly moisturizing and coloring
LIPSTICK SPF 25

Net Weight 0.14 oz. e (4 g)

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

PRINCIPAL DISPLAY PANEL - 4 g Tube Box - (ROSA ROMANTICA) - PINK

ésika

HYDRACOLOR 2 in 1
Highly moisturizing and coloring
LIPSTICK SPF 25

Net Weight 0.14 oz. e (4 g)

PRINCIPAL DISPLAY PANEL - 4 g Tube Box - (ROSA ROMANTICA) - PINK

PRINCIPAL DISPLAY PANEL - 4 g Tube Box - (NARANJA PRIMAVERA) - ORANGE

ésika

HYDRACOLOR 2 in 1
Highly moisturizing and coloring
LIPSTICK SPF 25

Net Weight 0.14 oz. e (4 g)

PRINCIPAL DISPLAY PANEL - 4 g Tube Box - (NARANJA PRIMAVERA) - ORANGE

PRINCIPAL DISPLAY PANEL - 4 g Tube Box - (FRAMBUESA MANIA) - RED

ésika

HYDRACOLOR 2 in 1
Highly moisturizing and coloring
LIPSTICK SPF 25

Net Weight 0.14 oz. e (4 g)

PRINCIPAL DISPLAY PANEL - 4 g Tube Box - (FRAMBUESA MANIA) - RED

PRINCIPAL DISPLAY PANEL - 4 g Tube Box - (ROSA DULZURA) - PINK

ésika

HYDRACOLOR 2 in 1
Highly moisturizing and coloring
LIPSTICK SPF 25

Net Weight 0.14 oz. e (4 g)

PRINCIPAL DISPLAY PANEL - 4 g Tube Box - (ROSA DULZURA) - PINK

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

ésika

HYDRACOLOR 2 in 1
Highly moisturizing and coloring
LIPSTICK SPF 25

Net Weight 0.14 oz. e (4 g)

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

PRINCIPAL DISPLAY PANEL - 4 g Tube Box - (CANELA NUDE) - ORANGE

ésika

HYDRACOLOR 2 in 1
Highly moisturizing and coloring
LIPSTICK SPF 25

Net Weight 0.14 oz. e (4 g)

PRINCIPAL DISPLAY PANEL - 4 g Tube Box - (CANELA NUDE) - ORANGE

PRINCIPAL DISPLAY PANEL - 4 g Tube Box - (MORA GLAM) - BROWN

ésika

HYDRACOLOR 2 in 1
Highly moisturizing and coloring
LIPSTICK SPF 25

Net Weight 0.14 oz. e (4 g)

PRINCIPAL DISPLAY PANEL - 4 g Tube Box - (MORA GLAM) - BROWN

PRINCIPAL DISPLAY PANEL - 4 g Tube Box - (CORAL INTENSE) - RED

ésika

HYDRACOLOR 2 in 1
Highly moisturizing and coloring
LIPSTICK SPF 25

Net Weight 0.14 oz. e (4 g)

PRINCIPAL DISPLAY PANEL - 4 g Tube Box - (CORAL INTENSE) - RED

PRINCIPAL DISPLAY PANEL - 4 g Tube Box - (FRESA COQUETA) - RED

ésika

HYDRACOLOR 2 in 1
Highly moisturizing and coloring
LIPSTICK SPF 25

Net Weight 0.14 oz. e (4 g)

PRINCIPAL DISPLAY PANEL - 4 g Tube Box - (FRESA COQUETA) - RED

PRINCIPAL DISPLAY PANEL - 4 g Tube Box - (PIMIENTA CALIENTE FEMME) - RED

ésika

HYDRACOLOR 2 in 1
Highly moisturizing and coloring
LIPSTICK SPF 25

Net Weight 0.14 oz. e (4 g)

PRINCIPAL DISPLAY PANEL - 4 g Tube Box - (PIMIENTA CALIENTE FEMME) - RED

PRINCIPAL DISPLAY PANEL - 4 g Tube Box - (GRANATE SEDUCTOR FEMME) - PURPLE

ésika

HYDRACOLOR 2 in 1
Highly moisturizing and coloring
LIPSTICK SPF 25

Net Weight 0.14 oz. e (4 g)

PRINCIPAL DISPLAY PANEL - 4 g Tube Box - (GRANATE SEDUCTOR FEMME) - PURPLE

PRINCIPAL DISPLAY PANEL - 4 g Tube Box - (FUCSIA CAUTIVANTE FEMME) - PINK

ésika

HYDRACOLOR 2 in 1
Highly moisturizing and coloring
LIPSTICK SPF 25

Net Weight 0.14 oz. e (4 g)

PRINCIPAL DISPLAY PANEL - 4 g Tube Box - (FUCSIA CAUTIVANTE FEMME) - PINK

PRINCIPAL DISPLAY PANEL - 4 g Tube Box - (ROSA ROMANTICA FEMME) - PINK

ésika

HYDRACOLOR 2 in 1
Highly moisturizing and coloring
LIPSTICK SPF 25

Net Weight 0.14 oz. e (4 g)

PRINCIPAL DISPLAY PANEL - 4 g Tube Box - (ROSA ROMANTICA FEMME) - PINK

PRINCIPAL DISPLAY PANEL - 4 g Tube Box - (ROJO INTRIGANTE FEMME) - RED

ésika

HYDRACOLOR 2 in 1
Highly moisturizing and coloring
LIPSTICK SPF 25

Net Weight 0.14 oz. e (4 g)

PRINCIPAL DISPLAY PANEL - 4 g Tube Box - (ROJO INTRIGANTE FEMME) - RED

PRINCIPAL DISPLAY PANEL - 4 g Tube Box - (ROSA ENCANTO FEMME) - PINK

ésika

HYDRACOLOR 2 in 1
Highly moisturizing and coloring
LIPSTICK SPF 25

Net Weight 0.14 oz. e (4 g)

PRINCIPAL DISPLAY PANEL - 4 g Tube Box - (ROSA ENCANTO FEMME) - PINK

ESIKA HYDRACOLOR 2 IN 1 HIGHLY MOISTURIZING AND COLORING SPF 25 (MARRON GLAMOUR) - BROWN
octinoxate and oxybenzone lipstick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:13537-916
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	0.066 g in 1 g
Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y)	Oxybenzone	0.015 g in 1 g

Ingredient Name	Strength
Inactive Ingredients
DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW)
TRIDECYL TRIMELLITATE (UNII: FY36J270ES)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
WATER (UNII: 059QF0KO0R)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
TRIDECYL STEARATE (UNII: A8OE252M6L)
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)
CARNAUBA WAX (UNII: R12CBM0EIZ)
GLYCERIN (UNII: PDC6A3C0OX)
NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
COCONUT OIL (UNII: Q9L0O73W7L)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
CERAMIDE 3 (UNII: 4370DF050B)
CHLORPHENESIN (UNII: I670DAL4SZ)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SHEA BUTTER (UNII: K49155WL9Y)
SOYBEAN OIL (UNII: 241ATL177A)
TOCOPHEROL (UNII: R0ZB2556P8)
MAGNESIUM CHLORIDE (UNII: 02F3473H9O)
POTASSIUM CHLORIDE (UNII: 660YQ98I10)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
WINE GRAPE (UNII: 3GOV20705G)
MICA (UNII: V8A1AW0880)
FERRIC OXIDE RED (UNII: 1K09F3G675)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
ALUMINUM OXIDE (UNII: LMI26O6933)
D&C RED NO. 21 (UNII: 08744Z6JNY)
D&C RED NO. 7 (UNII: ECW0LZ41X8)
D&C RED NO. 27 (UNII: 2LRS185U6K)
TALC (UNII: 7SEV7J4R1U)
D&C RED NO. 30 (UNII: 2S42T2808B)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:13537-916-02	1 in 1 BOX
1	NDC:13537-916-01	4 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH FINAL	part352	09/30/2014

ESIKA HYDRACOLOR 2 IN 1 HIGHLY MOISTURIZING AND COLORING SPF 25 (ROJO DESEO) - RED
octinoxate and oxybenzone lipstick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:13537-917
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	0.066 g in 1 g
Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y)	Oxybenzone	0.015 g in 1 g

Ingredient Name	Strength
Inactive Ingredients
DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW)
TRIDECYL TRIMELLITATE (UNII: FY36J270ES)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
WATER (UNII: 059QF0KO0R)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
TRIDECYL STEARATE (UNII: A8OE252M6L)
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)
CARNAUBA WAX (UNII: R12CBM0EIZ)
GLYCERIN (UNII: PDC6A3C0OX)
NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
COCONUT OIL (UNII: Q9L0O73W7L)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
CERAMIDE 3 (UNII: 4370DF050B)
CHLORPHENESIN (UNII: I670DAL4SZ)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SHEA BUTTER (UNII: K49155WL9Y)
SOYBEAN OIL (UNII: 241ATL177A)
TOCOPHEROL (UNII: R0ZB2556P8)
MAGNESIUM CHLORIDE (UNII: 02F3473H9O)
POTASSIUM CHLORIDE (UNII: 660YQ98I10)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
WINE GRAPE (UNII: 3GOV20705G)
MICA (UNII: V8A1AW0880)
FERRIC OXIDE RED (UNII: 1K09F3G675)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
ALUMINUM OXIDE (UNII: LMI26O6933)
D&C RED NO. 21 (UNII: 08744Z6JNY)
D&C RED NO. 7 (UNII: ECW0LZ41X8)
D&C RED NO. 27 (UNII: 2LRS185U6K)
TALC (UNII: 7SEV7J4R1U)
D&C RED NO. 30 (UNII: 2S42T2808B)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:13537-917-04	1 in 1 BOX
1	NDC:13537-917-03	4 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH FINAL	part352	09/30/2014

ESIKA HYDRACOLOR 2 IN 1 HIGHLY MOISTURIZING AND COLORING SPF 25 (ROJO INTRIGANTE) - RED
octinoxate and oxybenzone lipstick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:13537-918
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	0.066 g in 1 g
Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y)	Oxybenzone	0.015 g in 1 g

Ingredient Name	Strength
Inactive Ingredients
DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW)
TRIDECYL TRIMELLITATE (UNII: FY36J270ES)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
WATER (UNII: 059QF0KO0R)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
TRIDECYL STEARATE (UNII: A8OE252M6L)
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)
CARNAUBA WAX (UNII: R12CBM0EIZ)
GLYCERIN (UNII: PDC6A3C0OX)
NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
COCONUT OIL (UNII: Q9L0O73W7L)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
CERAMIDE 3 (UNII: 4370DF050B)
CHLORPHENESIN (UNII: I670DAL4SZ)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SHEA BUTTER (UNII: K49155WL9Y)
SOYBEAN OIL (UNII: 241ATL177A)
TOCOPHEROL (UNII: R0ZB2556P8)
MAGNESIUM CHLORIDE (UNII: 02F3473H9O)
POTASSIUM CHLORIDE (UNII: 660YQ98I10)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
WINE GRAPE (UNII: 3GOV20705G)
MICA (UNII: V8A1AW0880)
FERRIC OXIDE RED (UNII: 1K09F3G675)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
ALUMINUM OXIDE (UNII: LMI26O6933)
D&C RED NO. 21 (UNII: 08744Z6JNY)
D&C RED NO. 7 (UNII: ECW0LZ41X8)
D&C RED NO. 27 (UNII: 2LRS185U6K)
TALC (UNII: 7SEV7J4R1U)
D&C RED NO. 30 (UNII: 2S42T2808B)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:13537-918-06	1 in 1 BOX
1	NDC:13537-918-05	4 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH FINAL	part352	09/30/2014

ESIKA HYDRACOLOR 2 IN 1 HIGHLY MOISTURIZING AND COLORING SPF 25 (ROJO LUJURIA) - RED
octinoxate and oxybenzone lipstick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:13537-919
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	0.066 g in 1 g
Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y)	Oxybenzone	0.015 g in 1 g

Ingredient Name	Strength
Inactive Ingredients
DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW)
TRIDECYL TRIMELLITATE (UNII: FY36J270ES)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
WATER (UNII: 059QF0KO0R)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
TRIDECYL STEARATE (UNII: A8OE252M6L)
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)
CARNAUBA WAX (UNII: R12CBM0EIZ)
GLYCERIN (UNII: PDC6A3C0OX)
NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
COCONUT OIL (UNII: Q9L0O73W7L)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
CERAMIDE 3 (UNII: 4370DF050B)
CHLORPHENESIN (UNII: I670DAL4SZ)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SHEA BUTTER (UNII: K49155WL9Y)
SOYBEAN OIL (UNII: 241ATL177A)
TOCOPHEROL (UNII: R0ZB2556P8)
MAGNESIUM CHLORIDE (UNII: 02F3473H9O)
POTASSIUM CHLORIDE (UNII: 660YQ98I10)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
WINE GRAPE (UNII: 3GOV20705G)
MICA (UNII: V8A1AW0880)
FERRIC OXIDE RED (UNII: 1K09F3G675)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
ALUMINUM OXIDE (UNII: LMI26O6933)
D&C RED NO. 21 (UNII: 08744Z6JNY)
D&C RED NO. 7 (UNII: ECW0LZ41X8)
D&C RED NO. 27 (UNII: 2LRS185U6K)
TALC (UNII: 7SEV7J4R1U)
D&C RED NO. 30 (UNII: 2S42T2808B)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:13537-919-08	1 in 1 BOX
1	NDC:13537-919-07	4 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH FINAL	part352	09/30/2014

ESIKA HYDRACOLOR 2 IN 1 HIGHLY MOISTURIZING AND COLORING SPF 25 (CORAL CHIC) - PINK
octinoxate and oxybenzone lipstick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:13537-920
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	0.066 g in 1 g
Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y)	Oxybenzone	0.015 g in 1 g

Ingredient Name	Strength
Inactive Ingredients
DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW)
TRIDECYL TRIMELLITATE (UNII: FY36J270ES)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
WATER (UNII: 059QF0KO0R)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
TRIDECYL STEARATE (UNII: A8OE252M6L)
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)
CARNAUBA WAX (UNII: R12CBM0EIZ)
GLYCERIN (UNII: PDC6A3C0OX)
NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
COCONUT OIL (UNII: Q9L0O73W7L)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
CERAMIDE 3 (UNII: 4370DF050B)
CHLORPHENESIN (UNII: I670DAL4SZ)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SHEA BUTTER (UNII: K49155WL9Y)
SOYBEAN OIL (UNII: 241ATL177A)
TOCOPHEROL (UNII: R0ZB2556P8)
MAGNESIUM CHLORIDE (UNII: 02F3473H9O)
POTASSIUM CHLORIDE (UNII: 660YQ98I10)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
WINE GRAPE (UNII: 3GOV20705G)
MICA (UNII: V8A1AW0880)
FERRIC OXIDE RED (UNII: 1K09F3G675)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
ALUMINUM OXIDE (UNII: LMI26O6933)
D&C RED NO. 21 (UNII: 08744Z6JNY)
D&C RED NO. 7 (UNII: ECW0LZ41X8)
D&C RED NO. 27 (UNII: 2LRS185U6K)
TALC (UNII: 7SEV7J4R1U)
D&C RED NO. 30 (UNII: 2S42T2808B)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:13537-920-10	1 in 1 BOX
1	NDC:13537-920-09	4 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH FINAL	part352	09/30/2014

ESIKA HYDRACOLOR 2 IN 1 HIGHLY MOISTURIZING AND COLORING SPF 25 (ROSA ENCANTO) - PINK
octinoxate and oxybenzone lipstick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:13537-921
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	0.066 g in 1 g
Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y)	Oxybenzone	0.015 g in 1 g

Ingredient Name	Strength
Inactive Ingredients
DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW)
TRIDECYL TRIMELLITATE (UNII: FY36J270ES)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
WATER (UNII: 059QF0KO0R)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
TRIDECYL STEARATE (UNII: A8OE252M6L)
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)
CARNAUBA WAX (UNII: R12CBM0EIZ)
GLYCERIN (UNII: PDC6A3C0OX)
NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
COCONUT OIL (UNII: Q9L0O73W7L)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
CERAMIDE 3 (UNII: 4370DF050B)
CHLORPHENESIN (UNII: I670DAL4SZ)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SHEA BUTTER (UNII: K49155WL9Y)
SOYBEAN OIL (UNII: 241ATL177A)
TOCOPHEROL (UNII: R0ZB2556P8)
MAGNESIUM CHLORIDE (UNII: 02F3473H9O)
POTASSIUM CHLORIDE (UNII: 660YQ98I10)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
WINE GRAPE (UNII: 3GOV20705G)
MICA (UNII: V8A1AW0880)
FERRIC OXIDE RED (UNII: 1K09F3G675)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
ALUMINUM OXIDE (UNII: LMI26O6933)
D&C RED NO. 21 (UNII: 08744Z6JNY)
D&C RED NO. 7 (UNII: ECW0LZ41X8)
D&C RED NO. 27 (UNII: 2LRS185U6K)
TALC (UNII: 7SEV7J4R1U)
D&C RED NO. 30 (UNII: 2S42T2808B)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:13537-921-12	1 in 1 BOX
1	NDC:13537-921-11	4 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH FINAL	part352	09/30/2014

ESIKA HYDRACOLOR 2 IN 1 HIGHLY MOISTURIZING AND COLORING SPF 25 (BORGONA SEXY) - PURPLE
octinoxate and oxybenzone lipstick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:13537-922
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	0.066 g in 1 g
Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y)	Oxybenzone	0.015 g in 1 g

Ingredient Name	Strength
Inactive Ingredients
DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW)
TRIDECYL TRIMELLITATE (UNII: FY36J270ES)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
WATER (UNII: 059QF0KO0R)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
TRIDECYL STEARATE (UNII: A8OE252M6L)
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)
CARNAUBA WAX (UNII: R12CBM0EIZ)
GLYCERIN (UNII: PDC6A3C0OX)
NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
COCONUT OIL (UNII: Q9L0O73W7L)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
CERAMIDE 3 (UNII: 4370DF050B)
CHLORPHENESIN (UNII: I670DAL4SZ)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SHEA BUTTER (UNII: K49155WL9Y)
SOYBEAN OIL (UNII: 241ATL177A)
TOCOPHEROL (UNII: R0ZB2556P8)
MAGNESIUM CHLORIDE (UNII: 02F3473H9O)
POTASSIUM CHLORIDE (UNII: 660YQ98I10)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
WINE GRAPE (UNII: 3GOV20705G)
MICA (UNII: V8A1AW0880)
FERRIC OXIDE RED (UNII: 1K09F3G675)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
ALUMINUM OXIDE (UNII: LMI26O6933)
D&C RED NO. 21 (UNII: 08744Z6JNY)
D&C RED NO. 7 (UNII: ECW0LZ41X8)
D&C RED NO. 27 (UNII: 2LRS185U6K)
TALC (UNII: 7SEV7J4R1U)
D&C RED NO. 30 (UNII: 2S42T2808B)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:13537-922-14	1 in 1 BOX
1	NDC:13537-922-13	4 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH FINAL	part352	09/30/2014

ESIKA HYDRACOLOR 2 IN 1 HIGHLY MOISTURIZING AND COLORING SPF 25 (FUCSIA CAUTIVANTE) - PINK
octinoxate and oxybenzone lipstick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:13537-923
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	0.066 g in 1 g
Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y)	Oxybenzone	0.015 g in 1 g

Ingredient Name	Strength
Inactive Ingredients
DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW)
TRIDECYL TRIMELLITATE (UNII: FY36J270ES)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
WATER (UNII: 059QF0KO0R)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
TRIDECYL STEARATE (UNII: A8OE252M6L)
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)
CARNAUBA WAX (UNII: R12CBM0EIZ)
GLYCERIN (UNII: PDC6A3C0OX)
NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
COCONUT OIL (UNII: Q9L0O73W7L)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
CERAMIDE 3 (UNII: 4370DF050B)
CHLORPHENESIN (UNII: I670DAL4SZ)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SHEA BUTTER (UNII: K49155WL9Y)
SOYBEAN OIL (UNII: 241ATL177A)
TOCOPHEROL (UNII: R0ZB2556P8)
MAGNESIUM CHLORIDE (UNII: 02F3473H9O)
POTASSIUM CHLORIDE (UNII: 660YQ98I10)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
WINE GRAPE (UNII: 3GOV20705G)
MICA (UNII: V8A1AW0880)
FERRIC OXIDE RED (UNII: 1K09F3G675)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
ALUMINUM OXIDE (UNII: LMI26O6933)
D&C RED NO. 21 (UNII: 08744Z6JNY)
D&C RED NO. 7 (UNII: ECW0LZ41X8)
D&C RED NO. 27 (UNII: 2LRS185U6K)
TALC (UNII: 7SEV7J4R1U)
D&C RED NO. 30 (UNII: 2S42T2808B)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:13537-923-16	1 in 1 BOX
1	NDC:13537-923-15	4 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH FINAL	part352	09/30/2014

ESIKA HYDRACOLOR 2 IN 1 HIGHLY MOISTURIZING AND COLORING SPF 25 (GRANATE SEDUCTOR) - PURPLE
octinoxate and oxybenzone lipstick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:13537-924
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	0.066 g in 1 g
Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y)	Oxybenzone	0.015 g in 1 g

Ingredient Name	Strength
Inactive Ingredients
DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW)
TRIDECYL TRIMELLITATE (UNII: FY36J270ES)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
WATER (UNII: 059QF0KO0R)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
TRIDECYL STEARATE (UNII: A8OE252M6L)
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)
CARNAUBA WAX (UNII: R12CBM0EIZ)
GLYCERIN (UNII: PDC6A3C0OX)
NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
COCONUT OIL (UNII: Q9L0O73W7L)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
CERAMIDE 3 (UNII: 4370DF050B)
CHLORPHENESIN (UNII: I670DAL4SZ)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SHEA BUTTER (UNII: K49155WL9Y)
SOYBEAN OIL (UNII: 241ATL177A)
TOCOPHEROL (UNII: R0ZB2556P8)
MAGNESIUM CHLORIDE (UNII: 02F3473H9O)
POTASSIUM CHLORIDE (UNII: 660YQ98I10)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
WINE GRAPE (UNII: 3GOV20705G)
MICA (UNII: V8A1AW0880)
FERRIC OXIDE RED (UNII: 1K09F3G675)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
ALUMINUM OXIDE (UNII: LMI26O6933)
D&C RED NO. 21 (UNII: 08744Z6JNY)
D&C RED NO. 7 (UNII: ECW0LZ41X8)
D&C RED NO. 27 (UNII: 2LRS185U6K)
TALC (UNII: 7SEV7J4R1U)
D&C RED NO. 30 (UNII: 2S42T2808B)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:13537-924-18	1 in 1 BOX
1	NDC:13537-924-17	4 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH FINAL	part352	09/30/2014

ESIKA HYDRACOLOR 2 IN 1 HIGHLY MOISTURIZING AND COLORING SPF 25 (ROSA ROMANTICA) - PINK
octinoxate and oxybenzone lipstick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:13537-925
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	0.066 g in 1 g
Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y)	Oxybenzone	0.015 g in 1 g

Ingredient Name	Strength
Inactive Ingredients
DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW)
TRIDECYL TRIMELLITATE (UNII: FY36J270ES)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
WATER (UNII: 059QF0KO0R)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
TRIDECYL STEARATE (UNII: A8OE252M6L)
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)
CARNAUBA WAX (UNII: R12CBM0EIZ)
GLYCERIN (UNII: PDC6A3C0OX)
NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
COCONUT OIL (UNII: Q9L0O73W7L)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
CERAMIDE 3 (UNII: 4370DF050B)
CHLORPHENESIN (UNII: I670DAL4SZ)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SHEA BUTTER (UNII: K49155WL9Y)
SOYBEAN OIL (UNII: 241ATL177A)
TOCOPHEROL (UNII: R0ZB2556P8)
MAGNESIUM CHLORIDE (UNII: 02F3473H9O)
POTASSIUM CHLORIDE (UNII: 660YQ98I10)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
WINE GRAPE (UNII: 3GOV20705G)
MICA (UNII: V8A1AW0880)
FERRIC OXIDE RED (UNII: 1K09F3G675)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
ALUMINUM OXIDE (UNII: LMI26O6933)
D&C RED NO. 21 (UNII: 08744Z6JNY)
D&C RED NO. 7 (UNII: ECW0LZ41X8)
D&C RED NO. 27 (UNII: 2LRS185U6K)
TALC (UNII: 7SEV7J4R1U)
D&C RED NO. 30 (UNII: 2S42T2808B)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:13537-925-20	1 in 1 BOX
1	NDC:13537-925-19	4 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH FINAL	part352	09/30/2014

ESIKA HYDRACOLOR 2 IN 1 HIGHLY MOISTURIZING AND COLORING SPF 25 (NARANJA PRIMAVERA) - ORANGE
octinoxate and oxybenzone lipstick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:13537-926
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	0.066 g in 1 g
Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y)	Oxybenzone	0.015 g in 1 g

Ingredient Name	Strength
Inactive Ingredients
DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW)
TRIDECYL TRIMELLITATE (UNII: FY36J270ES)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
WATER (UNII: 059QF0KO0R)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
TRIDECYL STEARATE (UNII: A8OE252M6L)
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)
CARNAUBA WAX (UNII: R12CBM0EIZ)
GLYCERIN (UNII: PDC6A3C0OX)
NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
COCONUT OIL (UNII: Q9L0O73W7L)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
CERAMIDE 3 (UNII: 4370DF050B)
CHLORPHENESIN (UNII: I670DAL4SZ)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SHEA BUTTER (UNII: K49155WL9Y)
SOYBEAN OIL (UNII: 241ATL177A)
TOCOPHEROL (UNII: R0ZB2556P8)
MAGNESIUM CHLORIDE (UNII: 02F3473H9O)
POTASSIUM CHLORIDE (UNII: 660YQ98I10)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
WINE GRAPE (UNII: 3GOV20705G)
MICA (UNII: V8A1AW0880)
FERRIC OXIDE RED (UNII: 1K09F3G675)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
ALUMINUM OXIDE (UNII: LMI26O6933)
D&C RED NO. 21 (UNII: 08744Z6JNY)
D&C RED NO. 7 (UNII: ECW0LZ41X8)
D&C RED NO. 27 (UNII: 2LRS185U6K)
TALC (UNII: 7SEV7J4R1U)
D&C RED NO. 30 (UNII: 2S42T2808B)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:13537-926-22	1 in 1 BOX
1	NDC:13537-926-21	4 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH FINAL	part352	09/30/2014

ESIKA HYDRACOLOR 2 IN 1 HIGHLY MOISTURIZING AND COLORING SPF 25 (FRAMBUESA MANIA) - RED
octinoxate and oxybenzone lipstick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:13537-927
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	0.066 g in 1 g
Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y)	Oxybenzone	0.015 g in 1 g

Ingredient Name	Strength
Inactive Ingredients
DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW)
TRIDECYL TRIMELLITATE (UNII: FY36J270ES)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
WATER (UNII: 059QF0KO0R)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
TRIDECYL STEARATE (UNII: A8OE252M6L)
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)
CARNAUBA WAX (UNII: R12CBM0EIZ)
GLYCERIN (UNII: PDC6A3C0OX)
NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
COCONUT OIL (UNII: Q9L0O73W7L)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
CERAMIDE 3 (UNII: 4370DF050B)
CHLORPHENESIN (UNII: I670DAL4SZ)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SHEA BUTTER (UNII: K49155WL9Y)
SOYBEAN OIL (UNII: 241ATL177A)
TOCOPHEROL (UNII: R0ZB2556P8)
MAGNESIUM CHLORIDE (UNII: 02F3473H9O)
POTASSIUM CHLORIDE (UNII: 660YQ98I10)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
WINE GRAPE (UNII: 3GOV20705G)
MICA (UNII: V8A1AW0880)
FERRIC OXIDE RED (UNII: 1K09F3G675)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
ALUMINUM OXIDE (UNII: LMI26O6933)
D&C RED NO. 21 (UNII: 08744Z6JNY)
D&C RED NO. 7 (UNII: ECW0LZ41X8)
D&C RED NO. 27 (UNII: 2LRS185U6K)
TALC (UNII: 7SEV7J4R1U)
D&C RED NO. 30 (UNII: 2S42T2808B)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:13537-927-24	1 in 1 BOX
1	NDC:13537-927-23	4 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH FINAL	part352	09/30/2014

ESIKA HYDRACOLOR 2 IN 1 HIGHLY MOISTURIZING AND COLORING SPF 25 (ROSA DULZURA) - PINK
octinoxate and oxybenzone lipstick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:13537-928
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	0.066 g in 1 g
Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y)	Oxybenzone	0.015 g in 1 g

Ingredient Name	Strength
Inactive Ingredients
DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW)
TRIDECYL TRIMELLITATE (UNII: FY36J270ES)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
WATER (UNII: 059QF0KO0R)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
TRIDECYL STEARATE (UNII: A8OE252M6L)
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)
CARNAUBA WAX (UNII: R12CBM0EIZ)
GLYCERIN (UNII: PDC6A3C0OX)
NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
COCONUT OIL (UNII: Q9L0O73W7L)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
CERAMIDE 3 (UNII: 4370DF050B)
CHLORPHENESIN (UNII: I670DAL4SZ)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SHEA BUTTER (UNII: K49155WL9Y)
SOYBEAN OIL (UNII: 241ATL177A)
TOCOPHEROL (UNII: R0ZB2556P8)
MAGNESIUM CHLORIDE (UNII: 02F3473H9O)
POTASSIUM CHLORIDE (UNII: 660YQ98I10)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
WINE GRAPE (UNII: 3GOV20705G)
MICA (UNII: V8A1AW0880)
FERRIC OXIDE RED (UNII: 1K09F3G675)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
ALUMINUM OXIDE (UNII: LMI26O6933)
D&C RED NO. 21 (UNII: 08744Z6JNY)
D&C RED NO. 7 (UNII: ECW0LZ41X8)
D&C RED NO. 27 (UNII: 2LRS185U6K)
TALC (UNII: 7SEV7J4R1U)
D&C RED NO. 30 (UNII: 2S42T2808B)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:13537-928-26	1 in 1 BOX
1	NDC:13537-928-25	4 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH FINAL	part352	09/30/2014

ESIKA HYDRACOLOR 2 IN 1 HIGHLY MOISTURIZING AND COLORING SPF 25 (PIMIENTA CALIENTE) - BROWN
octinoxate and oxybenzone lipstick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:13537-929
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	0.066 g in 1 g
Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y)	Oxybenzone	0.015 g in 1 g

Ingredient Name	Strength
Inactive Ingredients
DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW)
TRIDECYL TRIMELLITATE (UNII: FY36J270ES)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
WATER (UNII: 059QF0KO0R)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
TRIDECYL STEARATE (UNII: A8OE252M6L)
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)
CARNAUBA WAX (UNII: R12CBM0EIZ)
GLYCERIN (UNII: PDC6A3C0OX)
NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
COCONUT OIL (UNII: Q9L0O73W7L)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
CERAMIDE 3 (UNII: 4370DF050B)
CHLORPHENESIN (UNII: I670DAL4SZ)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SHEA BUTTER (UNII: K49155WL9Y)
SOYBEAN OIL (UNII: 241ATL177A)
TOCOPHEROL (UNII: R0ZB2556P8)
MAGNESIUM CHLORIDE (UNII: 02F3473H9O)
POTASSIUM CHLORIDE (UNII: 660YQ98I10)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
WINE GRAPE (UNII: 3GOV20705G)
MICA (UNII: V8A1AW0880)
FERRIC OXIDE RED (UNII: 1K09F3G675)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
ALUMINUM OXIDE (UNII: LMI26O6933)
D&C RED NO. 21 (UNII: 08744Z6JNY)
D&C RED NO. 7 (UNII: ECW0LZ41X8)
D&C RED NO. 27 (UNII: 2LRS185U6K)
TALC (UNII: 7SEV7J4R1U)
D&C RED NO. 30 (UNII: 2S42T2808B)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:13537-929-28	1 in 1 BOX
1	NDC:13537-929-27	4 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH FINAL	part352	09/30/2014

ESIKA HYDRACOLOR 2 IN 1 HIGHLY MOISTURIZING AND COLORING SPF 25 (CANELA NUDE) - ORANGE
octinoxate and oxybenzone lipstick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:13537-930
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	0.066 g in 1 g
Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y)	Oxybenzone	0.015 g in 1 g

Ingredient Name	Strength
Inactive Ingredients
DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW)
TRIDECYL TRIMELLITATE (UNII: FY36J270ES)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
WATER (UNII: 059QF0KO0R)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
TRIDECYL STEARATE (UNII: A8OE252M6L)
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)
CARNAUBA WAX (UNII: R12CBM0EIZ)
GLYCERIN (UNII: PDC6A3C0OX)
NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
COCONUT OIL (UNII: Q9L0O73W7L)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
CERAMIDE 3 (UNII: 4370DF050B)
CHLORPHENESIN (UNII: I670DAL4SZ)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SHEA BUTTER (UNII: K49155WL9Y)
SOYBEAN OIL (UNII: 241ATL177A)
TOCOPHEROL (UNII: R0ZB2556P8)
MAGNESIUM CHLORIDE (UNII: 02F3473H9O)
POTASSIUM CHLORIDE (UNII: 660YQ98I10)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
WINE GRAPE (UNII: 3GOV20705G)
MICA (UNII: V8A1AW0880)
FERRIC OXIDE RED (UNII: 1K09F3G675)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
ALUMINUM OXIDE (UNII: LMI26O6933)
D&C RED NO. 21 (UNII: 08744Z6JNY)
D&C RED NO. 7 (UNII: ECW0LZ41X8)
D&C RED NO. 27 (UNII: 2LRS185U6K)
TALC (UNII: 7SEV7J4R1U)
D&C RED NO. 30 (UNII: 2S42T2808B)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:13537-930-30	1 in 1 BOX
1	NDC:13537-930-29	4 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH FINAL	part352	09/30/2014

ESIKA HYDRACOLOR 2 IN 1 HIGHLY MOISTURIZING AND COLORING SPF 25 (MORA GLAM) - BROWN
octinoxate and oxybenzone lipstick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:13537-931
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	0.066 g in 1 g
Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y)	Oxybenzone	0.015 g in 1 g

Ingredient Name	Strength
Inactive Ingredients
DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW)
TRIDECYL TRIMELLITATE (UNII: FY36J270ES)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
WATER (UNII: 059QF0KO0R)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
TRIDECYL STEARATE (UNII: A8OE252M6L)
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)
CARNAUBA WAX (UNII: R12CBM0EIZ)
GLYCERIN (UNII: PDC6A3C0OX)
NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
COCONUT OIL (UNII: Q9L0O73W7L)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
CERAMIDE 3 (UNII: 4370DF050B)
CHLORPHENESIN (UNII: I670DAL4SZ)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SHEA BUTTER (UNII: K49155WL9Y)
SOYBEAN OIL (UNII: 241ATL177A)
TOCOPHEROL (UNII: R0ZB2556P8)
MAGNESIUM CHLORIDE (UNII: 02F3473H9O)
POTASSIUM CHLORIDE (UNII: 660YQ98I10)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
WINE GRAPE (UNII: 3GOV20705G)
MICA (UNII: V8A1AW0880)
FERRIC OXIDE RED (UNII: 1K09F3G675)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
ALUMINUM OXIDE (UNII: LMI26O6933)
D&C RED NO. 21 (UNII: 08744Z6JNY)
D&C RED NO. 7 (UNII: ECW0LZ41X8)
D&C RED NO. 27 (UNII: 2LRS185U6K)
TALC (UNII: 7SEV7J4R1U)
D&C RED NO. 30 (UNII: 2S42T2808B)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:13537-931-32	1 in 1 BOX
1	NDC:13537-931-31	4 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH FINAL	part352	09/30/2014

ESIKA HYDRACOLOR 2 IN 1 HIGHLY MOISTURIZING AND COLORING SPF 25 (CORAL INTENSE) - RED
octinoxate and oxybenzone lipstick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:13537-932
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	0.066 g in 1 g
Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y)	Oxybenzone	0.015 g in 1 g

Ingredient Name	Strength
Inactive Ingredients
DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW)
TRIDECYL TRIMELLITATE (UNII: FY36J270ES)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
WATER (UNII: 059QF0KO0R)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
TRIDECYL STEARATE (UNII: A8OE252M6L)
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)
CARNAUBA WAX (UNII: R12CBM0EIZ)
GLYCERIN (UNII: PDC6A3C0OX)
NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
COCONUT OIL (UNII: Q9L0O73W7L)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
CERAMIDE 3 (UNII: 4370DF050B)
CHLORPHENESIN (UNII: I670DAL4SZ)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SHEA BUTTER (UNII: K49155WL9Y)
SOYBEAN OIL (UNII: 241ATL177A)
TOCOPHEROL (UNII: R0ZB2556P8)
MAGNESIUM CHLORIDE (UNII: 02F3473H9O)
POTASSIUM CHLORIDE (UNII: 660YQ98I10)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
WINE GRAPE (UNII: 3GOV20705G)
MICA (UNII: V8A1AW0880)
FERRIC OXIDE RED (UNII: 1K09F3G675)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
ALUMINUM OXIDE (UNII: LMI26O6933)
D&C RED NO. 21 (UNII: 08744Z6JNY)
D&C RED NO. 7 (UNII: ECW0LZ41X8)
D&C RED NO. 27 (UNII: 2LRS185U6K)
TALC (UNII: 7SEV7J4R1U)
D&C RED NO. 30 (UNII: 2S42T2808B)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:13537-932-34	1 in 1 BOX
1	NDC:13537-932-33	4 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH FINAL	part352	09/30/2014

ESIKA HYDRACOLOR 2 IN 1 HIGHLY MOISTURIZING AND COLORING SPF 25 (FRESA COQUETA) - RED
octinoxate and oxybenzone lipstick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:13537-933
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	0.066 g in 1 g
Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y)	Oxybenzone	0.015 g in 1 g

Ingredient Name	Strength
Inactive Ingredients
DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW)
TRIDECYL TRIMELLITATE (UNII: FY36J270ES)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
WATER (UNII: 059QF0KO0R)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
TRIDECYL STEARATE (UNII: A8OE252M6L)
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)
CARNAUBA WAX (UNII: R12CBM0EIZ)
GLYCERIN (UNII: PDC6A3C0OX)
NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
COCONUT OIL (UNII: Q9L0O73W7L)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
CERAMIDE 3 (UNII: 4370DF050B)
CHLORPHENESIN (UNII: I670DAL4SZ)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SHEA BUTTER (UNII: K49155WL9Y)
SOYBEAN OIL (UNII: 241ATL177A)
TOCOPHEROL (UNII: R0ZB2556P8)
MAGNESIUM CHLORIDE (UNII: 02F3473H9O)
POTASSIUM CHLORIDE (UNII: 660YQ98I10)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
WINE GRAPE (UNII: 3GOV20705G)
MICA (UNII: V8A1AW0880)
FERRIC OXIDE RED (UNII: 1K09F3G675)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
ALUMINUM OXIDE (UNII: LMI26O6933)
D&C RED NO. 21 (UNII: 08744Z6JNY)
D&C RED NO. 7 (UNII: ECW0LZ41X8)
D&C RED NO. 27 (UNII: 2LRS185U6K)
TALC (UNII: 7SEV7J4R1U)
D&C RED NO. 30 (UNII: 2S42T2808B)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:13537-933-36	1 in 1 BOX
1	NDC:13537-933-35	4 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH FINAL	part352	09/30/2014

ESIKA HYDRACOLOR 2 IN 1 HIGHLY MOISTURIZING AND COLORING SPF 25 (PIMIENTA CALIENTE FEMME) - RED
octinoxate and oxybenzone lipstick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:13537-934
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	0.066 g in 1 g
Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y)	Oxybenzone	0.015 g in 1 g

Ingredient Name	Strength
Inactive Ingredients
DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW)
TRIDECYL TRIMELLITATE (UNII: FY36J270ES)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
WATER (UNII: 059QF0KO0R)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
TRIDECYL STEARATE (UNII: A8OE252M6L)
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)
CARNAUBA WAX (UNII: R12CBM0EIZ)
GLYCERIN (UNII: PDC6A3C0OX)
NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
COCONUT OIL (UNII: Q9L0O73W7L)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
CERAMIDE 3 (UNII: 4370DF050B)
CHLORPHENESIN (UNII: I670DAL4SZ)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SHEA BUTTER (UNII: K49155WL9Y)
SOYBEAN OIL (UNII: 241ATL177A)
TOCOPHEROL (UNII: R0ZB2556P8)
MAGNESIUM CHLORIDE (UNII: 02F3473H9O)
POTASSIUM CHLORIDE (UNII: 660YQ98I10)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
WINE GRAPE (UNII: 3GOV20705G)
MICA (UNII: V8A1AW0880)
FERRIC OXIDE RED (UNII: 1K09F3G675)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
ALUMINUM OXIDE (UNII: LMI26O6933)
D&C RED NO. 21 (UNII: 08744Z6JNY)
D&C RED NO. 7 (UNII: ECW0LZ41X8)
D&C RED NO. 27 (UNII: 2LRS185U6K)
TALC (UNII: 7SEV7J4R1U)
D&C RED NO. 30 (UNII: 2S42T2808B)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:13537-934-38	1 in 1 BOX
1	NDC:13537-934-37	4 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH FINAL	part352	09/30/2014

ESIKA HYDRACOLOR 2 IN 1 HIGHLY MOISTURIZING AND COLORING SPF 25 (GRANATE SEDUCTOR FEMME) - PURPLE
octinoxate and oxybenzone lipstick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:13537-935
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	0.066 g in 1 g
Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y)	Oxybenzone	0.015 g in 1 g

Ingredient Name	Strength
Inactive Ingredients
DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW)
TRIDECYL TRIMELLITATE (UNII: FY36J270ES)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
WATER (UNII: 059QF0KO0R)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
TRIDECYL STEARATE (UNII: A8OE252M6L)
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)
CARNAUBA WAX (UNII: R12CBM0EIZ)
GLYCERIN (UNII: PDC6A3C0OX)
NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
COCONUT OIL (UNII: Q9L0O73W7L)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
CERAMIDE 3 (UNII: 4370DF050B)
CHLORPHENESIN (UNII: I670DAL4SZ)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SHEA BUTTER (UNII: K49155WL9Y)
SOYBEAN OIL (UNII: 241ATL177A)
TOCOPHEROL (UNII: R0ZB2556P8)
MAGNESIUM CHLORIDE (UNII: 02F3473H9O)
POTASSIUM CHLORIDE (UNII: 660YQ98I10)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
WINE GRAPE (UNII: 3GOV20705G)
MICA (UNII: V8A1AW0880)
FERRIC OXIDE RED (UNII: 1K09F3G675)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
ALUMINUM OXIDE (UNII: LMI26O6933)
D&C RED NO. 21 (UNII: 08744Z6JNY)
D&C RED NO. 7 (UNII: ECW0LZ41X8)
D&C RED NO. 27 (UNII: 2LRS185U6K)
TALC (UNII: 7SEV7J4R1U)
D&C RED NO. 30 (UNII: 2S42T2808B)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:13537-935-40	1 in 1 BOX
1	NDC:13537-935-39	4 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH FINAL	part352	09/30/2014

ESIKA HYDRACOLOR 2 IN 1 HIGHLY MOISTURIZING AND COLORING SPF 25 (FUCSIA CAUTIVANTE FEMME) - PINK
octinoxate and oxybenzone lipstick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:13537-936
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	0.066 g in 1 g
Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y)	Oxybenzone	0.015 g in 1 g

Ingredient Name	Strength
Inactive Ingredients
DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW)
TRIDECYL TRIMELLITATE (UNII: FY36J270ES)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
WATER (UNII: 059QF0KO0R)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
TRIDECYL STEARATE (UNII: A8OE252M6L)
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)
CARNAUBA WAX (UNII: R12CBM0EIZ)
GLYCERIN (UNII: PDC6A3C0OX)
NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
COCONUT OIL (UNII: Q9L0O73W7L)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
CERAMIDE 3 (UNII: 4370DF050B)
CHLORPHENESIN (UNII: I670DAL4SZ)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SHEA BUTTER (UNII: K49155WL9Y)
SOYBEAN OIL (UNII: 241ATL177A)
TOCOPHEROL (UNII: R0ZB2556P8)
MAGNESIUM CHLORIDE (UNII: 02F3473H9O)
POTASSIUM CHLORIDE (UNII: 660YQ98I10)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
WINE GRAPE (UNII: 3GOV20705G)
MICA (UNII: V8A1AW0880)
FERRIC OXIDE RED (UNII: 1K09F3G675)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
ALUMINUM OXIDE (UNII: LMI26O6933)
D&C RED NO. 21 (UNII: 08744Z6JNY)
D&C RED NO. 7 (UNII: ECW0LZ41X8)
D&C RED NO. 27 (UNII: 2LRS185U6K)
TALC (UNII: 7SEV7J4R1U)
D&C RED NO. 30 (UNII: 2S42T2808B)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:13537-936-42	1 in 1 BOX
1	NDC:13537-936-41	4 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH FINAL	part352	09/30/2014

ESIKA HYDRACOLOR 2 IN 1 HIGHLY MOISTURIZING AND COLORING SPF 25 (ROSA ROMANTICA FEMME) - PINK
octinoxate and oxybenzone lipstick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:13537-937
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	0.066 g in 1 g
Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y)	Oxybenzone	0.015 g in 1 g

Ingredient Name	Strength
Inactive Ingredients
DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW)
TRIDECYL TRIMELLITATE (UNII: FY36J270ES)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
WATER (UNII: 059QF0KO0R)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
TRIDECYL STEARATE (UNII: A8OE252M6L)
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)
CARNAUBA WAX (UNII: R12CBM0EIZ)
GLYCERIN (UNII: PDC6A3C0OX)
NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
COCONUT OIL (UNII: Q9L0O73W7L)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
CERAMIDE 3 (UNII: 4370DF050B)
CHLORPHENESIN (UNII: I670DAL4SZ)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SHEA BUTTER (UNII: K49155WL9Y)
SOYBEAN OIL (UNII: 241ATL177A)
TOCOPHEROL (UNII: R0ZB2556P8)
MAGNESIUM CHLORIDE (UNII: 02F3473H9O)
POTASSIUM CHLORIDE (UNII: 660YQ98I10)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
WINE GRAPE (UNII: 3GOV20705G)
MICA (UNII: V8A1AW0880)
FERRIC OXIDE RED (UNII: 1K09F3G675)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
ALUMINUM OXIDE (UNII: LMI26O6933)
D&C RED NO. 21 (UNII: 08744Z6JNY)
D&C RED NO. 7 (UNII: ECW0LZ41X8)
D&C RED NO. 27 (UNII: 2LRS185U6K)
TALC (UNII: 7SEV7J4R1U)
D&C RED NO. 30 (UNII: 2S42T2808B)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:13537-937-44	1 in 1 BOX
1	NDC:13537-937-43	4 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH FINAL	part352	09/30/2014

ESIKA HYDRACOLOR 2 IN 1 HIGHLY MOISTURIZING AND COLORING SPF 25 (ROJO INTRIGANTE FEMME) - RED
octinoxate and oxybenzone lipstick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:13537-938
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	0.066 g in 1 g
Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y)	Oxybenzone	0.015 g in 1 g

Ingredient Name	Strength
Inactive Ingredients
DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW)
TRIDECYL TRIMELLITATE (UNII: FY36J270ES)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
WATER (UNII: 059QF0KO0R)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
TRIDECYL STEARATE (UNII: A8OE252M6L)
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)
CARNAUBA WAX (UNII: R12CBM0EIZ)
GLYCERIN (UNII: PDC6A3C0OX)
NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
COCONUT OIL (UNII: Q9L0O73W7L)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
CERAMIDE 3 (UNII: 4370DF050B)
CHLORPHENESIN (UNII: I670DAL4SZ)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SHEA BUTTER (UNII: K49155WL9Y)
SOYBEAN OIL (UNII: 241ATL177A)
TOCOPHEROL (UNII: R0ZB2556P8)
MAGNESIUM CHLORIDE (UNII: 02F3473H9O)
POTASSIUM CHLORIDE (UNII: 660YQ98I10)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
WINE GRAPE (UNII: 3GOV20705G)
MICA (UNII: V8A1AW0880)
FERRIC OXIDE RED (UNII: 1K09F3G675)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
ALUMINUM OXIDE (UNII: LMI26O6933)
D&C RED NO. 21 (UNII: 08744Z6JNY)
D&C RED NO. 7 (UNII: ECW0LZ41X8)
D&C RED NO. 27 (UNII: 2LRS185U6K)
TALC (UNII: 7SEV7J4R1U)
D&C RED NO. 30 (UNII: 2S42T2808B)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:13537-938-46	1 in 1 BOX
1	NDC:13537-938-45	4 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH FINAL	part352	09/30/2014

ESIKA HYDRACOLOR 2 IN 1 HIGHLY MOISTURIZING AND COLORING SPF 25 (ROSA ENCANTO FEMME) - PINK
octinoxate and oxybenzone lipstick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:13537-939
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	0.066 g in 1 g
Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y)	Oxybenzone	0.015 g in 1 g

Ingredient Name	Strength
Inactive Ingredients
DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW)
TRIDECYL TRIMELLITATE (UNII: FY36J270ES)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
WATER (UNII: 059QF0KO0R)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
TRIDECYL STEARATE (UNII: A8OE252M6L)
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)
CARNAUBA WAX (UNII: R12CBM0EIZ)
GLYCERIN (UNII: PDC6A3C0OX)
NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
COCONUT OIL (UNII: Q9L0O73W7L)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
CERAMIDE 3 (UNII: 4370DF050B)
CHLORPHENESIN (UNII: I670DAL4SZ)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SHEA BUTTER (UNII: K49155WL9Y)
SOYBEAN OIL (UNII: 241ATL177A)
TOCOPHEROL (UNII: R0ZB2556P8)
MAGNESIUM CHLORIDE (UNII: 02F3473H9O)
POTASSIUM CHLORIDE (UNII: 660YQ98I10)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
WINE GRAPE (UNII: 3GOV20705G)
MICA (UNII: V8A1AW0880)
FERRIC OXIDE RED (UNII: 1K09F3G675)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
ALUMINUM OXIDE (UNII: LMI26O6933)
D&C RED NO. 21 (UNII: 08744Z6JNY)
D&C RED NO. 7 (UNII: ECW0LZ41X8)
D&C RED NO. 27 (UNII: 2LRS185U6K)
TALC (UNII: 7SEV7J4R1U)
D&C RED NO. 30 (UNII: 2S42T2808B)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:13537-939-48	1 in 1 BOX
1	NDC:13537-939-47	4 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH FINAL	part352	09/30/2014

Labeler - Ventura Corporation LTD (602751344)

Name	Address	ID/FEI	Business Operations
Establishment
Bel Star S.A. (Colombia)		880160197	MANUFACTURE(13537-916, 13537-917, 13537-918, 13537-919, 13537-920, 13537-921, 13537-922, 13537-923, 13537-924, 13537-925, 13537-926, 13537-927, 13537-928, 13537-929, 13537-930, 13537-931, 13537-932, 13537-933, 13537-934, 13537-935, 13537-936, 13537-937, 13537-938, 13537-939)

Revised: 10/2014

Document Id: fda58319-21c6-4b1e-a9d8-631890685dfe

Set id: aa79b1a4-6b33-47c9-b55e-b813d9b22265

Version: 1

Effective Time: 20141001

Ventura Corporation LTD