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 by

Drug Labeling and Warnings

ESIKA HYDRACOLOR 2 IN 1 HIGHLY MOISTURIZING AND COLORING SPF 25 by is a Otc medication manufactured, distributed, or labeled by Ventura Corporation LTD, Bel Star S.A. (Colombia). Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredients

OCTINOXATE: 6.64%
OXYBENZONE: 1.51%

Purpose

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. Rinse with water to remove. If swallowed, get medical help or contact a Poison Control Center right away.
• 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
• Apply stick following the curves of natural lip line. For added definition, use with a lip pencil

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

May contain:
CI 77019 (MICA), CI 77491 (IRON OXIDES), CI 77891 (TITANIUM DIOXIDE ), CI 45380 (RED 21 LAKE), CI 19140 (YELLOW 5 LAKE), CI 15850 (RED 7 LAKE), CI 45410 (RED 27 LAKE), CI 77499 (IRON OXIDES), CI 77492 (IRON OXIDES), TALC, PEG-8 METHYL ETHER TRIETHOXYSILANE, CI 75470 (CARMINE).

SPL UNCLASSIFIED SECTION

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

4 g e (.14 oz.)

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

ésika

HYDRACOLOR 2 in 1
Highly moisturizing and coloring
LIPSTICK SPF 25

4 g e (.14 oz.)

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

ésika

HYDRACOLOR 2 in 1
Highly moisturizing and coloring
LIPSTICK SPF 25

4 g e (.14 oz.)

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

ésika

HYDRACOLOR 2 in 1
Highly moisturizing and coloring
LIPSTICK SPF 25

4 g e (.14 oz.)

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

ésika

HYDRACOLOR 2 in 1
Highly moisturizing and coloring
LIPSTICK SPF 25

4 g e (.14 oz.)

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

ésika

HYDRACOLOR 2 in 1
Highly moisturizing and coloring
LIPSTICK SPF 25

4 g e (.14 oz.)

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

ésika

HYDRACOLOR 2 in 1
Highly moisturizing and coloring
LIPSTICK SPF 25

4 g e (.14 oz.)

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

ésika

HYDRACOLOR 2 in 1
Highly moisturizing and coloring
LIPSTICK SPF 25

4 g e (.14 oz.)

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

ésika

HYDRACOLOR 2 in 1
Highly moisturizing and coloring
LIPSTICK SPF 25

4 g e (.14 oz.)

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

ésika

HYDRACOLOR 2 in 1
Highly moisturizing and coloring
LIPSTICK SPF 25

4 g e (.14 oz.)

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

ésika

HYDRACOLOR 2 in 1
Highly moisturizing and coloring
LIPSTICK SPF 25

4 g e (.14 oz.)

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

ésika

HYDRACOLOR 2 in 1
Highly moisturizing and coloring
LIPSTICK SPF 25

4 g e (.14 oz.)

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

ésika

HYDRACOLOR 2 in 1
Highly moisturizing and coloring
LIPSTICK SPF 25

4 g e (.14 oz.)

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

ésika

HYDRACOLOR 2 in 1
Highly moisturizing and coloring
LIPSTICK SPF 25

4 g e (.14 oz.)

PRINCIPAL DISPLAY PANEL - 14 Tube Kit

HYDRACOLOR 2 in 1
Highly moisturizing
and coloring LIPSTICK SPF 25

ésika

8 g e (.28 oz.)

INGREDIENTS AND APPEARANCE

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: 13537-061
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	0.0664 g  in 1 g
Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y)	Oxybenzone	0.0151 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW)
TRIDECYL TRIMELLITATE (UNII: FY36J270ES)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
WATER (UNII: 059QF0KO0R)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)
TRIDECYL STEARATE (UNII: A8OE252M6L)
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)
Isomethyl-.Alpha.-Ionone (UNII: 9XP4LC555B)
LIMONENE, (+)- (UNII: GFD7C86Q1W)
LINALOOL, (+/-)- (UNII: D81QY6I88E)
.ALPHA.-AMYLCINNAMALDEHYDE (UNII: WC51CA3418)
.BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)
MICA (UNII: V8A1AW0880)
FERRIC OXIDE RED (UNII: 1K09F3G675)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
D&C RED NO. 21 (UNII: 08744Z6JNY)
aluminum oxide (UNII: LMI26O6933)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
D&C RED NO. 7 (UNII: ECW0LZ41X8)
D&C RED NO. 27 (UNII: 2LRS185U6K)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
TALC (UNII: 7SEV7J4R1U)
CARMINIC ACID (UNII: CID8Z8N95N)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 13537-061-02	1 in 1 BOX
1	NDC: 13537-061-01	4 g in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part352	04/03/2014

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: 13537-064
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	0.0664 g  in 1 g
Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y)	Oxybenzone	0.0151 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW)
TRIDECYL TRIMELLITATE (UNII: FY36J270ES)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
WATER (UNII: 059QF0KO0R)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)
TRIDECYL STEARATE (UNII: A8OE252M6L)
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)
Isomethyl-.Alpha.-Ionone (UNII: 9XP4LC555B)
LIMONENE, (+)- (UNII: GFD7C86Q1W)
LINALOOL, (+/-)- (UNII: D81QY6I88E)
.ALPHA.-AMYLCINNAMALDEHYDE (UNII: WC51CA3418)
.BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)
MICA (UNII: V8A1AW0880)
FERRIC OXIDE RED (UNII: 1K09F3G675)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
D&C RED NO. 21 (UNII: 08744Z6JNY)
aluminum oxide (UNII: LMI26O6933)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
D&C RED NO. 7 (UNII: ECW0LZ41X8)
D&C RED NO. 27 (UNII: 2LRS185U6K)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
TALC (UNII: 7SEV7J4R1U)
CARMINIC ACID (UNII: CID8Z8N95N)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 13537-064-04	1 in 1 BOX
1	NDC: 13537-064-03	4 g in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part352	04/03/2014

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: 13537-065
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	0.0664 g  in 1 g
Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y)	Oxybenzone	0.0151 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW)
TRIDECYL TRIMELLITATE (UNII: FY36J270ES)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
WATER (UNII: 059QF0KO0R)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)
TRIDECYL STEARATE (UNII: A8OE252M6L)
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)
Isomethyl-.Alpha.-Ionone (UNII: 9XP4LC555B)
LIMONENE, (+)- (UNII: GFD7C86Q1W)
LINALOOL, (+/-)- (UNII: D81QY6I88E)
.ALPHA.-AMYLCINNAMALDEHYDE (UNII: WC51CA3418)
.BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)
MICA (UNII: V8A1AW0880)
FERRIC OXIDE RED (UNII: 1K09F3G675)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
D&C RED NO. 21 (UNII: 08744Z6JNY)
aluminum oxide (UNII: LMI26O6933)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
D&C RED NO. 7 (UNII: ECW0LZ41X8)
D&C RED NO. 27 (UNII: 2LRS185U6K)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
TALC (UNII: 7SEV7J4R1U)
CARMINIC ACID (UNII: CID8Z8N95N)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 13537-065-06	1 in 1 BOX
1	NDC: 13537-065-05	4 g in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part352	04/03/2014

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: 13537-066
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	0.0664 g  in 1 g
Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y)	Oxybenzone	0.0151 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW)
TRIDECYL TRIMELLITATE (UNII: FY36J270ES)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
WATER (UNII: 059QF0KO0R)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)
TRIDECYL STEARATE (UNII: A8OE252M6L)
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)
Isomethyl-.Alpha.-Ionone (UNII: 9XP4LC555B)
LIMONENE, (+)- (UNII: GFD7C86Q1W)
LINALOOL, (+/-)- (UNII: D81QY6I88E)
.ALPHA.-AMYLCINNAMALDEHYDE (UNII: WC51CA3418)
.BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)
MICA (UNII: V8A1AW0880)
FERRIC OXIDE RED (UNII: 1K09F3G675)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
D&C RED NO. 21 (UNII: 08744Z6JNY)
aluminum oxide (UNII: LMI26O6933)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
D&C RED NO. 7 (UNII: ECW0LZ41X8)
D&C RED NO. 27 (UNII: 2LRS185U6K)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
TALC (UNII: 7SEV7J4R1U)
CARMINIC ACID (UNII: CID8Z8N95N)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 13537-066-08	1 in 1 BOX
1	NDC: 13537-066-07	4 g in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part352	04/03/2014

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: 13537-067
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	0.0664 g  in 1 g
Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y)	Oxybenzone	0.0151 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW)
TRIDECYL TRIMELLITATE (UNII: FY36J270ES)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
WATER (UNII: 059QF0KO0R)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)
TRIDECYL STEARATE (UNII: A8OE252M6L)
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)
Isomethyl-.Alpha.-Ionone (UNII: 9XP4LC555B)
LIMONENE, (+)- (UNII: GFD7C86Q1W)
LINALOOL, (+/-)- (UNII: D81QY6I88E)
.ALPHA.-AMYLCINNAMALDEHYDE (UNII: WC51CA3418)
.BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)
MICA (UNII: V8A1AW0880)
FERRIC OXIDE RED (UNII: 1K09F3G675)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
D&C RED NO. 21 (UNII: 08744Z6JNY)
aluminum oxide (UNII: LMI26O6933)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
D&C RED NO. 7 (UNII: ECW0LZ41X8)
D&C RED NO. 27 (UNII: 2LRS185U6K)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
TALC (UNII: 7SEV7J4R1U)
CARMINIC ACID (UNII: CID8Z8N95N)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 13537-067-10	1 in 1 BOX
1	NDC: 13537-067-09	4 g in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part352	04/03/2014

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: 13537-068
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	0.0664 g  in 1 g
Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y)	Oxybenzone	0.0151 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW)
TRIDECYL TRIMELLITATE (UNII: FY36J270ES)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
WATER (UNII: 059QF0KO0R)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)
TRIDECYL STEARATE (UNII: A8OE252M6L)
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)
Isomethyl-.Alpha.-Ionone (UNII: 9XP4LC555B)
LIMONENE, (+)- (UNII: GFD7C86Q1W)
LINALOOL, (+/-)- (UNII: D81QY6I88E)
.ALPHA.-AMYLCINNAMALDEHYDE (UNII: WC51CA3418)
.BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)
MICA (UNII: V8A1AW0880)
FERRIC OXIDE RED (UNII: 1K09F3G675)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
D&C RED NO. 21 (UNII: 08744Z6JNY)
aluminum oxide (UNII: LMI26O6933)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
D&C RED NO. 7 (UNII: ECW0LZ41X8)
D&C RED NO. 27 (UNII: 2LRS185U6K)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
TALC (UNII: 7SEV7J4R1U)
CARMINIC ACID (UNII: CID8Z8N95N)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 13537-068-12	1 in 1 BOX
1	NDC: 13537-068-11	4 g in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part352	04/03/2014

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: 13537-069
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	0.0664 g  in 1 g
Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y)	Oxybenzone	0.0151 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW)
TRIDECYL TRIMELLITATE (UNII: FY36J270ES)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
WATER (UNII: 059QF0KO0R)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)
TRIDECYL STEARATE (UNII: A8OE252M6L)
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)
Isomethyl-.Alpha.-Ionone (UNII: 9XP4LC555B)
LIMONENE, (+)- (UNII: GFD7C86Q1W)
LINALOOL, (+/-)- (UNII: D81QY6I88E)
.ALPHA.-AMYLCINNAMALDEHYDE (UNII: WC51CA3418)
.BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)
MICA (UNII: V8A1AW0880)
FERRIC OXIDE RED (UNII: 1K09F3G675)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
D&C RED NO. 21 (UNII: 08744Z6JNY)
aluminum oxide (UNII: LMI26O6933)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
D&C RED NO. 7 (UNII: ECW0LZ41X8)
D&C RED NO. 27 (UNII: 2LRS185U6K)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
TALC (UNII: 7SEV7J4R1U)
CARMINIC ACID (UNII: CID8Z8N95N)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 13537-069-14	1 in 1 BOX
1	NDC: 13537-069-13	4 g in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part352	04/03/2014

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: 13537-070
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	0.0664 g  in 1 g
Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y)	Oxybenzone	0.0151 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW)
TRIDECYL TRIMELLITATE (UNII: FY36J270ES)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
WATER (UNII: 059QF0KO0R)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)
TRIDECYL STEARATE (UNII: A8OE252M6L)
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)
Isomethyl-.Alpha.-Ionone (UNII: 9XP4LC555B)
LIMONENE, (+)- (UNII: GFD7C86Q1W)
LINALOOL, (+/-)- (UNII: D81QY6I88E)
.ALPHA.-AMYLCINNAMALDEHYDE (UNII: WC51CA3418)
.BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)
MICA (UNII: V8A1AW0880)
FERRIC OXIDE RED (UNII: 1K09F3G675)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
D&C RED NO. 21 (UNII: 08744Z6JNY)
aluminum oxide (UNII: LMI26O6933)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
D&C RED NO. 7 (UNII: ECW0LZ41X8)
D&C RED NO. 27 (UNII: 2LRS185U6K)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
TALC (UNII: 7SEV7J4R1U)
CARMINIC ACID (UNII: CID8Z8N95N)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 13537-070-16	1 in 1 BOX
1	NDC: 13537-070-15	4 g in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part352	04/03/2014

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: 13537-071
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	0.0664 g  in 1 g
Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y)	Oxybenzone	0.0151 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW)
TRIDECYL TRIMELLITATE (UNII: FY36J270ES)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
WATER (UNII: 059QF0KO0R)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)
TRIDECYL STEARATE (UNII: A8OE252M6L)
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)
Isomethyl-.Alpha.-Ionone (UNII: 9XP4LC555B)
LIMONENE, (+)- (UNII: GFD7C86Q1W)
LINALOOL, (+/-)- (UNII: D81QY6I88E)
.ALPHA.-AMYLCINNAMALDEHYDE (UNII: WC51CA3418)
.BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)
MICA (UNII: V8A1AW0880)
FERRIC OXIDE RED (UNII: 1K09F3G675)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
D&C RED NO. 21 (UNII: 08744Z6JNY)
aluminum oxide (UNII: LMI26O6933)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
D&C RED NO. 7 (UNII: ECW0LZ41X8)
D&C RED NO. 27 (UNII: 2LRS185U6K)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
TALC (UNII: 7SEV7J4R1U)
CARMINIC ACID (UNII: CID8Z8N95N)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 13537-071-18	1 in 1 BOX
1	NDC: 13537-071-17	4 g in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part352	04/03/2014

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: 13537-072
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	0.0664 g  in 1 g
Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y)	Oxybenzone	0.0151 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW)
TRIDECYL TRIMELLITATE (UNII: FY36J270ES)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
WATER (UNII: 059QF0KO0R)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)
TRIDECYL STEARATE (UNII: A8OE252M6L)
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)
Isomethyl-.Alpha.-Ionone (UNII: 9XP4LC555B)
LIMONENE, (+)- (UNII: GFD7C86Q1W)
LINALOOL, (+/-)- (UNII: D81QY6I88E)
.ALPHA.-AMYLCINNAMALDEHYDE (UNII: WC51CA3418)
.BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)
MICA (UNII: V8A1AW0880)
FERRIC OXIDE RED (UNII: 1K09F3G675)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
D&C RED NO. 21 (UNII: 08744Z6JNY)
aluminum oxide (UNII: LMI26O6933)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
D&C RED NO. 7 (UNII: ECW0LZ41X8)
D&C RED NO. 27 (UNII: 2LRS185U6K)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
TALC (UNII: 7SEV7J4R1U)
CARMINIC ACID (UNII: CID8Z8N95N)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 13537-072-20	1 in 1 BOX
1	NDC: 13537-072-19	4 g in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part352	04/03/2014

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: 13537-073
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	0.0664 g  in 1 g
Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y)	Oxybenzone	0.0151 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW)
TRIDECYL TRIMELLITATE (UNII: FY36J270ES)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
WATER (UNII: 059QF0KO0R)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)
TRIDECYL STEARATE (UNII: A8OE252M6L)
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)
Isomethyl-.Alpha.-Ionone (UNII: 9XP4LC555B)
LIMONENE, (+)- (UNII: GFD7C86Q1W)
LINALOOL, (+/-)- (UNII: D81QY6I88E)
.ALPHA.-AMYLCINNAMALDEHYDE (UNII: WC51CA3418)
.BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)
MICA (UNII: V8A1AW0880)
FERRIC OXIDE RED (UNII: 1K09F3G675)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
D&C RED NO. 21 (UNII: 08744Z6JNY)
aluminum oxide (UNII: LMI26O6933)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
D&C RED NO. 7 (UNII: ECW0LZ41X8)
D&C RED NO. 27 (UNII: 2LRS185U6K)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
TALC (UNII: 7SEV7J4R1U)
CARMINIC ACID (UNII: CID8Z8N95N)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 13537-073-22	1 in 1 BOX
1	NDC: 13537-073-21	4 g in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part352	04/03/2014

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: 13537-074
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	0.0664 g  in 1 g
Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y)	Oxybenzone	0.0151 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW)
TRIDECYL TRIMELLITATE (UNII: FY36J270ES)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
WATER (UNII: 059QF0KO0R)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)
TRIDECYL STEARATE (UNII: A8OE252M6L)
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)
Isomethyl-.Alpha.-Ionone (UNII: 9XP4LC555B)
LIMONENE, (+)- (UNII: GFD7C86Q1W)
LINALOOL, (+/-)- (UNII: D81QY6I88E)
.ALPHA.-AMYLCINNAMALDEHYDE (UNII: WC51CA3418)
.BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)
MICA (UNII: V8A1AW0880)
FERRIC OXIDE RED (UNII: 1K09F3G675)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
D&C RED NO. 21 (UNII: 08744Z6JNY)
aluminum oxide (UNII: LMI26O6933)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
D&C RED NO. 7 (UNII: ECW0LZ41X8)
D&C RED NO. 27 (UNII: 2LRS185U6K)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
TALC (UNII: 7SEV7J4R1U)
CARMINIC ACID (UNII: CID8Z8N95N)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 13537-074-24	1 in 1 BOX
1	NDC: 13537-074-23	4 g in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part352	04/03/2014

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: 13537-075
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	0.0664 g  in 1 g
Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y)	Oxybenzone	0.0151 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW)
TRIDECYL TRIMELLITATE (UNII: FY36J270ES)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
WATER (UNII: 059QF0KO0R)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)
TRIDECYL STEARATE (UNII: A8OE252M6L)
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)
Isomethyl-.Alpha.-Ionone (UNII: 9XP4LC555B)
LIMONENE, (+)- (UNII: GFD7C86Q1W)
LINALOOL, (+/-)- (UNII: D81QY6I88E)
.ALPHA.-AMYLCINNAMALDEHYDE (UNII: WC51CA3418)
.BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)
MICA (UNII: V8A1AW0880)
FERRIC OXIDE RED (UNII: 1K09F3G675)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
D&C RED NO. 21 (UNII: 08744Z6JNY)
aluminum oxide (UNII: LMI26O6933)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
D&C RED NO. 7 (UNII: ECW0LZ41X8)
D&C RED NO. 27 (UNII: 2LRS185U6K)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
TALC (UNII: 7SEV7J4R1U)
CARMINIC ACID (UNII: CID8Z8N95N)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 13537-075-26	1 in 1 BOX
1	NDC: 13537-075-25	4 g in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part352	04/03/2014

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: 13537-076
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	0.0664 g  in 1 g
Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y)	Oxybenzone	0.0151 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW)
TRIDECYL TRIMELLITATE (UNII: FY36J270ES)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
WATER (UNII: 059QF0KO0R)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)
TRIDECYL STEARATE (UNII: A8OE252M6L)
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)
Isomethyl-.Alpha.-Ionone (UNII: 9XP4LC555B)
LIMONENE, (+)- (UNII: GFD7C86Q1W)
LINALOOL, (+/-)- (UNII: D81QY6I88E)
.ALPHA.-AMYLCINNAMALDEHYDE (UNII: WC51CA3418)
.BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)
MICA (UNII: V8A1AW0880)
FERRIC OXIDE RED (UNII: 1K09F3G675)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
D&C RED NO. 21 (UNII: 08744Z6JNY)
aluminum oxide (UNII: LMI26O6933)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
D&C RED NO. 7 (UNII: ECW0LZ41X8)
D&C RED NO. 27 (UNII: 2LRS185U6K)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
TALC (UNII: 7SEV7J4R1U)
CARMINIC ACID (UNII: CID8Z8N95N)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 13537-076-28	1 in 1 BOX
1	NDC: 13537-076-27	4 g in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part352	04/03/2014

ESIKA HYDRACOLOR 2 IN 1 HIGHLY MOISTURIZING AND COLORING SPF 25 
octinoxate and oxybenzone kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 13537-077

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 13537-077-29	1 in 1 CASE
2	NDC: 13537-077-30	1 in 1 CARTON

Quantity of Parts
Part #	Package Quantity	Total Product Quantity
Part 1	1 CASE	0.57 g
Part 2	1 CASE	0.57 g
Part 3	1 CASE	0.57 g
Part 4	1 CASE	0.57 g
Part 5	1 CASE	0.57 g
Part 6	1 CASE	0.57 g
Part 7	1 CASE	0.57 g
Part 8	1 CASE	0.57 g
Part 9	1 CASE	0.57 g
Part 10	1 CASE	0.57 g
Part 11	1 CASE	0.57 g
Part 12	1 CASE	0.57 g
Part 13	1 CASE	0.57 g
Part 14	1 CASE	0.57 g

Part 1 of 14

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

Product Information
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	0.0664 g  in 1 g
Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y)	Oxybenzone	0.0151 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW)
TRIDECYL TRIMELLITATE (UNII: FY36J270ES)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
WATER (UNII: 059QF0KO0R)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)
TRIDECYL STEARATE (UNII: A8OE252M6L)
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)
Isomethyl-.Alpha.-Ionone (UNII: 9XP4LC555B)
LIMONENE, (+)- (UNII: GFD7C86Q1W)
LINALOOL, (+/-)- (UNII: D81QY6I88E)
.ALPHA.-AMYLCINNAMALDEHYDE (UNII: WC51CA3418)
.BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)
MICA (UNII: V8A1AW0880)
FERRIC OXIDE RED (UNII: 1K09F3G675)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
D&C RED NO. 21 (UNII: 08744Z6JNY)
aluminum oxide (UNII: LMI26O6933)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
D&C RED NO. 7 (UNII: ECW0LZ41X8)
D&C RED NO. 27 (UNII: 2LRS185U6K)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
TALC (UNII: 7SEV7J4R1U)
CARMINIC ACID (UNII: CID8Z8N95N)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1		0.57 g in 1 CASE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part352	04/03/2014

Part 2 of 14

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

Product Information
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	0.0664 g  in 1 g
Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y)	Oxybenzone	0.0151 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW)
TRIDECYL TRIMELLITATE (UNII: FY36J270ES)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
WATER (UNII: 059QF0KO0R)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)
TRIDECYL STEARATE (UNII: A8OE252M6L)
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)
Isomethyl-.Alpha.-Ionone (UNII: 9XP4LC555B)
LIMONENE, (+)- (UNII: GFD7C86Q1W)
LINALOOL, (+/-)- (UNII: D81QY6I88E)
.ALPHA.-AMYLCINNAMALDEHYDE (UNII: WC51CA3418)
.BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)
MICA (UNII: V8A1AW0880)
FERRIC OXIDE RED (UNII: 1K09F3G675)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
D&C RED NO. 21 (UNII: 08744Z6JNY)
aluminum oxide (UNII: LMI26O6933)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
D&C RED NO. 7 (UNII: ECW0LZ41X8)
D&C RED NO. 27 (UNII: 2LRS185U6K)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
TALC (UNII: 7SEV7J4R1U)
CARMINIC ACID (UNII: CID8Z8N95N)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1		0.57 g in 1 CASE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part352	04/03/2014

Part 3 of 14

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

Product Information
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	0.0664 g  in 1 g
Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y)	Oxybenzone	0.0151 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW)
TRIDECYL TRIMELLITATE (UNII: FY36J270ES)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
WATER (UNII: 059QF0KO0R)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)
TRIDECYL STEARATE (UNII: A8OE252M6L)
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)
Isomethyl-.Alpha.-Ionone (UNII: 9XP4LC555B)
LIMONENE, (+)- (UNII: GFD7C86Q1W)
LINALOOL, (+/-)- (UNII: D81QY6I88E)
.ALPHA.-AMYLCINNAMALDEHYDE (UNII: WC51CA3418)
.BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)
MICA (UNII: V8A1AW0880)
FERRIC OXIDE RED (UNII: 1K09F3G675)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
D&C RED NO. 21 (UNII: 08744Z6JNY)
aluminum oxide (UNII: LMI26O6933)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
D&C RED NO. 7 (UNII: ECW0LZ41X8)
D&C RED NO. 27 (UNII: 2LRS185U6K)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
TALC (UNII: 7SEV7J4R1U)
CARMINIC ACID (UNII: CID8Z8N95N)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1		0.57 g in 1 CASE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part352	04/03/2014

Part 4 of 14

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

Product Information
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	0.0664 g  in 1 g
Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y)	Oxybenzone	0.0151 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW)
TRIDECYL TRIMELLITATE (UNII: FY36J270ES)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
WATER (UNII: 059QF0KO0R)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)
TRIDECYL STEARATE (UNII: A8OE252M6L)
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)
Isomethyl-.Alpha.-Ionone (UNII: 9XP4LC555B)
LIMONENE, (+)- (UNII: GFD7C86Q1W)
LINALOOL, (+/-)- (UNII: D81QY6I88E)
.ALPHA.-AMYLCINNAMALDEHYDE (UNII: WC51CA3418)
.BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)
MICA (UNII: V8A1AW0880)
FERRIC OXIDE RED (UNII: 1K09F3G675)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
D&C RED NO. 21 (UNII: 08744Z6JNY)
aluminum oxide (UNII: LMI26O6933)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
D&C RED NO. 7 (UNII: ECW0LZ41X8)
D&C RED NO. 27 (UNII: 2LRS185U6K)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
TALC (UNII: 7SEV7J4R1U)
CARMINIC ACID (UNII: CID8Z8N95N)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1		0.57 g in 1 CASE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part352	04/03/2014

Part 5 of 14

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

Product Information
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	0.0664 g  in 1 g
Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y)	Oxybenzone	0.0151 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW)
TRIDECYL TRIMELLITATE (UNII: FY36J270ES)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
WATER (UNII: 059QF0KO0R)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)
TRIDECYL STEARATE (UNII: A8OE252M6L)
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)
Isomethyl-.Alpha.-Ionone (UNII: 9XP4LC555B)
LIMONENE, (+)- (UNII: GFD7C86Q1W)
LINALOOL, (+/-)- (UNII: D81QY6I88E)
.ALPHA.-AMYLCINNAMALDEHYDE (UNII: WC51CA3418)
.BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)
MICA (UNII: V8A1AW0880)
FERRIC OXIDE RED (UNII: 1K09F3G675)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
D&C RED NO. 21 (UNII: 08744Z6JNY)
aluminum oxide (UNII: LMI26O6933)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
D&C RED NO. 7 (UNII: ECW0LZ41X8)
D&C RED NO. 27 (UNII: 2LRS185U6K)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
TALC (UNII: 7SEV7J4R1U)
CARMINIC ACID (UNII: CID8Z8N95N)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1		0.57 g in 1 CASE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part352	04/03/2014

Part 6 of 14

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

Product Information
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	0.0664 g  in 1 g
Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y)	Oxybenzone	0.0151 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW)
TRIDECYL TRIMELLITATE (UNII: FY36J270ES)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
WATER (UNII: 059QF0KO0R)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)
TRIDECYL STEARATE (UNII: A8OE252M6L)
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)
Isomethyl-.Alpha.-Ionone (UNII: 9XP4LC555B)
LIMONENE, (+)- (UNII: GFD7C86Q1W)
LINALOOL, (+/-)- (UNII: D81QY6I88E)
.ALPHA.-AMYLCINNAMALDEHYDE (UNII: WC51CA3418)
.BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)
MICA (UNII: V8A1AW0880)
FERRIC OXIDE RED (UNII: 1K09F3G675)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
D&C RED NO. 21 (UNII: 08744Z6JNY)
aluminum oxide (UNII: LMI26O6933)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
D&C RED NO. 7 (UNII: ECW0LZ41X8)
D&C RED NO. 27 (UNII: 2LRS185U6K)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
TALC (UNII: 7SEV7J4R1U)
CARMINIC ACID (UNII: CID8Z8N95N)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1		0.57 g in 1 CASE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part352	04/03/2014

Part 7 of 14

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

Product Information
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	0.0664 g  in 1 g
Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y)	Oxybenzone	0.0151 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW)
TRIDECYL TRIMELLITATE (UNII: FY36J270ES)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
WATER (UNII: 059QF0KO0R)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)
TRIDECYL STEARATE (UNII: A8OE252M6L)
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)
Isomethyl-.Alpha.-Ionone (UNII: 9XP4LC555B)
LIMONENE, (+)- (UNII: GFD7C86Q1W)
LINALOOL, (+/-)- (UNII: D81QY6I88E)
.ALPHA.-AMYLCINNAMALDEHYDE (UNII: WC51CA3418)
.BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)
MICA (UNII: V8A1AW0880)
FERRIC OXIDE RED (UNII: 1K09F3G675)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
D&C RED NO. 21 (UNII: 08744Z6JNY)
aluminum oxide (UNII: LMI26O6933)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
D&C RED NO. 7 (UNII: ECW0LZ41X8)
D&C RED NO. 27 (UNII: 2LRS185U6K)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
TALC (UNII: 7SEV7J4R1U)
CARMINIC ACID (UNII: CID8Z8N95N)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1		0.57 g in 1 CASE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part352	04/03/2014

Part 8 of 14

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

Product Information
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	0.0664 g  in 1 g
Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y)	Oxybenzone	0.0151 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW)
TRIDECYL TRIMELLITATE (UNII: FY36J270ES)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
WATER (UNII: 059QF0KO0R)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)
TRIDECYL STEARATE (UNII: A8OE252M6L)
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)
Isomethyl-.Alpha.-Ionone (UNII: 9XP4LC555B)
LIMONENE, (+)- (UNII: GFD7C86Q1W)
LINALOOL, (+/-)- (UNII: D81QY6I88E)
.ALPHA.-AMYLCINNAMALDEHYDE (UNII: WC51CA3418)
.BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)
MICA (UNII: V8A1AW0880)
FERRIC OXIDE RED (UNII: 1K09F3G675)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
D&C RED NO. 21 (UNII: 08744Z6JNY)
aluminum oxide (UNII: LMI26O6933)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
D&C RED NO. 7 (UNII: ECW0LZ41X8)
D&C RED NO. 27 (UNII: 2LRS185U6K)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
TALC (UNII: 7SEV7J4R1U)
CARMINIC ACID (UNII: CID8Z8N95N)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1		0.57 g in 1 CASE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part352	04/03/2014

Part 9 of 14

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

Product Information
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	0.0664 g  in 1 g
Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y)	Oxybenzone	0.0151 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW)
TRIDECYL TRIMELLITATE (UNII: FY36J270ES)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
WATER (UNII: 059QF0KO0R)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)
TRIDECYL STEARATE (UNII: A8OE252M6L)
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)
Isomethyl-.Alpha.-Ionone (UNII: 9XP4LC555B)
LIMONENE, (+)- (UNII: GFD7C86Q1W)
LINALOOL, (+/-)- (UNII: D81QY6I88E)
.ALPHA.-AMYLCINNAMALDEHYDE (UNII: WC51CA3418)
.BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)
MICA (UNII: V8A1AW0880)
FERRIC OXIDE RED (UNII: 1K09F3G675)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
D&C RED NO. 21 (UNII: 08744Z6JNY)
aluminum oxide (UNII: LMI26O6933)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
D&C RED NO. 7 (UNII: ECW0LZ41X8)
D&C RED NO. 27 (UNII: 2LRS185U6K)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
TALC (UNII: 7SEV7J4R1U)
CARMINIC ACID (UNII: CID8Z8N95N)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1		0.57 g in 1 CASE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part352	04/03/2014

Part 10 of 14

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

Product Information
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	0.0664 g  in 1 g
Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y)	Oxybenzone	0.0151 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW)
TRIDECYL TRIMELLITATE (UNII: FY36J270ES)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
WATER (UNII: 059QF0KO0R)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)
TRIDECYL STEARATE (UNII: A8OE252M6L)
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)
Isomethyl-.Alpha.-Ionone (UNII: 9XP4LC555B)
LIMONENE, (+)- (UNII: GFD7C86Q1W)
LINALOOL, (+/-)- (UNII: D81QY6I88E)
.ALPHA.-AMYLCINNAMALDEHYDE (UNII: WC51CA3418)
.BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)
MICA (UNII: V8A1AW0880)
FERRIC OXIDE RED (UNII: 1K09F3G675)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
D&C RED NO. 21 (UNII: 08744Z6JNY)
aluminum oxide (UNII: LMI26O6933)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
D&C RED NO. 7 (UNII: ECW0LZ41X8)
D&C RED NO. 27 (UNII: 2LRS185U6K)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
TALC (UNII: 7SEV7J4R1U)
CARMINIC ACID (UNII: CID8Z8N95N)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1		0.57 g in 1 CASE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part352	04/03/2014

Part 11 of 14

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

Product Information
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	0.0664 g  in 1 g
Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y)	Oxybenzone	0.0151 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW)
TRIDECYL TRIMELLITATE (UNII: FY36J270ES)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
WATER (UNII: 059QF0KO0R)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)
TRIDECYL STEARATE (UNII: A8OE252M6L)
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)
Isomethyl-.Alpha.-Ionone (UNII: 9XP4LC555B)
LIMONENE, (+)- (UNII: GFD7C86Q1W)
LINALOOL, (+/-)- (UNII: D81QY6I88E)
.ALPHA.-AMYLCINNAMALDEHYDE (UNII: WC51CA3418)
.BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)
MICA (UNII: V8A1AW0880)
FERRIC OXIDE RED (UNII: 1K09F3G675)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
D&C RED NO. 21 (UNII: 08744Z6JNY)
aluminum oxide (UNII: LMI26O6933)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
D&C RED NO. 7 (UNII: ECW0LZ41X8)
D&C RED NO. 27 (UNII: 2LRS185U6K)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
TALC (UNII: 7SEV7J4R1U)
CARMINIC ACID (UNII: CID8Z8N95N)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1		0.57 g in 1 CASE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part352	04/03/2014

Part 12 of 14

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

Product Information
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	0.0664 g  in 1 g
Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y)	Oxybenzone	0.0151 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW)
TRIDECYL TRIMELLITATE (UNII: FY36J270ES)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
WATER (UNII: 059QF0KO0R)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)
TRIDECYL STEARATE (UNII: A8OE252M6L)
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)
Isomethyl-.Alpha.-Ionone (UNII: 9XP4LC555B)
LIMONENE, (+)- (UNII: GFD7C86Q1W)
LINALOOL, (+/-)- (UNII: D81QY6I88E)
.ALPHA.-AMYLCINNAMALDEHYDE (UNII: WC51CA3418)
.BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)
MICA (UNII: V8A1AW0880)
FERRIC OXIDE RED (UNII: 1K09F3G675)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
D&C RED NO. 21 (UNII: 08744Z6JNY)
aluminum oxide (UNII: LMI26O6933)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
D&C RED NO. 7 (UNII: ECW0LZ41X8)
D&C RED NO. 27 (UNII: 2LRS185U6K)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
TALC (UNII: 7SEV7J4R1U)
CARMINIC ACID (UNII: CID8Z8N95N)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1		0.57 g in 1 CASE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part352	04/03/2014

Part 13 of 14

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

Product Information
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	0.0664 g  in 1 g
Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y)	Oxybenzone	0.0151 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW)
TRIDECYL TRIMELLITATE (UNII: FY36J270ES)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
WATER (UNII: 059QF0KO0R)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)
TRIDECYL STEARATE (UNII: A8OE252M6L)
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)
Isomethyl-.Alpha.-Ionone (UNII: 9XP4LC555B)
LIMONENE, (+)- (UNII: GFD7C86Q1W)
LINALOOL, (+/-)- (UNII: D81QY6I88E)
.ALPHA.-AMYLCINNAMALDEHYDE (UNII: WC51CA3418)
.BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)
MICA (UNII: V8A1AW0880)
FERRIC OXIDE RED (UNII: 1K09F3G675)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
D&C RED NO. 21 (UNII: 08744Z6JNY)
aluminum oxide (UNII: LMI26O6933)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
D&C RED NO. 7 (UNII: ECW0LZ41X8)
D&C RED NO. 27 (UNII: 2LRS185U6K)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
TALC (UNII: 7SEV7J4R1U)
CARMINIC ACID (UNII: CID8Z8N95N)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1		0.57 g in 1 CASE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part352	04/03/2014

Part 14 of 14

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

Product Information
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	0.0664 g  in 1 g
Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y)	Oxybenzone	0.0151 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW)
TRIDECYL TRIMELLITATE (UNII: FY36J270ES)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
WATER (UNII: 059QF0KO0R)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)
TRIDECYL STEARATE (UNII: A8OE252M6L)
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)
Isomethyl-.Alpha.-Ionone (UNII: 9XP4LC555B)
LIMONENE, (+)- (UNII: GFD7C86Q1W)
LINALOOL, (+/-)- (UNII: D81QY6I88E)
.ALPHA.-AMYLCINNAMALDEHYDE (UNII: WC51CA3418)
.BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)
MICA (UNII: V8A1AW0880)
FERRIC OXIDE RED (UNII: 1K09F3G675)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
D&C RED NO. 21 (UNII: 08744Z6JNY)
aluminum oxide (UNII: LMI26O6933)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
D&C RED NO. 7 (UNII: ECW0LZ41X8)
D&C RED NO. 27 (UNII: 2LRS185U6K)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
TALC (UNII: 7SEV7J4R1U)
CARMINIC ACID (UNII: CID8Z8N95N)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1		0.57 g in 1 CASE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part352	04/03/2014

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part352	04/03/2014

Labeler - Ventura Corporation LTD (602751344)

Establishment
Name	Address	ID/FEI	Business Operations
Bel Star S.A. (Colombia)		880160197	MANUFACTURE(13537-061, 13537-064, 13537-065, 13537-066, 13537-067, 13537-068, 13537-069, 13537-070, 13537-071, 13537-072, 13537-073, 13537-074, 13537-075, 13537-076, 13537-077)