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

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

Category: HUMAN OTC DRUG LABEL
DEA Schedule: None
Marketing Status: OTC monograph final

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

Drug Label Information

Updated November 26, 2018

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

Download DRUG LABEL INFO: PDF XML
Official Label (Printer Friendly)

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SPL UNCLASSIFIED SECTION

Drug Facts
ACTIVE INGREDIENT

Active Ingredients Purpose

OCTINOXATE 7.5% Sunscreen

ZINC OXIDE 3.92% Sunscreen
Uses
- Helps prevent sunburn.
Warnings
- Skin Cancer / Skin Aging Alert: Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to help prevent sunburn, not skin cancer or early skin aging.
- For external use only.
- Do not use on damaged or broken skin.
- When using this product keep out of eyes. Rinse with water to remove.
- Stop use and ask a doctor if rash occurs.
- Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Directions
- Apply liberally and evenly 15 minutes before sun exposure.
- Reapply at least every 2 hours
- Use a water resistant sunscreen if swimming or sweating.
- Children under 6 months of age: Ask a doctor
Other information
- Protect the product in this container from excessive heat and direct sun.
Inactive ingredients

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

MAY CONTAIN: RED 30 LAKE, TITANIUM DIOXIDE, IRON OXIDES, MICA, RED 27 LAKE, YELLOW 5 LAKE, RED 7 LAKE, RED 21 LAKE, TALC, BLUE 1 LAKE, CARMINE.
SPL UNCLASSIFIED SECTION

Dist. by Ventura Corp, Ltd., San Juan, Puerto Rico 00926.
PRINCIPAL DISPLAY PANEL - 4 g Tube Box - (PIMIENTA CALIENTE) - BROWN

ésika
PRO

HIDRACOLOR
3 IN 1

Moisturizing Lipstick,
Color and Perfecting
Effect SPF 25

Net Weight
0.14 oz. e (4 g)
PRINCIPAL DISPLAY PANEL - 4 g Tube Box - (ROJO DESEO) - RED

ésika
PRO

HIDRACOLOR
3 IN 1

Moisturizing Lipstick,
Color and Perfecting
Effect SPF 25

Net Weight
0.14 oz. e (4 g)
PRINCIPAL DISPLAY PANEL - 4 g Tube Box - (ROJO ESIKA) - RED

ésika
PRO

HIDRACOLOR
3 IN 1

Moisturizing Lipstick,
Color and Perfecting
Effect SPF 25

Net Weight
0.14 oz. e (4 g)
PRINCIPAL DISPLAY PANEL - 4 g Tube Box - (MARRON TOPACIO) - BROWN

ésika
PRO

HIDRACOLOR
3 IN 1

Moisturizing Lipstick,
Color and Perfecting
Effect SPF 25

Net Weight
0.14 oz. e (4 g)
PRINCIPAL DISPLAY PANEL - 4 g Tube Box - (ROSA GEOMETRIC) - PINK

ésika
PRO

HIDRACOLOR
3 IN 1

Moisturizing Lipstick,
Color and Perfecting
Effect SPF 25

Net Weight
0.14 oz. e (4 g)
PRINCIPAL DISPLAY PANEL - 4 g Tube Box - (ROSA ENCANTO) - PINK

ésika
PRO

HIDRACOLOR
3 IN 1

Moisturizing Lipstick,
Color and Perfecting
Effect SPF 25

Net Weight
0.14 oz. e (4 g)
PRINCIPAL DISPLAY PANEL - 4 g Tube Box - (MORA GLAM) - PURPLE

ésika
PRO

HIDRACOLOR
3 IN 1

Moisturizing Lipstick,
Color and Perfecting
Effect SPF 25

Net Weight
0.14 oz. e (4 g)
PRINCIPAL DISPLAY PANEL - 4 g Tube Box - (GRANATE SEDUCTOR) - PURPLE

ésika
PRO

HIDRACOLOR
3 IN 1

Moisturizing Lipstick,
Color and Perfecting
Effect SPF 25

Net Weight
0.14 oz. e (4 g)
PRINCIPAL DISPLAY PANEL - 4 g Tube Box - (BORGONA SEXY) - PURPLE

ésika
PRO

HIDRACOLOR
3 IN 1

Moisturizing Lipstick,
Color and Perfecting
Effect SPF 25

Net Weight
0.14 oz. e (4 g)
PRINCIPAL DISPLAY PANEL - 4 g Tube Box - (FRESA HOT) - PINK

ésika
PRO

HIDRACOLOR
3 IN 1

Moisturizing Lipstick,
Color and Perfecting
Effect SPF 25

Net Weight
0.14 oz. e (4 g)
PRINCIPAL DISPLAY PANEL - 4 g Tube Box - (FUCSIA CAUTIVANTE) - PINK

ésika
PRO

HIDRACOLOR
3 IN 1

Moisturizing Lipstick,
Color and Perfecting
Effect SPF 25

Net Weight
0.14 oz. e (4 g)
PRINCIPAL DISPLAY PANEL - 4 g Tube Box - (FUCSIA INTENSE) - PINK

ésika
PRO

HIDRACOLOR
3 IN 1

Moisturizing Lipstick,
Color and Perfecting
Effect SPF 25

Net Weight
0.14 oz. e (4 g)
PRINCIPAL DISPLAY PANEL - 4 g Tube Box - (NARANJA ESFERA) - ORANGE

ésika
PRO

HIDRACOLOR
3 IN 1

Moisturizing Lipstick,
Color and Perfecting
Effect SPF 25

Net Weight
0.14 oz. e (4 g)
PRINCIPAL DISPLAY PANEL - 4 g Tube Box - (ROSA NUDE) - PINK

ésika
PRO

HIDRACOLOR
3 IN 1

Moisturizing Lipstick,
Color and Perfecting
Effect SPF 25

Net Weight
0.14 oz. e (4 g)
PRINCIPAL DISPLAY PANEL - 4 g Tube Box - (PEACH NUDE) - BROWN

ésika
PRO

HIDRACOLOR
3 IN 1

Moisturizing Lipstick,
Color and Perfecting
Effect SPF 25

Net Weight
0.14 oz. e (4 g)
PRINCIPAL DISPLAY PANEL - 4 g Tube Box - (CORAL CHIC) - PINK

ésika
PRO

HIDRACOLOR
3 IN 1

Moisturizing Lipstick,
Color and Perfecting
Effect SPF 25

Net Weight
0.14 oz. e (4 g)
PRINCIPAL DISPLAY PANEL - 4 g Tube Box - (ROJO TROPICAL) - RED

ésika
PRO

HIDRACOLOR
3 IN 1

Moisturizing Lipstick,
Color and Perfecting
Effect SPF 25

Net Weight
0.14 oz. e (4 g)
PRINCIPAL DISPLAY PANEL - 4 g Tube Box - (NARANJA CITRICO) - ORANGE

ésika
PRO

HIDRACOLOR
3 IN 1

Moisturizing Lipstick,
Color and Perfecting
Effect SPF 25

Net Weight
0.14 oz. e (4 g)
PRINCIPAL DISPLAY PANEL - 4 g Tube Box - (NUDE PUNCH) - ORANGE

ésika
PRO

HIDRACOLOR
3 IN 1

Moisturizing Lipstick,
Color and Perfecting
Effect SPF 25

Net Weight
0.14 oz. e (4 g)
PRINCIPAL DISPLAY PANEL - 4 g Tube Box - (MORA ATREVIDA) - PURPLE

ésika
PRO

HIDRACOLOR
3 IN 1

Moisturizing Lipstick,
Color and Perfecting
Effect SPF 25

Net Weight
0.14 oz. e (4 g)
PRINCIPAL DISPLAY PANEL - 4 g Tube Box - (NUDE SAVANNA) - ORANGE

ésika
PRO

HIDRACOLOR
3 IN 1

Moisturizing Lipstick,
Color and Perfecting
Effect SPF 25

Net Weight
0.14 oz. e (4 g)
PRINCIPAL DISPLAY PANEL - 4 g Tube Box - (ROJO SENSUAL) - RED

ésika
PRO

HIDRACOLOR
3 IN 1

Moisturizing Lipstick,
Color and Perfecting
Effect SPF 25

Net Weight
0.14 oz. e (4 g)
PRINCIPAL DISPLAY PANEL - 4 g Tube Box - (NUDE MOCCHA) - ORANGE

ésika
PRO

HIDRACOLOR
3 IN 1

Moisturizing Lipstick,
Color and Perfecting
Effect SPF 25

Net Weight
0.14 oz. e (4 g)
PRINCIPAL DISPLAY PANEL - 4 g Tube Box - (BRONCE METALLIC) - BROWN

ésika
PRO

HIDRACOLOR
3 IN 1

Moisturizing Lipstick,
Color and Perfecting
Effect SPF 25

Net Weight
0.14 oz. e (4 g)
PRINCIPAL DISPLAY PANEL - Kit Carton

HIDRACOLOR 3 IN 1

Moisturizing Lipstick,
Color and Perfecting Effect SPF 25

ésika
PRO

Net Wt. 0.28 oz. e (8 g)

Active Ingredients	Purpose
OCTINOXATE 7.5%	Sunscreen
ZINC OXIDE 3.92%	Sunscreen

INGREDIENTS AND APPEARANCE

ESIKA PRO HIDRACOLOR 3 IN 1 MOISTURIZING, COLOR AND PERFECTING EFFECT SPF 25 (PIMIENTA CALIENTE) - BROWN
octinoxate and zinc oxide lipstick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:13537-958
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	0.075 g in 1 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	0.0392 g in 1 g

Ingredient Name	Strength
Inactive Ingredients
DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW)
TRIDECYL TRIMELLITATE (UNII: FY36J270ES)
ISONONYL ISONONANOATE (UNII: S4V5BS6GCX)
CERESIN (UNII: Q1LS2UJO3A)
WATER (UNII: 059QF0KO0R)
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)
TRIDECYL STEARATE (UNII: A8OE252M6L)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
CARNAUBA WAX (UNII: R12CBM0EIZ)
GLYCERIN (UNII: PDC6A3C0OX)
NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K)
SHEA BUTTER (UNII: K49155WL9Y)
POLYTETRAFLUOROETHYLENE (UNII: E1NC1JVS3O)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
COCONUT OIL (UNII: Q9L0O73W7L)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
CERAMIDE NP (UNII: 4370DF050B)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
CHLORPHENESIN (UNII: I670DAL4SZ)
DIMETHICONE (UNII: 92RU3N3Y1O)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
SOYBEAN OIL (UNII: 241ATL177A)
TOCOPHEROL (UNII: R0ZB2556P8)
MAGNESIUM CHLORIDE (UNII: 02F3473H9O)
POTASSIUM CHLORIDE (UNII: 660YQ98I10)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)
LIMONENE, (+)- (UNII: GFD7C86Q1W)
LINALOOL, (+/-)- (UNII: D81QY6I88E)
.ALPHA.-AMYLCINNAMALDEHYDE (UNII: WC51CA3418)
.BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)
D&C RED NO. 30 (UNII: 2S42T2808B)
ALUMINUM OXIDE (UNII: LMI26O6933)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FERRIC OXIDE RED (UNII: 1K09F3G675)
MICA (UNII: V8A1AW0880)
D&C RED NO. 27 (UNII: 2LRS185U6K)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
D&C RED NO. 7 (UNII: ECW0LZ41X8)
D&C RED NO. 21 (UNII: 08744Z6JNY)
TALC (UNII: 7SEV7J4R1U)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:13537-958-02	1 in 1 BOX	07/12/2016
1	NDC:13537-958-01	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	07/12/2016

ESIKA PRO HIDRACOLOR 3 IN 1 MOISTURIZING, COLOR AND PERFECTING EFFECT SPF 25 (ROJO DESEO) - RED
octinoxate and zinc oxide lipstick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:13537-959
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	0.075 g in 1 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	0.0392 g in 1 g

Ingredient Name	Strength
Inactive Ingredients
DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW)
TRIDECYL TRIMELLITATE (UNII: FY36J270ES)
ISONONYL ISONONANOATE (UNII: S4V5BS6GCX)
CERESIN (UNII: Q1LS2UJO3A)
WATER (UNII: 059QF0KO0R)
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)
TRIDECYL STEARATE (UNII: A8OE252M6L)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
CARNAUBA WAX (UNII: R12CBM0EIZ)
GLYCERIN (UNII: PDC6A3C0OX)
NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K)
SHEA BUTTER (UNII: K49155WL9Y)
POLYTETRAFLUOROETHYLENE (UNII: E1NC1JVS3O)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
COCONUT OIL (UNII: Q9L0O73W7L)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
CERAMIDE NP (UNII: 4370DF050B)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
CHLORPHENESIN (UNII: I670DAL4SZ)
DIMETHICONE (UNII: 92RU3N3Y1O)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
SOYBEAN OIL (UNII: 241ATL177A)
TOCOPHEROL (UNII: R0ZB2556P8)
MAGNESIUM CHLORIDE (UNII: 02F3473H9O)
POTASSIUM CHLORIDE (UNII: 660YQ98I10)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)
LIMONENE, (+)- (UNII: GFD7C86Q1W)
LINALOOL, (+/-)- (UNII: D81QY6I88E)
.ALPHA.-AMYLCINNAMALDEHYDE (UNII: WC51CA3418)
.BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)
D&C RED NO. 30 (UNII: 2S42T2808B)
ALUMINUM OXIDE (UNII: LMI26O6933)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FERRIC OXIDE RED (UNII: 1K09F3G675)
MICA (UNII: V8A1AW0880)
D&C RED NO. 27 (UNII: 2LRS185U6K)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
D&C RED NO. 7 (UNII: ECW0LZ41X8)
D&C RED NO. 21 (UNII: 08744Z6JNY)
TALC (UNII: 7SEV7J4R1U)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:13537-959-04	1 in 1 BOX	07/12/2016
1	NDC:13537-959-03	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	07/12/2016

ESIKA PRO HIDRACOLOR 3 IN 1 MOISTURIZING, COLOR AND PERFECTING EFFECT SPF 25 (ROJO ESIKA) - RED
octinoxate and zinc oxide lipstick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:13537-960
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	0.075 g in 1 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	0.0392 g in 1 g

Ingredient Name	Strength
Inactive Ingredients
DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW)
TRIDECYL TRIMELLITATE (UNII: FY36J270ES)
ISONONYL ISONONANOATE (UNII: S4V5BS6GCX)
CERESIN (UNII: Q1LS2UJO3A)
WATER (UNII: 059QF0KO0R)
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)
TRIDECYL STEARATE (UNII: A8OE252M6L)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
CARNAUBA WAX (UNII: R12CBM0EIZ)
GLYCERIN (UNII: PDC6A3C0OX)
NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K)
SHEA BUTTER (UNII: K49155WL9Y)
POLYTETRAFLUOROETHYLENE (UNII: E1NC1JVS3O)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
COCONUT OIL (UNII: Q9L0O73W7L)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
CERAMIDE NP (UNII: 4370DF050B)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
CHLORPHENESIN (UNII: I670DAL4SZ)
DIMETHICONE (UNII: 92RU3N3Y1O)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
SOYBEAN OIL (UNII: 241ATL177A)
TOCOPHEROL (UNII: R0ZB2556P8)
MAGNESIUM CHLORIDE (UNII: 02F3473H9O)
POTASSIUM CHLORIDE (UNII: 660YQ98I10)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)
LIMONENE, (+)- (UNII: GFD7C86Q1W)
LINALOOL, (+/-)- (UNII: D81QY6I88E)
.ALPHA.-AMYLCINNAMALDEHYDE (UNII: WC51CA3418)
.BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)
D&C RED NO. 30 (UNII: 2S42T2808B)
ALUMINUM OXIDE (UNII: LMI26O6933)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FERRIC OXIDE RED (UNII: 1K09F3G675)
MICA (UNII: V8A1AW0880)
D&C RED NO. 27 (UNII: 2LRS185U6K)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
D&C RED NO. 7 (UNII: ECW0LZ41X8)
D&C RED NO. 21 (UNII: 08744Z6JNY)
TALC (UNII: 7SEV7J4R1U)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:13537-960-06	1 in 1 BOX	07/12/2016
1	NDC:13537-960-05	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	07/12/2016

ESIKA PRO HIDRACOLOR 3 IN 1 MOISTURIZING, COLOR AND PERFECTING EFFECT SPF 25 (MARRON TOPACIO) - BROWN
octinoxate and zinc oxide lipstick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:13537-966
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	0.075 g in 1 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	0.0392 g in 1 g

Ingredient Name	Strength
Inactive Ingredients
DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW)
TRIDECYL TRIMELLITATE (UNII: FY36J270ES)
ISONONYL ISONONANOATE (UNII: S4V5BS6GCX)
CERESIN (UNII: Q1LS2UJO3A)
WATER (UNII: 059QF0KO0R)
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)
TRIDECYL STEARATE (UNII: A8OE252M6L)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
CARNAUBA WAX (UNII: R12CBM0EIZ)
GLYCERIN (UNII: PDC6A3C0OX)
NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K)
SHEA BUTTER (UNII: K49155WL9Y)
POLYTETRAFLUOROETHYLENE (UNII: E1NC1JVS3O)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
COCONUT OIL (UNII: Q9L0O73W7L)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
CERAMIDE NP (UNII: 4370DF050B)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
CHLORPHENESIN (UNII: I670DAL4SZ)
DIMETHICONE (UNII: 92RU3N3Y1O)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
SOYBEAN OIL (UNII: 241ATL177A)
TOCOPHEROL (UNII: R0ZB2556P8)
MAGNESIUM CHLORIDE (UNII: 02F3473H9O)
POTASSIUM CHLORIDE (UNII: 660YQ98I10)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)
LIMONENE, (+)- (UNII: GFD7C86Q1W)
LINALOOL, (+/-)- (UNII: D81QY6I88E)
.ALPHA.-AMYLCINNAMALDEHYDE (UNII: WC51CA3418)
.BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)
D&C RED NO. 30 (UNII: 2S42T2808B)
ALUMINUM OXIDE (UNII: LMI26O6933)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FERRIC OXIDE RED (UNII: 1K09F3G675)
MICA (UNII: V8A1AW0880)
D&C RED NO. 27 (UNII: 2LRS185U6K)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
D&C RED NO. 7 (UNII: ECW0LZ41X8)
D&C RED NO. 21 (UNII: 08744Z6JNY)
TALC (UNII: 7SEV7J4R1U)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:13537-966-08	1 in 1 BOX	07/12/2016
1	NDC:13537-966-07	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	07/12/2016

ESIKA PRO HIDRACOLOR 3 IN 1 MOISTURIZING, COLOR AND PERFECTING EFFECT SPF 25 (ROSA GEOMETRIC) - PINK
octinoxate and zinc oxide lipstick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:13537-967
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	0.075 g in 1 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	0.0392 g in 1 g

Ingredient Name	Strength
Inactive Ingredients
DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW)
TRIDECYL TRIMELLITATE (UNII: FY36J270ES)
ISONONYL ISONONANOATE (UNII: S4V5BS6GCX)
CERESIN (UNII: Q1LS2UJO3A)
WATER (UNII: 059QF0KO0R)
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)
TRIDECYL STEARATE (UNII: A8OE252M6L)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
CARNAUBA WAX (UNII: R12CBM0EIZ)
GLYCERIN (UNII: PDC6A3C0OX)
NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K)
SHEA BUTTER (UNII: K49155WL9Y)
POLYTETRAFLUOROETHYLENE (UNII: E1NC1JVS3O)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
COCONUT OIL (UNII: Q9L0O73W7L)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
CERAMIDE NP (UNII: 4370DF050B)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
CHLORPHENESIN (UNII: I670DAL4SZ)
DIMETHICONE (UNII: 92RU3N3Y1O)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
SOYBEAN OIL (UNII: 241ATL177A)
TOCOPHEROL (UNII: R0ZB2556P8)
MAGNESIUM CHLORIDE (UNII: 02F3473H9O)
POTASSIUM CHLORIDE (UNII: 660YQ98I10)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)
LIMONENE, (+)- (UNII: GFD7C86Q1W)
LINALOOL, (+/-)- (UNII: D81QY6I88E)
.ALPHA.-AMYLCINNAMALDEHYDE (UNII: WC51CA3418)
.BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)
D&C RED NO. 30 (UNII: 2S42T2808B)
ALUMINUM OXIDE (UNII: LMI26O6933)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FERRIC OXIDE RED (UNII: 1K09F3G675)
MICA (UNII: V8A1AW0880)
D&C RED NO. 27 (UNII: 2LRS185U6K)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
D&C RED NO. 7 (UNII: ECW0LZ41X8)
D&C RED NO. 21 (UNII: 08744Z6JNY)
TALC (UNII: 7SEV7J4R1U)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:13537-967-10	1 in 1 BOX	07/12/2016
1	NDC:13537-967-09	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	07/12/2016

ESIKA PRO HIDRACOLOR 3 IN 1 MOISTURIZING, COLOR AND PERFECTING EFFECT SPF 25 (ROSA ENCANTO) - PINK
octinoxate and zinc oxide lipstick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:13537-968
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	0.075 g in 1 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	0.0392 g in 1 g

Ingredient Name	Strength
Inactive Ingredients
DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW)
TRIDECYL TRIMELLITATE (UNII: FY36J270ES)
ISONONYL ISONONANOATE (UNII: S4V5BS6GCX)
CERESIN (UNII: Q1LS2UJO3A)
WATER (UNII: 059QF0KO0R)
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)
TRIDECYL STEARATE (UNII: A8OE252M6L)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
CARNAUBA WAX (UNII: R12CBM0EIZ)
GLYCERIN (UNII: PDC6A3C0OX)
NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K)
SHEA BUTTER (UNII: K49155WL9Y)
POLYTETRAFLUOROETHYLENE (UNII: E1NC1JVS3O)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
COCONUT OIL (UNII: Q9L0O73W7L)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
CERAMIDE NP (UNII: 4370DF050B)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
CHLORPHENESIN (UNII: I670DAL4SZ)
DIMETHICONE (UNII: 92RU3N3Y1O)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
SOYBEAN OIL (UNII: 241ATL177A)
TOCOPHEROL (UNII: R0ZB2556P8)
MAGNESIUM CHLORIDE (UNII: 02F3473H9O)
POTASSIUM CHLORIDE (UNII: 660YQ98I10)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)
LIMONENE, (+)- (UNII: GFD7C86Q1W)
LINALOOL, (+/-)- (UNII: D81QY6I88E)
.ALPHA.-AMYLCINNAMALDEHYDE (UNII: WC51CA3418)
.BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)
D&C RED NO. 30 (UNII: 2S42T2808B)
ALUMINUM OXIDE (UNII: LMI26O6933)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FERRIC OXIDE RED (UNII: 1K09F3G675)
MICA (UNII: V8A1AW0880)
D&C RED NO. 27 (UNII: 2LRS185U6K)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
D&C RED NO. 7 (UNII: ECW0LZ41X8)
D&C RED NO. 21 (UNII: 08744Z6JNY)
TALC (UNII: 7SEV7J4R1U)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:13537-968-12	1 in 1 BOX	07/12/2016
1	NDC:13537-968-11	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	07/12/2016

ESIKA PRO HIDRACOLOR 3 IN 1 MOISTURIZING, COLOR AND PERFECTING EFFECT SPF 25 (MORA GLAM) - PURPLE
octinoxate and zinc oxide lipstick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:13537-969
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	0.075 g in 1 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	0.0392 g in 1 g

Ingredient Name	Strength
Inactive Ingredients
DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW)
TRIDECYL TRIMELLITATE (UNII: FY36J270ES)
ISONONYL ISONONANOATE (UNII: S4V5BS6GCX)
CERESIN (UNII: Q1LS2UJO3A)
WATER (UNII: 059QF0KO0R)
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)
TRIDECYL STEARATE (UNII: A8OE252M6L)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
CARNAUBA WAX (UNII: R12CBM0EIZ)
GLYCERIN (UNII: PDC6A3C0OX)
NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K)
SHEA BUTTER (UNII: K49155WL9Y)
POLYTETRAFLUOROETHYLENE (UNII: E1NC1JVS3O)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
COCONUT OIL (UNII: Q9L0O73W7L)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
CERAMIDE NP (UNII: 4370DF050B)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
CHLORPHENESIN (UNII: I670DAL4SZ)
DIMETHICONE (UNII: 92RU3N3Y1O)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
SOYBEAN OIL (UNII: 241ATL177A)
TOCOPHEROL (UNII: R0ZB2556P8)
MAGNESIUM CHLORIDE (UNII: 02F3473H9O)
POTASSIUM CHLORIDE (UNII: 660YQ98I10)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)
LIMONENE, (+)- (UNII: GFD7C86Q1W)
LINALOOL, (+/-)- (UNII: D81QY6I88E)
.ALPHA.-AMYLCINNAMALDEHYDE (UNII: WC51CA3418)
.BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)
D&C RED NO. 30 (UNII: 2S42T2808B)
ALUMINUM OXIDE (UNII: LMI26O6933)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FERRIC OXIDE RED (UNII: 1K09F3G675)
MICA (UNII: V8A1AW0880)
D&C RED NO. 27 (UNII: 2LRS185U6K)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
D&C RED NO. 7 (UNII: ECW0LZ41X8)
D&C RED NO. 21 (UNII: 08744Z6JNY)
TALC (UNII: 7SEV7J4R1U)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:13537-969-14	1 in 1 BOX	07/12/2016
1	NDC:13537-969-13	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	07/12/2016

ESIKA PRO HIDRACOLOR 3 IN 1 MOISTURIZING, COLOR AND PERFECTING EFFECT SPF 25 (GRANATE SEDUCTOR) - PURPLE
octinoxate and zinc oxide lipstick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:13537-970
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	0.075 g in 1 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	0.0392 g in 1 g

Ingredient Name	Strength
Inactive Ingredients
DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW)
TRIDECYL TRIMELLITATE (UNII: FY36J270ES)
ISONONYL ISONONANOATE (UNII: S4V5BS6GCX)
CERESIN (UNII: Q1LS2UJO3A)
WATER (UNII: 059QF0KO0R)
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)
TRIDECYL STEARATE (UNII: A8OE252M6L)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
CARNAUBA WAX (UNII: R12CBM0EIZ)
GLYCERIN (UNII: PDC6A3C0OX)
NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K)
SHEA BUTTER (UNII: K49155WL9Y)
POLYTETRAFLUOROETHYLENE (UNII: E1NC1JVS3O)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
COCONUT OIL (UNII: Q9L0O73W7L)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
CERAMIDE NP (UNII: 4370DF050B)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
CHLORPHENESIN (UNII: I670DAL4SZ)
DIMETHICONE (UNII: 92RU3N3Y1O)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
SOYBEAN OIL (UNII: 241ATL177A)
TOCOPHEROL (UNII: R0ZB2556P8)
MAGNESIUM CHLORIDE (UNII: 02F3473H9O)
POTASSIUM CHLORIDE (UNII: 660YQ98I10)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)
LIMONENE, (+)- (UNII: GFD7C86Q1W)
LINALOOL, (+/-)- (UNII: D81QY6I88E)
.ALPHA.-AMYLCINNAMALDEHYDE (UNII: WC51CA3418)
.BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)
D&C RED NO. 30 (UNII: 2S42T2808B)
ALUMINUM OXIDE (UNII: LMI26O6933)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FERRIC OXIDE RED (UNII: 1K09F3G675)
MICA (UNII: V8A1AW0880)
D&C RED NO. 27 (UNII: 2LRS185U6K)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
D&C RED NO. 7 (UNII: ECW0LZ41X8)
D&C RED NO. 21 (UNII: 08744Z6JNY)
TALC (UNII: 7SEV7J4R1U)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:13537-970-18	1 in 1 BOX	07/12/2016
1	NDC:13537-970-17	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	07/12/2016

ESIKA PRO HIDRACOLOR 3 IN 1 MOISTURIZING, COLOR AND PERFECTING EFFECT SPF 25 (BORGONA SEXY) - PURPLE
octinoxate and zinc oxide lipstick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:13537-971
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	0.075 g in 1 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	0.0392 g in 1 g

Ingredient Name	Strength
Inactive Ingredients
DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW)
TRIDECYL TRIMELLITATE (UNII: FY36J270ES)
ISONONYL ISONONANOATE (UNII: S4V5BS6GCX)
CERESIN (UNII: Q1LS2UJO3A)
WATER (UNII: 059QF0KO0R)
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)
TRIDECYL STEARATE (UNII: A8OE252M6L)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
CARNAUBA WAX (UNII: R12CBM0EIZ)
GLYCERIN (UNII: PDC6A3C0OX)
NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K)
SHEA BUTTER (UNII: K49155WL9Y)
POLYTETRAFLUOROETHYLENE (UNII: E1NC1JVS3O)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
COCONUT OIL (UNII: Q9L0O73W7L)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
CERAMIDE NP (UNII: 4370DF050B)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
CHLORPHENESIN (UNII: I670DAL4SZ)
DIMETHICONE (UNII: 92RU3N3Y1O)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
SOYBEAN OIL (UNII: 241ATL177A)
TOCOPHEROL (UNII: R0ZB2556P8)
MAGNESIUM CHLORIDE (UNII: 02F3473H9O)
POTASSIUM CHLORIDE (UNII: 660YQ98I10)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)
LIMONENE, (+)- (UNII: GFD7C86Q1W)
LINALOOL, (+/-)- (UNII: D81QY6I88E)
.ALPHA.-AMYLCINNAMALDEHYDE (UNII: WC51CA3418)
.BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)
D&C RED NO. 30 (UNII: 2S42T2808B)
ALUMINUM OXIDE (UNII: LMI26O6933)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FERRIC OXIDE RED (UNII: 1K09F3G675)
MICA (UNII: V8A1AW0880)
D&C RED NO. 27 (UNII: 2LRS185U6K)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
D&C RED NO. 7 (UNII: ECW0LZ41X8)
D&C RED NO. 21 (UNII: 08744Z6JNY)
TALC (UNII: 7SEV7J4R1U)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:13537-971-20	1 in 1 BOX	07/12/2016
1	NDC:13537-971-19	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	07/12/2016

ESIKA PRO HIDRACOLOR 3 IN 1 MOISTURIZING, COLOR AND PERFECTING EFFECT SPF 25 (FRESA HOT) - PINK
octinoxate and zinc oxide lipstick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:13537-972
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	0.075 g in 1 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	0.0392 g in 1 g

Ingredient Name	Strength
Inactive Ingredients
DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW)
TRIDECYL TRIMELLITATE (UNII: FY36J270ES)
ISONONYL ISONONANOATE (UNII: S4V5BS6GCX)
CERESIN (UNII: Q1LS2UJO3A)
WATER (UNII: 059QF0KO0R)
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)
TRIDECYL STEARATE (UNII: A8OE252M6L)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
CARNAUBA WAX (UNII: R12CBM0EIZ)
GLYCERIN (UNII: PDC6A3C0OX)
NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K)
SHEA BUTTER (UNII: K49155WL9Y)
POLYTETRAFLUOROETHYLENE (UNII: E1NC1JVS3O)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
COCONUT OIL (UNII: Q9L0O73W7L)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
CERAMIDE NP (UNII: 4370DF050B)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
CHLORPHENESIN (UNII: I670DAL4SZ)
DIMETHICONE (UNII: 92RU3N3Y1O)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
SOYBEAN OIL (UNII: 241ATL177A)
TOCOPHEROL (UNII: R0ZB2556P8)
MAGNESIUM CHLORIDE (UNII: 02F3473H9O)
POTASSIUM CHLORIDE (UNII: 660YQ98I10)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)
LIMONENE, (+)- (UNII: GFD7C86Q1W)
LINALOOL, (+/-)- (UNII: D81QY6I88E)
.ALPHA.-AMYLCINNAMALDEHYDE (UNII: WC51CA3418)
.BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)
D&C RED NO. 30 (UNII: 2S42T2808B)
ALUMINUM OXIDE (UNII: LMI26O6933)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FERRIC OXIDE RED (UNII: 1K09F3G675)
MICA (UNII: V8A1AW0880)
D&C RED NO. 27 (UNII: 2LRS185U6K)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
D&C RED NO. 7 (UNII: ECW0LZ41X8)
D&C RED NO. 21 (UNII: 08744Z6JNY)
TALC (UNII: 7SEV7J4R1U)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:13537-972-22	1 in 1 BOX	07/12/2016
1	NDC:13537-972-21	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	07/12/2016

ESIKA PRO HIDRACOLOR 3 IN 1 MOISTURIZING, COLOR AND PERFECTING EFFECT SPF 25 (FUCSIA CAUTIVANTE) - PINK
octinoxate and zinc oxide lipstick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:13537-973
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	0.075 g in 1 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	0.0392 g in 1 g

Ingredient Name	Strength
Inactive Ingredients
DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW)
TRIDECYL TRIMELLITATE (UNII: FY36J270ES)
ISONONYL ISONONANOATE (UNII: S4V5BS6GCX)
CERESIN (UNII: Q1LS2UJO3A)
WATER (UNII: 059QF0KO0R)
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)
TRIDECYL STEARATE (UNII: A8OE252M6L)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
CARNAUBA WAX (UNII: R12CBM0EIZ)
GLYCERIN (UNII: PDC6A3C0OX)
NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K)
SHEA BUTTER (UNII: K49155WL9Y)
POLYTETRAFLUOROETHYLENE (UNII: E1NC1JVS3O)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
COCONUT OIL (UNII: Q9L0O73W7L)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
CERAMIDE NP (UNII: 4370DF050B)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
CHLORPHENESIN (UNII: I670DAL4SZ)
DIMETHICONE (UNII: 92RU3N3Y1O)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
SOYBEAN OIL (UNII: 241ATL177A)
TOCOPHEROL (UNII: R0ZB2556P8)
MAGNESIUM CHLORIDE (UNII: 02F3473H9O)
POTASSIUM CHLORIDE (UNII: 660YQ98I10)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)
LIMONENE, (+)- (UNII: GFD7C86Q1W)
LINALOOL, (+/-)- (UNII: D81QY6I88E)
.ALPHA.-AMYLCINNAMALDEHYDE (UNII: WC51CA3418)
.BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)
D&C RED NO. 30 (UNII: 2S42T2808B)
ALUMINUM OXIDE (UNII: LMI26O6933)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FERRIC OXIDE RED (UNII: 1K09F3G675)
MICA (UNII: V8A1AW0880)
D&C RED NO. 27 (UNII: 2LRS185U6K)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
D&C RED NO. 7 (UNII: ECW0LZ41X8)
D&C RED NO. 21 (UNII: 08744Z6JNY)
TALC (UNII: 7SEV7J4R1U)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:13537-973-24	1 in 1 BOX	07/12/2016
1	NDC:13537-973-23	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	07/12/2016

ESIKA PRO HIDRACOLOR 3 IN 1 MOISTURIZING, COLOR AND PERFECTING EFFECT SPF 25 (FUCSIA INTENSE) - PINK
octinoxate and zinc oxide lipstick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:13537-974
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	0.075 g in 1 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	0.0392 g in 1 g

Ingredient Name	Strength
Inactive Ingredients
DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW)
TRIDECYL TRIMELLITATE (UNII: FY36J270ES)
ISONONYL ISONONANOATE (UNII: S4V5BS6GCX)
CERESIN (UNII: Q1LS2UJO3A)
WATER (UNII: 059QF0KO0R)
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)
TRIDECYL STEARATE (UNII: A8OE252M6L)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
CARNAUBA WAX (UNII: R12CBM0EIZ)
GLYCERIN (UNII: PDC6A3C0OX)
NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K)
SHEA BUTTER (UNII: K49155WL9Y)
POLYTETRAFLUOROETHYLENE (UNII: E1NC1JVS3O)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
COCONUT OIL (UNII: Q9L0O73W7L)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
CERAMIDE NP (UNII: 4370DF050B)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
CHLORPHENESIN (UNII: I670DAL4SZ)
DIMETHICONE (UNII: 92RU3N3Y1O)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
SOYBEAN OIL (UNII: 241ATL177A)
TOCOPHEROL (UNII: R0ZB2556P8)
MAGNESIUM CHLORIDE (UNII: 02F3473H9O)
POTASSIUM CHLORIDE (UNII: 660YQ98I10)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)
LIMONENE, (+)- (UNII: GFD7C86Q1W)
LINALOOL, (+/-)- (UNII: D81QY6I88E)
.ALPHA.-AMYLCINNAMALDEHYDE (UNII: WC51CA3418)
.BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)
D&C RED NO. 30 (UNII: 2S42T2808B)
ALUMINUM OXIDE (UNII: LMI26O6933)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FERRIC OXIDE RED (UNII: 1K09F3G675)
MICA (UNII: V8A1AW0880)
D&C RED NO. 27 (UNII: 2LRS185U6K)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
D&C RED NO. 7 (UNII: ECW0LZ41X8)
D&C RED NO. 21 (UNII: 08744Z6JNY)
TALC (UNII: 7SEV7J4R1U)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:13537-974-24	1 in 1 BOX	07/12/2016
1	NDC:13537-974-23	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	07/12/2016

ESIKA PRO HIDRACOLOR 3 IN 1 MOISTURIZING, COLOR AND PERFECTING EFFECT SPF 25 (NARANJA ESFERA) - ORANGE
octinoxate and zinc oxide lipstick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:13537-975
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	0.075 g in 1 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	0.0392 g in 1 g

Ingredient Name	Strength
Inactive Ingredients
DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW)
TRIDECYL TRIMELLITATE (UNII: FY36J270ES)
ISONONYL ISONONANOATE (UNII: S4V5BS6GCX)
CERESIN (UNII: Q1LS2UJO3A)
WATER (UNII: 059QF0KO0R)
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)
TRIDECYL STEARATE (UNII: A8OE252M6L)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
CARNAUBA WAX (UNII: R12CBM0EIZ)
GLYCERIN (UNII: PDC6A3C0OX)
NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K)
SHEA BUTTER (UNII: K49155WL9Y)
POLYTETRAFLUOROETHYLENE (UNII: E1NC1JVS3O)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
COCONUT OIL (UNII: Q9L0O73W7L)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
CERAMIDE NP (UNII: 4370DF050B)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
CHLORPHENESIN (UNII: I670DAL4SZ)
DIMETHICONE (UNII: 92RU3N3Y1O)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
SOYBEAN OIL (UNII: 241ATL177A)
TOCOPHEROL (UNII: R0ZB2556P8)
MAGNESIUM CHLORIDE (UNII: 02F3473H9O)
POTASSIUM CHLORIDE (UNII: 660YQ98I10)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)
LIMONENE, (+)- (UNII: GFD7C86Q1W)
LINALOOL, (+/-)- (UNII: D81QY6I88E)
.ALPHA.-AMYLCINNAMALDEHYDE (UNII: WC51CA3418)
.BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)
D&C RED NO. 30 (UNII: 2S42T2808B)
ALUMINUM OXIDE (UNII: LMI26O6933)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FERRIC OXIDE RED (UNII: 1K09F3G675)
MICA (UNII: V8A1AW0880)
D&C RED NO. 27 (UNII: 2LRS185U6K)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
D&C RED NO. 7 (UNII: ECW0LZ41X8)
D&C RED NO. 21 (UNII: 08744Z6JNY)
TALC (UNII: 7SEV7J4R1U)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:13537-975-24	1 in 1 BOX	07/12/2016
1	NDC:13537-975-23	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	07/12/2016

ESIKA PRO HIDRACOLOR 3 IN 1 MOISTURIZING, COLOR AND PERFECTING EFFECT SPF 25 (ROSA NUDE) - PINK
octinoxate and zinc oxide lipstick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:13537-976
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	0.075 g in 1 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	0.0392 g in 1 g

Ingredient Name	Strength
Inactive Ingredients
DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW)
TRIDECYL TRIMELLITATE (UNII: FY36J270ES)
ISONONYL ISONONANOATE (UNII: S4V5BS6GCX)
CERESIN (UNII: Q1LS2UJO3A)
WATER (UNII: 059QF0KO0R)
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)
TRIDECYL STEARATE (UNII: A8OE252M6L)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
CARNAUBA WAX (UNII: R12CBM0EIZ)
GLYCERIN (UNII: PDC6A3C0OX)
NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K)
SHEA BUTTER (UNII: K49155WL9Y)
POLYTETRAFLUOROETHYLENE (UNII: E1NC1JVS3O)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
COCONUT OIL (UNII: Q9L0O73W7L)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
CERAMIDE NP (UNII: 4370DF050B)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
CHLORPHENESIN (UNII: I670DAL4SZ)
DIMETHICONE (UNII: 92RU3N3Y1O)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
SOYBEAN OIL (UNII: 241ATL177A)
TOCOPHEROL (UNII: R0ZB2556P8)
MAGNESIUM CHLORIDE (UNII: 02F3473H9O)
POTASSIUM CHLORIDE (UNII: 660YQ98I10)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)
LIMONENE, (+)- (UNII: GFD7C86Q1W)
LINALOOL, (+/-)- (UNII: D81QY6I88E)
.ALPHA.-AMYLCINNAMALDEHYDE (UNII: WC51CA3418)
.BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)
D&C RED NO. 30 (UNII: 2S42T2808B)
ALUMINUM OXIDE (UNII: LMI26O6933)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FERRIC OXIDE RED (UNII: 1K09F3G675)
MICA (UNII: V8A1AW0880)
D&C RED NO. 27 (UNII: 2LRS185U6K)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
D&C RED NO. 7 (UNII: ECW0LZ41X8)
D&C RED NO. 21 (UNII: 08744Z6JNY)
TALC (UNII: 7SEV7J4R1U)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:13537-976-24	1 in 1 BOX	07/12/2016
1	NDC:13537-976-23	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	07/12/2016

ESIKA PRO HIDRACOLOR 3 IN 1 MOISTURIZING, COLOR AND PERFECTING EFFECT SPF 25 (PEACH NUDE) - BROWN
octinoxate and zinc oxide lipstick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:13537-977
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	0.075 g in 1 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	0.0392 g in 1 g

Ingredient Name	Strength
Inactive Ingredients
DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW)
TRIDECYL TRIMELLITATE (UNII: FY36J270ES)
ISONONYL ISONONANOATE (UNII: S4V5BS6GCX)
CERESIN (UNII: Q1LS2UJO3A)
WATER (UNII: 059QF0KO0R)
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)
TRIDECYL STEARATE (UNII: A8OE252M6L)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
CARNAUBA WAX (UNII: R12CBM0EIZ)
GLYCERIN (UNII: PDC6A3C0OX)
NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K)
SHEA BUTTER (UNII: K49155WL9Y)
POLYTETRAFLUOROETHYLENE (UNII: E1NC1JVS3O)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
COCONUT OIL (UNII: Q9L0O73W7L)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
CERAMIDE NP (UNII: 4370DF050B)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
CHLORPHENESIN (UNII: I670DAL4SZ)
DIMETHICONE (UNII: 92RU3N3Y1O)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
SOYBEAN OIL (UNII: 241ATL177A)
TOCOPHEROL (UNII: R0ZB2556P8)
MAGNESIUM CHLORIDE (UNII: 02F3473H9O)
POTASSIUM CHLORIDE (UNII: 660YQ98I10)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)
LIMONENE, (+)- (UNII: GFD7C86Q1W)
LINALOOL, (+/-)- (UNII: D81QY6I88E)
.ALPHA.-AMYLCINNAMALDEHYDE (UNII: WC51CA3418)
.BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)
D&C RED NO. 30 (UNII: 2S42T2808B)
ALUMINUM OXIDE (UNII: LMI26O6933)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FERRIC OXIDE RED (UNII: 1K09F3G675)
MICA (UNII: V8A1AW0880)
D&C RED NO. 27 (UNII: 2LRS185U6K)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
D&C RED NO. 7 (UNII: ECW0LZ41X8)
D&C RED NO. 21 (UNII: 08744Z6JNY)
TALC (UNII: 7SEV7J4R1U)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:13537-977-24	1 in 1 BOX	07/12/2016
1	NDC:13537-977-23	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	07/12/2016

ESIKA PRO HIDRACOLOR 3 IN 1 MOISTURIZING, COLOR AND PERFECTING EFFECT SPF 25 (CORAL CHIC) - PINK
octinoxate and zinc oxide lipstick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:13537-978
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	0.075 g in 1 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	0.0392 g in 1 g

Ingredient Name	Strength
Inactive Ingredients
DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW)
TRIDECYL TRIMELLITATE (UNII: FY36J270ES)
ISONONYL ISONONANOATE (UNII: S4V5BS6GCX)
CERESIN (UNII: Q1LS2UJO3A)
WATER (UNII: 059QF0KO0R)
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)
TRIDECYL STEARATE (UNII: A8OE252M6L)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
CARNAUBA WAX (UNII: R12CBM0EIZ)
GLYCERIN (UNII: PDC6A3C0OX)
NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K)
SHEA BUTTER (UNII: K49155WL9Y)
POLYTETRAFLUOROETHYLENE (UNII: E1NC1JVS3O)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
COCONUT OIL (UNII: Q9L0O73W7L)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
CERAMIDE NP (UNII: 4370DF050B)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
CHLORPHENESIN (UNII: I670DAL4SZ)
DIMETHICONE (UNII: 92RU3N3Y1O)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
SOYBEAN OIL (UNII: 241ATL177A)
TOCOPHEROL (UNII: R0ZB2556P8)
MAGNESIUM CHLORIDE (UNII: 02F3473H9O)
POTASSIUM CHLORIDE (UNII: 660YQ98I10)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)
LIMONENE, (+)- (UNII: GFD7C86Q1W)
LINALOOL, (+/-)- (UNII: D81QY6I88E)
.ALPHA.-AMYLCINNAMALDEHYDE (UNII: WC51CA3418)
.BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)
D&C RED NO. 30 (UNII: 2S42T2808B)
ALUMINUM OXIDE (UNII: LMI26O6933)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FERRIC OXIDE RED (UNII: 1K09F3G675)
MICA (UNII: V8A1AW0880)
D&C RED NO. 27 (UNII: 2LRS185U6K)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
D&C RED NO. 7 (UNII: ECW0LZ41X8)
D&C RED NO. 21 (UNII: 08744Z6JNY)
TALC (UNII: 7SEV7J4R1U)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:13537-978-24	1 in 1 BOX	07/12/2016
1	NDC:13537-978-23	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	07/12/2016

ESIKA PRO HIDRACOLOR 3 IN 1 MOISTURIZING, COLOR AND PERFECTING EFFECT SPF 25 (ROJO TROPICAL) - RED
octinoxate and zinc oxide lipstick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:13537-979
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	0.075 g in 1 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	0.0392 g in 1 g

Ingredient Name	Strength
Inactive Ingredients
DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW)
TRIDECYL TRIMELLITATE (UNII: FY36J270ES)
ISONONYL ISONONANOATE (UNII: S4V5BS6GCX)
CERESIN (UNII: Q1LS2UJO3A)
WATER (UNII: 059QF0KO0R)
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)
TRIDECYL STEARATE (UNII: A8OE252M6L)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
CARNAUBA WAX (UNII: R12CBM0EIZ)
GLYCERIN (UNII: PDC6A3C0OX)
NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K)
SHEA BUTTER (UNII: K49155WL9Y)
POLYTETRAFLUOROETHYLENE (UNII: E1NC1JVS3O)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
COCONUT OIL (UNII: Q9L0O73W7L)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
CERAMIDE NP (UNII: 4370DF050B)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
CHLORPHENESIN (UNII: I670DAL4SZ)
DIMETHICONE (UNII: 92RU3N3Y1O)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
SOYBEAN OIL (UNII: 241ATL177A)
TOCOPHEROL (UNII: R0ZB2556P8)
MAGNESIUM CHLORIDE (UNII: 02F3473H9O)
POTASSIUM CHLORIDE (UNII: 660YQ98I10)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)
LIMONENE, (+)- (UNII: GFD7C86Q1W)
LINALOOL, (+/-)- (UNII: D81QY6I88E)
.ALPHA.-AMYLCINNAMALDEHYDE (UNII: WC51CA3418)
.BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)
D&C RED NO. 30 (UNII: 2S42T2808B)
ALUMINUM OXIDE (UNII: LMI26O6933)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FERRIC OXIDE RED (UNII: 1K09F3G675)
MICA (UNII: V8A1AW0880)
D&C RED NO. 27 (UNII: 2LRS185U6K)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
D&C RED NO. 7 (UNII: ECW0LZ41X8)
D&C RED NO. 21 (UNII: 08744Z6JNY)
TALC (UNII: 7SEV7J4R1U)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:13537-979-24	1 in 1 BOX	07/12/2016
1	NDC:13537-979-23	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	07/12/2016

ESIKA PRO HIDRACOLOR 3 IN 1 MOISTURIZING, COLOR AND PERFECTING EFFECT SPF 25 (NARANJA CITRICO) - ORANGE
octinoxate and zinc oxide lipstick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:13537-980
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	0.075 g in 1 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	0.0392 g in 1 g

Ingredient Name	Strength
Inactive Ingredients
DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW)
TRIDECYL TRIMELLITATE (UNII: FY36J270ES)
ISONONYL ISONONANOATE (UNII: S4V5BS6GCX)
CERESIN (UNII: Q1LS2UJO3A)
WATER (UNII: 059QF0KO0R)
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)
TRIDECYL STEARATE (UNII: A8OE252M6L)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
CARNAUBA WAX (UNII: R12CBM0EIZ)
GLYCERIN (UNII: PDC6A3C0OX)
NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K)
SHEA BUTTER (UNII: K49155WL9Y)
POLYTETRAFLUOROETHYLENE (UNII: E1NC1JVS3O)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
COCONUT OIL (UNII: Q9L0O73W7L)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
CERAMIDE NP (UNII: 4370DF050B)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
CHLORPHENESIN (UNII: I670DAL4SZ)
DIMETHICONE (UNII: 92RU3N3Y1O)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
SOYBEAN OIL (UNII: 241ATL177A)
TOCOPHEROL (UNII: R0ZB2556P8)
MAGNESIUM CHLORIDE (UNII: 02F3473H9O)
POTASSIUM CHLORIDE (UNII: 660YQ98I10)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)
LIMONENE, (+)- (UNII: GFD7C86Q1W)
LINALOOL, (+/-)- (UNII: D81QY6I88E)
.ALPHA.-AMYLCINNAMALDEHYDE (UNII: WC51CA3418)
.BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)
D&C RED NO. 30 (UNII: 2S42T2808B)
ALUMINUM OXIDE (UNII: LMI26O6933)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FERRIC OXIDE RED (UNII: 1K09F3G675)
MICA (UNII: V8A1AW0880)
D&C RED NO. 27 (UNII: 2LRS185U6K)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
D&C RED NO. 7 (UNII: ECW0LZ41X8)
D&C RED NO. 21 (UNII: 08744Z6JNY)
TALC (UNII: 7SEV7J4R1U)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:13537-980-24	1 in 1 BOX	07/12/2016
1	NDC:13537-980-23	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	07/12/2016

ESIKA PRO HIDRACOLOR 3 IN 1 MOISTURIZING, COLOR AND PERFECTING EFFECT SPF 25 (NUDE PUNCH) - ORANGE
octinoxate and zinc oxide lipstick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:13537-981
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	0.075 g in 1 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	0.0392 g in 1 g

Ingredient Name	Strength
Inactive Ingredients
DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW)
TRIDECYL TRIMELLITATE (UNII: FY36J270ES)
ISONONYL ISONONANOATE (UNII: S4V5BS6GCX)
CERESIN (UNII: Q1LS2UJO3A)
WATER (UNII: 059QF0KO0R)
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)
TRIDECYL STEARATE (UNII: A8OE252M6L)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
CARNAUBA WAX (UNII: R12CBM0EIZ)
GLYCERIN (UNII: PDC6A3C0OX)
NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K)
SHEA BUTTER (UNII: K49155WL9Y)
POLYTETRAFLUOROETHYLENE (UNII: E1NC1JVS3O)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
COCONUT OIL (UNII: Q9L0O73W7L)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
CERAMIDE NP (UNII: 4370DF050B)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
CHLORPHENESIN (UNII: I670DAL4SZ)
DIMETHICONE (UNII: 92RU3N3Y1O)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
SOYBEAN OIL (UNII: 241ATL177A)
TOCOPHEROL (UNII: R0ZB2556P8)
MAGNESIUM CHLORIDE (UNII: 02F3473H9O)
POTASSIUM CHLORIDE (UNII: 660YQ98I10)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)
LIMONENE, (+)- (UNII: GFD7C86Q1W)
LINALOOL, (+/-)- (UNII: D81QY6I88E)
.ALPHA.-AMYLCINNAMALDEHYDE (UNII: WC51CA3418)
.BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)
D&C RED NO. 30 (UNII: 2S42T2808B)
ALUMINUM OXIDE (UNII: LMI26O6933)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FERRIC OXIDE RED (UNII: 1K09F3G675)
MICA (UNII: V8A1AW0880)
D&C RED NO. 27 (UNII: 2LRS185U6K)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
D&C RED NO. 7 (UNII: ECW0LZ41X8)
D&C RED NO. 21 (UNII: 08744Z6JNY)
TALC (UNII: 7SEV7J4R1U)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:13537-981-24	1 in 1 BOX	07/12/2016
1	NDC:13537-981-23	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	07/12/2016

ESIKA PRO HIDRACOLOR 3 IN 1 MOISTURIZING, COLOR AND PERFECTING EFFECT SPF 25 (MORA ATREVIDA) - PURPLE
octinoxate and zinc oxide lipstick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:13537-982
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	0.075 g in 1 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	0.0392 g in 1 g

Ingredient Name	Strength
Inactive Ingredients
DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW)
TRIDECYL TRIMELLITATE (UNII: FY36J270ES)
ISONONYL ISONONANOATE (UNII: S4V5BS6GCX)
CERESIN (UNII: Q1LS2UJO3A)
WATER (UNII: 059QF0KO0R)
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)
TRIDECYL STEARATE (UNII: A8OE252M6L)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
CARNAUBA WAX (UNII: R12CBM0EIZ)
GLYCERIN (UNII: PDC6A3C0OX)
NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K)
SHEA BUTTER (UNII: K49155WL9Y)
POLYTETRAFLUOROETHYLENE (UNII: E1NC1JVS3O)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
COCONUT OIL (UNII: Q9L0O73W7L)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
CERAMIDE NP (UNII: 4370DF050B)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
CHLORPHENESIN (UNII: I670DAL4SZ)
DIMETHICONE (UNII: 92RU3N3Y1O)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
SOYBEAN OIL (UNII: 241ATL177A)
TOCOPHEROL (UNII: R0ZB2556P8)
MAGNESIUM CHLORIDE (UNII: 02F3473H9O)
POTASSIUM CHLORIDE (UNII: 660YQ98I10)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)
LIMONENE, (+)- (UNII: GFD7C86Q1W)
LINALOOL, (+/-)- (UNII: D81QY6I88E)
.ALPHA.-AMYLCINNAMALDEHYDE (UNII: WC51CA3418)
.BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)
D&C RED NO. 30 (UNII: 2S42T2808B)
ALUMINUM OXIDE (UNII: LMI26O6933)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FERRIC OXIDE RED (UNII: 1K09F3G675)
MICA (UNII: V8A1AW0880)
D&C RED NO. 27 (UNII: 2LRS185U6K)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
D&C RED NO. 7 (UNII: ECW0LZ41X8)
D&C RED NO. 21 (UNII: 08744Z6JNY)
TALC (UNII: 7SEV7J4R1U)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:13537-982-24	1 in 1 BOX	07/12/2016
1	NDC:13537-982-23	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	07/12/2016

ESIKA PRO HIDRACOLOR 3 IN 1 MOISTURIZING, COLOR AND PERFECTING EFFECT SPF 25 (NUDE SAVANNA) - ORANGE
octinoxate and zinc oxide lipstick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:13537-983
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	0.075 g in 1 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	0.0392 g in 1 g

Ingredient Name	Strength
Inactive Ingredients
DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW)
TRIDECYL TRIMELLITATE (UNII: FY36J270ES)
ISONONYL ISONONANOATE (UNII: S4V5BS6GCX)
CERESIN (UNII: Q1LS2UJO3A)
WATER (UNII: 059QF0KO0R)
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)
TRIDECYL STEARATE (UNII: A8OE252M6L)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
CARNAUBA WAX (UNII: R12CBM0EIZ)
GLYCERIN (UNII: PDC6A3C0OX)
NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K)
SHEA BUTTER (UNII: K49155WL9Y)
POLYTETRAFLUOROETHYLENE (UNII: E1NC1JVS3O)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
COCONUT OIL (UNII: Q9L0O73W7L)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
CERAMIDE NP (UNII: 4370DF050B)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
CHLORPHENESIN (UNII: I670DAL4SZ)
DIMETHICONE (UNII: 92RU3N3Y1O)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
SOYBEAN OIL (UNII: 241ATL177A)
TOCOPHEROL (UNII: R0ZB2556P8)
MAGNESIUM CHLORIDE (UNII: 02F3473H9O)
POTASSIUM CHLORIDE (UNII: 660YQ98I10)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)
LIMONENE, (+)- (UNII: GFD7C86Q1W)
LINALOOL, (+/-)- (UNII: D81QY6I88E)
.ALPHA.-AMYLCINNAMALDEHYDE (UNII: WC51CA3418)
.BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)
D&C RED NO. 30 (UNII: 2S42T2808B)
ALUMINUM OXIDE (UNII: LMI26O6933)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FERRIC OXIDE RED (UNII: 1K09F3G675)
MICA (UNII: V8A1AW0880)
D&C RED NO. 27 (UNII: 2LRS185U6K)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
D&C RED NO. 7 (UNII: ECW0LZ41X8)
D&C RED NO. 21 (UNII: 08744Z6JNY)
TALC (UNII: 7SEV7J4R1U)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:13537-983-24	1 in 1 BOX	07/12/2016
1	NDC:13537-983-23	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	07/12/2016

ESIKA PRO HIDRACOLOR 3 IN 1 MOISTURIZING, COLOR AND PERFECTING EFFECT SPF 25 (ROJO SENSUAL) - RED
octinoxate and zinc oxide lipstick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:13537-984
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	0.075 g in 1 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	0.0392 g in 1 g

Ingredient Name	Strength
Inactive Ingredients
DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW)
TRIDECYL TRIMELLITATE (UNII: FY36J270ES)
ISONONYL ISONONANOATE (UNII: S4V5BS6GCX)
CERESIN (UNII: Q1LS2UJO3A)
WATER (UNII: 059QF0KO0R)
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)
TRIDECYL STEARATE (UNII: A8OE252M6L)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
CARNAUBA WAX (UNII: R12CBM0EIZ)
GLYCERIN (UNII: PDC6A3C0OX)
NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K)
SHEA BUTTER (UNII: K49155WL9Y)
POLYTETRAFLUOROETHYLENE (UNII: E1NC1JVS3O)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
COCONUT OIL (UNII: Q9L0O73W7L)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
CERAMIDE NP (UNII: 4370DF050B)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
CHLORPHENESIN (UNII: I670DAL4SZ)
DIMETHICONE (UNII: 92RU3N3Y1O)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
SOYBEAN OIL (UNII: 241ATL177A)
TOCOPHEROL (UNII: R0ZB2556P8)
MAGNESIUM CHLORIDE (UNII: 02F3473H9O)
POTASSIUM CHLORIDE (UNII: 660YQ98I10)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)
LIMONENE, (+)- (UNII: GFD7C86Q1W)
LINALOOL, (+/-)- (UNII: D81QY6I88E)
.ALPHA.-AMYLCINNAMALDEHYDE (UNII: WC51CA3418)
.BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)
D&C RED NO. 30 (UNII: 2S42T2808B)
ALUMINUM OXIDE (UNII: LMI26O6933)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FERRIC OXIDE RED (UNII: 1K09F3G675)
MICA (UNII: V8A1AW0880)
D&C RED NO. 27 (UNII: 2LRS185U6K)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
D&C RED NO. 7 (UNII: ECW0LZ41X8)
D&C RED NO. 21 (UNII: 08744Z6JNY)
TALC (UNII: 7SEV7J4R1U)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:13537-984-24	1 in 1 BOX	07/12/2016
1	NDC:13537-984-23	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	07/12/2016

ESIKA PRO HIDRACOLOR 3 IN 1 MOISTURIZING, COLOR AND PERFECTING EFFECT SPF 25 (NUDE MOCCHA) - ORANGE
octinoxate and zinc oxide lipstick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:13537-985
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	0.075 g in 1 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	0.0392 g in 1 g

Ingredient Name	Strength
Inactive Ingredients
DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW)
TRIDECYL TRIMELLITATE (UNII: FY36J270ES)
ISONONYL ISONONANOATE (UNII: S4V5BS6GCX)
CERESIN (UNII: Q1LS2UJO3A)
WATER (UNII: 059QF0KO0R)
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)
TRIDECYL STEARATE (UNII: A8OE252M6L)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
CARNAUBA WAX (UNII: R12CBM0EIZ)
GLYCERIN (UNII: PDC6A3C0OX)
NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K)
SHEA BUTTER (UNII: K49155WL9Y)
POLYTETRAFLUOROETHYLENE (UNII: E1NC1JVS3O)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
COCONUT OIL (UNII: Q9L0O73W7L)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
CERAMIDE NP (UNII: 4370DF050B)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
CHLORPHENESIN (UNII: I670DAL4SZ)
DIMETHICONE (UNII: 92RU3N3Y1O)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
SOYBEAN OIL (UNII: 241ATL177A)
TOCOPHEROL (UNII: R0ZB2556P8)
MAGNESIUM CHLORIDE (UNII: 02F3473H9O)
POTASSIUM CHLORIDE (UNII: 660YQ98I10)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)
LIMONENE, (+)- (UNII: GFD7C86Q1W)
LINALOOL, (+/-)- (UNII: D81QY6I88E)
.ALPHA.-AMYLCINNAMALDEHYDE (UNII: WC51CA3418)
.BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)
D&C RED NO. 30 (UNII: 2S42T2808B)
ALUMINUM OXIDE (UNII: LMI26O6933)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FERRIC OXIDE RED (UNII: 1K09F3G675)
MICA (UNII: V8A1AW0880)
D&C RED NO. 27 (UNII: 2LRS185U6K)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
D&C RED NO. 7 (UNII: ECW0LZ41X8)
D&C RED NO. 21 (UNII: 08744Z6JNY)
TALC (UNII: 7SEV7J4R1U)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:13537-985-24	1 in 1 BOX	07/12/2016
1	NDC:13537-985-23	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	07/12/2016

ESIKA PRO HIDRACOLOR 3 IN 1 MOISTURIZING, COLOR AND PERFECTING EFFECT SPF 25 (BRONCE METALLIC) - BROWN
octinoxate and zinc oxide lipstick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:13537-986
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	0.075 g in 1 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	0.0392 g in 1 g

Ingredient Name	Strength
Inactive Ingredients
DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW)
TRIDECYL TRIMELLITATE (UNII: FY36J270ES)
ISONONYL ISONONANOATE (UNII: S4V5BS6GCX)
CERESIN (UNII: Q1LS2UJO3A)
WATER (UNII: 059QF0KO0R)
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)
TRIDECYL STEARATE (UNII: A8OE252M6L)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
CARNAUBA WAX (UNII: R12CBM0EIZ)
GLYCERIN (UNII: PDC6A3C0OX)
NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K)
SHEA BUTTER (UNII: K49155WL9Y)
POLYTETRAFLUOROETHYLENE (UNII: E1NC1JVS3O)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
COCONUT OIL (UNII: Q9L0O73W7L)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
CERAMIDE NP (UNII: 4370DF050B)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
CHLORPHENESIN (UNII: I670DAL4SZ)
DIMETHICONE (UNII: 92RU3N3Y1O)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
SOYBEAN OIL (UNII: 241ATL177A)
TOCOPHEROL (UNII: R0ZB2556P8)
MAGNESIUM CHLORIDE (UNII: 02F3473H9O)
POTASSIUM CHLORIDE (UNII: 660YQ98I10)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)
LIMONENE, (+)- (UNII: GFD7C86Q1W)
LINALOOL, (+/-)- (UNII: D81QY6I88E)
.ALPHA.-AMYLCINNAMALDEHYDE (UNII: WC51CA3418)
.BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)
D&C RED NO. 30 (UNII: 2S42T2808B)
ALUMINUM OXIDE (UNII: LMI26O6933)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FERRIC OXIDE RED (UNII: 1K09F3G675)
MICA (UNII: V8A1AW0880)
D&C RED NO. 27 (UNII: 2LRS185U6K)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
D&C RED NO. 7 (UNII: ECW0LZ41X8)
D&C RED NO. 21 (UNII: 08744Z6JNY)
TALC (UNII: 7SEV7J4R1U)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:13537-986-24	1 in 1 BOX	07/12/2016
1	NDC:13537-986-23	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	07/12/2016

ESIKA PRO HIDRACOLOR 3 IN 1 MOISTURIZING, COLOR AND PERFECTING EFFECT SPF 25
octinoxate and zinc oxide kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:13537-987

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:13537-987-28	3 in 1 BOX	07/12/2016
1	NDC:13537-987-27	1 in 1 TUBE

Part #	Package Quantity	Total Product Quantity
Quantity of Parts
Part 1	1 TUBE	8 g
Part 2	1 TUBE	8 g
Part 3	1 TUBE	8 g
Part 4	1 TUBE	8 g
Part 5	1 TUBE	8 g
Part 6	1 TUBE	8 g
Part 7	1 TUBE	8 g
Part 8	1 TUBE	8 g
Part 9	1 TUBE	8 g
Part 10	1 TUBE	8 g
Part 11	1 TUBE	8 g
Part 12	1 TUBE	8 g
Part 13	1 TUBE	8 g
Part 14	1 TUBE	8 g
Part 15	1 TUBE	8 g
Part 16	1 TUBE	8 g
Part 17	1 TUBE	8 g
Part 18	1 TUBE	8 g
Part 19	1 TUBE	8 g
Part 20	1 TUBE	8 g
Part 21	1 TUBE	8 g
Part 22	1 TUBE	8 g
Part 23	1 TUBE	8 g
Part 24	1 TUBE	8 g

Part 1 of 24

ESIKA PRO HIDRACOLOR 3 IN 1 MOISTURIZING, COLOR AND PERFECTING EFFECT SPF 25 (PIMIENTA CALIENTE) - BROWN
octinoxate and zinc oxide lipstick

Product Information
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	0.075 g in 1 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	0.0392 g in 1 g

Ingredient Name	Strength
Inactive Ingredients
DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW)
TRIDECYL TRIMELLITATE (UNII: FY36J270ES)
ISONONYL ISONONANOATE (UNII: S4V5BS6GCX)
CERESIN (UNII: Q1LS2UJO3A)
WATER (UNII: 059QF0KO0R)
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)
TRIDECYL STEARATE (UNII: A8OE252M6L)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
CARNAUBA WAX (UNII: R12CBM0EIZ)
GLYCERIN (UNII: PDC6A3C0OX)
NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K)
SHEA BUTTER (UNII: K49155WL9Y)
POLYTETRAFLUOROETHYLENE (UNII: E1NC1JVS3O)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
COCONUT OIL (UNII: Q9L0O73W7L)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
CERAMIDE NP (UNII: 4370DF050B)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
CHLORPHENESIN (UNII: I670DAL4SZ)
DIMETHICONE (UNII: 92RU3N3Y1O)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
SOYBEAN OIL (UNII: 241ATL177A)
TOCOPHEROL (UNII: R0ZB2556P8)
MAGNESIUM CHLORIDE (UNII: 02F3473H9O)
POTASSIUM CHLORIDE (UNII: 660YQ98I10)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)
LIMONENE, (+)- (UNII: GFD7C86Q1W)
LINALOOL, (+/-)- (UNII: D81QY6I88E)
.ALPHA.-AMYLCINNAMALDEHYDE (UNII: WC51CA3418)
.BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)
D&C RED NO. 30 (UNII: 2S42T2808B)
ALUMINUM OXIDE (UNII: LMI26O6933)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FERRIC OXIDE RED (UNII: 1K09F3G675)
MICA (UNII: V8A1AW0880)
D&C RED NO. 27 (UNII: 2LRS185U6K)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
D&C RED NO. 7 (UNII: ECW0LZ41X8)
D&C RED NO. 21 (UNII: 08744Z6JNY)
TALC (UNII: 7SEV7J4R1U)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1		8 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	07/12/2016

Part 2 of 24

ESIKA PRO HIDRACOLOR 3 IN 1 MOISTURIZING, COLOR AND PERFECTING EFFECT SPF 25 (ROJO DESEO) - RED
octinoxate and zinc oxide lipstick

Product Information
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	0.075 g in 1 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	0.0392 g in 1 g

Ingredient Name	Strength
Inactive Ingredients
DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW)
TRIDECYL TRIMELLITATE (UNII: FY36J270ES)
ISONONYL ISONONANOATE (UNII: S4V5BS6GCX)
CERESIN (UNII: Q1LS2UJO3A)
WATER (UNII: 059QF0KO0R)
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)
TRIDECYL STEARATE (UNII: A8OE252M6L)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
CARNAUBA WAX (UNII: R12CBM0EIZ)
GLYCERIN (UNII: PDC6A3C0OX)
NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K)
SHEA BUTTER (UNII: K49155WL9Y)
POLYTETRAFLUOROETHYLENE (UNII: E1NC1JVS3O)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
COCONUT OIL (UNII: Q9L0O73W7L)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
CERAMIDE NP (UNII: 4370DF050B)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
CHLORPHENESIN (UNII: I670DAL4SZ)
DIMETHICONE (UNII: 92RU3N3Y1O)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
SOYBEAN OIL (UNII: 241ATL177A)
TOCOPHEROL (UNII: R0ZB2556P8)
MAGNESIUM CHLORIDE (UNII: 02F3473H9O)
POTASSIUM CHLORIDE (UNII: 660YQ98I10)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)
LIMONENE, (+)- (UNII: GFD7C86Q1W)
LINALOOL, (+/-)- (UNII: D81QY6I88E)
.ALPHA.-AMYLCINNAMALDEHYDE (UNII: WC51CA3418)
.BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)
D&C RED NO. 30 (UNII: 2S42T2808B)
ALUMINUM OXIDE (UNII: LMI26O6933)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FERRIC OXIDE RED (UNII: 1K09F3G675)
MICA (UNII: V8A1AW0880)
D&C RED NO. 27 (UNII: 2LRS185U6K)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
D&C RED NO. 7 (UNII: ECW0LZ41X8)
D&C RED NO. 21 (UNII: 08744Z6JNY)
TALC (UNII: 7SEV7J4R1U)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1		8 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	07/12/2016

Part 3 of 24

ESIKA PRO HIDRACOLOR 3 IN 1 MOISTURIZING, COLOR AND PERFECTING EFFECT SPF 25 (ROJO ESIKA) - RED
octinoxate and zinc oxide lipstick

Product Information
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	0.075 g in 1 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	0.0392 g in 1 g

Ingredient Name	Strength
Inactive Ingredients
DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW)
TRIDECYL TRIMELLITATE (UNII: FY36J270ES)
ISONONYL ISONONANOATE (UNII: S4V5BS6GCX)
CERESIN (UNII: Q1LS2UJO3A)
WATER (UNII: 059QF0KO0R)
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)
TRIDECYL STEARATE (UNII: A8OE252M6L)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
CARNAUBA WAX (UNII: R12CBM0EIZ)
GLYCERIN (UNII: PDC6A3C0OX)
NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K)
SHEA BUTTER (UNII: K49155WL9Y)
POLYTETRAFLUOROETHYLENE (UNII: E1NC1JVS3O)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
COCONUT OIL (UNII: Q9L0O73W7L)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
CERAMIDE NP (UNII: 4370DF050B)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
CHLORPHENESIN (UNII: I670DAL4SZ)
DIMETHICONE (UNII: 92RU3N3Y1O)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
SOYBEAN OIL (UNII: 241ATL177A)
TOCOPHEROL (UNII: R0ZB2556P8)
MAGNESIUM CHLORIDE (UNII: 02F3473H9O)
POTASSIUM CHLORIDE (UNII: 660YQ98I10)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)
LIMONENE, (+)- (UNII: GFD7C86Q1W)
LINALOOL, (+/-)- (UNII: D81QY6I88E)
.ALPHA.-AMYLCINNAMALDEHYDE (UNII: WC51CA3418)
.BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)
D&C RED NO. 30 (UNII: 2S42T2808B)
ALUMINUM OXIDE (UNII: LMI26O6933)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FERRIC OXIDE RED (UNII: 1K09F3G675)
MICA (UNII: V8A1AW0880)
D&C RED NO. 27 (UNII: 2LRS185U6K)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
D&C RED NO. 7 (UNII: ECW0LZ41X8)
D&C RED NO. 21 (UNII: 08744Z6JNY)
TALC (UNII: 7SEV7J4R1U)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1		8 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	07/12/2016

Part 4 of 24

ESIKA PRO HIDRACOLOR 3 IN 1 MOISTURIZING, COLOR AND PERFECTING EFFECT SPF 25 (MARRON TOPACIO) - BROWN
octinoxate and zinc oxide lipstick

Product Information
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	0.075 g in 1 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	0.0392 g in 1 g

Ingredient Name	Strength
Inactive Ingredients
DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW)
TRIDECYL TRIMELLITATE (UNII: FY36J270ES)
ISONONYL ISONONANOATE (UNII: S4V5BS6GCX)
CERESIN (UNII: Q1LS2UJO3A)
WATER (UNII: 059QF0KO0R)
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)
TRIDECYL STEARATE (UNII: A8OE252M6L)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
CARNAUBA WAX (UNII: R12CBM0EIZ)
GLYCERIN (UNII: PDC6A3C0OX)
NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K)
SHEA BUTTER (UNII: K49155WL9Y)
POLYTETRAFLUOROETHYLENE (UNII: E1NC1JVS3O)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
COCONUT OIL (UNII: Q9L0O73W7L)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
CERAMIDE NP (UNII: 4370DF050B)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
CHLORPHENESIN (UNII: I670DAL4SZ)
DIMETHICONE (UNII: 92RU3N3Y1O)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
SOYBEAN OIL (UNII: 241ATL177A)
TOCOPHEROL (UNII: R0ZB2556P8)
MAGNESIUM CHLORIDE (UNII: 02F3473H9O)
POTASSIUM CHLORIDE (UNII: 660YQ98I10)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)
LIMONENE, (+)- (UNII: GFD7C86Q1W)
LINALOOL, (+/-)- (UNII: D81QY6I88E)
.ALPHA.-AMYLCINNAMALDEHYDE (UNII: WC51CA3418)
.BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)
D&C RED NO. 30 (UNII: 2S42T2808B)
ALUMINUM OXIDE (UNII: LMI26O6933)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FERRIC OXIDE RED (UNII: 1K09F3G675)
MICA (UNII: V8A1AW0880)
D&C RED NO. 27 (UNII: 2LRS185U6K)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
D&C RED NO. 7 (UNII: ECW0LZ41X8)
D&C RED NO. 21 (UNII: 08744Z6JNY)
TALC (UNII: 7SEV7J4R1U)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1		8 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	07/12/2016

Part 5 of 24

ESIKA PRO HIDRACOLOR 3 IN 1 MOISTURIZING, COLOR AND PERFECTING EFFECT SPF 25 (ROSA GEOMETRIC) - PINK
octinoxate and zinc oxide lipstick

Product Information
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	0.075 g in 1 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	0.0392 g in 1 g

Ingredient Name	Strength
Inactive Ingredients
DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW)
TRIDECYL TRIMELLITATE (UNII: FY36J270ES)
ISONONYL ISONONANOATE (UNII: S4V5BS6GCX)
CERESIN (UNII: Q1LS2UJO3A)
WATER (UNII: 059QF0KO0R)
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)
TRIDECYL STEARATE (UNII: A8OE252M6L)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
CARNAUBA WAX (UNII: R12CBM0EIZ)
GLYCERIN (UNII: PDC6A3C0OX)
NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K)
SHEA BUTTER (UNII: K49155WL9Y)
POLYTETRAFLUOROETHYLENE (UNII: E1NC1JVS3O)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
COCONUT OIL (UNII: Q9L0O73W7L)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
CERAMIDE NP (UNII: 4370DF050B)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
CHLORPHENESIN (UNII: I670DAL4SZ)
DIMETHICONE (UNII: 92RU3N3Y1O)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
SOYBEAN OIL (UNII: 241ATL177A)
TOCOPHEROL (UNII: R0ZB2556P8)
MAGNESIUM CHLORIDE (UNII: 02F3473H9O)
POTASSIUM CHLORIDE (UNII: 660YQ98I10)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)
LIMONENE, (+)- (UNII: GFD7C86Q1W)
LINALOOL, (+/-)- (UNII: D81QY6I88E)
.ALPHA.-AMYLCINNAMALDEHYDE (UNII: WC51CA3418)
.BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)
D&C RED NO. 30 (UNII: 2S42T2808B)
ALUMINUM OXIDE (UNII: LMI26O6933)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FERRIC OXIDE RED (UNII: 1K09F3G675)
MICA (UNII: V8A1AW0880)
D&C RED NO. 27 (UNII: 2LRS185U6K)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
D&C RED NO. 7 (UNII: ECW0LZ41X8)
D&C RED NO. 21 (UNII: 08744Z6JNY)
TALC (UNII: 7SEV7J4R1U)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1		8 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	07/12/2016

Part 6 of 24

ESIKA PRO HIDRACOLOR 3 IN 1 MOISTURIZING, COLOR AND PERFECTING EFFECT SPF 25 (ROSA ENCANTO) - PINK
octinoxate and zinc oxide lipstick

Product Information
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	0.075 g in 1 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	0.0392 g in 1 g

Ingredient Name	Strength
Inactive Ingredients
DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW)
TRIDECYL TRIMELLITATE (UNII: FY36J270ES)
ISONONYL ISONONANOATE (UNII: S4V5BS6GCX)
CERESIN (UNII: Q1LS2UJO3A)
WATER (UNII: 059QF0KO0R)
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)
TRIDECYL STEARATE (UNII: A8OE252M6L)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
CARNAUBA WAX (UNII: R12CBM0EIZ)
GLYCERIN (UNII: PDC6A3C0OX)
NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K)
SHEA BUTTER (UNII: K49155WL9Y)
POLYTETRAFLUOROETHYLENE (UNII: E1NC1JVS3O)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
COCONUT OIL (UNII: Q9L0O73W7L)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
CERAMIDE NP (UNII: 4370DF050B)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
CHLORPHENESIN (UNII: I670DAL4SZ)
DIMETHICONE (UNII: 92RU3N3Y1O)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
SOYBEAN OIL (UNII: 241ATL177A)
TOCOPHEROL (UNII: R0ZB2556P8)
MAGNESIUM CHLORIDE (UNII: 02F3473H9O)
POTASSIUM CHLORIDE (UNII: 660YQ98I10)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)
LIMONENE, (+)- (UNII: GFD7C86Q1W)
LINALOOL, (+/-)- (UNII: D81QY6I88E)
.ALPHA.-AMYLCINNAMALDEHYDE (UNII: WC51CA3418)
.BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)
D&C RED NO. 30 (UNII: 2S42T2808B)
ALUMINUM OXIDE (UNII: LMI26O6933)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FERRIC OXIDE RED (UNII: 1K09F3G675)
MICA (UNII: V8A1AW0880)
D&C RED NO. 27 (UNII: 2LRS185U6K)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
D&C RED NO. 7 (UNII: ECW0LZ41X8)
D&C RED NO. 21 (UNII: 08744Z6JNY)
TALC (UNII: 7SEV7J4R1U)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1		8 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	07/12/2016

Part 7 of 24

ESIKA PRO HIDRACOLOR 3 IN 1 MOISTURIZING, COLOR AND PERFECTING EFFECT SPF 25 (MORA GLAM) - PURPLE
octinoxate and zinc oxide lipstick

Product Information
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	0.075 g in 1 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	0.0392 g in 1 g

Ingredient Name	Strength
Inactive Ingredients
DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW)
TRIDECYL TRIMELLITATE (UNII: FY36J270ES)
ISONONYL ISONONANOATE (UNII: S4V5BS6GCX)
CERESIN (UNII: Q1LS2UJO3A)
WATER (UNII: 059QF0KO0R)
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)
TRIDECYL STEARATE (UNII: A8OE252M6L)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
CARNAUBA WAX (UNII: R12CBM0EIZ)
GLYCERIN (UNII: PDC6A3C0OX)
NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K)
SHEA BUTTER (UNII: K49155WL9Y)
POLYTETRAFLUOROETHYLENE (UNII: E1NC1JVS3O)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
COCONUT OIL (UNII: Q9L0O73W7L)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
CERAMIDE NP (UNII: 4370DF050B)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
CHLORPHENESIN (UNII: I670DAL4SZ)
DIMETHICONE (UNII: 92RU3N3Y1O)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
SOYBEAN OIL (UNII: 241ATL177A)
TOCOPHEROL (UNII: R0ZB2556P8)
MAGNESIUM CHLORIDE (UNII: 02F3473H9O)
POTASSIUM CHLORIDE (UNII: 660YQ98I10)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)
LIMONENE, (+)- (UNII: GFD7C86Q1W)
LINALOOL, (+/-)- (UNII: D81QY6I88E)
.ALPHA.-AMYLCINNAMALDEHYDE (UNII: WC51CA3418)
.BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)
D&C RED NO. 30 (UNII: 2S42T2808B)
ALUMINUM OXIDE (UNII: LMI26O6933)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FERRIC OXIDE RED (UNII: 1K09F3G675)
MICA (UNII: V8A1AW0880)
D&C RED NO. 27 (UNII: 2LRS185U6K)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
D&C RED NO. 7 (UNII: ECW0LZ41X8)
D&C RED NO. 21 (UNII: 08744Z6JNY)
TALC (UNII: 7SEV7J4R1U)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1		8 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	07/12/2016

Part 8 of 24

ESIKA PRO HIDRACOLOR 3 IN 1 MOISTURIZING, COLOR AND PERFECTING EFFECT SPF 25 (GRANATE SEDUCTOR) - PURPLE
octinoxate and zinc oxide lipstick

Product Information
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	0.075 g in 1 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	0.0392 g in 1 g

Ingredient Name	Strength
Inactive Ingredients
DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW)
TRIDECYL TRIMELLITATE (UNII: FY36J270ES)
ISONONYL ISONONANOATE (UNII: S4V5BS6GCX)
CERESIN (UNII: Q1LS2UJO3A)
WATER (UNII: 059QF0KO0R)
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)
TRIDECYL STEARATE (UNII: A8OE252M6L)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
CARNAUBA WAX (UNII: R12CBM0EIZ)
GLYCERIN (UNII: PDC6A3C0OX)
NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K)
SHEA BUTTER (UNII: K49155WL9Y)
POLYTETRAFLUOROETHYLENE (UNII: E1NC1JVS3O)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
COCONUT OIL (UNII: Q9L0O73W7L)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
CERAMIDE NP (UNII: 4370DF050B)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
CHLORPHENESIN (UNII: I670DAL4SZ)
DIMETHICONE (UNII: 92RU3N3Y1O)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
SOYBEAN OIL (UNII: 241ATL177A)
TOCOPHEROL (UNII: R0ZB2556P8)
MAGNESIUM CHLORIDE (UNII: 02F3473H9O)
POTASSIUM CHLORIDE (UNII: 660YQ98I10)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)
LIMONENE, (+)- (UNII: GFD7C86Q1W)
LINALOOL, (+/-)- (UNII: D81QY6I88E)
.ALPHA.-AMYLCINNAMALDEHYDE (UNII: WC51CA3418)
.BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)
D&C RED NO. 30 (UNII: 2S42T2808B)
ALUMINUM OXIDE (UNII: LMI26O6933)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FERRIC OXIDE RED (UNII: 1K09F3G675)
MICA (UNII: V8A1AW0880)
D&C RED NO. 27 (UNII: 2LRS185U6K)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
D&C RED NO. 7 (UNII: ECW0LZ41X8)
D&C RED NO. 21 (UNII: 08744Z6JNY)
TALC (UNII: 7SEV7J4R1U)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1		8 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	07/12/2016

Part 9 of 24

ESIKA PRO HIDRACOLOR 3 IN 1 MOISTURIZING, COLOR AND PERFECTING EFFECT SPF 25 (BORGONA SEXY) - PURPLE
octinoxate and zinc oxide lipstick

Product Information
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	0.075 g in 1 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	0.0392 g in 1 g

Ingredient Name	Strength
Inactive Ingredients
DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW)
TRIDECYL TRIMELLITATE (UNII: FY36J270ES)
ISONONYL ISONONANOATE (UNII: S4V5BS6GCX)
CERESIN (UNII: Q1LS2UJO3A)
WATER (UNII: 059QF0KO0R)
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)
TRIDECYL STEARATE (UNII: A8OE252M6L)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
CARNAUBA WAX (UNII: R12CBM0EIZ)
GLYCERIN (UNII: PDC6A3C0OX)
NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K)
SHEA BUTTER (UNII: K49155WL9Y)
POLYTETRAFLUOROETHYLENE (UNII: E1NC1JVS3O)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
COCONUT OIL (UNII: Q9L0O73W7L)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
CERAMIDE NP (UNII: 4370DF050B)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
CHLORPHENESIN (UNII: I670DAL4SZ)
DIMETHICONE (UNII: 92RU3N3Y1O)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
SOYBEAN OIL (UNII: 241ATL177A)
TOCOPHEROL (UNII: R0ZB2556P8)
MAGNESIUM CHLORIDE (UNII: 02F3473H9O)
POTASSIUM CHLORIDE (UNII: 660YQ98I10)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)
LIMONENE, (+)- (UNII: GFD7C86Q1W)
LINALOOL, (+/-)- (UNII: D81QY6I88E)
.ALPHA.-AMYLCINNAMALDEHYDE (UNII: WC51CA3418)
.BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)
D&C RED NO. 30 (UNII: 2S42T2808B)
ALUMINUM OXIDE (UNII: LMI26O6933)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FERRIC OXIDE RED (UNII: 1K09F3G675)
MICA (UNII: V8A1AW0880)
D&C RED NO. 27 (UNII: 2LRS185U6K)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
D&C RED NO. 7 (UNII: ECW0LZ41X8)
D&C RED NO. 21 (UNII: 08744Z6JNY)
TALC (UNII: 7SEV7J4R1U)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1		8 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	07/12/2016

Part 10 of 24

ESIKA PRO HIDRACOLOR 3 IN 1 MOISTURIZING, COLOR AND PERFECTING EFFECT SPF 25 (FRESA HOT) - PINK
octinoxate and zinc oxide lipstick

Product Information
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	0.075 g in 1 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	0.0392 g in 1 g

Ingredient Name	Strength
Inactive Ingredients
DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW)
TRIDECYL TRIMELLITATE (UNII: FY36J270ES)
ISONONYL ISONONANOATE (UNII: S4V5BS6GCX)
CERESIN (UNII: Q1LS2UJO3A)
WATER (UNII: 059QF0KO0R)
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)
TRIDECYL STEARATE (UNII: A8OE252M6L)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
CARNAUBA WAX (UNII: R12CBM0EIZ)
GLYCERIN (UNII: PDC6A3C0OX)
NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K)
SHEA BUTTER (UNII: K49155WL9Y)
POLYTETRAFLUOROETHYLENE (UNII: E1NC1JVS3O)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
COCONUT OIL (UNII: Q9L0O73W7L)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
CERAMIDE NP (UNII: 4370DF050B)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
CHLORPHENESIN (UNII: I670DAL4SZ)
DIMETHICONE (UNII: 92RU3N3Y1O)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
SOYBEAN OIL (UNII: 241ATL177A)
TOCOPHEROL (UNII: R0ZB2556P8)
MAGNESIUM CHLORIDE (UNII: 02F3473H9O)
POTASSIUM CHLORIDE (UNII: 660YQ98I10)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)
LIMONENE, (+)- (UNII: GFD7C86Q1W)
LINALOOL, (+/-)- (UNII: D81QY6I88E)
.ALPHA.-AMYLCINNAMALDEHYDE (UNII: WC51CA3418)
.BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)
D&C RED NO. 30 (UNII: 2S42T2808B)
ALUMINUM OXIDE (UNII: LMI26O6933)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FERRIC OXIDE RED (UNII: 1K09F3G675)
MICA (UNII: V8A1AW0880)
D&C RED NO. 27 (UNII: 2LRS185U6K)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
D&C RED NO. 7 (UNII: ECW0LZ41X8)
D&C RED NO. 21 (UNII: 08744Z6JNY)
TALC (UNII: 7SEV7J4R1U)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1		8 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	07/12/2016

Part 11 of 24

ESIKA PRO HIDRACOLOR 3 IN 1 MOISTURIZING, COLOR AND PERFECTING EFFECT SPF 25 (FUCSIA CAUTIVANTE) - PINK
octinoxate and zinc oxide lipstick

Product Information
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	0.075 g in 1 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	0.0392 g in 1 g

Ingredient Name	Strength
Inactive Ingredients
DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW)
TRIDECYL TRIMELLITATE (UNII: FY36J270ES)
ISONONYL ISONONANOATE (UNII: S4V5BS6GCX)
CERESIN (UNII: Q1LS2UJO3A)
WATER (UNII: 059QF0KO0R)
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)
TRIDECYL STEARATE (UNII: A8OE252M6L)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
CARNAUBA WAX (UNII: R12CBM0EIZ)
GLYCERIN (UNII: PDC6A3C0OX)
NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K)
SHEA BUTTER (UNII: K49155WL9Y)
POLYTETRAFLUOROETHYLENE (UNII: E1NC1JVS3O)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
COCONUT OIL (UNII: Q9L0O73W7L)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
CERAMIDE NP (UNII: 4370DF050B)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
CHLORPHENESIN (UNII: I670DAL4SZ)
DIMETHICONE (UNII: 92RU3N3Y1O)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
SOYBEAN OIL (UNII: 241ATL177A)
TOCOPHEROL (UNII: R0ZB2556P8)
MAGNESIUM CHLORIDE (UNII: 02F3473H9O)
POTASSIUM CHLORIDE (UNII: 660YQ98I10)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)
LIMONENE, (+)- (UNII: GFD7C86Q1W)
LINALOOL, (+/-)- (UNII: D81QY6I88E)
.ALPHA.-AMYLCINNAMALDEHYDE (UNII: WC51CA3418)
.BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)
D&C RED NO. 30 (UNII: 2S42T2808B)
ALUMINUM OXIDE (UNII: LMI26O6933)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FERRIC OXIDE RED (UNII: 1K09F3G675)
MICA (UNII: V8A1AW0880)
D&C RED NO. 27 (UNII: 2LRS185U6K)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
D&C RED NO. 7 (UNII: ECW0LZ41X8)
D&C RED NO. 21 (UNII: 08744Z6JNY)
TALC (UNII: 7SEV7J4R1U)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1		8 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	07/12/2016

Part 12 of 24

ESIKA PRO HIDRACOLOR 3 IN 1 MOISTURIZING, COLOR AND PERFECTING EFFECT SPF 25 (FUCSIA INTENSE) - PINK
octinoxate and zinc oxide lipstick

Product Information
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	0.075 g in 1 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	0.0392 g in 1 g

Ingredient Name	Strength
Inactive Ingredients
DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW)
TRIDECYL TRIMELLITATE (UNII: FY36J270ES)
ISONONYL ISONONANOATE (UNII: S4V5BS6GCX)
CERESIN (UNII: Q1LS2UJO3A)
WATER (UNII: 059QF0KO0R)
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)
TRIDECYL STEARATE (UNII: A8OE252M6L)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
CARNAUBA WAX (UNII: R12CBM0EIZ)
GLYCERIN (UNII: PDC6A3C0OX)
NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K)
SHEA BUTTER (UNII: K49155WL9Y)
POLYTETRAFLUOROETHYLENE (UNII: E1NC1JVS3O)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
COCONUT OIL (UNII: Q9L0O73W7L)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
CERAMIDE NP (UNII: 4370DF050B)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
CHLORPHENESIN (UNII: I670DAL4SZ)
DIMETHICONE (UNII: 92RU3N3Y1O)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
SOYBEAN OIL (UNII: 241ATL177A)
TOCOPHEROL (UNII: R0ZB2556P8)
MAGNESIUM CHLORIDE (UNII: 02F3473H9O)
POTASSIUM CHLORIDE (UNII: 660YQ98I10)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)
LIMONENE, (+)- (UNII: GFD7C86Q1W)
LINALOOL, (+/-)- (UNII: D81QY6I88E)
.ALPHA.-AMYLCINNAMALDEHYDE (UNII: WC51CA3418)
.BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)
D&C RED NO. 30 (UNII: 2S42T2808B)
ALUMINUM OXIDE (UNII: LMI26O6933)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FERRIC OXIDE RED (UNII: 1K09F3G675)
MICA (UNII: V8A1AW0880)
D&C RED NO. 27 (UNII: 2LRS185U6K)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
D&C RED NO. 7 (UNII: ECW0LZ41X8)
D&C RED NO. 21 (UNII: 08744Z6JNY)
TALC (UNII: 7SEV7J4R1U)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1		8 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	07/12/2016

Part 13 of 24

ESIKA PRO HIDRACOLOR 3 IN 1 MOISTURIZING, COLOR AND PERFECTING EFFECT SPF 25 (NARANJA ESFERA) - ORANGE
octinoxate and zinc oxide lipstick

Product Information
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	0.075 g in 1 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	0.0392 g in 1 g

Ingredient Name	Strength
Inactive Ingredients
DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW)
TRIDECYL TRIMELLITATE (UNII: FY36J270ES)
ISONONYL ISONONANOATE (UNII: S4V5BS6GCX)
CERESIN (UNII: Q1LS2UJO3A)
WATER (UNII: 059QF0KO0R)
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)
TRIDECYL STEARATE (UNII: A8OE252M6L)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
CARNAUBA WAX (UNII: R12CBM0EIZ)
GLYCERIN (UNII: PDC6A3C0OX)
NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K)
SHEA BUTTER (UNII: K49155WL9Y)
POLYTETRAFLUOROETHYLENE (UNII: E1NC1JVS3O)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
COCONUT OIL (UNII: Q9L0O73W7L)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
CERAMIDE NP (UNII: 4370DF050B)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
CHLORPHENESIN (UNII: I670DAL4SZ)
DIMETHICONE (UNII: 92RU3N3Y1O)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
SOYBEAN OIL (UNII: 241ATL177A)
TOCOPHEROL (UNII: R0ZB2556P8)
MAGNESIUM CHLORIDE (UNII: 02F3473H9O)
POTASSIUM CHLORIDE (UNII: 660YQ98I10)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)
LIMONENE, (+)- (UNII: GFD7C86Q1W)
LINALOOL, (+/-)- (UNII: D81QY6I88E)
.ALPHA.-AMYLCINNAMALDEHYDE (UNII: WC51CA3418)
.BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)
D&C RED NO. 30 (UNII: 2S42T2808B)
ALUMINUM OXIDE (UNII: LMI26O6933)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FERRIC OXIDE RED (UNII: 1K09F3G675)
MICA (UNII: V8A1AW0880)
D&C RED NO. 27 (UNII: 2LRS185U6K)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
D&C RED NO. 7 (UNII: ECW0LZ41X8)
D&C RED NO. 21 (UNII: 08744Z6JNY)
TALC (UNII: 7SEV7J4R1U)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1		8 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	07/12/2016

Part 14 of 24

ESIKA PRO HIDRACOLOR 3 IN 1 MOISTURIZING, COLOR AND PERFECTING EFFECT SPF 25 (ROSA NUDE) - PINK
octinoxate and zinc oxide lipstick

Product Information
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	0.075 g in 1 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	0.0392 g in 1 g

Ingredient Name	Strength
Inactive Ingredients
DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW)
TRIDECYL TRIMELLITATE (UNII: FY36J270ES)
ISONONYL ISONONANOATE (UNII: S4V5BS6GCX)
CERESIN (UNII: Q1LS2UJO3A)
WATER (UNII: 059QF0KO0R)
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)
TRIDECYL STEARATE (UNII: A8OE252M6L)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
CARNAUBA WAX (UNII: R12CBM0EIZ)
GLYCERIN (UNII: PDC6A3C0OX)
NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K)
SHEA BUTTER (UNII: K49155WL9Y)
POLYTETRAFLUOROETHYLENE (UNII: E1NC1JVS3O)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
COCONUT OIL (UNII: Q9L0O73W7L)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
CERAMIDE NP (UNII: 4370DF050B)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
CHLORPHENESIN (UNII: I670DAL4SZ)
DIMETHICONE (UNII: 92RU3N3Y1O)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
SOYBEAN OIL (UNII: 241ATL177A)
TOCOPHEROL (UNII: R0ZB2556P8)
MAGNESIUM CHLORIDE (UNII: 02F3473H9O)
POTASSIUM CHLORIDE (UNII: 660YQ98I10)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)
LIMONENE, (+)- (UNII: GFD7C86Q1W)
LINALOOL, (+/-)- (UNII: D81QY6I88E)
.ALPHA.-AMYLCINNAMALDEHYDE (UNII: WC51CA3418)
.BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)
D&C RED NO. 30 (UNII: 2S42T2808B)
ALUMINUM OXIDE (UNII: LMI26O6933)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FERRIC OXIDE RED (UNII: 1K09F3G675)
MICA (UNII: V8A1AW0880)
D&C RED NO. 27 (UNII: 2LRS185U6K)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
D&C RED NO. 7 (UNII: ECW0LZ41X8)
D&C RED NO. 21 (UNII: 08744Z6JNY)
TALC (UNII: 7SEV7J4R1U)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1		8 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	07/12/2016

Part 15 of 24

ESIKA PRO HIDRACOLOR 3 IN 1 MOISTURIZING, COLOR AND PERFECTING EFFECT SPF 25 (PEACH NUDE) - BROWN
octinoxate and zinc oxide lipstick

Product Information
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	0.075 g in 1 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	0.0392 g in 1 g

Ingredient Name	Strength
Inactive Ingredients
DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW)
TRIDECYL TRIMELLITATE (UNII: FY36J270ES)
ISONONYL ISONONANOATE (UNII: S4V5BS6GCX)
CERESIN (UNII: Q1LS2UJO3A)
WATER (UNII: 059QF0KO0R)
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)
TRIDECYL STEARATE (UNII: A8OE252M6L)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
CARNAUBA WAX (UNII: R12CBM0EIZ)
GLYCERIN (UNII: PDC6A3C0OX)
NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K)
SHEA BUTTER (UNII: K49155WL9Y)
POLYTETRAFLUOROETHYLENE (UNII: E1NC1JVS3O)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
COCONUT OIL (UNII: Q9L0O73W7L)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
CERAMIDE NP (UNII: 4370DF050B)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
CHLORPHENESIN (UNII: I670DAL4SZ)
DIMETHICONE (UNII: 92RU3N3Y1O)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
SOYBEAN OIL (UNII: 241ATL177A)
TOCOPHEROL (UNII: R0ZB2556P8)
MAGNESIUM CHLORIDE (UNII: 02F3473H9O)
POTASSIUM CHLORIDE (UNII: 660YQ98I10)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)
LIMONENE, (+)- (UNII: GFD7C86Q1W)
LINALOOL, (+/-)- (UNII: D81QY6I88E)
.ALPHA.-AMYLCINNAMALDEHYDE (UNII: WC51CA3418)
.BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)
D&C RED NO. 30 (UNII: 2S42T2808B)
ALUMINUM OXIDE (UNII: LMI26O6933)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FERRIC OXIDE RED (UNII: 1K09F3G675)
MICA (UNII: V8A1AW0880)
D&C RED NO. 27 (UNII: 2LRS185U6K)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
D&C RED NO. 7 (UNII: ECW0LZ41X8)
D&C RED NO. 21 (UNII: 08744Z6JNY)
TALC (UNII: 7SEV7J4R1U)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1		8 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	07/12/2016

Part 16 of 24

ESIKA PRO HIDRACOLOR 3 IN 1 MOISTURIZING, COLOR AND PERFECTING EFFECT SPF 25 (CORAL CHIC) - PINK
octinoxate and zinc oxide lipstick

Product Information
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	0.075 g in 1 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	0.0392 g in 1 g

Ingredient Name	Strength
Inactive Ingredients
DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW)
TRIDECYL TRIMELLITATE (UNII: FY36J270ES)
ISONONYL ISONONANOATE (UNII: S4V5BS6GCX)
CERESIN (UNII: Q1LS2UJO3A)
WATER (UNII: 059QF0KO0R)
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)
TRIDECYL STEARATE (UNII: A8OE252M6L)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
CARNAUBA WAX (UNII: R12CBM0EIZ)
GLYCERIN (UNII: PDC6A3C0OX)
NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K)
SHEA BUTTER (UNII: K49155WL9Y)
POLYTETRAFLUOROETHYLENE (UNII: E1NC1JVS3O)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
COCONUT OIL (UNII: Q9L0O73W7L)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
CERAMIDE NP (UNII: 4370DF050B)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
CHLORPHENESIN (UNII: I670DAL4SZ)
DIMETHICONE (UNII: 92RU3N3Y1O)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
SOYBEAN OIL (UNII: 241ATL177A)
TOCOPHEROL (UNII: R0ZB2556P8)
MAGNESIUM CHLORIDE (UNII: 02F3473H9O)
POTASSIUM CHLORIDE (UNII: 660YQ98I10)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)
LIMONENE, (+)- (UNII: GFD7C86Q1W)
LINALOOL, (+/-)- (UNII: D81QY6I88E)
.ALPHA.-AMYLCINNAMALDEHYDE (UNII: WC51CA3418)
.BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)
D&C RED NO. 30 (UNII: 2S42T2808B)
ALUMINUM OXIDE (UNII: LMI26O6933)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FERRIC OXIDE RED (UNII: 1K09F3G675)
MICA (UNII: V8A1AW0880)
D&C RED NO. 27 (UNII: 2LRS185U6K)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
D&C RED NO. 7 (UNII: ECW0LZ41X8)
D&C RED NO. 21 (UNII: 08744Z6JNY)
TALC (UNII: 7SEV7J4R1U)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1		8 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	07/12/2016

Part 17 of 24

ESIKA PRO HIDRACOLOR 3 IN 1 MOISTURIZING, COLOR AND PERFECTING EFFECT SPF 25 (ROJO TROPICAL) - RED
octinoxate and zinc oxide lipstick

Product Information
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	0.075 g in 1 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	0.0392 g in 1 g

Ingredient Name	Strength
Inactive Ingredients
DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW)
TRIDECYL TRIMELLITATE (UNII: FY36J270ES)
ISONONYL ISONONANOATE (UNII: S4V5BS6GCX)
CERESIN (UNII: Q1LS2UJO3A)
WATER (UNII: 059QF0KO0R)
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)
TRIDECYL STEARATE (UNII: A8OE252M6L)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
CARNAUBA WAX (UNII: R12CBM0EIZ)
GLYCERIN (UNII: PDC6A3C0OX)
NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K)
SHEA BUTTER (UNII: K49155WL9Y)
POLYTETRAFLUOROETHYLENE (UNII: E1NC1JVS3O)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
COCONUT OIL (UNII: Q9L0O73W7L)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
CERAMIDE NP (UNII: 4370DF050B)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
CHLORPHENESIN (UNII: I670DAL4SZ)
DIMETHICONE (UNII: 92RU3N3Y1O)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
SOYBEAN OIL (UNII: 241ATL177A)
TOCOPHEROL (UNII: R0ZB2556P8)
MAGNESIUM CHLORIDE (UNII: 02F3473H9O)
POTASSIUM CHLORIDE (UNII: 660YQ98I10)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)
LIMONENE, (+)- (UNII: GFD7C86Q1W)
LINALOOL, (+/-)- (UNII: D81QY6I88E)
.ALPHA.-AMYLCINNAMALDEHYDE (UNII: WC51CA3418)
.BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)
D&C RED NO. 30 (UNII: 2S42T2808B)
ALUMINUM OXIDE (UNII: LMI26O6933)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FERRIC OXIDE RED (UNII: 1K09F3G675)
MICA (UNII: V8A1AW0880)
D&C RED NO. 27 (UNII: 2LRS185U6K)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
D&C RED NO. 7 (UNII: ECW0LZ41X8)
D&C RED NO. 21 (UNII: 08744Z6JNY)
TALC (UNII: 7SEV7J4R1U)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1		8 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	07/12/2016

Part 18 of 24

ESIKA PRO HIDRACOLOR 3 IN 1 MOISTURIZING, COLOR AND PERFECTING EFFECT SPF 25 (NARANJA CITRICO) - ORANGE
octinoxate and zinc oxide lipstick

Product Information
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	0.075 g in 1 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	0.0392 g in 1 g

Ingredient Name	Strength
Inactive Ingredients
DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW)
TRIDECYL TRIMELLITATE (UNII: FY36J270ES)
ISONONYL ISONONANOATE (UNII: S4V5BS6GCX)
CERESIN (UNII: Q1LS2UJO3A)
WATER (UNII: 059QF0KO0R)
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)
TRIDECYL STEARATE (UNII: A8OE252M6L)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
CARNAUBA WAX (UNII: R12CBM0EIZ)
GLYCERIN (UNII: PDC6A3C0OX)
NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K)
SHEA BUTTER (UNII: K49155WL9Y)
POLYTETRAFLUOROETHYLENE (UNII: E1NC1JVS3O)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
COCONUT OIL (UNII: Q9L0O73W7L)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
CERAMIDE NP (UNII: 4370DF050B)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
CHLORPHENESIN (UNII: I670DAL4SZ)
DIMETHICONE (UNII: 92RU3N3Y1O)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
SOYBEAN OIL (UNII: 241ATL177A)
TOCOPHEROL (UNII: R0ZB2556P8)
MAGNESIUM CHLORIDE (UNII: 02F3473H9O)
POTASSIUM CHLORIDE (UNII: 660YQ98I10)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)
LIMONENE, (+)- (UNII: GFD7C86Q1W)
LINALOOL, (+/-)- (UNII: D81QY6I88E)
.ALPHA.-AMYLCINNAMALDEHYDE (UNII: WC51CA3418)
.BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)
D&C RED NO. 30 (UNII: 2S42T2808B)
ALUMINUM OXIDE (UNII: LMI26O6933)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FERRIC OXIDE RED (UNII: 1K09F3G675)
MICA (UNII: V8A1AW0880)
D&C RED NO. 27 (UNII: 2LRS185U6K)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
D&C RED NO. 7 (UNII: ECW0LZ41X8)
D&C RED NO. 21 (UNII: 08744Z6JNY)
TALC (UNII: 7SEV7J4R1U)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1		8 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	07/12/2016

Part 19 of 24

ESIKA PRO HIDRACOLOR 3 IN 1 MOISTURIZING, COLOR AND PERFECTING EFFECT SPF 25 (NUDE PUNCH) - ORANGE
octinoxate and zinc oxide lipstick

Product Information
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	0.075 g in 1 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	0.0392 g in 1 g

Ingredient Name	Strength
Inactive Ingredients
DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW)
TRIDECYL TRIMELLITATE (UNII: FY36J270ES)
ISONONYL ISONONANOATE (UNII: S4V5BS6GCX)
CERESIN (UNII: Q1LS2UJO3A)
WATER (UNII: 059QF0KO0R)
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)
TRIDECYL STEARATE (UNII: A8OE252M6L)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
CARNAUBA WAX (UNII: R12CBM0EIZ)
GLYCERIN (UNII: PDC6A3C0OX)
NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K)
SHEA BUTTER (UNII: K49155WL9Y)
POLYTETRAFLUOROETHYLENE (UNII: E1NC1JVS3O)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
COCONUT OIL (UNII: Q9L0O73W7L)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
CERAMIDE NP (UNII: 4370DF050B)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
CHLORPHENESIN (UNII: I670DAL4SZ)
DIMETHICONE (UNII: 92RU3N3Y1O)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
SOYBEAN OIL (UNII: 241ATL177A)
TOCOPHEROL (UNII: R0ZB2556P8)
MAGNESIUM CHLORIDE (UNII: 02F3473H9O)
POTASSIUM CHLORIDE (UNII: 660YQ98I10)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)
LIMONENE, (+)- (UNII: GFD7C86Q1W)
LINALOOL, (+/-)- (UNII: D81QY6I88E)
.ALPHA.-AMYLCINNAMALDEHYDE (UNII: WC51CA3418)
.BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)
D&C RED NO. 30 (UNII: 2S42T2808B)
ALUMINUM OXIDE (UNII: LMI26O6933)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FERRIC OXIDE RED (UNII: 1K09F3G675)
MICA (UNII: V8A1AW0880)
D&C RED NO. 27 (UNII: 2LRS185U6K)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
D&C RED NO. 7 (UNII: ECW0LZ41X8)
D&C RED NO. 21 (UNII: 08744Z6JNY)
TALC (UNII: 7SEV7J4R1U)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1		8 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	07/12/2016

Part 20 of 24

ESIKA PRO HIDRACOLOR 3 IN 1 MOISTURIZING, COLOR AND PERFECTING EFFECT SPF 25 (MORA ATREVIDA) - PURPLE
octinoxate and zinc oxide lipstick

Product Information
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	0.075 g in 1 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	0.0392 g in 1 g

Ingredient Name	Strength
Inactive Ingredients
DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW)
TRIDECYL TRIMELLITATE (UNII: FY36J270ES)
ISONONYL ISONONANOATE (UNII: S4V5BS6GCX)
CERESIN (UNII: Q1LS2UJO3A)
WATER (UNII: 059QF0KO0R)
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)
TRIDECYL STEARATE (UNII: A8OE252M6L)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
CARNAUBA WAX (UNII: R12CBM0EIZ)
GLYCERIN (UNII: PDC6A3C0OX)
NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K)
SHEA BUTTER (UNII: K49155WL9Y)
POLYTETRAFLUOROETHYLENE (UNII: E1NC1JVS3O)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
COCONUT OIL (UNII: Q9L0O73W7L)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
CERAMIDE NP (UNII: 4370DF050B)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
CHLORPHENESIN (UNII: I670DAL4SZ)
DIMETHICONE (UNII: 92RU3N3Y1O)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
SOYBEAN OIL (UNII: 241ATL177A)
TOCOPHEROL (UNII: R0ZB2556P8)
MAGNESIUM CHLORIDE (UNII: 02F3473H9O)
POTASSIUM CHLORIDE (UNII: 660YQ98I10)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)
LIMONENE, (+)- (UNII: GFD7C86Q1W)
LINALOOL, (+/-)- (UNII: D81QY6I88E)
.ALPHA.-AMYLCINNAMALDEHYDE (UNII: WC51CA3418)
.BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)
D&C RED NO. 30 (UNII: 2S42T2808B)
ALUMINUM OXIDE (UNII: LMI26O6933)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FERRIC OXIDE RED (UNII: 1K09F3G675)
MICA (UNII: V8A1AW0880)
D&C RED NO. 27 (UNII: 2LRS185U6K)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
D&C RED NO. 7 (UNII: ECW0LZ41X8)
D&C RED NO. 21 (UNII: 08744Z6JNY)
TALC (UNII: 7SEV7J4R1U)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1		8 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	07/12/2016

Part 21 of 24

ESIKA PRO HIDRACOLOR 3 IN 1 MOISTURIZING, COLOR AND PERFECTING EFFECT SPF 25 (NUDE SAVANNA) - ORANGE
octinoxate and zinc oxide lipstick

Product Information
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	0.075 g in 1 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	0.0392 g in 1 g

Ingredient Name	Strength
Inactive Ingredients
DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW)
TRIDECYL TRIMELLITATE (UNII: FY36J270ES)
ISONONYL ISONONANOATE (UNII: S4V5BS6GCX)
CERESIN (UNII: Q1LS2UJO3A)
WATER (UNII: 059QF0KO0R)
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)
TRIDECYL STEARATE (UNII: A8OE252M6L)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
CARNAUBA WAX (UNII: R12CBM0EIZ)
GLYCERIN (UNII: PDC6A3C0OX)
NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K)
SHEA BUTTER (UNII: K49155WL9Y)
POLYTETRAFLUOROETHYLENE (UNII: E1NC1JVS3O)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
COCONUT OIL (UNII: Q9L0O73W7L)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
CERAMIDE NP (UNII: 4370DF050B)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
CHLORPHENESIN (UNII: I670DAL4SZ)
DIMETHICONE (UNII: 92RU3N3Y1O)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
SOYBEAN OIL (UNII: 241ATL177A)
TOCOPHEROL (UNII: R0ZB2556P8)
MAGNESIUM CHLORIDE (UNII: 02F3473H9O)
POTASSIUM CHLORIDE (UNII: 660YQ98I10)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)
LIMONENE, (+)- (UNII: GFD7C86Q1W)
LINALOOL, (+/-)- (UNII: D81QY6I88E)
.ALPHA.-AMYLCINNAMALDEHYDE (UNII: WC51CA3418)
.BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)
D&C RED NO. 30 (UNII: 2S42T2808B)
ALUMINUM OXIDE (UNII: LMI26O6933)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FERRIC OXIDE RED (UNII: 1K09F3G675)
MICA (UNII: V8A1AW0880)
D&C RED NO. 27 (UNII: 2LRS185U6K)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
D&C RED NO. 7 (UNII: ECW0LZ41X8)
D&C RED NO. 21 (UNII: 08744Z6JNY)
TALC (UNII: 7SEV7J4R1U)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1		8 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	07/12/2016

Part 22 of 24

ESIKA PRO HIDRACOLOR 3 IN 1 MOISTURIZING, COLOR AND PERFECTING EFFECT SPF 25 (ROJO SENSUAL) - RED
octinoxate and zinc oxide lipstick

Product Information
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	0.075 g in 1 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	0.0392 g in 1 g

Ingredient Name	Strength
Inactive Ingredients
DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW)
TRIDECYL TRIMELLITATE (UNII: FY36J270ES)
ISONONYL ISONONANOATE (UNII: S4V5BS6GCX)
CERESIN (UNII: Q1LS2UJO3A)
WATER (UNII: 059QF0KO0R)
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)
TRIDECYL STEARATE (UNII: A8OE252M6L)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
CARNAUBA WAX (UNII: R12CBM0EIZ)
GLYCERIN (UNII: PDC6A3C0OX)
NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K)
SHEA BUTTER (UNII: K49155WL9Y)
POLYTETRAFLUOROETHYLENE (UNII: E1NC1JVS3O)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
COCONUT OIL (UNII: Q9L0O73W7L)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
CERAMIDE NP (UNII: 4370DF050B)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
CHLORPHENESIN (UNII: I670DAL4SZ)
DIMETHICONE (UNII: 92RU3N3Y1O)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
SOYBEAN OIL (UNII: 241ATL177A)
TOCOPHEROL (UNII: R0ZB2556P8)
MAGNESIUM CHLORIDE (UNII: 02F3473H9O)
POTASSIUM CHLORIDE (UNII: 660YQ98I10)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)
LIMONENE, (+)- (UNII: GFD7C86Q1W)
LINALOOL, (+/-)- (UNII: D81QY6I88E)
.ALPHA.-AMYLCINNAMALDEHYDE (UNII: WC51CA3418)
.BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)
D&C RED NO. 30 (UNII: 2S42T2808B)
ALUMINUM OXIDE (UNII: LMI26O6933)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FERRIC OXIDE RED (UNII: 1K09F3G675)
MICA (UNII: V8A1AW0880)
D&C RED NO. 27 (UNII: 2LRS185U6K)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
D&C RED NO. 7 (UNII: ECW0LZ41X8)
D&C RED NO. 21 (UNII: 08744Z6JNY)
TALC (UNII: 7SEV7J4R1U)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1		8 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	07/12/2016

Part 23 of 24

ESIKA PRO HIDRACOLOR 3 IN 1 MOISTURIZING, COLOR AND PERFECTING EFFECT SPF 25 (NUDE MOCCHA) - ORANGE
octinoxate and zinc oxide lipstick

Product Information
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	0.075 g in 1 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	0.0392 g in 1 g

Ingredient Name	Strength
Inactive Ingredients
DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW)
TRIDECYL TRIMELLITATE (UNII: FY36J270ES)
ISONONYL ISONONANOATE (UNII: S4V5BS6GCX)
CERESIN (UNII: Q1LS2UJO3A)
WATER (UNII: 059QF0KO0R)
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)
TRIDECYL STEARATE (UNII: A8OE252M6L)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
CARNAUBA WAX (UNII: R12CBM0EIZ)
GLYCERIN (UNII: PDC6A3C0OX)
NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K)
SHEA BUTTER (UNII: K49155WL9Y)
POLYTETRAFLUOROETHYLENE (UNII: E1NC1JVS3O)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
COCONUT OIL (UNII: Q9L0O73W7L)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
CERAMIDE NP (UNII: 4370DF050B)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
CHLORPHENESIN (UNII: I670DAL4SZ)
DIMETHICONE (UNII: 92RU3N3Y1O)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
SOYBEAN OIL (UNII: 241ATL177A)
TOCOPHEROL (UNII: R0ZB2556P8)
MAGNESIUM CHLORIDE (UNII: 02F3473H9O)
POTASSIUM CHLORIDE (UNII: 660YQ98I10)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)
LIMONENE, (+)- (UNII: GFD7C86Q1W)
LINALOOL, (+/-)- (UNII: D81QY6I88E)
.ALPHA.-AMYLCINNAMALDEHYDE (UNII: WC51CA3418)
.BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)
D&C RED NO. 30 (UNII: 2S42T2808B)
ALUMINUM OXIDE (UNII: LMI26O6933)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FERRIC OXIDE RED (UNII: 1K09F3G675)
MICA (UNII: V8A1AW0880)
D&C RED NO. 27 (UNII: 2LRS185U6K)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
D&C RED NO. 7 (UNII: ECW0LZ41X8)
D&C RED NO. 21 (UNII: 08744Z6JNY)
TALC (UNII: 7SEV7J4R1U)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1		8 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	07/12/2016

Part 24 of 24

ESIKA PRO HIDRACOLOR 3 IN 1 MOISTURIZING, COLOR AND PERFECTING EFFECT SPF 25 (BRONCE METALLIC) - BROWN
octinoxate and zinc oxide lipstick

Product Information
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	0.075 g in 1 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	0.0392 g in 1 g

Ingredient Name	Strength
Inactive Ingredients
DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW)
TRIDECYL TRIMELLITATE (UNII: FY36J270ES)
ISONONYL ISONONANOATE (UNII: S4V5BS6GCX)
CERESIN (UNII: Q1LS2UJO3A)
WATER (UNII: 059QF0KO0R)
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)
TRIDECYL STEARATE (UNII: A8OE252M6L)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
CARNAUBA WAX (UNII: R12CBM0EIZ)
GLYCERIN (UNII: PDC6A3C0OX)
NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K)
SHEA BUTTER (UNII: K49155WL9Y)
POLYTETRAFLUOROETHYLENE (UNII: E1NC1JVS3O)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
COCONUT OIL (UNII: Q9L0O73W7L)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
CERAMIDE NP (UNII: 4370DF050B)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
CHLORPHENESIN (UNII: I670DAL4SZ)
DIMETHICONE (UNII: 92RU3N3Y1O)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
SOYBEAN OIL (UNII: 241ATL177A)
TOCOPHEROL (UNII: R0ZB2556P8)
MAGNESIUM CHLORIDE (UNII: 02F3473H9O)
POTASSIUM CHLORIDE (UNII: 660YQ98I10)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)
LIMONENE, (+)- (UNII: GFD7C86Q1W)
LINALOOL, (+/-)- (UNII: D81QY6I88E)
.ALPHA.-AMYLCINNAMALDEHYDE (UNII: WC51CA3418)
.BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)
D&C RED NO. 30 (UNII: 2S42T2808B)
ALUMINUM OXIDE (UNII: LMI26O6933)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FERRIC OXIDE RED (UNII: 1K09F3G675)
MICA (UNII: V8A1AW0880)
D&C RED NO. 27 (UNII: 2LRS185U6K)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
D&C RED NO. 7 (UNII: ECW0LZ41X8)
D&C RED NO. 21 (UNII: 08744Z6JNY)
TALC (UNII: 7SEV7J4R1U)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1		8 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	07/12/2016

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH FINAL	part352	07/12/2016

Labeler - Ventura Corporation LTD DUNS (602751344)

Name	Address	ID/FEI	Business Operations
Establishment
Bel Star S.A. (Colombia)		880160197	MANUFACTURE(13537-958, 13537-959, 13537-960, 13537-966, 13537-967, 13537-968, 13537-969, 13537-970, 13537-971, 13537-972, 13537-973, 13537-974, 13537-975, 13537-976, 13537-977, 13537-978, 13537-979, 13537-980, 13537-981, 13537-982, 13537-983, 13537-984, 13537-985, 13537-986, 13537-987)

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Published Date (What is this?)	Version	Files
Nov 28, 2018	2 (current)	download
Jul 19, 2016	1	download

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	NDC
1	13537-958-01
2	13537-958-02 (inactivated)
3	13537-959-03
4	13537-959-04 (inactivated)
5	13537-960-05
6	13537-960-06 (inactivated)
7	13537-966-07
8	13537-966-08 (inactivated)
9	13537-967-09
10	13537-967-10 (inactivated)
11	13537-968-11
12	13537-968-12 (inactivated)
13	13537-969-13
14	13537-969-14 (inactivated)
15	13537-970-17
16	13537-970-18 (inactivated)
17	13537-971-19
18	13537-971-20 (inactivated)
19	13537-972-21
20	13537-972-22 (inactivated)
21	13537-973-23
22	13537-973-24 (inactivated)
23	13537-974-23
24	13537-974-24 (inactivated)
25	13537-975-23
26	13537-975-24 (inactivated)
27	13537-976-23
28	13537-976-24 (inactivated)
29	13537-977-23
30	13537-977-24 (inactivated)
31	13537-978-23
32	13537-978-24 (inactivated)
33	13537-979-23
34	13537-979-24 (inactivated)
35	13537-980-23
36	13537-980-24 (inactivated)
37	13537-981-23
38	13537-981-24 (inactivated)
39	13537-982-23
40	13537-982-24 (inactivated)
41	13537-983-23
42	13537-983-24 (inactivated)
43	13537-984-23
44	13537-984-24 (inactivated)
45	13537-985-23
46	13537-985-24 (inactivated)
47	13537-986-23
48	13537-986-24 (inactivated)
49	13537-987-27
50	13537-987-28 (inactivated)

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Number of versions: 2

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If this SPL contains inactivated NDCs listed by the FDA initiated compliance action, they will be specified as such.