ESIKA PRO INSTANT PERFECTION 3 EN 1 FACE REFINING FOUNDATION SPF 25 CLARO 1 - BEIGE- octinoxate and zinc oxide lotion ESIKA PRO INSTANT PERFECTION 3 EN 1 FACE REFINING FOUNDATION SPF 25 CLARO 2 - BEIGE- octinoxate and zinc oxide lotion ESIKA PRO INSTANT PERFECTION 3 EN 1 FACE REFINING FOUNDATION SPF 25 MEDIO 1 - BEIGE- octinoxate and zinc oxide lotion ESIKA PRO INSTANT PERFECTION 3 EN 1 FACE REFINING FOUNDATION SPF 25 MEDIO 2 - BEIGE- octinoxate and zinc oxide lotion ESIKA PRO INSTANT PERFECTION 3 EN 1 FACE REFINING FOUNDATION SPF 25 MEDIO 3 - BEIGE- octinoxate and zinc oxide lotion ESIKA PRO INSTANT PERFECTION 3 EN 1 FACE REFINING FOUNDATION SPF 25 MEDIO 4 - BEIGE- octinoxate and zinc oxide lotion ESIKA PRO INSTANT PERFECTION 3 EN 1 FACE REFINING FOUNDATION SPF 25 MEDIO 5 - BEIGE- octinoxate and zinc oxide lotion

ESIKA PRO INSTANT PERFECTION 3 EN 1 FACE REFINING FOUNDATION SPF 25 by

Drug Labeling and Warnings

ESIKA PRO INSTANT PERFECTION 3 EN 1 FACE REFINING FOUNDATION SPF 25 by is a Otc medication manufactured, distributed, or labeled by Ventura International LTD, Bel Star S.A. (Colombia). Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active Ingredients	Purpose
OCTINOXATE 6.5 %	Sunscreen
ZINC OXIDE 3.5 %	Sunscreen

Uses

• Helps prevent sunburn.

Warnings

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

• Do not use on damaged or broken skin.

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

• Stop use and ask a doctor if rash occurs.

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

Directions

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

Other information

• Protect the product in this container from excessive heat and direct sun

Inactive ingredients

ISODODECANE, DIMETHICONE, POLYSILICONE-11, WATER, ZEA MAYS (CORN) STARCH, PEG-10 DIMETHICONE, GLYCERIN, BENZIMIDAZOLE DIAMOND AMIDOETHYL UREA CARBAMOYL PROPYL POLYMETHYLSILSESQUIOXANE, ALUMINA, SILICA, POLYMETHYLSILSESQUIOXANE, BENTONITE, PHENOXYETHANOL, HDI/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER, METHYLPROPANEDIOL, TOCOPHERYL ACETATE, CAPRYLYL GLYCOL, CHLORPHENESIN, TRIETHOXYCAPRYLYLSILANE, SILANEDIOL SALICYLATE, OLIVE OIL DECYL ESTERS, TROMETHAMINE, LAURETH-12, CERAMIDE 3, CITRIC ACID, HYDRATED SILICA, LACTIC ACID, SQUALENE, CHLORELLA VULGARIS EXTRACT, SEA SALT, TOCOPHEROL. MAY CONTAIN: TITANIUM DIOXIDE, IRON OXIDES, MICA.

SPL UNCLASSIFIED SECTION

Dist. by Ventura Int Ltd. DBA Belcorp USA, Miami,
FL 33126.

PRINCIPAL DISPLAY PANEL - 30 g Tube Box - CLARO 1 - BEIGE

ésika
PRO

INSTANT PERFECTION
3 EN 1

Face Refining Foundation
SPF 25

Net Wt. 1 oz e (30 g)

PRINCIPAL DISPLAY PANEL - 30 g Tube Box - CLARO 2 - BEIGE

ésika
PRO

INSTANT PERFECTION
3 EN 1

Face Refining Foundation
SPF 25

Net Wt. 1 oz e (30 g)

PRINCIPAL DISPLAY PANEL - 30 g Tube Box - MEDIO 1 - BEIGE

ésika
PRO

INSTANT PERFECTION
3 EN 1

Face Refining Foundation
SPF 25

Net Wt. 1 oz e (30 g)

PRINCIPAL DISPLAY PANEL - 30 g Tube Box - MEDIO 2 - BEIGE

ésika
PRO

INSTANT PERFECTION
3 EN 1

Face Refining Foundation
SPF 25

Net Wt. 1 oz e (30 g)

PRINCIPAL DISPLAY PANEL - 30 g Tube Box - MEDIO 3 - BEIGE

ésika
PRO

INSTANT PERFECTION
3 EN 1

Face Refining Foundation
SPF 25

Net Wt. 1 oz e (30 g)

PRINCIPAL DISPLAY PANEL - 30 g Tube Box - MEDIO 4 - BEIGE

ésika
PRO

INSTANT PERFECTION
3 EN 1

Face Refining Foundation
SPF 25

Net Wt. 1 oz e (30 g)

PRINCIPAL DISPLAY PANEL - 30 g Tube Box - MEDIO 5 - BEIGE

ésika
PRO

INSTANT PERFECTION
3 EN 1

Face Refining Foundation
SPF 25

Net Wt. 1 oz e (30 g)

PRINCIPAL DISPLAY PANEL - 3 g Tube Box - CLARO 1 - BEIGE

ésika
PRO

INSTANT
PERFECTION 3 EN 1

Face Refining
Foundation SPF 25

Net Wt. 0.10 oz. e (3 g)

PRINCIPAL DISPLAY PANEL - 3 g Tube Box - CLARO 2 - BEIGE

ésika
PRO

INSTANT
PERFECTION 3 EN 1

Face Refining
Foundation SPF 25

Net Wt. 0.10 oz. e (3 g)

PRINCIPAL DISPLAY PANEL - 3 g Tube Box - MEDIO 1 - BEIGE

ésika
PRO

INSTANT
PERFECTION 3 EN 1

Face Refining
Foundation SPF 25

Net Wt. 0.10 oz. e (3 g)

PRINCIPAL DISPLAY PANEL - 3 g Tube Box - MEDIO 2 - BEIGE

ésika
PRO

INSTANT
PERFECTION 3 EN 1

Face Refining
Foundation SPF 25

Net Wt. 0.10 oz. e (3 g)

PRINCIPAL DISPLAY PANEL - 3 g Tube Box - MEDIO 3 - BEIGE

ésika
PRO

INSTANT
PERFECTION 3 EN 1

Face Refining
Foundation SPF 25

Net Wt. 0.10 oz. e (3 g)

PRINCIPAL DISPLAY PANEL - 3 g Tube Box - MEDIO 4 - BEIGE

ésika
PRO

INSTANT
PERFECTION 3 EN 1

Face Refining
Foundation SPF 25

Net Wt. 0.10 oz. e (3 g)

PRINCIPAL DISPLAY PANEL - 3 g Tube Box - MEDIO 5 - BEIGE

ésika
PRO

INSTANT
PERFECTION 3 EN 1

Face Refining
Foundation SPF 25

Net Wt. 0.10 oz. e (3 g)

INGREDIENTS AND APPEARANCE

ESIKA PRO INSTANT PERFECTION 3 EN 1 FACE REFINING FOUNDATION SPF 25   CLARO 1 - BEIGE
octinoxate and zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 14783-064
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	0.065 g  in 1 g
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z)	Zinc Oxide	0.036 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
ISODODECANE (UNII: A8289P68Y2)
DIMETHICONE (UNII: 92RU3N3Y1O)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)
WATER (UNII: 059QF0KO0R)
STARCH, CORN (UNII: O8232NY3SJ)
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
GLYCERIN (UNII: PDC6A3C0OX)
ALUMINUM OXIDE (UNII: LMI26O6933)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
BENTONITE (UNII: A3N5ZCN45C)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
HEXAMETHYLENE DIISOCYANATE/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER (UNII: WB5K9Y35Y9)
METHYLPROPANEDIOL (UNII: N8F53B3R4R)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
CHLORPHENESIN (UNII: I670DAL4SZ)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
SILANEDIOL SALICYLATE (UNII: C054DF30K0)
OLIVE OIL DECYL ESTERS (UNII: 3AQ222F18X)
TROMETHAMINE (UNII: 023C2WHX2V)
LAURETH-12 (UNII: OAH19558U1)
CERAMIDE NP (UNII: 4370DF050B)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
HYDRATED SILICA (UNII: Y6O7T4G8P9)
LACTIC ACID, UNSPECIFIED FORM (UNII: 33X04XA5AT)
SQUALENE (UNII: 7QWM220FJH)
CHLORELLA VULGARIS (UNII: RYQ4R60M02)
SEA SALT (UNII: 87GE52P74G)
TOCOPHEROL (UNII: R0ZB2556P8)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FERRIC OXIDE RED (UNII: 1K09F3G675)
MICA (UNII: V8A1AW0880)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 14783-064-02	1 in 1 BOX	12/16/2016
1	NDC: 14783-064-01	30 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part352	12/16/2016

ESIKA PRO INSTANT PERFECTION 3 EN 1 FACE REFINING FOUNDATION SPF 25   CLARO 2 - BEIGE
octinoxate and zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 14783-065
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	0.065 g  in 1 g
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z)	Zinc Oxide	0.036 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
ISODODECANE (UNII: A8289P68Y2)
DIMETHICONE (UNII: 92RU3N3Y1O)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)
WATER (UNII: 059QF0KO0R)
STARCH, CORN (UNII: O8232NY3SJ)
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
GLYCERIN (UNII: PDC6A3C0OX)
ALUMINUM OXIDE (UNII: LMI26O6933)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
BENTONITE (UNII: A3N5ZCN45C)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
HEXAMETHYLENE DIISOCYANATE/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER (UNII: WB5K9Y35Y9)
METHYLPROPANEDIOL (UNII: N8F53B3R4R)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
CHLORPHENESIN (UNII: I670DAL4SZ)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
SILANEDIOL SALICYLATE (UNII: C054DF30K0)
OLIVE OIL DECYL ESTERS (UNII: 3AQ222F18X)
TROMETHAMINE (UNII: 023C2WHX2V)
LAURETH-12 (UNII: OAH19558U1)
CERAMIDE NP (UNII: 4370DF050B)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
HYDRATED SILICA (UNII: Y6O7T4G8P9)
LACTIC ACID, UNSPECIFIED FORM (UNII: 33X04XA5AT)
SQUALENE (UNII: 7QWM220FJH)
CHLORELLA VULGARIS (UNII: RYQ4R60M02)
SEA SALT (UNII: 87GE52P74G)
TOCOPHEROL (UNII: R0ZB2556P8)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FERRIC OXIDE RED (UNII: 1K09F3G675)
MICA (UNII: V8A1AW0880)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 14783-065-02	1 in 1 BOX	12/16/2016
1	NDC: 14783-065-01	30 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part352	12/16/2016

ESIKA PRO INSTANT PERFECTION 3 EN 1 FACE REFINING FOUNDATION SPF 25   MEDIO 1 - BEIGE
octinoxate and zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 14783-066
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	0.065 g  in 1 g
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z)	Zinc Oxide	0.036 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
ISODODECANE (UNII: A8289P68Y2)
DIMETHICONE (UNII: 92RU3N3Y1O)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)
WATER (UNII: 059QF0KO0R)
STARCH, CORN (UNII: O8232NY3SJ)
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
GLYCERIN (UNII: PDC6A3C0OX)
ALUMINUM OXIDE (UNII: LMI26O6933)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
BENTONITE (UNII: A3N5ZCN45C)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
HEXAMETHYLENE DIISOCYANATE/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER (UNII: WB5K9Y35Y9)
METHYLPROPANEDIOL (UNII: N8F53B3R4R)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
CHLORPHENESIN (UNII: I670DAL4SZ)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
SILANEDIOL SALICYLATE (UNII: C054DF30K0)
OLIVE OIL DECYL ESTERS (UNII: 3AQ222F18X)
TROMETHAMINE (UNII: 023C2WHX2V)
LAURETH-12 (UNII: OAH19558U1)
CERAMIDE NP (UNII: 4370DF050B)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
HYDRATED SILICA (UNII: Y6O7T4G8P9)
LACTIC ACID, UNSPECIFIED FORM (UNII: 33X04XA5AT)
SQUALENE (UNII: 7QWM220FJH)
CHLORELLA VULGARIS (UNII: RYQ4R60M02)
SEA SALT (UNII: 87GE52P74G)
TOCOPHEROL (UNII: R0ZB2556P8)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FERRIC OXIDE RED (UNII: 1K09F3G675)
MICA (UNII: V8A1AW0880)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 14783-066-02	1 in 1 BOX	12/16/2016
1	NDC: 14783-066-01	30 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part352	12/16/2016

ESIKA PRO INSTANT PERFECTION 3 EN 1 FACE REFINING FOUNDATION SPF 25   MEDIO 2 - BEIGE
octinoxate and zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 14783-067
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	0.065 g  in 1 g
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z)	Zinc Oxide	0.036 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
ISODODECANE (UNII: A8289P68Y2)
DIMETHICONE (UNII: 92RU3N3Y1O)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)
WATER (UNII: 059QF0KO0R)
STARCH, CORN (UNII: O8232NY3SJ)
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
GLYCERIN (UNII: PDC6A3C0OX)
ALUMINUM OXIDE (UNII: LMI26O6933)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
BENTONITE (UNII: A3N5ZCN45C)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
HEXAMETHYLENE DIISOCYANATE/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER (UNII: WB5K9Y35Y9)
METHYLPROPANEDIOL (UNII: N8F53B3R4R)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
CHLORPHENESIN (UNII: I670DAL4SZ)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
SILANEDIOL SALICYLATE (UNII: C054DF30K0)
OLIVE OIL DECYL ESTERS (UNII: 3AQ222F18X)
TROMETHAMINE (UNII: 023C2WHX2V)
LAURETH-12 (UNII: OAH19558U1)
CERAMIDE NP (UNII: 4370DF050B)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
HYDRATED SILICA (UNII: Y6O7T4G8P9)
LACTIC ACID, UNSPECIFIED FORM (UNII: 33X04XA5AT)
SQUALENE (UNII: 7QWM220FJH)
CHLORELLA VULGARIS (UNII: RYQ4R60M02)
SEA SALT (UNII: 87GE52P74G)
TOCOPHEROL (UNII: R0ZB2556P8)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FERRIC OXIDE RED (UNII: 1K09F3G675)
MICA (UNII: V8A1AW0880)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 14783-067-02	1 in 1 BOX	12/16/2016
1	NDC: 14783-067-01	30 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part352	12/16/2016

ESIKA PRO INSTANT PERFECTION 3 EN 1 FACE REFINING FOUNDATION SPF 25   MEDIO 3 - BEIGE
octinoxate and zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 14783-068
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	0.065 g  in 1 g
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z)	Zinc Oxide	0.036 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
ISODODECANE (UNII: A8289P68Y2)
DIMETHICONE (UNII: 92RU3N3Y1O)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)
WATER (UNII: 059QF0KO0R)
STARCH, CORN (UNII: O8232NY3SJ)
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
GLYCERIN (UNII: PDC6A3C0OX)
ALUMINUM OXIDE (UNII: LMI26O6933)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
BENTONITE (UNII: A3N5ZCN45C)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
HEXAMETHYLENE DIISOCYANATE/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER (UNII: WB5K9Y35Y9)
METHYLPROPANEDIOL (UNII: N8F53B3R4R)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
CHLORPHENESIN (UNII: I670DAL4SZ)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
SILANEDIOL SALICYLATE (UNII: C054DF30K0)
OLIVE OIL DECYL ESTERS (UNII: 3AQ222F18X)
TROMETHAMINE (UNII: 023C2WHX2V)
LAURETH-12 (UNII: OAH19558U1)
CERAMIDE NP (UNII: 4370DF050B)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
HYDRATED SILICA (UNII: Y6O7T4G8P9)
LACTIC ACID, UNSPECIFIED FORM (UNII: 33X04XA5AT)
SQUALENE (UNII: 7QWM220FJH)
CHLORELLA VULGARIS (UNII: RYQ4R60M02)
SEA SALT (UNII: 87GE52P74G)
TOCOPHEROL (UNII: R0ZB2556P8)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FERRIC OXIDE RED (UNII: 1K09F3G675)
MICA (UNII: V8A1AW0880)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 14783-068-02	1 in 1 BOX	12/16/2016
1	NDC: 14783-068-01	30 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part352	12/16/2016

ESIKA PRO INSTANT PERFECTION 3 EN 1 FACE REFINING FOUNDATION SPF 25   MEDIO 4 - BEIGE
octinoxate and zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 14783-069
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	0.065 g  in 1 g
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z)	Zinc Oxide	0.036 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
ISODODECANE (UNII: A8289P68Y2)
DIMETHICONE (UNII: 92RU3N3Y1O)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)
WATER (UNII: 059QF0KO0R)
STARCH, CORN (UNII: O8232NY3SJ)
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
GLYCERIN (UNII: PDC6A3C0OX)
ALUMINUM OXIDE (UNII: LMI26O6933)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
BENTONITE (UNII: A3N5ZCN45C)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
HEXAMETHYLENE DIISOCYANATE/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER (UNII: WB5K9Y35Y9)
METHYLPROPANEDIOL (UNII: N8F53B3R4R)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
CHLORPHENESIN (UNII: I670DAL4SZ)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
SILANEDIOL SALICYLATE (UNII: C054DF30K0)
OLIVE OIL DECYL ESTERS (UNII: 3AQ222F18X)
TROMETHAMINE (UNII: 023C2WHX2V)
LAURETH-12 (UNII: OAH19558U1)
CERAMIDE NP (UNII: 4370DF050B)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
HYDRATED SILICA (UNII: Y6O7T4G8P9)
LACTIC ACID, UNSPECIFIED FORM (UNII: 33X04XA5AT)
SQUALENE (UNII: 7QWM220FJH)
CHLORELLA VULGARIS (UNII: RYQ4R60M02)
SEA SALT (UNII: 87GE52P74G)
TOCOPHEROL (UNII: R0ZB2556P8)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FERRIC OXIDE RED (UNII: 1K09F3G675)
MICA (UNII: V8A1AW0880)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 14783-069-02	1 in 1 BOX	12/16/2016
1	NDC: 14783-069-01	30 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part352	12/16/2016

ESIKA PRO INSTANT PERFECTION 3 EN 1 FACE REFINING FOUNDATION SPF 25   MEDIO 5 - BEIGE
octinoxate and zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 14783-070
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	0.065 g  in 1 g
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z)	Zinc Oxide	0.036 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
ISODODECANE (UNII: A8289P68Y2)
DIMETHICONE (UNII: 92RU3N3Y1O)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)
WATER (UNII: 059QF0KO0R)
STARCH, CORN (UNII: O8232NY3SJ)
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
GLYCERIN (UNII: PDC6A3C0OX)
ALUMINUM OXIDE (UNII: LMI26O6933)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
BENTONITE (UNII: A3N5ZCN45C)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
HEXAMETHYLENE DIISOCYANATE/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER (UNII: WB5K9Y35Y9)
METHYLPROPANEDIOL (UNII: N8F53B3R4R)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
CHLORPHENESIN (UNII: I670DAL4SZ)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
SILANEDIOL SALICYLATE (UNII: C054DF30K0)
OLIVE OIL DECYL ESTERS (UNII: 3AQ222F18X)
TROMETHAMINE (UNII: 023C2WHX2V)
LAURETH-12 (UNII: OAH19558U1)
CERAMIDE NP (UNII: 4370DF050B)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
HYDRATED SILICA (UNII: Y6O7T4G8P9)
LACTIC ACID, UNSPECIFIED FORM (UNII: 33X04XA5AT)
SQUALENE (UNII: 7QWM220FJH)
CHLORELLA VULGARIS (UNII: RYQ4R60M02)
SEA SALT (UNII: 87GE52P74G)
TOCOPHEROL (UNII: R0ZB2556P8)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FERRIC OXIDE RED (UNII: 1K09F3G675)
MICA (UNII: V8A1AW0880)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 14783-070-02	1 in 1 BOX	12/16/2016
1	NDC: 14783-070-01	30 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part352	12/16/2016

ESIKA PRO INSTANT PERFECTION 3 EN 1 FACE REFINING FOUNDATION SPF 25   CLARO 1 - BEIGE
octinoxate and zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 14783-071
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	0.065 g  in 1 g
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z)	Zinc Oxide	0.036 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
ISODODECANE (UNII: A8289P68Y2)
DIMETHICONE (UNII: 92RU3N3Y1O)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)
WATER (UNII: 059QF0KO0R)
STARCH, CORN (UNII: O8232NY3SJ)
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
GLYCERIN (UNII: PDC6A3C0OX)
ALUMINUM OXIDE (UNII: LMI26O6933)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
BENTONITE (UNII: A3N5ZCN45C)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
HEXAMETHYLENE DIISOCYANATE/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER (UNII: WB5K9Y35Y9)
METHYLPROPANEDIOL (UNII: N8F53B3R4R)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
CHLORPHENESIN (UNII: I670DAL4SZ)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
SILANEDIOL SALICYLATE (UNII: C054DF30K0)
OLIVE OIL DECYL ESTERS (UNII: 3AQ222F18X)
TROMETHAMINE (UNII: 023C2WHX2V)
LAURETH-12 (UNII: OAH19558U1)
CERAMIDE NP (UNII: 4370DF050B)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
HYDRATED SILICA (UNII: Y6O7T4G8P9)
LACTIC ACID, UNSPECIFIED FORM (UNII: 33X04XA5AT)
SQUALENE (UNII: 7QWM220FJH)
CHLORELLA VULGARIS (UNII: RYQ4R60M02)
SEA SALT (UNII: 87GE52P74G)
TOCOPHEROL (UNII: R0ZB2556P8)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FERRIC OXIDE RED (UNII: 1K09F3G675)
MICA (UNII: V8A1AW0880)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 14783-071-02	1 in 1 BOX	12/16/2016
1	NDC: 14783-071-01	3 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part352	12/16/2016

ESIKA PRO INSTANT PERFECTION 3 EN 1 FACE REFINING FOUNDATION SPF 25   CLARO 2 - BEIGE
octinoxate and zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 14783-073
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	0.065 g  in 1 g
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z)	Zinc Oxide	0.036 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
ISODODECANE (UNII: A8289P68Y2)
DIMETHICONE (UNII: 92RU3N3Y1O)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)
WATER (UNII: 059QF0KO0R)
STARCH, CORN (UNII: O8232NY3SJ)
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
GLYCERIN (UNII: PDC6A3C0OX)
ALUMINUM OXIDE (UNII: LMI26O6933)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
BENTONITE (UNII: A3N5ZCN45C)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
HEXAMETHYLENE DIISOCYANATE/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER (UNII: WB5K9Y35Y9)
METHYLPROPANEDIOL (UNII: N8F53B3R4R)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
CHLORPHENESIN (UNII: I670DAL4SZ)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
SILANEDIOL SALICYLATE (UNII: C054DF30K0)
OLIVE OIL DECYL ESTERS (UNII: 3AQ222F18X)
TROMETHAMINE (UNII: 023C2WHX2V)
LAURETH-12 (UNII: OAH19558U1)
CERAMIDE NP (UNII: 4370DF050B)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
HYDRATED SILICA (UNII: Y6O7T4G8P9)
LACTIC ACID, UNSPECIFIED FORM (UNII: 33X04XA5AT)
SQUALENE (UNII: 7QWM220FJH)
CHLORELLA VULGARIS (UNII: RYQ4R60M02)
SEA SALT (UNII: 87GE52P74G)
TOCOPHEROL (UNII: R0ZB2556P8)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FERRIC OXIDE RED (UNII: 1K09F3G675)
MICA (UNII: V8A1AW0880)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 14783-073-02	1 in 1 BOX	12/16/2016
1	NDC: 14783-073-01	3 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part352	12/16/2016

ESIKA PRO INSTANT PERFECTION 3 EN 1 FACE REFINING FOUNDATION SPF 25   MEDIO 1 - BEIGE
octinoxate and zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 14783-074
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	0.065 g  in 1 g
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z)	Zinc Oxide	0.036 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
ISODODECANE (UNII: A8289P68Y2)
DIMETHICONE (UNII: 92RU3N3Y1O)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)
WATER (UNII: 059QF0KO0R)
STARCH, CORN (UNII: O8232NY3SJ)
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
GLYCERIN (UNII: PDC6A3C0OX)
ALUMINUM OXIDE (UNII: LMI26O6933)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
BENTONITE (UNII: A3N5ZCN45C)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
HEXAMETHYLENE DIISOCYANATE/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER (UNII: WB5K9Y35Y9)
METHYLPROPANEDIOL (UNII: N8F53B3R4R)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
CHLORPHENESIN (UNII: I670DAL4SZ)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
SILANEDIOL SALICYLATE (UNII: C054DF30K0)
OLIVE OIL DECYL ESTERS (UNII: 3AQ222F18X)
TROMETHAMINE (UNII: 023C2WHX2V)
LAURETH-12 (UNII: OAH19558U1)
CERAMIDE NP (UNII: 4370DF050B)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
HYDRATED SILICA (UNII: Y6O7T4G8P9)
LACTIC ACID, UNSPECIFIED FORM (UNII: 33X04XA5AT)
SQUALENE (UNII: 7QWM220FJH)
CHLORELLA VULGARIS (UNII: RYQ4R60M02)
SEA SALT (UNII: 87GE52P74G)
TOCOPHEROL (UNII: R0ZB2556P8)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FERRIC OXIDE RED (UNII: 1K09F3G675)
MICA (UNII: V8A1AW0880)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 14783-074-02	1 in 1 BOX	12/16/2016
1	NDC: 14783-074-01	3 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part352	12/16/2016

ESIKA PRO INSTANT PERFECTION 3 EN 1 FACE REFINING FOUNDATION SPF 25   MEDIO 2 - BEIGE
octinoxate and zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 14783-075
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	0.065 g  in 1 g
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z)	Zinc Oxide	0.036 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
ISODODECANE (UNII: A8289P68Y2)
DIMETHICONE (UNII: 92RU3N3Y1O)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)
WATER (UNII: 059QF0KO0R)
STARCH, CORN (UNII: O8232NY3SJ)
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
GLYCERIN (UNII: PDC6A3C0OX)
ALUMINUM OXIDE (UNII: LMI26O6933)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
BENTONITE (UNII: A3N5ZCN45C)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
HEXAMETHYLENE DIISOCYANATE/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER (UNII: WB5K9Y35Y9)
METHYLPROPANEDIOL (UNII: N8F53B3R4R)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
CHLORPHENESIN (UNII: I670DAL4SZ)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
SILANEDIOL SALICYLATE (UNII: C054DF30K0)
OLIVE OIL DECYL ESTERS (UNII: 3AQ222F18X)
TROMETHAMINE (UNII: 023C2WHX2V)
LAURETH-12 (UNII: OAH19558U1)
CERAMIDE NP (UNII: 4370DF050B)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
HYDRATED SILICA (UNII: Y6O7T4G8P9)
LACTIC ACID, UNSPECIFIED FORM (UNII: 33X04XA5AT)
SQUALENE (UNII: 7QWM220FJH)
CHLORELLA VULGARIS (UNII: RYQ4R60M02)
SEA SALT (UNII: 87GE52P74G)
TOCOPHEROL (UNII: R0ZB2556P8)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FERRIC OXIDE RED (UNII: 1K09F3G675)
MICA (UNII: V8A1AW0880)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 14783-075-02	1 in 1 BOX	12/16/2016
1	NDC: 14783-075-01	3 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part352	12/16/2016

ESIKA PRO INSTANT PERFECTION 3 EN 1 FACE REFINING FOUNDATION SPF 25   MEDIO 3 - BEIGE
octinoxate and zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 14783-076
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	0.065 g  in 1 g
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z)	Zinc Oxide	0.036 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
ISODODECANE (UNII: A8289P68Y2)
DIMETHICONE (UNII: 92RU3N3Y1O)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)
WATER (UNII: 059QF0KO0R)
STARCH, CORN (UNII: O8232NY3SJ)
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
GLYCERIN (UNII: PDC6A3C0OX)
ALUMINUM OXIDE (UNII: LMI26O6933)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
BENTONITE (UNII: A3N5ZCN45C)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
HEXAMETHYLENE DIISOCYANATE/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER (UNII: WB5K9Y35Y9)
METHYLPROPANEDIOL (UNII: N8F53B3R4R)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
CHLORPHENESIN (UNII: I670DAL4SZ)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
SILANEDIOL SALICYLATE (UNII: C054DF30K0)
OLIVE OIL DECYL ESTERS (UNII: 3AQ222F18X)
TROMETHAMINE (UNII: 023C2WHX2V)
LAURETH-12 (UNII: OAH19558U1)
CERAMIDE NP (UNII: 4370DF050B)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
HYDRATED SILICA (UNII: Y6O7T4G8P9)
LACTIC ACID, UNSPECIFIED FORM (UNII: 33X04XA5AT)
SQUALENE (UNII: 7QWM220FJH)
CHLORELLA VULGARIS (UNII: RYQ4R60M02)
SEA SALT (UNII: 87GE52P74G)
TOCOPHEROL (UNII: R0ZB2556P8)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FERRIC OXIDE RED (UNII: 1K09F3G675)
MICA (UNII: V8A1AW0880)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 14783-076-02	1 in 1 BOX	12/16/2016
1	NDC: 14783-076-01	3 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part352	12/16/2016

ESIKA PRO INSTANT PERFECTION 3 EN 1 FACE REFINING FOUNDATION SPF 25   MEDIO 4 - BEIGE
octinoxate and zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 14783-078
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	0.065 g  in 1 g
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z)	Zinc Oxide	0.036 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
ISODODECANE (UNII: A8289P68Y2)
DIMETHICONE (UNII: 92RU3N3Y1O)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)
WATER (UNII: 059QF0KO0R)
STARCH, CORN (UNII: O8232NY3SJ)
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
GLYCERIN (UNII: PDC6A3C0OX)
ALUMINUM OXIDE (UNII: LMI26O6933)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
BENTONITE (UNII: A3N5ZCN45C)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
HEXAMETHYLENE DIISOCYANATE/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER (UNII: WB5K9Y35Y9)
METHYLPROPANEDIOL (UNII: N8F53B3R4R)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
CHLORPHENESIN (UNII: I670DAL4SZ)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
SILANEDIOL SALICYLATE (UNII: C054DF30K0)
OLIVE OIL DECYL ESTERS (UNII: 3AQ222F18X)
TROMETHAMINE (UNII: 023C2WHX2V)
LAURETH-12 (UNII: OAH19558U1)
CERAMIDE NP (UNII: 4370DF050B)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
HYDRATED SILICA (UNII: Y6O7T4G8P9)
LACTIC ACID, UNSPECIFIED FORM (UNII: 33X04XA5AT)
SQUALENE (UNII: 7QWM220FJH)
CHLORELLA VULGARIS (UNII: RYQ4R60M02)
SEA SALT (UNII: 87GE52P74G)
TOCOPHEROL (UNII: R0ZB2556P8)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FERRIC OXIDE RED (UNII: 1K09F3G675)
MICA (UNII: V8A1AW0880)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 14783-078-02	1 in 1 BOX	12/16/2016
1	NDC: 14783-078-01	3 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part352	12/16/2016

ESIKA PRO INSTANT PERFECTION 3 EN 1 FACE REFINING FOUNDATION SPF 25   MEDIO 5 - BEIGE
octinoxate and zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 14783-079
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	0.065 g  in 1 g
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z)	Zinc Oxide	0.036 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
ISODODECANE (UNII: A8289P68Y2)
DIMETHICONE (UNII: 92RU3N3Y1O)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)
WATER (UNII: 059QF0KO0R)
STARCH, CORN (UNII: O8232NY3SJ)
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
GLYCERIN (UNII: PDC6A3C0OX)
ALUMINUM OXIDE (UNII: LMI26O6933)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
BENTONITE (UNII: A3N5ZCN45C)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
HEXAMETHYLENE DIISOCYANATE/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER (UNII: WB5K9Y35Y9)
METHYLPROPANEDIOL (UNII: N8F53B3R4R)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
CHLORPHENESIN (UNII: I670DAL4SZ)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
SILANEDIOL SALICYLATE (UNII: C054DF30K0)
OLIVE OIL DECYL ESTERS (UNII: 3AQ222F18X)
TROMETHAMINE (UNII: 023C2WHX2V)
LAURETH-12 (UNII: OAH19558U1)
CERAMIDE NP (UNII: 4370DF050B)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
HYDRATED SILICA (UNII: Y6O7T4G8P9)
LACTIC ACID, UNSPECIFIED FORM (UNII: 33X04XA5AT)
SQUALENE (UNII: 7QWM220FJH)
CHLORELLA VULGARIS (UNII: RYQ4R60M02)
SEA SALT (UNII: 87GE52P74G)
TOCOPHEROL (UNII: R0ZB2556P8)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FERRIC OXIDE RED (UNII: 1K09F3G675)
MICA (UNII: V8A1AW0880)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 14783-079-02	1 in 1 BOX	12/16/2016
1	NDC: 14783-079-01	3 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part352	12/16/2016

Labeler - Ventura International LTD (603192787)

Establishment
Name	Address	ID/FEI	Business Operations
Bel Star S.A. (Colombia)		880160197	MANUFACTURE(14783-064, 14783-065, 14783-066, 14783-067, 14783-068, 14783-069, 14783-070, 14783-071, 14783-073, 14783-074, 14783-075, 14783-076, 14783-078, 14783-079)