ESIKA PRO NATURAL MATTIFYING FOUNDATION ADAPTABLE TO YOUR SKIN TONE SPF 20 CLARO 1/BEIGE- octinoxate and zinc oxide cream ESIKA PRO NATURAL MATTIFYING FOUNDATION ADAPTABLE TO YOUR SKIN TONE SPF 20 CLARO 2/BEIGE- octinoxate and zinc oxide cream ESIKA PRO NATURAL MATTIFYING FOUNDATION ADAPTABLE TO YOUR SKIN TONE SPF 20 MEDIO1/BEIGE- octinoxate and zinc oxide cream ESIKA PRO NATURAL MATTIFYING FOUNDATION ADAPTABLE TO YOUR SKIN TONE SPF 20 MEDIO2/BEIGE- octinoxate and zinc oxide cream ESIKA PRO NATURAL MATTIFYING FOUNDATION ADAPTABLE TO YOUR SKIN TONE SPF 20 MEDIO3/BEIGE- octinoxate and zinc oxide cream ESIKA PRO NATURAL MATTIFYING FOUNDATION ADAPTABLE TO YOUR SKIN TONE SPF 20 MEDIO4/BEIGE- octinoxate and zinc oxide cream ESIKA PRO NATURAL MATTIFYING FOUNDATION ADAPTABLE TO YOUR SKIN TONE SPF 20 MEDIO5/BEIGE- octinoxate and zinc oxide cream

ESIKA PRO NATURAL MATTIFYING FOUNDATION ADAPTABLE TO YOUR SKIN TONE SPF 20 by

Drug Labeling and Warnings

ESIKA PRO NATURAL MATTIFYING FOUNDATION ADAPTABLE TO YOUR SKIN TONE SPF 20 by is a Otc medication manufactured, distributed, or labeled by Ventura Corporation, 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 5 %	Sunscreen
ZINC OXIDE 4.2 %	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

WATER, DIMETHICONE, ISODODECANE, PEG-10 DIMETHICONE, GLYCERIN, PROPYLENE GLYCOL, POLYMETHYLSILSESQUIOXANE, POLYSILICONE-11, DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER, HDI/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER, PEG/PPG-18/18 DIMETHICONE, HYDROXYACETOPHENONE, SILICA DIMETHYL SILYLATE, SODIUM CHLORIDE, PHENOXYETHANOL, SILICA, TOCOPHERYL ACETATE, METHYLPROPANEDIOL, CAPRYLYL GLYCOL, CHLORPHENESIN, DISTEARDIMONIUM HECTORITE, TRIETHOXYCAPRYLYLSILANE, SILANEDIOL SALICYLATE, BUTYLENE GLYCOL, TROMETHAMINE, FRAGRANCE, AESCULUS HIPPOCASTANUM (HORSE CHESTNUT) SEED EXTRACT, CAMELLIA SINENSIS LEAF EXTRACT, HYDROLYZED WHEAT PROTEIN, SILYBUM MARIANUM FRUIT EXTRACT, LINALOOL, d-LIMONENE, ALPHA-ISOMETHYL IONONE.

MAY CONTAIN : TITANIUM DIOXIDE, IRON OXIDES.

SPL UNCLASSIFIED SECTION

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

PRINCIPAL DISPLAY PANEL - 30 g Bottle Box - Claro 1/Beige

ésika
PRO

NATURAL MATTE

Mattifying foundation
adaptable to your skin
tone SPF 20

Net wt. 1 oz. e (30 g)

PRINCIPAL DISPLAY PANEL - 30 g Bottle Box - Claro 2/Beige

ésika
PRO

NATURAL MATTE

Mattifying foundation
adaptable to your skin
tone SPF 20

Net wt. 1 oz. e (30 g)

PRINCIPAL DISPLAY PANEL - 30 g Bottle Box - Medio1/Beige

ésika
PRO

NATURAL MATTE

Mattifying foundation
adaptable to your skin
tone SPF 20

Net wt. 1 oz. e (30 g)

PRINCIPAL DISPLAY PANEL - 30 g Bottle Box - Medio2/Beige

ésika
PRO

NATURAL MATTE

Mattifying foundation
adaptable to your skin
tone SPF 20

Net wt. 1 oz. e (30 g)

PRINCIPAL DISPLAY PANEL - 30 g Bottle Box - Medio3/Beige

ésika
PRO

NATURAL MATTE

Mattifying foundation
adaptable to your skin
tone SPF 20

Net wt. 1 oz. e (30 g)

PRINCIPAL DISPLAY PANEL - 30 g Bottle Box - Medio4/Beige

ésika
PRO

NATURAL MATTE

Mattifying foundation
adaptable to your skin
tone SPF 20

Net wt. 1 oz. e (30 g)

PRINCIPAL DISPLAY PANEL - 30 g Bottle Box - Medio5/Beige

ésika
PRO

NATURAL MATTE

Mattifying foundation
adaptable to your skin
tone SPF 20

Net wt. 1 oz. e (30 g)

INGREDIENTS AND APPEARANCE

ESIKA PRO NATURAL MATTIFYING FOUNDATION ADAPTABLE TO YOUR SKIN TONE SPF 20   CLARO 1/BEIGE
octinoxate and zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 43596-0125
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	0.05 g  in 1 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	0.042 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
DIMETHICONE (UNII: 92RU3N3Y1O)
ISODODECANE (UNII: A8289P68Y2)
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
GLYCERIN (UNII: PDC6A3C0OX)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)
HEXAMETHYLENE DIISOCYANATE/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER (UNII: WB5K9Y35Y9)
PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794)
HYDROXYACETOPHENONE (UNII: G1L3HT4CMH)
SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
METHYLPROPANEDIOL (UNII: N8F53B3R4R)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
CHLORPHENESIN (UNII: I670DAL4SZ)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
SILANEDIOL SALICYLATE (UNII: C054DF30K0)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
TROMETHAMINE (UNII: 023C2WHX2V)
HORSE CHESTNUT (UNII: 3C18L6RJAZ)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
HYDROLYZED WHEAT PROTEIN (ENZYMATIC; 3000 MW) (UNII: J2S07SB0YL)
MILK THISTLE (UNII: U946SH95EE)
LINALOOL, (+/-)- (UNII: D81QY6I88E)
LIMONENE, (+)- (UNII: GFD7C86Q1W)
ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FERRIC OXIDE RED (UNII: 1K09F3G675)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 43596-0125-2	1 in 1 BOX	10/19/2018
1	NDC: 43596-0125-1	30 g in 1 BOTTLE; 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	10/19/2018

ESIKA PRO NATURAL MATTIFYING FOUNDATION ADAPTABLE TO YOUR SKIN TONE SPF 20   CLARO 2/BEIGE
octinoxate and zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 43596-0119
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	0.05 g  in 1 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	0.042 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
DIMETHICONE (UNII: 92RU3N3Y1O)
ISODODECANE (UNII: A8289P68Y2)
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
GLYCERIN (UNII: PDC6A3C0OX)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)
HEXAMETHYLENE DIISOCYANATE/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER (UNII: WB5K9Y35Y9)
PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794)
HYDROXYACETOPHENONE (UNII: G1L3HT4CMH)
SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
METHYLPROPANEDIOL (UNII: N8F53B3R4R)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
CHLORPHENESIN (UNII: I670DAL4SZ)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
SILANEDIOL SALICYLATE (UNII: C054DF30K0)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
TROMETHAMINE (UNII: 023C2WHX2V)
HORSE CHESTNUT (UNII: 3C18L6RJAZ)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
HYDROLYZED WHEAT PROTEIN (ENZYMATIC; 3000 MW) (UNII: J2S07SB0YL)
MILK THISTLE (UNII: U946SH95EE)
LINALOOL, (+/-)- (UNII: D81QY6I88E)
LIMONENE, (+)- (UNII: GFD7C86Q1W)
ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FERRIC OXIDE RED (UNII: 1K09F3G675)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 43596-0119-2	1 in 1 BOX	10/19/2018
1	NDC: 43596-0119-1	30 g in 1 BOTTLE; 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	10/19/2018

ESIKA PRO NATURAL MATTIFYING FOUNDATION ADAPTABLE TO YOUR SKIN TONE SPF 20   MEDIO1/BEIGE
octinoxate and zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 43596-0120
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	0.05 g  in 1 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	0.042 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
DIMETHICONE (UNII: 92RU3N3Y1O)
ISODODECANE (UNII: A8289P68Y2)
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
GLYCERIN (UNII: PDC6A3C0OX)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)
HEXAMETHYLENE DIISOCYANATE/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER (UNII: WB5K9Y35Y9)
PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794)
HYDROXYACETOPHENONE (UNII: G1L3HT4CMH)
SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
METHYLPROPANEDIOL (UNII: N8F53B3R4R)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
CHLORPHENESIN (UNII: I670DAL4SZ)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
SILANEDIOL SALICYLATE (UNII: C054DF30K0)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
TROMETHAMINE (UNII: 023C2WHX2V)
HORSE CHESTNUT (UNII: 3C18L6RJAZ)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
HYDROLYZED WHEAT PROTEIN (ENZYMATIC; 3000 MW) (UNII: J2S07SB0YL)
MILK THISTLE (UNII: U946SH95EE)
LINALOOL, (+/-)- (UNII: D81QY6I88E)
LIMONENE, (+)- (UNII: GFD7C86Q1W)
ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FERRIC OXIDE RED (UNII: 1K09F3G675)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 43596-0120-2	1 in 1 BOX	10/19/2018
1	NDC: 43596-0120-1	30 g in 1 BOTTLE; 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	10/19/2018

ESIKA PRO NATURAL MATTIFYING FOUNDATION ADAPTABLE TO YOUR SKIN TONE SPF 20   MEDIO2/BEIGE
octinoxate and zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 43596-0121
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	0.05 g  in 1 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	0.042 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
DIMETHICONE (UNII: 92RU3N3Y1O)
ISODODECANE (UNII: A8289P68Y2)
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
GLYCERIN (UNII: PDC6A3C0OX)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)
HEXAMETHYLENE DIISOCYANATE/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER (UNII: WB5K9Y35Y9)
PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794)
HYDROXYACETOPHENONE (UNII: G1L3HT4CMH)
SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
METHYLPROPANEDIOL (UNII: N8F53B3R4R)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
CHLORPHENESIN (UNII: I670DAL4SZ)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
SILANEDIOL SALICYLATE (UNII: C054DF30K0)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
TROMETHAMINE (UNII: 023C2WHX2V)
HORSE CHESTNUT (UNII: 3C18L6RJAZ)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
HYDROLYZED WHEAT PROTEIN (ENZYMATIC; 3000 MW) (UNII: J2S07SB0YL)
MILK THISTLE (UNII: U946SH95EE)
LINALOOL, (+/-)- (UNII: D81QY6I88E)
LIMONENE, (+)- (UNII: GFD7C86Q1W)
ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FERRIC OXIDE RED (UNII: 1K09F3G675)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 43596-0121-2	1 in 1 BOX	10/19/2018
1	NDC: 43596-0121-1	30 g in 1 BOTTLE; 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	10/19/2018

ESIKA PRO NATURAL MATTIFYING FOUNDATION ADAPTABLE TO YOUR SKIN TONE SPF 20   MEDIO3/BEIGE
octinoxate and zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 43596-0122
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	0.05 g  in 1 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	0.042 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
DIMETHICONE (UNII: 92RU3N3Y1O)
ISODODECANE (UNII: A8289P68Y2)
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
GLYCERIN (UNII: PDC6A3C0OX)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)
HEXAMETHYLENE DIISOCYANATE/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER (UNII: WB5K9Y35Y9)
PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794)
HYDROXYACETOPHENONE (UNII: G1L3HT4CMH)
SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
METHYLPROPANEDIOL (UNII: N8F53B3R4R)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
CHLORPHENESIN (UNII: I670DAL4SZ)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
SILANEDIOL SALICYLATE (UNII: C054DF30K0)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
TROMETHAMINE (UNII: 023C2WHX2V)
HORSE CHESTNUT (UNII: 3C18L6RJAZ)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
HYDROLYZED WHEAT PROTEIN (ENZYMATIC; 3000 MW) (UNII: J2S07SB0YL)
MILK THISTLE (UNII: U946SH95EE)
LINALOOL, (+/-)- (UNII: D81QY6I88E)
LIMONENE, (+)- (UNII: GFD7C86Q1W)
ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FERRIC OXIDE RED (UNII: 1K09F3G675)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 43596-0122-2	1 in 1 BOX	10/19/2018
1	NDC: 43596-0122-1	30 g in 1 BOTTLE; 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	10/19/2018

ESIKA PRO NATURAL MATTIFYING FOUNDATION ADAPTABLE TO YOUR SKIN TONE SPF 20   MEDIO4/BEIGE
octinoxate and zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 43596-0123
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	0.05 g  in 1 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	0.042 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
DIMETHICONE (UNII: 92RU3N3Y1O)
ISODODECANE (UNII: A8289P68Y2)
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
GLYCERIN (UNII: PDC6A3C0OX)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)
HEXAMETHYLENE DIISOCYANATE/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER (UNII: WB5K9Y35Y9)
PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794)
HYDROXYACETOPHENONE (UNII: G1L3HT4CMH)
SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
METHYLPROPANEDIOL (UNII: N8F53B3R4R)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
CHLORPHENESIN (UNII: I670DAL4SZ)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
SILANEDIOL SALICYLATE (UNII: C054DF30K0)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
TROMETHAMINE (UNII: 023C2WHX2V)
HORSE CHESTNUT (UNII: 3C18L6RJAZ)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
HYDROLYZED WHEAT PROTEIN (ENZYMATIC; 3000 MW) (UNII: J2S07SB0YL)
MILK THISTLE (UNII: U946SH95EE)
LINALOOL, (+/-)- (UNII: D81QY6I88E)
LIMONENE, (+)- (UNII: GFD7C86Q1W)
ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FERRIC OXIDE RED (UNII: 1K09F3G675)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 43596-0123-2	1 in 1 BOX	10/19/2018
1	NDC: 43596-0123-1	30 g in 1 BOTTLE; 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	10/19/2018

ESIKA PRO NATURAL MATTIFYING FOUNDATION ADAPTABLE TO YOUR SKIN TONE SPF 20   MEDIO5/BEIGE
octinoxate and zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 43596-0124
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	0.05 g  in 1 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	0.042 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
DIMETHICONE (UNII: 92RU3N3Y1O)
ISODODECANE (UNII: A8289P68Y2)
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
GLYCERIN (UNII: PDC6A3C0OX)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)
HEXAMETHYLENE DIISOCYANATE/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER (UNII: WB5K9Y35Y9)
PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794)
HYDROXYACETOPHENONE (UNII: G1L3HT4CMH)
SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
METHYLPROPANEDIOL (UNII: N8F53B3R4R)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
CHLORPHENESIN (UNII: I670DAL4SZ)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
SILANEDIOL SALICYLATE (UNII: C054DF30K0)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
TROMETHAMINE (UNII: 023C2WHX2V)
HORSE CHESTNUT (UNII: 3C18L6RJAZ)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
HYDROLYZED WHEAT PROTEIN (ENZYMATIC; 3000 MW) (UNII: J2S07SB0YL)
MILK THISTLE (UNII: U946SH95EE)
LINALOOL, (+/-)- (UNII: D81QY6I88E)
LIMONENE, (+)- (UNII: GFD7C86Q1W)
ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FERRIC OXIDE RED (UNII: 1K09F3G675)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 43596-0124-2	1 in 1 BOX	10/19/2018
1	NDC: 43596-0124-1	30 g in 1 BOTTLE; 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	10/19/2018

Labeler - Ventura Corporation (602751344)

Establishment
Name	Address	ID/FEI	Business Operations
Bel Star S.A. (Colombia)		880160197	MANUFACTURE(43596-0125, 43596-0119, 43596-0120, 43596-0121, 43596-0122, 43596-0123, 43596-0124)