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
Ventura Corporation

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

----------

ÉSIKA PRO NATURAL MATTIFYING FOUNDATION ADAPTABLE TO YOUR SKIN TONE SPF 20

Drug Facts

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.

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 1/Beige

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 - Claro 2/Beige

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 - Medio1/Beige

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 - Medio2/Beige

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 - Medio3/Beige

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 - Medio4/Beige

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)

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

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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
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 Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
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 Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

Ingredient Name	Strength
Inactive Ingredients
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)
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)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
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 Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
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 Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
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 Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
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 Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
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 Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part352	10/19/2018

Labeler - Ventura Corporation (602751344)

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

Revised: 11/2020

Document Id: b4f5d92a-1f82-dbca-e053-2995a90ad759

Set id: ad8524d1-cbce-48d9-a968-a06636a48600

Version: 2

Effective Time: 20201125

Ventura Corporation