ESIKA PRO NATURAL MATTE MATTIFYING FOUNDATION ADAPTABLE TO YOUR SKIN TONE SPF 20 CLARO 1/BEIGE- octinoxate and zinc oxide cream
ESIKA PRO NATURAL MATTE MATTIFYING FOUNDATION ADAPTABLE TO YOUR SKIN TONE SPF 20 MEDIO1/BEIGE- octinoxate and zinc oxide cream
ESIKA PRO NATURAL MATTE MATTIFYING FOUNDATION ADAPTABLE TO YOUR SKIN TONE SPF 20 CLARO 2/BEIGE- octinoxate and zinc oxide cream
ESIKA PRO NATURAL MATTE MATTIFYING FOUNDATION ADAPTABLE TO YOUR SKIN TONE SPF 20 MEDIO2/BEIGE- octinoxate and zinc oxide cream
ESIKA PRO NATURAL MATTE MATTIFYING FOUNDATION ADAPTABLE TO YOUR SKIN TONE SPF 20 MEDIO3/BEIGE- octinoxate and zinc oxide cream
ESIKA PRO NATURAL MATTE MATTIFYING FOUNDATION ADAPTABLE TO YOUR SKIN TONE SPF 20 MEDIO4/BEIGE- octinoxate and zinc oxide cream
ESIKA PRO NATURAL MATTE MATTIFYING FOUNDATION ADAPTABLE TO YOUR SKIN TONE SPF 20 MEDIO5/BEIGE- octinoxate and zinc oxide cream
Bel Star S.A. (Colombia)

----------

ÉSIKA PRO NATURAL MATTE 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, notskin cancer or early skin aging.

For external use only.

Do not useon damaged or broken skin.

When using this productkeep out of eyes. Rinse with water to remove.

Stop use and ask a doctor ifrash 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 MATTE 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:14141-125
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:14141-125-02	1 in 1 BOX	10/19/2018
1	NDC:14141-125-01	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 Drug	M020	10/19/2018	07/09/2023

ESIKA PRO NATURAL MATTE 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:14141-120
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
PHENOXYETHANOL (UNII: HIE492ZZ3T)
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)
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:14141-120-02	1 in 1 BOX	10/19/2018
1	NDC:14141-120-01	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 Drug	M020	10/19/2018	07/23/2023

ESIKA PRO NATURAL MATTE 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:14141-119
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:14141-119-02	1 in 1 BOX	10/19/2018
1	NDC:14141-119-01	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 Drug	M020	10/19/2018	07/23/2023

ESIKA PRO NATURAL MATTE 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:14141-121
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:14141-121-02	1 in 1 BOX	10/19/2018
1	NDC:14141-121-01	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 Drug	M020	10/19/2018	07/23/2023

ESIKA PRO NATURAL MATTE 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:14141-122
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:14141-122-02	1 in 1 BOX	10/19/2018
1	NDC:14141-122-01	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 Drug	M020	10/19/2018	07/09/2023

ESIKA PRO NATURAL MATTE 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:14141-123
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:14141-123-02	1 in 1 BOX	10/19/2018
1	NDC:14141-123-01	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 Drug	M020	10/19/2018	07/09/2023

ESIKA PRO NATURAL MATTE 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:14141-124
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:14141-124-02	1 in 1 BOX	10/19/2018
1	NDC:14141-124-01	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 Drug	M020	10/19/2018	07/23/2023

Labeler - Bel Star S.A. (Colombia) (880160197)

Name	Address	ID/FEI	Business Operations
Establishment
Bel Star S.A. (Colombia)		880160197	manufacture(14141-119, 14141-120, 14141-121, 14141-122, 14141-123, 14141-124, 14141-125)

Revised: 12/2023

Document Id: 0cd1bdbc-5b7c-9f6b-e063-6294a90a7043

Set id: d7d40e66-ae00-4dfd-bed9-299528668387

Version: 2

Effective Time: 20231218

Bel Star S.A. (Colombia)