ESIKA- octinoxate and oxybenzone lotion

ESIKA by

Drug Labeling and Warnings

ESIKA by is a Otc medication manufactured, distributed, or labeled by Ventura Corporation (San Juan, P.R), Bel Star S.A. (Colombia). Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredients

Octinoxate (5%), Oxybenzone (2%)

Purpose

Sunscreen

Uses

• Helps prevent sunburn.
• Higher SPF gives more sunburn protection.
• Provides moderate protection against sunburn.

Warnings

• For external use only

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

• Stop use and ask a doctor if rash and irritation develops and lasts.

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

Directions

• Apply smootly every morning before sun exposure and as needed.
• Apply to the forehead, nose, chin and both cheeks. Blend with circular motion and spread softly.
• Moderate sun protection product.

Other information

• Sun alert: Limiting sun exposure, wearing protective clothing, and using sunscreens may reduce the risk of skin aging, skin cancer, and other harmful effects of the sun.

Inactive ingredients

Aqua (water), cyclomethicone, cyclopentasiloxane, talc, cetyl peg/ppg-10/1 dimethicone, polyglyceryl-4 isostearate, pisum sativum (pea) extract), peg-12 dimethicone crosspolymer, hexyl laurate, isostearyl neopentanoate, disteardimonium hectorite, cyclohexasiloxane, rosa centifolia flower water, sodium chloride, mannitol, dimethicone, propylene carbonate, propylene glycol, phenoxyethanol, octyldodecanol, butylene glycol, dimethiconol, methylparaben, propylparaben, cetearyl dimethicone crosspolymer, tocopheryl acetate, microcristallina cera (microcrystalline wax), methicone, polymethylsilsesquioxane, petrolatum, phospholipids, bha, bht, cyclodextrin, butylparaben, ethylparaben, cholesterol, faex extract (yeast extract), isobutylparaben, candelilla cera (euphorbia cerifera (candelilla) wax), cera alba (beeswax), cetearyl alcohol, cetearyl glucoside, copernicia cerifera cera (copernicia cerifera (carnauba) wax), polyglyceryl-2 dipolyhydroxystearate, olea europaea oil unsaponifiables (olea europaea (olive) oil unsaponifiables), glycosphingolipids, disodium succinate. May contain: CI 77891 (titanium dioxide), CI 77492 (iron oxides), CI 77491 (iron oxides), CI 77499 (iron oxides).

PRINCIPAL DISPLAY PANEL - 30 ml Carton - Beige 1

ēsika

Hydro-Nutritive
Foundation
SPF 13

30 ml e (1 fl.oz.)

PRINCIPAL DISPLAY PANEL - 30 ml Carton - Beige 2

ēsika

Hydro-Nutritive
Foundation
SPF 13

30 ml e (1 fl.oz.)

PRINCIPAL DISPLAY PANEL - 30 ml Carton - Beige 3

ēsika

Hydro-Nutritive
Foundation
SPF 13

30 ml e (1 fl.oz.)

PRINCIPAL DISPLAY PANEL - 30 ml Carton - Beige 4

ēsika

Hydro-Nutritive
Foundation
SPF 13

30 ml e (1 fl.oz.)

PRINCIPAL DISPLAY PANEL - 30 ml Carton - Beige 5

ēsika

Hydro-Nutritive
Foundation
SPF 13

30 ml e (1 fl.oz.)

PRINCIPAL DISPLAY PANEL - 30 ml Carton - Beige 6

ēsika

Hydro-Nutritive
Foundation
SPF 13

30 ml e (1 fl.oz.)

PRINCIPAL DISPLAY PANEL - 30 ml Carton - Rosa 1

ēsika

Hydro-Nutritive
Foundation
SPF 13

30 ml e (1 fl.oz.)

PRINCIPAL DISPLAY PANEL - 30 ml Carton - Rosa 2

ēsika

Hydro-Nutritive
Foundation
SPF 13

30 ml e (1 fl.oz.)

PRINCIPAL DISPLAY PANEL - 30 ml Carton - Rosa 3

ēsika

Hydro-Nutritive
Foundation
SPF 13

30 ml e (1 fl.oz.)

PRINCIPAL DISPLAY PANEL - 30 ml Carton - Rosa 4

ēsika

Hydro-Nutritive
Foundation
SPF 13

30 ml e (1 fl.oz.)

PRINCIPAL DISPLAY PANEL - 30 ml Carton - Rosa 5

ēsika

Hydro-Nutritive
Foundation
SPF 13

30 ml e (1 fl.oz.)

PRINCIPAL DISPLAY PANEL - 30 ml Carton - Rosa 6

ēsika

Hydro-Nutritive
Foundation
SPF 13

30 ml e (1 fl.oz.)

INGREDIENTS AND APPEARANCE

ESIKA   HYDRO-NUTRATIVE FOUNDATION SPF 13
octinoxate and oxybenzone lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 13537-305
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	0.05 mg  in 1 mL
Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y)	Oxybenzone	0.02 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
water (UNII: 059QF0KO0R)
cyclomethicone (UNII: NMQ347994Z)
cyclomethicone 5 (UNII: 0THT5PCI0R)
talc (UNII: 7SEV7J4R1U)
polyglyceryl-4 isostearate (UNII: 820DPX33S7)
pea (UNII: W4X7H8GYFM)
hexyl laurate (UNII: 4CG9F9W01Q)
cyclomethicone 6 (UNII: XHK3U310BA)
rosa centifolia flower oil (UNII: H32V31VMWY)
sodium chloride (UNII: 451W47IQ8X)
mannitol (UNII: 3OWL53L36A)
dimethicone (UNII: 92RU3N3Y1O)
propylene carbonate (UNII: 8D08K3S51E)
propylene glycol (UNII: 6DC9Q167V3)
phenoxyethanol (UNII: HIE492ZZ3T)
octyldodecanol (UNII: 461N1O614Y)
butylene glycol (UNII: 3XUS85K0RA)
methylparaben (UNII: A2I8C7HI9T)
propylparaben (UNII: Z8IX2SC1OH)
microcrystalline wax (UNII: XOF597Q3KY)
petrolatum (UNII: 4T6H12BN9U)
butylated hydroxyanisole (UNII: REK4960K2U)
butylated hydroxytoluene (UNII: 1P9D0Z171K)
butylparaben (UNII: 3QPI1U3FV8)
ethylparaben (UNII: 14255EXE39)
cholesterol (UNII: 97C5T2UQ7J)
yeast (UNII: 3NY3SM6B8U)
isobutylparaben (UNII: 0QQJ25X58G)
candelilla wax (UNII: WL0328HX19)
yellow wax (UNII: 2ZA36H0S2V)
cetostearyl alcohol (UNII: 2DMT128M1S)
cetearyl glucoside (UNII: 09FUA47KNA)
carnauba wax (UNII: R12CBM0EIZ)
olive oil (UNII: 6UYK2W1W1E)
sodium succinate anhydrous (UNII: V8ZGC8ISR3)
titanium dioxide (UNII: 15FIX9V2JP)
ferric oxide yellow (UNII: EX438O2MRT)
ferric oxide red (UNII: 1K09F3G675)
ferrosoferric oxide (UNII: XM0M87F357)

Product Characteristics
Color	BROWN (Beige 1)	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 13537-305-02	1 in 1 BOX
1	NDC: 13537-305-01	30 mL in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part352	05/17/2011

ESIKA   HYDRO-NUTRATIVE FOUNDATION SPF 13
octinoxate and oxybenzone lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 13537-306
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	0.05 mg  in 1 mL
Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y)	Oxybenzone	0.02 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
water (UNII: 059QF0KO0R)
cyclomethicone (UNII: NMQ347994Z)
cyclomethicone 5 (UNII: 0THT5PCI0R)
talc (UNII: 7SEV7J4R1U)
polyglyceryl-4 isostearate (UNII: 820DPX33S7)
pea (UNII: W4X7H8GYFM)
hexyl laurate (UNII: 4CG9F9W01Q)
cyclomethicone 6 (UNII: XHK3U310BA)
rosa centifolia flower oil (UNII: H32V31VMWY)
sodium chloride (UNII: 451W47IQ8X)
mannitol (UNII: 3OWL53L36A)
dimethicone (UNII: 92RU3N3Y1O)
propylene carbonate (UNII: 8D08K3S51E)
propylene glycol (UNII: 6DC9Q167V3)
phenoxyethanol (UNII: HIE492ZZ3T)
octyldodecanol (UNII: 461N1O614Y)
butylene glycol (UNII: 3XUS85K0RA)
methylparaben (UNII: A2I8C7HI9T)
propylparaben (UNII: Z8IX2SC1OH)
microcrystalline wax (UNII: XOF597Q3KY)
petrolatum (UNII: 4T6H12BN9U)
butylated hydroxyanisole (UNII: REK4960K2U)
butylated hydroxytoluene (UNII: 1P9D0Z171K)
butylparaben (UNII: 3QPI1U3FV8)
ethylparaben (UNII: 14255EXE39)
cholesterol (UNII: 97C5T2UQ7J)
yeast (UNII: 3NY3SM6B8U)
isobutylparaben (UNII: 0QQJ25X58G)
candelilla wax (UNII: WL0328HX19)
yellow wax (UNII: 2ZA36H0S2V)
cetostearyl alcohol (UNII: 2DMT128M1S)
cetearyl glucoside (UNII: 09FUA47KNA)
carnauba wax (UNII: R12CBM0EIZ)
olive oil (UNII: 6UYK2W1W1E)
sodium succinate anhydrous (UNII: V8ZGC8ISR3)
titanium dioxide (UNII: 15FIX9V2JP)
ferric oxide yellow (UNII: EX438O2MRT)
ferric oxide red (UNII: 1K09F3G675)
ferrosoferric oxide (UNII: XM0M87F357)

Product Characteristics
Color	BROWN (Beige 2)	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 13537-306-02	1 in 1 BOX
1	NDC: 13537-306-01	30 mL in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part352	05/17/2011

ESIKA   HYDRO-NUTRATIVE FOUNDATION SPF 13
octinoxate and oxybenzone lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 13537-307
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	0.05 mg  in 1 mL
Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y)	Oxybenzone	0.02 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
water (UNII: 059QF0KO0R)
cyclomethicone (UNII: NMQ347994Z)
cyclomethicone 5 (UNII: 0THT5PCI0R)
talc (UNII: 7SEV7J4R1U)
polyglyceryl-4 isostearate (UNII: 820DPX33S7)
pea (UNII: W4X7H8GYFM)
hexyl laurate (UNII: 4CG9F9W01Q)
cyclomethicone 6 (UNII: XHK3U310BA)
rosa centifolia flower oil (UNII: H32V31VMWY)
sodium chloride (UNII: 451W47IQ8X)
mannitol (UNII: 3OWL53L36A)
dimethicone (UNII: 92RU3N3Y1O)
propylene carbonate (UNII: 8D08K3S51E)
propylene glycol (UNII: 6DC9Q167V3)
phenoxyethanol (UNII: HIE492ZZ3T)
octyldodecanol (UNII: 461N1O614Y)
butylene glycol (UNII: 3XUS85K0RA)
methylparaben (UNII: A2I8C7HI9T)
propylparaben (UNII: Z8IX2SC1OH)
microcrystalline wax (UNII: XOF597Q3KY)
petrolatum (UNII: 4T6H12BN9U)
butylated hydroxyanisole (UNII: REK4960K2U)
butylated hydroxytoluene (UNII: 1P9D0Z171K)
butylparaben (UNII: 3QPI1U3FV8)
ethylparaben (UNII: 14255EXE39)
cholesterol (UNII: 97C5T2UQ7J)
yeast (UNII: 3NY3SM6B8U)
isobutylparaben (UNII: 0QQJ25X58G)
candelilla wax (UNII: WL0328HX19)
yellow wax (UNII: 2ZA36H0S2V)
cetostearyl alcohol (UNII: 2DMT128M1S)
cetearyl glucoside (UNII: 09FUA47KNA)
carnauba wax (UNII: R12CBM0EIZ)
olive oil (UNII: 6UYK2W1W1E)
sodium succinate anhydrous (UNII: V8ZGC8ISR3)
titanium dioxide (UNII: 15FIX9V2JP)
ferric oxide yellow (UNII: EX438O2MRT)
ferric oxide red (UNII: 1K09F3G675)
ferrosoferric oxide (UNII: XM0M87F357)

Product Characteristics
Color	BROWN (Beige 3)	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 13537-307-02	1 in 1 BOX
1	NDC: 13537-307-01	30 mL in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part352	05/17/2011

ESIKA   HYDRO-NUTRATIVE FOUNDATION SPF 13
octinoxate and oxybenzone lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 13537-308
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	0.05 mg  in 1 mL
Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y)	Oxybenzone	0.02 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
water (UNII: 059QF0KO0R)
cyclomethicone (UNII: NMQ347994Z)
cyclomethicone 5 (UNII: 0THT5PCI0R)
talc (UNII: 7SEV7J4R1U)
polyglyceryl-4 isostearate (UNII: 820DPX33S7)
pea (UNII: W4X7H8GYFM)
hexyl laurate (UNII: 4CG9F9W01Q)
cyclomethicone 6 (UNII: XHK3U310BA)
rosa centifolia flower oil (UNII: H32V31VMWY)
sodium chloride (UNII: 451W47IQ8X)
mannitol (UNII: 3OWL53L36A)
dimethicone (UNII: 92RU3N3Y1O)
propylene carbonate (UNII: 8D08K3S51E)
propylene glycol (UNII: 6DC9Q167V3)
phenoxyethanol (UNII: HIE492ZZ3T)
octyldodecanol (UNII: 461N1O614Y)
butylene glycol (UNII: 3XUS85K0RA)
methylparaben (UNII: A2I8C7HI9T)
propylparaben (UNII: Z8IX2SC1OH)
microcrystalline wax (UNII: XOF597Q3KY)
petrolatum (UNII: 4T6H12BN9U)
butylated hydroxyanisole (UNII: REK4960K2U)
butylated hydroxytoluene (UNII: 1P9D0Z171K)
butylparaben (UNII: 3QPI1U3FV8)
ethylparaben (UNII: 14255EXE39)
cholesterol (UNII: 97C5T2UQ7J)
yeast (UNII: 3NY3SM6B8U)
isobutylparaben (UNII: 0QQJ25X58G)
candelilla wax (UNII: WL0328HX19)
yellow wax (UNII: 2ZA36H0S2V)
cetostearyl alcohol (UNII: 2DMT128M1S)
cetearyl glucoside (UNII: 09FUA47KNA)
carnauba wax (UNII: R12CBM0EIZ)
olive oil (UNII: 6UYK2W1W1E)
sodium succinate anhydrous (UNII: V8ZGC8ISR3)
titanium dioxide (UNII: 15FIX9V2JP)
ferric oxide yellow (UNII: EX438O2MRT)
ferric oxide red (UNII: 1K09F3G675)
ferrosoferric oxide (UNII: XM0M87F357)

Product Characteristics
Color	BROWN (Beige 4)	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 13537-308-02	1 in 1 BOX
1	NDC: 13537-308-01	30 mL in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part352	05/17/2011

ESIKA   HYDRO-NUTRATIVE FOUNDATION SPF 13
octinoxate and oxybenzone lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 13537-309
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	0.05 mg  in 1 mL
Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y)	Oxybenzone	0.02 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
water (UNII: 059QF0KO0R)
cyclomethicone (UNII: NMQ347994Z)
cyclomethicone 5 (UNII: 0THT5PCI0R)
talc (UNII: 7SEV7J4R1U)
polyglyceryl-4 isostearate (UNII: 820DPX33S7)
pea (UNII: W4X7H8GYFM)
hexyl laurate (UNII: 4CG9F9W01Q)
cyclomethicone 6 (UNII: XHK3U310BA)
rosa centifolia flower oil (UNII: H32V31VMWY)
sodium chloride (UNII: 451W47IQ8X)
mannitol (UNII: 3OWL53L36A)
dimethicone (UNII: 92RU3N3Y1O)
propylene carbonate (UNII: 8D08K3S51E)
propylene glycol (UNII: 6DC9Q167V3)
phenoxyethanol (UNII: HIE492ZZ3T)
octyldodecanol (UNII: 461N1O614Y)
butylene glycol (UNII: 3XUS85K0RA)
methylparaben (UNII: A2I8C7HI9T)
propylparaben (UNII: Z8IX2SC1OH)
microcrystalline wax (UNII: XOF597Q3KY)
petrolatum (UNII: 4T6H12BN9U)
butylated hydroxyanisole (UNII: REK4960K2U)
butylated hydroxytoluene (UNII: 1P9D0Z171K)
butylparaben (UNII: 3QPI1U3FV8)
ethylparaben (UNII: 14255EXE39)
cholesterol (UNII: 97C5T2UQ7J)
yeast (UNII: 3NY3SM6B8U)
isobutylparaben (UNII: 0QQJ25X58G)
candelilla wax (UNII: WL0328HX19)
yellow wax (UNII: 2ZA36H0S2V)
cetostearyl alcohol (UNII: 2DMT128M1S)
cetearyl glucoside (UNII: 09FUA47KNA)
carnauba wax (UNII: R12CBM0EIZ)
olive oil (UNII: 6UYK2W1W1E)
sodium succinate anhydrous (UNII: V8ZGC8ISR3)
titanium dioxide (UNII: 15FIX9V2JP)
ferric oxide yellow (UNII: EX438O2MRT)
ferric oxide red (UNII: 1K09F3G675)
ferrosoferric oxide (UNII: XM0M87F357)

Product Characteristics
Color	BROWN (Beige 5)	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 13537-309-02	1 in 1 BOX
1	NDC: 13537-309-01	30 mL in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part352	05/17/2011

ESIKA   HYDRO-NUTRATIVE FOUNDATION SPF 13
octinoxate and oxybenzone lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 13537-310
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	0.05 mg  in 1 mL
Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y)	Oxybenzone	0.02 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
water (UNII: 059QF0KO0R)
cyclomethicone (UNII: NMQ347994Z)
cyclomethicone 5 (UNII: 0THT5PCI0R)
talc (UNII: 7SEV7J4R1U)
polyglyceryl-4 isostearate (UNII: 820DPX33S7)
pea (UNII: W4X7H8GYFM)
hexyl laurate (UNII: 4CG9F9W01Q)
cyclomethicone 6 (UNII: XHK3U310BA)
rosa centifolia flower oil (UNII: H32V31VMWY)
sodium chloride (UNII: 451W47IQ8X)
mannitol (UNII: 3OWL53L36A)
dimethicone (UNII: 92RU3N3Y1O)
propylene carbonate (UNII: 8D08K3S51E)
propylene glycol (UNII: 6DC9Q167V3)
phenoxyethanol (UNII: HIE492ZZ3T)
octyldodecanol (UNII: 461N1O614Y)
butylene glycol (UNII: 3XUS85K0RA)
methylparaben (UNII: A2I8C7HI9T)
propylparaben (UNII: Z8IX2SC1OH)
microcrystalline wax (UNII: XOF597Q3KY)
petrolatum (UNII: 4T6H12BN9U)
butylated hydroxyanisole (UNII: REK4960K2U)
butylated hydroxytoluene (UNII: 1P9D0Z171K)
butylparaben (UNII: 3QPI1U3FV8)
ethylparaben (UNII: 14255EXE39)
cholesterol (UNII: 97C5T2UQ7J)
yeast (UNII: 3NY3SM6B8U)
isobutylparaben (UNII: 0QQJ25X58G)
candelilla wax (UNII: WL0328HX19)
yellow wax (UNII: 2ZA36H0S2V)
cetostearyl alcohol (UNII: 2DMT128M1S)
cetearyl glucoside (UNII: 09FUA47KNA)
carnauba wax (UNII: R12CBM0EIZ)
olive oil (UNII: 6UYK2W1W1E)
sodium succinate anhydrous (UNII: V8ZGC8ISR3)
titanium dioxide (UNII: 15FIX9V2JP)
ferric oxide yellow (UNII: EX438O2MRT)
ferric oxide red (UNII: 1K09F3G675)
ferrosoferric oxide (UNII: XM0M87F357)

Product Characteristics
Color	BROWN (Beige 6)	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 13537-310-02	1 in 1 BOX
1	NDC: 13537-310-01	30 mL in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part352	05/17/2011

ESIKA   HYDRO-NUTRATIVE FOUNDATION SPF 13
octinoxate and oxybenzone lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 13537-311
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	0.05 mg  in 1 mL
Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y)	Oxybenzone	0.02 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
water (UNII: 059QF0KO0R)
cyclomethicone (UNII: NMQ347994Z)
cyclomethicone 5 (UNII: 0THT5PCI0R)
talc (UNII: 7SEV7J4R1U)
polyglyceryl-4 isostearate (UNII: 820DPX33S7)
pea (UNII: W4X7H8GYFM)
hexyl laurate (UNII: 4CG9F9W01Q)
cyclomethicone 6 (UNII: XHK3U310BA)
rosa centifolia flower oil (UNII: H32V31VMWY)
sodium chloride (UNII: 451W47IQ8X)
mannitol (UNII: 3OWL53L36A)
dimethicone (UNII: 92RU3N3Y1O)
propylene carbonate (UNII: 8D08K3S51E)
propylene glycol (UNII: 6DC9Q167V3)
phenoxyethanol (UNII: HIE492ZZ3T)
octyldodecanol (UNII: 461N1O614Y)
butylene glycol (UNII: 3XUS85K0RA)
methylparaben (UNII: A2I8C7HI9T)
propylparaben (UNII: Z8IX2SC1OH)
microcrystalline wax (UNII: XOF597Q3KY)
petrolatum (UNII: 4T6H12BN9U)
butylated hydroxyanisole (UNII: REK4960K2U)
butylated hydroxytoluene (UNII: 1P9D0Z171K)
butylparaben (UNII: 3QPI1U3FV8)
ethylparaben (UNII: 14255EXE39)
cholesterol (UNII: 97C5T2UQ7J)
yeast (UNII: 3NY3SM6B8U)
isobutylparaben (UNII: 0QQJ25X58G)
candelilla wax (UNII: WL0328HX19)
yellow wax (UNII: 2ZA36H0S2V)
cetostearyl alcohol (UNII: 2DMT128M1S)
cetearyl glucoside (UNII: 09FUA47KNA)
carnauba wax (UNII: R12CBM0EIZ)
olive oil (UNII: 6UYK2W1W1E)
sodium succinate anhydrous (UNII: V8ZGC8ISR3)
titanium dioxide (UNII: 15FIX9V2JP)
ferric oxide yellow (UNII: EX438O2MRT)
ferric oxide red (UNII: 1K09F3G675)
ferrosoferric oxide (UNII: XM0M87F357)

Product Characteristics
Color	RED (Rosa 1)	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 13537-311-02	1 in 1 BOX
1	NDC: 13537-311-01	30 mL in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part352	05/17/2011

ESIKA   HYDRO-NUTRATIVE FOUNDATION SPF 13
octinoxate and oxybenzone lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 13537-312
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	0.05 mg  in 1 mL
Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y)	Oxybenzone	0.02 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
water (UNII: 059QF0KO0R)
cyclomethicone (UNII: NMQ347994Z)
cyclomethicone 5 (UNII: 0THT5PCI0R)
talc (UNII: 7SEV7J4R1U)
polyglyceryl-4 isostearate (UNII: 820DPX33S7)
pea (UNII: W4X7H8GYFM)
hexyl laurate (UNII: 4CG9F9W01Q)
cyclomethicone 6 (UNII: XHK3U310BA)
rosa centifolia flower oil (UNII: H32V31VMWY)
sodium chloride (UNII: 451W47IQ8X)
mannitol (UNII: 3OWL53L36A)
dimethicone (UNII: 92RU3N3Y1O)
propylene carbonate (UNII: 8D08K3S51E)
propylene glycol (UNII: 6DC9Q167V3)
phenoxyethanol (UNII: HIE492ZZ3T)
octyldodecanol (UNII: 461N1O614Y)
butylene glycol (UNII: 3XUS85K0RA)
methylparaben (UNII: A2I8C7HI9T)
propylparaben (UNII: Z8IX2SC1OH)
microcrystalline wax (UNII: XOF597Q3KY)
petrolatum (UNII: 4T6H12BN9U)
butylated hydroxyanisole (UNII: REK4960K2U)
butylated hydroxytoluene (UNII: 1P9D0Z171K)
butylparaben (UNII: 3QPI1U3FV8)
ethylparaben (UNII: 14255EXE39)
cholesterol (UNII: 97C5T2UQ7J)
yeast (UNII: 3NY3SM6B8U)
isobutylparaben (UNII: 0QQJ25X58G)
candelilla wax (UNII: WL0328HX19)
yellow wax (UNII: 2ZA36H0S2V)
cetostearyl alcohol (UNII: 2DMT128M1S)
cetearyl glucoside (UNII: 09FUA47KNA)
carnauba wax (UNII: R12CBM0EIZ)
olive oil (UNII: 6UYK2W1W1E)
sodium succinate anhydrous (UNII: V8ZGC8ISR3)
titanium dioxide (UNII: 15FIX9V2JP)
ferric oxide yellow (UNII: EX438O2MRT)
ferric oxide red (UNII: 1K09F3G675)
ferrosoferric oxide (UNII: XM0M87F357)

Product Characteristics
Color	RED (Rosa 2)	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 13537-312-02	1 in 1 BOX
1	NDC: 13537-312-01	30 mL in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part352	05/17/2011

ESIKA   HYDRO-NUTRATIVE FOUNDATION SPF 13
octinoxate and oxybenzone lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 13537-313
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	0.05 mg  in 1 mL
Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y)	Oxybenzone	0.02 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
water (UNII: 059QF0KO0R)
cyclomethicone (UNII: NMQ347994Z)
cyclomethicone 5 (UNII: 0THT5PCI0R)
talc (UNII: 7SEV7J4R1U)
polyglyceryl-4 isostearate (UNII: 820DPX33S7)
pea (UNII: W4X7H8GYFM)
hexyl laurate (UNII: 4CG9F9W01Q)
cyclomethicone 6 (UNII: XHK3U310BA)
rosa centifolia flower oil (UNII: H32V31VMWY)
sodium chloride (UNII: 451W47IQ8X)
mannitol (UNII: 3OWL53L36A)
dimethicone (UNII: 92RU3N3Y1O)
propylene carbonate (UNII: 8D08K3S51E)
propylene glycol (UNII: 6DC9Q167V3)
phenoxyethanol (UNII: HIE492ZZ3T)
octyldodecanol (UNII: 461N1O614Y)
butylene glycol (UNII: 3XUS85K0RA)
methylparaben (UNII: A2I8C7HI9T)
propylparaben (UNII: Z8IX2SC1OH)
microcrystalline wax (UNII: XOF597Q3KY)
petrolatum (UNII: 4T6H12BN9U)
butylated hydroxyanisole (UNII: REK4960K2U)
butylated hydroxytoluene (UNII: 1P9D0Z171K)
butylparaben (UNII: 3QPI1U3FV8)
ethylparaben (UNII: 14255EXE39)
cholesterol (UNII: 97C5T2UQ7J)
yeast (UNII: 3NY3SM6B8U)
isobutylparaben (UNII: 0QQJ25X58G)
candelilla wax (UNII: WL0328HX19)
yellow wax (UNII: 2ZA36H0S2V)
cetostearyl alcohol (UNII: 2DMT128M1S)
cetearyl glucoside (UNII: 09FUA47KNA)
carnauba wax (UNII: R12CBM0EIZ)
olive oil (UNII: 6UYK2W1W1E)
sodium succinate anhydrous (UNII: V8ZGC8ISR3)
titanium dioxide (UNII: 15FIX9V2JP)
ferric oxide yellow (UNII: EX438O2MRT)
ferric oxide red (UNII: 1K09F3G675)
ferrosoferric oxide (UNII: XM0M87F357)

Product Characteristics
Color	RED (Rosa 3)	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 13537-313-02	1 in 1 BOX
1	NDC: 13537-313-01	30 mL in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part352	05/17/2011

ESIKA   HYDRO-NUTRATIVE FOUNDATION SPF 13
octinoxate and oxybenzone lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 13537-314
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	0.05 mg  in 1 mL
Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y)	Oxybenzone	0.02 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
water (UNII: 059QF0KO0R)
cyclomethicone (UNII: NMQ347994Z)
cyclomethicone 5 (UNII: 0THT5PCI0R)
talc (UNII: 7SEV7J4R1U)
polyglyceryl-4 isostearate (UNII: 820DPX33S7)
pea (UNII: W4X7H8GYFM)
hexyl laurate (UNII: 4CG9F9W01Q)
cyclomethicone 6 (UNII: XHK3U310BA)
rosa centifolia flower oil (UNII: H32V31VMWY)
sodium chloride (UNII: 451W47IQ8X)
mannitol (UNII: 3OWL53L36A)
dimethicone (UNII: 92RU3N3Y1O)
propylene carbonate (UNII: 8D08K3S51E)
propylene glycol (UNII: 6DC9Q167V3)
phenoxyethanol (UNII: HIE492ZZ3T)
octyldodecanol (UNII: 461N1O614Y)
butylene glycol (UNII: 3XUS85K0RA)
methylparaben (UNII: A2I8C7HI9T)
propylparaben (UNII: Z8IX2SC1OH)
microcrystalline wax (UNII: XOF597Q3KY)
petrolatum (UNII: 4T6H12BN9U)
butylated hydroxyanisole (UNII: REK4960K2U)
butylated hydroxytoluene (UNII: 1P9D0Z171K)
butylparaben (UNII: 3QPI1U3FV8)
ethylparaben (UNII: 14255EXE39)
cholesterol (UNII: 97C5T2UQ7J)
yeast (UNII: 3NY3SM6B8U)
isobutylparaben (UNII: 0QQJ25X58G)
candelilla wax (UNII: WL0328HX19)
yellow wax (UNII: 2ZA36H0S2V)
cetostearyl alcohol (UNII: 2DMT128M1S)
cetearyl glucoside (UNII: 09FUA47KNA)
carnauba wax (UNII: R12CBM0EIZ)
olive oil (UNII: 6UYK2W1W1E)
sodium succinate anhydrous (UNII: V8ZGC8ISR3)
titanium dioxide (UNII: 15FIX9V2JP)
ferric oxide yellow (UNII: EX438O2MRT)
ferric oxide red (UNII: 1K09F3G675)
ferrosoferric oxide (UNII: XM0M87F357)

Product Characteristics
Color	RED (Rosa 4)	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 13537-314-02	1 in 1 BOX
1	NDC: 13537-314-01	30 mL in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part352	05/17/2011

ESIKA   HYDRO-NUTRATIVE FOUNDATION SPF 13
octinoxate and oxybenzone lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 13537-315
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	0.05 mg  in 1 mL
Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y)	Oxybenzone	0.02 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
water (UNII: 059QF0KO0R)
cyclomethicone (UNII: NMQ347994Z)
cyclomethicone 5 (UNII: 0THT5PCI0R)
talc (UNII: 7SEV7J4R1U)
polyglyceryl-4 isostearate (UNII: 820DPX33S7)
pea (UNII: W4X7H8GYFM)
hexyl laurate (UNII: 4CG9F9W01Q)
cyclomethicone 6 (UNII: XHK3U310BA)
rosa centifolia flower oil (UNII: H32V31VMWY)
sodium chloride (UNII: 451W47IQ8X)
mannitol (UNII: 3OWL53L36A)
dimethicone (UNII: 92RU3N3Y1O)
propylene carbonate (UNII: 8D08K3S51E)
propylene glycol (UNII: 6DC9Q167V3)
phenoxyethanol (UNII: HIE492ZZ3T)
octyldodecanol (UNII: 461N1O614Y)
butylene glycol (UNII: 3XUS85K0RA)
methylparaben (UNII: A2I8C7HI9T)
propylparaben (UNII: Z8IX2SC1OH)
microcrystalline wax (UNII: XOF597Q3KY)
petrolatum (UNII: 4T6H12BN9U)
butylated hydroxyanisole (UNII: REK4960K2U)
butylated hydroxytoluene (UNII: 1P9D0Z171K)
butylparaben (UNII: 3QPI1U3FV8)
ethylparaben (UNII: 14255EXE39)
cholesterol (UNII: 97C5T2UQ7J)
yeast (UNII: 3NY3SM6B8U)
isobutylparaben (UNII: 0QQJ25X58G)
candelilla wax (UNII: WL0328HX19)
yellow wax (UNII: 2ZA36H0S2V)
cetostearyl alcohol (UNII: 2DMT128M1S)
cetearyl glucoside (UNII: 09FUA47KNA)
carnauba wax (UNII: R12CBM0EIZ)
olive oil (UNII: 6UYK2W1W1E)
sodium succinate anhydrous (UNII: V8ZGC8ISR3)
titanium dioxide (UNII: 15FIX9V2JP)
ferric oxide yellow (UNII: EX438O2MRT)
ferric oxide red (UNII: 1K09F3G675)
ferrosoferric oxide (UNII: XM0M87F357)

Product Characteristics
Color	RED (Rosa 5)	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 13537-315-02	1 in 1 BOX
1	NDC: 13537-315-01	30 mL in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part352	05/17/2011

ESIKA   HYDRO-NUTRATIVE FOUNDATION SPF 13
octinoxate and oxybenzone lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 13537-316
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	0.05 mg  in 1 mL
Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y)	Oxybenzone	0.02 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
water (UNII: 059QF0KO0R)
cyclomethicone (UNII: NMQ347994Z)
cyclomethicone 5 (UNII: 0THT5PCI0R)
talc (UNII: 7SEV7J4R1U)
polyglyceryl-4 isostearate (UNII: 820DPX33S7)
pea (UNII: W4X7H8GYFM)
hexyl laurate (UNII: 4CG9F9W01Q)
cyclomethicone 6 (UNII: XHK3U310BA)
rosa centifolia flower oil (UNII: H32V31VMWY)
sodium chloride (UNII: 451W47IQ8X)
mannitol (UNII: 3OWL53L36A)
dimethicone (UNII: 92RU3N3Y1O)
propylene carbonate (UNII: 8D08K3S51E)
propylene glycol (UNII: 6DC9Q167V3)
phenoxyethanol (UNII: HIE492ZZ3T)
octyldodecanol (UNII: 461N1O614Y)
butylene glycol (UNII: 3XUS85K0RA)
methylparaben (UNII: A2I8C7HI9T)
propylparaben (UNII: Z8IX2SC1OH)
microcrystalline wax (UNII: XOF597Q3KY)
petrolatum (UNII: 4T6H12BN9U)
butylated hydroxyanisole (UNII: REK4960K2U)
butylated hydroxytoluene (UNII: 1P9D0Z171K)
butylparaben (UNII: 3QPI1U3FV8)
ethylparaben (UNII: 14255EXE39)
cholesterol (UNII: 97C5T2UQ7J)
yeast (UNII: 3NY3SM6B8U)
isobutylparaben (UNII: 0QQJ25X58G)
candelilla wax (UNII: WL0328HX19)
yellow wax (UNII: 2ZA36H0S2V)
cetostearyl alcohol (UNII: 2DMT128M1S)
cetearyl glucoside (UNII: 09FUA47KNA)
carnauba wax (UNII: R12CBM0EIZ)
olive oil (UNII: 6UYK2W1W1E)
sodium succinate anhydrous (UNII: V8ZGC8ISR3)
titanium dioxide (UNII: 15FIX9V2JP)
ferric oxide yellow (UNII: EX438O2MRT)
ferric oxide red (UNII: 1K09F3G675)
ferrosoferric oxide (UNII: XM0M87F357)

Product Characteristics
Color	RED (Rosa 6)	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 13537-316-02	1 in 1 BOX
1	NDC: 13537-316-01	30 mL in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part352	05/17/2011

Labeler - Ventura Corporation (San Juan, P.R) (602751344)

Establishment
Name	Address	ID/FEI	Business Operations
Bel Star S.A. (Colombia)		880160197	MANUFACTURE