ESIKA- octinoxate, oxybenzone, and titanium dioxide powder

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 (7%), Oxybenzone (2%), Titanium Dioxide (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 evenly on face and neck using a latex pad. Touch up when necessary.
• 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

Isostearyl neopentanoate, C12-15 alkyl benzoate, polymethyl methacrylate, corn starch, silica, mica, ethylhexyl palmitate, ozokerite, copernicia cerifera cera (copernicia cerifera (carnauba) wax), phenoxyethanol, octyldodecanol, trimethylsiloxysilicate, dimethicone, methylparaben, tocopheryl acetate, microcrystalline wax, propylparaben, petrolatum, phospholipids, bht, c9-13 fluoroalcohol, butylparaben, ethylparaben, phosphoric acid, cholesterol, isobutylparaben, candelilla cera (euphorbia cerifera (candelilla) wax), cera alba (beeswax), cetearyl alcohol, cetearyl glucoside, polyglyceryl-2 dipolyhydroxystearate, glycosphingolipids, chitosan, ci 77492 (iron oxides), ci 77491 (iron oxides), ci 77499 (iron oxides).

PRINCIPAL DISPLAY PANEL - 6 g Carton - Beige 1

ēsika

3-in-1 Pro Make Up
Foundation SPF 20

6 g e (.21 oz.)

PRINCIPAL DISPLAY PANEL - 6 g Carton - Beige 2

ēsika

3-in-1 Pro Make Up
Foundation SPF 20

6 g e (.21 oz.)

PRINCIPAL DISPLAY PANEL - 6 g Carton - Beige 3

ēsika

3-in-1 Pro Make Up
Foundation SPF 20

6 g e (.21 oz.)

PRINCIPAL DISPLAY PANEL - 6 g Carton - Beige 4

ēsika

3-in-1 Pro Make Up
Foundation SPF 20

6 g e (.21 oz.)

PRINCIPAL DISPLAY PANEL - 6 g Carton - Beige 5

ēsika

3-in-1 Pro Make Up
Foundation SPF 20

6 g e (.21 oz.)

PRINCIPAL DISPLAY PANEL - 6 g Carton - Beige 6

ēsika

3-in-1 Pro Make Up
Foundation SPF 20

6 g e (.21 oz.)

PRINCIPAL DISPLAY PANEL - 6 g Carton - Rosa 1

ēsika

3-in-1 Pro Make Up
Foundation SPF 20

6 g e (.21 oz.)

PRINCIPAL DISPLAY PANEL - 6 g Carton - Rosa 2

ēsika

3-in-1 Pro Make Up
Foundation SPF 20

6 g e (.21 oz.)

PRINCIPAL DISPLAY PANEL - 6 g Carton - Rosa 3

ēsika

3-in-1 Pro Make Up
Foundation SPF 20

6 g e (.21 oz.)

PRINCIPAL DISPLAY PANEL - 6 g Carton - Rosa 4

ēsika

3-in-1 Pro Make Up
Foundation SPF 20

6 g e (.21 oz.)

PRINCIPAL DISPLAY PANEL - 6 g Carton - Rosa 5

ēsika

3-in-1 Pro Make Up
Foundation SPF 20

6 g e (.21 oz.)

PRINCIPAL DISPLAY PANEL - 6 g Carton - Rosa 6

ēsika

3-in-1 Pro Make Up
Foundation SPF 20

6 g e (.21 oz.)

INGREDIENTS AND APPEARANCE

ESIKA   3-IN-1 PRO MAKEUP FOUNDATION SPF 20
octinoxate, oxybenzone, and titanium dioxide powder

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 13537-329
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	0.07 g  in 1 g
Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y)	Oxybenzone	0.02 g  in 1 g
Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP)	Titanium Dioxide	0.02 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
Alkyl (C12-15) Benzoate (UNII: A9EJ3J61HQ)
starch, corn (UNII: O8232NY3SJ)
silicon dioxide (UNII: ETJ7Z6XBU4)
mica (UNII: V8A1AW0880)
ethylhexyl palmitate (UNII: 2865993309)
ceresin (UNII: Q1LS2UJO3A)
carnauba wax (UNII: R12CBM0EIZ)
phenoxyethanol (UNII: HIE492ZZ3T)
octyldodecanol (UNII: 461N1O614Y)
dimethicone (UNII: 92RU3N3Y1O)
methylparaben (UNII: A2I8C7HI9T)
microcrystalline wax (UNII: XOF597Q3KY)
propylparaben (UNII: Z8IX2SC1OH)
petrolatum (UNII: 4T6H12BN9U)
butylated hydroxytoluene (UNII: 1P9D0Z171K)
butylparaben (UNII: 3QPI1U3FV8)
ethylparaben (UNII: 14255EXE39)
phosphoric acid (UNII: E4GA8884NN)
cholesterol (UNII: 97C5T2UQ7J)
isobutylparaben (UNII: 0QQJ25X58G)
candelilla wax (UNII: WL0328HX19)
yellow wax (UNII: 2ZA36H0S2V)
cetostearyl alcohol (UNII: 2DMT128M1S)
cetearyl glucoside (UNII: 09FUA47KNA)
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: 13537-329-02	1 in 1 BOX
1	NDC: 13537-329-01	6 g in 1 CASE

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

ESIKA   3-IN-1 PRO MAKEUP FOUNDATION SPF 20
octinoxate, oxybenzone, and titanium dioxide powder

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 13537-330
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	0.07 g  in 1 g
Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y)	Oxybenzone	0.02 g  in 1 g
Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP)	Titanium Dioxide	0.02 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
Alkyl (C12-15) Benzoate (UNII: A9EJ3J61HQ)
starch, corn (UNII: O8232NY3SJ)
silicon dioxide (UNII: ETJ7Z6XBU4)
mica (UNII: V8A1AW0880)
ethylhexyl palmitate (UNII: 2865993309)
ceresin (UNII: Q1LS2UJO3A)
carnauba wax (UNII: R12CBM0EIZ)
phenoxyethanol (UNII: HIE492ZZ3T)
octyldodecanol (UNII: 461N1O614Y)
dimethicone (UNII: 92RU3N3Y1O)
methylparaben (UNII: A2I8C7HI9T)
microcrystalline wax (UNII: XOF597Q3KY)
propylparaben (UNII: Z8IX2SC1OH)
petrolatum (UNII: 4T6H12BN9U)
butylated hydroxytoluene (UNII: 1P9D0Z171K)
butylparaben (UNII: 3QPI1U3FV8)
ethylparaben (UNII: 14255EXE39)
phosphoric acid (UNII: E4GA8884NN)
cholesterol (UNII: 97C5T2UQ7J)
isobutylparaben (UNII: 0QQJ25X58G)
candelilla wax (UNII: WL0328HX19)
yellow wax (UNII: 2ZA36H0S2V)
cetostearyl alcohol (UNII: 2DMT128M1S)
cetearyl glucoside (UNII: 09FUA47KNA)
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: 13537-330-02	1 in 1 BOX
1	NDC: 13537-330-01	6 g in 1 CASE

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

ESIKA   3-IN-1 PRO MAKEUP FOUNDATION SPF 20
octinoxate, oxybenzone, and titanium dioxide powder

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 13537-331
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	0.07 g  in 1 g
Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y)	Oxybenzone	0.02 g  in 1 g
Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP)	Titanium Dioxide	0.02 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
Alkyl (C12-15) Benzoate (UNII: A9EJ3J61HQ)
starch, corn (UNII: O8232NY3SJ)
silicon dioxide (UNII: ETJ7Z6XBU4)
mica (UNII: V8A1AW0880)
ethylhexyl palmitate (UNII: 2865993309)
ceresin (UNII: Q1LS2UJO3A)
carnauba wax (UNII: R12CBM0EIZ)
phenoxyethanol (UNII: HIE492ZZ3T)
octyldodecanol (UNII: 461N1O614Y)
dimethicone (UNII: 92RU3N3Y1O)
methylparaben (UNII: A2I8C7HI9T)
microcrystalline wax (UNII: XOF597Q3KY)
propylparaben (UNII: Z8IX2SC1OH)
petrolatum (UNII: 4T6H12BN9U)
butylated hydroxytoluene (UNII: 1P9D0Z171K)
butylparaben (UNII: 3QPI1U3FV8)
ethylparaben (UNII: 14255EXE39)
phosphoric acid (UNII: E4GA8884NN)
cholesterol (UNII: 97C5T2UQ7J)
isobutylparaben (UNII: 0QQJ25X58G)
candelilla wax (UNII: WL0328HX19)
yellow wax (UNII: 2ZA36H0S2V)
cetostearyl alcohol (UNII: 2DMT128M1S)
cetearyl glucoside (UNII: 09FUA47KNA)
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: 13537-331-02	1 in 1 BOX
1	NDC: 13537-331-01	6 g in 1 CASE

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

ESIKA   3-IN-1 PRO MAKEUP FOUNDATION SPF 20
octinoxate, oxybenzone, and titanium dioxide powder

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 13537-332
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	0.07 g  in 1 g
Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y)	Oxybenzone	0.02 g  in 1 g
Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP)	Titanium Dioxide	0.02 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
Alkyl (C12-15) Benzoate (UNII: A9EJ3J61HQ)
starch, corn (UNII: O8232NY3SJ)
silicon dioxide (UNII: ETJ7Z6XBU4)
mica (UNII: V8A1AW0880)
ethylhexyl palmitate (UNII: 2865993309)
ceresin (UNII: Q1LS2UJO3A)
carnauba wax (UNII: R12CBM0EIZ)
phenoxyethanol (UNII: HIE492ZZ3T)
octyldodecanol (UNII: 461N1O614Y)
dimethicone (UNII: 92RU3N3Y1O)
methylparaben (UNII: A2I8C7HI9T)
microcrystalline wax (UNII: XOF597Q3KY)
propylparaben (UNII: Z8IX2SC1OH)
petrolatum (UNII: 4T6H12BN9U)
butylated hydroxytoluene (UNII: 1P9D0Z171K)
butylparaben (UNII: 3QPI1U3FV8)
ethylparaben (UNII: 14255EXE39)
phosphoric acid (UNII: E4GA8884NN)
cholesterol (UNII: 97C5T2UQ7J)
isobutylparaben (UNII: 0QQJ25X58G)
candelilla wax (UNII: WL0328HX19)
yellow wax (UNII: 2ZA36H0S2V)
cetostearyl alcohol (UNII: 2DMT128M1S)
cetearyl glucoside (UNII: 09FUA47KNA)
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: 13537-332-02	1 in 1 BOX
1	NDC: 13537-332-01	6 g in 1 CASE

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

ESIKA   3-IN-1 PRO MAKEUP FOUNDATION SPF 20
octinoxate, oxybenzone, and titanium dioxide powder

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 13537-333
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	0.07 g  in 1 g
Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y)	Oxybenzone	0.02 g  in 1 g
Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP)	Titanium Dioxide	0.02 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
Alkyl (C12-15) Benzoate (UNII: A9EJ3J61HQ)
starch, corn (UNII: O8232NY3SJ)
silicon dioxide (UNII: ETJ7Z6XBU4)
mica (UNII: V8A1AW0880)
ethylhexyl palmitate (UNII: 2865993309)
ceresin (UNII: Q1LS2UJO3A)
carnauba wax (UNII: R12CBM0EIZ)
phenoxyethanol (UNII: HIE492ZZ3T)
octyldodecanol (UNII: 461N1O614Y)
dimethicone (UNII: 92RU3N3Y1O)
methylparaben (UNII: A2I8C7HI9T)
microcrystalline wax (UNII: XOF597Q3KY)
propylparaben (UNII: Z8IX2SC1OH)
petrolatum (UNII: 4T6H12BN9U)
butylated hydroxytoluene (UNII: 1P9D0Z171K)
butylparaben (UNII: 3QPI1U3FV8)
ethylparaben (UNII: 14255EXE39)
phosphoric acid (UNII: E4GA8884NN)
cholesterol (UNII: 97C5T2UQ7J)
isobutylparaben (UNII: 0QQJ25X58G)
candelilla wax (UNII: WL0328HX19)
yellow wax (UNII: 2ZA36H0S2V)
cetostearyl alcohol (UNII: 2DMT128M1S)
cetearyl glucoside (UNII: 09FUA47KNA)
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: 13537-333-02	1 in 1 BOX
1	NDC: 13537-333-01	6 g in 1 CASE

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

ESIKA   3-IN-1 PRO MAKEUP FOUNDATION SPF 20
octinoxate, oxybenzone, and titanium dioxide powder

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 13537-334
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	0.07 g  in 1 g
Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y)	Oxybenzone	0.02 g  in 1 g
Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP)	Titanium Dioxide	0.02 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
Alkyl (C12-15) Benzoate (UNII: A9EJ3J61HQ)
starch, corn (UNII: O8232NY3SJ)
silicon dioxide (UNII: ETJ7Z6XBU4)
mica (UNII: V8A1AW0880)
ethylhexyl palmitate (UNII: 2865993309)
ceresin (UNII: Q1LS2UJO3A)
carnauba wax (UNII: R12CBM0EIZ)
phenoxyethanol (UNII: HIE492ZZ3T)
octyldodecanol (UNII: 461N1O614Y)
dimethicone (UNII: 92RU3N3Y1O)
methylparaben (UNII: A2I8C7HI9T)
microcrystalline wax (UNII: XOF597Q3KY)
propylparaben (UNII: Z8IX2SC1OH)
petrolatum (UNII: 4T6H12BN9U)
butylated hydroxytoluene (UNII: 1P9D0Z171K)
butylparaben (UNII: 3QPI1U3FV8)
ethylparaben (UNII: 14255EXE39)
phosphoric acid (UNII: E4GA8884NN)
cholesterol (UNII: 97C5T2UQ7J)
isobutylparaben (UNII: 0QQJ25X58G)
candelilla wax (UNII: WL0328HX19)
yellow wax (UNII: 2ZA36H0S2V)
cetostearyl alcohol (UNII: 2DMT128M1S)
cetearyl glucoside (UNII: 09FUA47KNA)
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: 13537-334-02	1 in 1 BOX
1	NDC: 13537-334-01	6 g in 1 CASE

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

ESIKA   3-IN-1 PRO MAKEUP FOUNDATION SPF 20
octinoxate, oxybenzone, and titanium dioxide powder

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 13537-335
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	0.07 g  in 1 g
Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y)	Oxybenzone	0.02 g  in 1 g
Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP)	Titanium Dioxide	0.02 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
Alkyl (C12-15) Benzoate (UNII: A9EJ3J61HQ)
starch, corn (UNII: O8232NY3SJ)
silicon dioxide (UNII: ETJ7Z6XBU4)
mica (UNII: V8A1AW0880)
ethylhexyl palmitate (UNII: 2865993309)
ceresin (UNII: Q1LS2UJO3A)
carnauba wax (UNII: R12CBM0EIZ)
phenoxyethanol (UNII: HIE492ZZ3T)
octyldodecanol (UNII: 461N1O614Y)
dimethicone (UNII: 92RU3N3Y1O)
methylparaben (UNII: A2I8C7HI9T)
microcrystalline wax (UNII: XOF597Q3KY)
propylparaben (UNII: Z8IX2SC1OH)
petrolatum (UNII: 4T6H12BN9U)
butylated hydroxytoluene (UNII: 1P9D0Z171K)
butylparaben (UNII: 3QPI1U3FV8)
ethylparaben (UNII: 14255EXE39)
phosphoric acid (UNII: E4GA8884NN)
cholesterol (UNII: 97C5T2UQ7J)
isobutylparaben (UNII: 0QQJ25X58G)
candelilla wax (UNII: WL0328HX19)
yellow wax (UNII: 2ZA36H0S2V)
cetostearyl alcohol (UNII: 2DMT128M1S)
cetearyl glucoside (UNII: 09FUA47KNA)
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: 13537-335-02	1 in 1 BOX
1	NDC: 13537-335-01	6 g in 1 CASE

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

ESIKA   3-IN-1 PRO MAKEUP FOUNDATION SPF 20
octinoxate, oxybenzone, and titanium dioxide powder

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 13537-336
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	0.07 g  in 1 g
Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y)	Oxybenzone	0.02 g  in 1 g
Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP)	Titanium Dioxide	0.02 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
Alkyl (C12-15) Benzoate (UNII: A9EJ3J61HQ)
starch, corn (UNII: O8232NY3SJ)
silicon dioxide (UNII: ETJ7Z6XBU4)
mica (UNII: V8A1AW0880)
ethylhexyl palmitate (UNII: 2865993309)
ceresin (UNII: Q1LS2UJO3A)
carnauba wax (UNII: R12CBM0EIZ)
phenoxyethanol (UNII: HIE492ZZ3T)
octyldodecanol (UNII: 461N1O614Y)
dimethicone (UNII: 92RU3N3Y1O)
methylparaben (UNII: A2I8C7HI9T)
microcrystalline wax (UNII: XOF597Q3KY)
propylparaben (UNII: Z8IX2SC1OH)
petrolatum (UNII: 4T6H12BN9U)
butylated hydroxytoluene (UNII: 1P9D0Z171K)
butylparaben (UNII: 3QPI1U3FV8)
ethylparaben (UNII: 14255EXE39)
phosphoric acid (UNII: E4GA8884NN)
cholesterol (UNII: 97C5T2UQ7J)
isobutylparaben (UNII: 0QQJ25X58G)
candelilla wax (UNII: WL0328HX19)
yellow wax (UNII: 2ZA36H0S2V)
cetostearyl alcohol (UNII: 2DMT128M1S)
cetearyl glucoside (UNII: 09FUA47KNA)
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: 13537-336-02	1 in 1 BOX
1	NDC: 13537-336-01	6 g in 1 CASE

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

ESIKA   3-IN-1 PRO MAKEUP FOUNDATION SPF 20
octinoxate, oxybenzone, and titanium dioxide powder

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 13537-337
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	0.07 g  in 1 g
Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y)	Oxybenzone	0.02 g  in 1 g
Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP)	Titanium Dioxide	0.02 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
Alkyl (C12-15) Benzoate (UNII: A9EJ3J61HQ)
starch, corn (UNII: O8232NY3SJ)
silicon dioxide (UNII: ETJ7Z6XBU4)
mica (UNII: V8A1AW0880)
ethylhexyl palmitate (UNII: 2865993309)
ceresin (UNII: Q1LS2UJO3A)
carnauba wax (UNII: R12CBM0EIZ)
phenoxyethanol (UNII: HIE492ZZ3T)
octyldodecanol (UNII: 461N1O614Y)
dimethicone (UNII: 92RU3N3Y1O)
methylparaben (UNII: A2I8C7HI9T)
microcrystalline wax (UNII: XOF597Q3KY)
propylparaben (UNII: Z8IX2SC1OH)
petrolatum (UNII: 4T6H12BN9U)
butylated hydroxytoluene (UNII: 1P9D0Z171K)
butylparaben (UNII: 3QPI1U3FV8)
ethylparaben (UNII: 14255EXE39)
phosphoric acid (UNII: E4GA8884NN)
cholesterol (UNII: 97C5T2UQ7J)
isobutylparaben (UNII: 0QQJ25X58G)
candelilla wax (UNII: WL0328HX19)
yellow wax (UNII: 2ZA36H0S2V)
cetostearyl alcohol (UNII: 2DMT128M1S)
cetearyl glucoside (UNII: 09FUA47KNA)
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: 13537-337-02	1 in 1 BOX
1	NDC: 13537-337-01	6 g in 1 CASE

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

ESIKA   3-IN-1 PRO MAKEUP FOUNDATION SPF 20
octinoxate, oxybenzone, and titanium dioxide powder

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 13537-338
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	0.07 g  in 1 g
Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y)	Oxybenzone	0.02 g  in 1 g
Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP)	Titanium Dioxide	0.02 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
Alkyl (C12-15) Benzoate (UNII: A9EJ3J61HQ)
starch, corn (UNII: O8232NY3SJ)
silicon dioxide (UNII: ETJ7Z6XBU4)
mica (UNII: V8A1AW0880)
ethylhexyl palmitate (UNII: 2865993309)
ceresin (UNII: Q1LS2UJO3A)
carnauba wax (UNII: R12CBM0EIZ)
phenoxyethanol (UNII: HIE492ZZ3T)
octyldodecanol (UNII: 461N1O614Y)
dimethicone (UNII: 92RU3N3Y1O)
methylparaben (UNII: A2I8C7HI9T)
microcrystalline wax (UNII: XOF597Q3KY)
propylparaben (UNII: Z8IX2SC1OH)
petrolatum (UNII: 4T6H12BN9U)
butylated hydroxytoluene (UNII: 1P9D0Z171K)
butylparaben (UNII: 3QPI1U3FV8)
ethylparaben (UNII: 14255EXE39)
phosphoric acid (UNII: E4GA8884NN)
cholesterol (UNII: 97C5T2UQ7J)
isobutylparaben (UNII: 0QQJ25X58G)
candelilla wax (UNII: WL0328HX19)
yellow wax (UNII: 2ZA36H0S2V)
cetostearyl alcohol (UNII: 2DMT128M1S)
cetearyl glucoside (UNII: 09FUA47KNA)
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: 13537-338-02	1 in 1 BOX
1	NDC: 13537-338-01	6 g in 1 CASE

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

ESIKA   3-IN-1 PRO MAKEUP FOUNDATION SPF 20
octinoxate, oxybenzone, and titanium dioxide powder

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 13537-339
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	0.07 g  in 1 g
Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y)	Oxybenzone	0.02 g  in 1 g
Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP)	Titanium Dioxide	0.02 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
Alkyl (C12-15) Benzoate (UNII: A9EJ3J61HQ)
starch, corn (UNII: O8232NY3SJ)
silicon dioxide (UNII: ETJ7Z6XBU4)
mica (UNII: V8A1AW0880)
ethylhexyl palmitate (UNII: 2865993309)
ceresin (UNII: Q1LS2UJO3A)
carnauba wax (UNII: R12CBM0EIZ)
phenoxyethanol (UNII: HIE492ZZ3T)
octyldodecanol (UNII: 461N1O614Y)
dimethicone (UNII: 92RU3N3Y1O)
methylparaben (UNII: A2I8C7HI9T)
microcrystalline wax (UNII: XOF597Q3KY)
propylparaben (UNII: Z8IX2SC1OH)
petrolatum (UNII: 4T6H12BN9U)
butylated hydroxytoluene (UNII: 1P9D0Z171K)
butylparaben (UNII: 3QPI1U3FV8)
ethylparaben (UNII: 14255EXE39)
phosphoric acid (UNII: E4GA8884NN)
cholesterol (UNII: 97C5T2UQ7J)
isobutylparaben (UNII: 0QQJ25X58G)
candelilla wax (UNII: WL0328HX19)
yellow wax (UNII: 2ZA36H0S2V)
cetostearyl alcohol (UNII: 2DMT128M1S)
cetearyl glucoside (UNII: 09FUA47KNA)
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: 13537-339-02	1 in 1 BOX
1	NDC: 13537-339-01	6 g in 1 CASE

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

ESIKA   3-IN-1 PRO MAKEUP FOUNDATION SPF 20
octinoxate, oxybenzone, and titanium dioxide powder

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 13537-340
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	0.07 g  in 1 g
Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y)	Oxybenzone	0.02 g  in 1 g
Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP)	Titanium Dioxide	0.02 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
Alkyl (C12-15) Benzoate (UNII: A9EJ3J61HQ)
starch, corn (UNII: O8232NY3SJ)
silicon dioxide (UNII: ETJ7Z6XBU4)
mica (UNII: V8A1AW0880)
ethylhexyl palmitate (UNII: 2865993309)
ceresin (UNII: Q1LS2UJO3A)
carnauba wax (UNII: R12CBM0EIZ)
phenoxyethanol (UNII: HIE492ZZ3T)
octyldodecanol (UNII: 461N1O614Y)
dimethicone (UNII: 92RU3N3Y1O)
methylparaben (UNII: A2I8C7HI9T)
microcrystalline wax (UNII: XOF597Q3KY)
propylparaben (UNII: Z8IX2SC1OH)
petrolatum (UNII: 4T6H12BN9U)
butylated hydroxytoluene (UNII: 1P9D0Z171K)
butylparaben (UNII: 3QPI1U3FV8)
ethylparaben (UNII: 14255EXE39)
phosphoric acid (UNII: E4GA8884NN)
cholesterol (UNII: 97C5T2UQ7J)
isobutylparaben (UNII: 0QQJ25X58G)
candelilla wax (UNII: WL0328HX19)
yellow wax (UNII: 2ZA36H0S2V)
cetostearyl alcohol (UNII: 2DMT128M1S)
cetearyl glucoside (UNII: 09FUA47KNA)
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: 13537-340-02	1 in 1 BOX
1	NDC: 13537-340-01	6 g in 1 CASE

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