ESIKA 3-IN-1 PRO MAKEUP FOUNDATION SPF 20- octinoxate, oxybenzone, and titanium dioxide powder
Ventura Corporation (San Juan, P.R)

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.

----------

ēsika
3-in-1 Pro Make Up
Foundation SPF 20

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

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

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

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

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

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

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

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

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

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

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

PRINCIPAL DISPLAY PANEL - 6 g Carton - Rosa 6

ēsika

3-in-1 Pro Make Up
Foundation SPF 20

6 g e (.21 oz.)

PRINCIPAL DISPLAY PANEL - 6 g Carton

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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

Ingredient Name	Strength
Inactive Ingredients
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

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:13537-329-02	1 in 1 BOX
1	NDC:13537-329-01	6 g in 1 CASE

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

Ingredient Name	Strength
Inactive Ingredients
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

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:13537-330-02	1 in 1 BOX
1	NDC:13537-330-01	6 g in 1 CASE

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

Ingredient Name	Strength
Inactive Ingredients
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

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:13537-331-02	1 in 1 BOX
1	NDC:13537-331-01	6 g in 1 CASE

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

Ingredient Name	Strength
Inactive Ingredients
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

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:13537-332-02	1 in 1 BOX
1	NDC:13537-332-01	6 g in 1 CASE

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

Ingredient Name	Strength
Inactive Ingredients
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

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:13537-333-02	1 in 1 BOX
1	NDC:13537-333-01	6 g in 1 CASE

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

Ingredient Name	Strength
Inactive Ingredients
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

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:13537-334-02	1 in 1 BOX
1	NDC:13537-334-01	6 g in 1 CASE

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

Ingredient Name	Strength
Inactive Ingredients
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

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:13537-335-02	1 in 1 BOX
1	NDC:13537-335-01	6 g in 1 CASE

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

Ingredient Name	Strength
Inactive Ingredients
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

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:13537-336-02	1 in 1 BOX
1	NDC:13537-336-01	6 g in 1 CASE

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

Ingredient Name	Strength
Inactive Ingredients
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

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:13537-337-02	1 in 1 BOX
1	NDC:13537-337-01	6 g in 1 CASE

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

Ingredient Name	Strength
Inactive Ingredients
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

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:13537-338-02	1 in 1 BOX
1	NDC:13537-338-01	6 g in 1 CASE

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

Ingredient Name	Strength
Inactive Ingredients
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

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:13537-339-02	1 in 1 BOX
1	NDC:13537-339-01	6 g in 1 CASE

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

Ingredient Name	Strength
Inactive Ingredients
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

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:13537-340-02	1 in 1 BOX
1	NDC:13537-340-01	6 g in 1 CASE

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

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

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

Revised: 5/2011

Document Id: da7ce050-9728-4e54-8aa9-a0502aceef72

Set id: ab6f5e9a-bc06-4612-90a0-b1607198232d

Version: 1

Effective Time: 20110518

Ventura Corporation (San Juan, P.R)