DailyMed - ESIKA 3-IN-1 PRO MAKE UP FOUNDATION SPF 20 BASE DE MAQUILLAJE PARA ROSTRO 3-EN-1 PRO FPS 20 (ROSE 1) - ROSE- octinoxate, oxybenzone, and titanium dioxide cream ESIKA 3-IN-1 PRO MAKE UP FOUNDATION SPF 20 BASE DE MAQUILLAJE PARA ROSTRO 3-EN-1 PRO FPS 20 (ROSE 2) - ROSE- octinoxate, oxybenzone, and titanium dioxide cream ESIKA 3-IN-1 PRO MAKE UP FOUNDATION SPF 20 BASE DE MAQUILLA .......EIGE- octinoxate, oxybenzone, and titanium dioxide cream ESIKA 3-IN-1 PRO MAKE UP FOUNDATION SPF 20 BASE DE MAQUILLAJE PARA ROSTRO 3-EN-1 PRO FPS 20 (BEIGE 5) - BEIGE- octinoxate, oxybenzone, and titanium dioxide cream ESIKA 3-IN-1 PRO MAKE UP FOUNDATION SPF 20 BASE DE MAQUILLAJE PARA ROSTRO 3-EN-1 PRO FPS 20 (BEIGE 6) - BEIGE- octinoxate, oxybenzone, and titanium dioxide cream

Contains inactivated NDC Code(s)
NDC Code(s): 13537-187-23, 13537-187-24, 13537-188-21, 13537-188-22, view more
13537-189-19, 13537-189-20, 13537-190-17, 13537-190-18, 13537-191-15, 13537-191-16, 13537-192-13, 13537-192-14, 13537-193-11, 13537-193-12, 13537-194-09, 13537-194-10, 13537-195-07, 13537-195-08, 13537-196-05, 13537-196-06, 13537-197-03, 13537-197-04, 13537-198-01, 13537-198-02
Packager: Ventura Corporation LTD

Category: HUMAN OTC DRUG LABEL
DEA Schedule: None
Marketing Status: OTC monograph not final

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.

Drug Label Information

Updated March 6, 2014

If you are a consumer or patient please visit this version.

Download DRUG LABEL INFO: PDF XML
Official Label (Printer Friendly)

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SPL UNCLASSIFIED SECTION

Drug Facts
Active Ingredients

OCTINOXATE 7.0 %,OXYBENZONE 2.0%, TITANIUM DIOXIDE 2.0%
Purpose

Sunscreen
Uses
- Helps prevent sunburn
Warnings
- Skin Cancer / Skin Aging Alert: Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to help prevent sunburn, not skin cancer or early skin aging.
- For external use only.
- Do not use on damage or broken skin.
- When using this product keep out of eyes. Rinse with water to remove.
- Stop use and ask a doctor if rash occurs.
- Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Directions
- Apply liberally and evenly 15 minutes before sun exposure.
- Children under 6 months of age: Ask a doctor.
- Reapply at least every 2 hours.
- Use a water resistant sunscreen if swimming or sweating.
Other information

Protect the product in this container from excessive heat and direct sun.
Inactive Ingredients

ISOSTEARYL NEOPENTANOATE, C12-15 ALKYL BENZOATE,POLYMETHYL METHACRYLATE, ZEA MAYS STARCH (ZEA MAYS (CORN) STARCH), SILICA, MICA, ETHYLHEXYL METHOXYCINNAMATE, ETHYLHEXYL PALMITATE, OZOKERITE, COPERNICIA CERIFERA CERA (COPERNICIA CERIFERA (CARNAUBA) WAX), BENZOPHENONE-3, TITANIUM DIOXIDE, PHENOXYETHANOL, OCTYLDODECANOL, TRIMETHYLSILOXYSILICATE, DIMETHICONE, METHYLPARABEN, TOCOPHERYL ACETATE, MICROCRISTALLINA CERA (MICROCRYSTALLINE WAX), PROPYLPARABEN, PETROLATUM, PHOSPHOLIPIDS, BHT, C9-13 FLUOROALCOHOL, BUTYLPARABEN, ETHYLPARABEN, PHOSPHORIC ACID, CHOLESTEROL, ISOBUTYLPARABEN, POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE, CANDELILLA CERA (EUPHORBIA CERIFERA (CANDELILLA) WAX), CERA ALBA (BEESWAX), CETEARYL GLUCOSIDE, CETEARYL ALCOHOL, GLYCOSPHINGOLIPIDS. May contain: CI 77491 (IRON OXIDES), CI 77492 (IRON OXIDES), CI 77499 (IRON OXIDES), CI 77891 (TITANIUM DIOXIDE ), CHITOSAN.
SPL UNCLASSIFIED SECTION

P.R.: Dist. by Ventura Corporation, Ltd., San Juan, Puerto Rico 00926.
PRINCIPAL DISPLAY PANEL - 6 g Bottle Box - (ROSE 1) - ROSE

ésika

3-in-1 Pro Make Up
Foundation SPF 20

Base de Maquillaje para Rostro
3-en-1 Pro FPS 20

6 g e (.21 oz.)
PRINCIPAL DISPLAY PANEL - 6 g Bottle Box - (ROSE 2) - ROSE

ésika

3-in-1 Pro Make Up
Foundation SPF 20

Base de Maquillaje para Rostro
3-en-1 Pro FPS 20

6 g e (.21 oz.)
PRINCIPAL DISPLAY PANEL - 6 g Bottle Box - (ROSE 3) - ROSE

ésika

3-in-1 Pro Make Up
Foundation SPF 20

Base de Maquillaje para Rostro
3-en-1 Pro FPS 20

6 g e (.21 oz.)
PRINCIPAL DISPLAY PANEL - 6 g Bottle Box - (ROSE 4) - ROSE

ésika

3-in-1 Pro Make Up
Foundation SPF 20

Base de Maquillaje para Rostro
3-en-1 Pro FPS 20

6 g e (.21 oz.)
PRINCIPAL DISPLAY PANEL - 6 g Bottle Box - (ROSE 5) - ROSE

ésika

3-in-1 Pro Make Up
Foundation SPF 20

Base de Maquillaje para Rostro
3-en-1 Pro FPS 20

6 g e (.21 oz.)
PRINCIPAL DISPLAY PANEL - 6 g Bottle Box (ROSE 6) - ROSE

ésika

3-in-1 Pro Make Up
Foundation SPF 20

Base de Maquillaje para Rostro
3-en-1 Pro FPS 20

6 g e (.21 oz.)
PRINCIPAL DISPLAY PANEL - 6 g Bottle Box - (BEIGE 1) - BEIGE

ésika

3-in-1 Pro Make Up
Foundation SPF 20

Base de Maquillaje para Rostro
3-en-1 Pro FPS 20

6 g e (.21 oz.)
PRINCIPAL DISPLAY PANEL - 6 g Bottle Box - (BEIGE 2) - BEIGE

ésika

3-in-1 Pro Make Up
Foundation SPF 20

Base de Maquillaje para Rostro
3-en-1 Pro FPS 20

6 g e (.21 oz.)
PRINCIPAL DISPLAY PANEL - 6 g Bottle Box - (BEIGE 3) - BEIGE

ésika

3-in-1 Pro Make Up
Foundation SPF 20

Base de Maquillaje para Rostro
3-en-1 Pro FPS 20

6 g e (.21 oz.)
PRINCIPAL DISPLAY PANEL - 6 g Bottle Box - (BEIGE 4) - BEIGE

ésika

3-in-1 Pro Make Up
Foundation SPF 20

Base de Maquillaje para Rostro
3-en-1 Pro FPS 20

6 g e (.21 oz.)
PRINCIPAL DISPLAY PANEL - 6 g Bottle Box - (BEIGE 5) - BEIGE

ésika

3-in-1 Pro Make Up
Foundation SPF 20

Base de Maquillaje para Rostro
3-en-1 Pro FPS 20

6 g e (.21 oz.)
PRINCIPAL DISPLAY PANEL - 6 g Bottle Box - (BEIGE 6) - BEIGE

ésika

3-in-1 Pro Make Up
Foundation SPF 20

Base de Maquillaje para Rostro
3-en-1 Pro FPS 20

6 g e (.21 oz.)

INGREDIENTS AND APPEARANCE

ESIKA 3-IN-1 PRO MAKE UP FOUNDATION SPF 20 BASE DE MAQUILLAJE PARA ROSTRO 3-EN-1 PRO FPS 20 (ROSE 1) - ROSE
octinoxate, oxybenzone, and titanium dioxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:13537-198
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
ISOSTEARYL NEOPENTANOATE (UNII: 411THY156Q)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
STARCH, CORN (UNII: O8232NY3SJ)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
MICA (UNII: V8A1AW0880)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
CARNAUBA WAX (UNII: R12CBM0EIZ)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
OCTYLDODECANOL (UNII: 461N1O614Y)
DIMETHICONE (UNII: 92RU3N3Y1O)
METHYLPARABEN (UNII: A2I8C7HI9T)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
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)
POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE (UNII: 9229XJ4V12)
CANDELILLA WAX (UNII: WL0328HX19)
YELLOW WAX (UNII: 2ZA36H0S2V)
CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)

#	Item Code	Package Description
Packaging
1	NDC:13537-198-02	1 in 1 BOX
1	NDC:13537-198-01	6 g in 1 BOTTLE

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH NOT FINAL	part352	03/06/2014

ESIKA 3-IN-1 PRO MAKE UP FOUNDATION SPF 20 BASE DE MAQUILLAJE PARA ROSTRO 3-EN-1 PRO FPS 20 (ROSE 2) - ROSE
octinoxate, oxybenzone, and titanium dioxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:13537-197
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
ISOSTEARYL NEOPENTANOATE (UNII: 411THY156Q)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
STARCH, CORN (UNII: O8232NY3SJ)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
MICA (UNII: V8A1AW0880)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
CARNAUBA WAX (UNII: R12CBM0EIZ)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
OCTYLDODECANOL (UNII: 461N1O614Y)
DIMETHICONE (UNII: 92RU3N3Y1O)
METHYLPARABEN (UNII: A2I8C7HI9T)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
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)
POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE (UNII: 9229XJ4V12)
CANDELILLA WAX (UNII: WL0328HX19)
YELLOW WAX (UNII: 2ZA36H0S2V)
CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)

#	Item Code	Package Description
Packaging
1	NDC:13537-197-04	1 in 1 BOX
1	NDC:13537-197-03	6 g in 1 BOTTLE

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH NOT FINAL	part352	03/06/2014

ESIKA 3-IN-1 PRO MAKE UP FOUNDATION SPF 20 BASE DE MAQUILLAJE PARA ROSTRO 3-EN-1 PRO FPS 20 (ROSE 3) - ROSE
octinoxate, oxybenzone, and titanium dioxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:13537-196
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
ISOSTEARYL NEOPENTANOATE (UNII: 411THY156Q)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
STARCH, CORN (UNII: O8232NY3SJ)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
MICA (UNII: V8A1AW0880)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
CARNAUBA WAX (UNII: R12CBM0EIZ)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
OCTYLDODECANOL (UNII: 461N1O614Y)
DIMETHICONE (UNII: 92RU3N3Y1O)
METHYLPARABEN (UNII: A2I8C7HI9T)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
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)
POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE (UNII: 9229XJ4V12)
CANDELILLA WAX (UNII: WL0328HX19)
YELLOW WAX (UNII: 2ZA36H0S2V)
CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)

#	Item Code	Package Description
Packaging
1	NDC:13537-196-06	1 in 1 BOX
1	NDC:13537-196-05	6 g in 1 BOTTLE

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH NOT FINAL	part352	03/06/2014

ESIKA 3-IN-1 PRO MAKE UP FOUNDATION SPF 20 BASE DE MAQUILLAJE PARA ROSTRO 3-EN-1 PRO FPS 20 (ROSE 4) - ROSE
octinoxate, oxybenzone, and titanium dioxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:13537-195
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
ISOSTEARYL NEOPENTANOATE (UNII: 411THY156Q)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
STARCH, CORN (UNII: O8232NY3SJ)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
MICA (UNII: V8A1AW0880)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
CARNAUBA WAX (UNII: R12CBM0EIZ)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
OCTYLDODECANOL (UNII: 461N1O614Y)
DIMETHICONE (UNII: 92RU3N3Y1O)
METHYLPARABEN (UNII: A2I8C7HI9T)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
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)
POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE (UNII: 9229XJ4V12)
CANDELILLA WAX (UNII: WL0328HX19)
YELLOW WAX (UNII: 2ZA36H0S2V)
CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)

#	Item Code	Package Description
Packaging
1	NDC:13537-195-08	1 in 1 BOX
1	NDC:13537-195-07	6 g in 1 BOTTLE

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH NOT FINAL	part352	03/06/2014

ESIKA 3-IN-1 PRO MAKE UP FOUNDATION SPF 20 BASE DE MAQUILLAJE PARA ROSTRO 3-EN-1 PRO FPS 20 (ROSE 5) - ROSE
octinoxate, oxybenzone, and titanium dioxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:13537-194
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
ISOSTEARYL NEOPENTANOATE (UNII: 411THY156Q)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
STARCH, CORN (UNII: O8232NY3SJ)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
MICA (UNII: V8A1AW0880)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
CARNAUBA WAX (UNII: R12CBM0EIZ)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
OCTYLDODECANOL (UNII: 461N1O614Y)
DIMETHICONE (UNII: 92RU3N3Y1O)
METHYLPARABEN (UNII: A2I8C7HI9T)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
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)
POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE (UNII: 9229XJ4V12)
CANDELILLA WAX (UNII: WL0328HX19)
YELLOW WAX (UNII: 2ZA36H0S2V)
CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)

#	Item Code	Package Description
Packaging
1	NDC:13537-194-10	1 in 1 BOX
1	NDC:13537-194-09	6 g in 1 BOTTLE

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH NOT FINAL	part352	03/06/2014

ESIKA 3-IN-1 PRO MAKE UP FOUNDATION SPF 20 BASE DE MAQUILLAJE PARA ROSTRO 3-EN-1 PRO FPS 20 (ROSE 6) - ROSE
octinoxate, oxybenzone, and titanium dioxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:13537-193
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
ISOSTEARYL NEOPENTANOATE (UNII: 411THY156Q)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
STARCH, CORN (UNII: O8232NY3SJ)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
MICA (UNII: V8A1AW0880)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
CARNAUBA WAX (UNII: R12CBM0EIZ)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
OCTYLDODECANOL (UNII: 461N1O614Y)
DIMETHICONE (UNII: 92RU3N3Y1O)
METHYLPARABEN (UNII: A2I8C7HI9T)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
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)
POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE (UNII: 9229XJ4V12)
CANDELILLA WAX (UNII: WL0328HX19)
YELLOW WAX (UNII: 2ZA36H0S2V)
CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)

#	Item Code	Package Description
Packaging
1	NDC:13537-193-12	1 in 1 BOX
1	NDC:13537-193-11	6 g in 1 BOTTLE

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH NOT FINAL	part352	03/06/2014

ESIKA 3-IN-1 PRO MAKE UP FOUNDATION SPF 20 BASE DE MAQUILLAJE PARA ROSTRO 3-EN-1 PRO FPS 20 (BEIGE 1) - BEIGE
octinoxate, oxybenzone, and titanium dioxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:13537-192
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
ISOSTEARYL NEOPENTANOATE (UNII: 411THY156Q)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
STARCH, CORN (UNII: O8232NY3SJ)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
MICA (UNII: V8A1AW0880)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
CARNAUBA WAX (UNII: R12CBM0EIZ)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
OCTYLDODECANOL (UNII: 461N1O614Y)
DIMETHICONE (UNII: 92RU3N3Y1O)
METHYLPARABEN (UNII: A2I8C7HI9T)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
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)
POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE (UNII: 9229XJ4V12)
CANDELILLA WAX (UNII: WL0328HX19)
YELLOW WAX (UNII: 2ZA36H0S2V)
CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)

#	Item Code	Package Description
Packaging
1	NDC:13537-192-14	1 in 1 BOX
1	NDC:13537-192-13	6 g in 1 BOTTLE

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH NOT FINAL	part352	03/06/2014

ESIKA 3-IN-1 PRO MAKE UP FOUNDATION SPF 20 BASE DE MAQUILLAJE PARA ROSTRO 3-EN-1 PRO FPS 20 (BEIGE 2) - BEIGE
octinoxate, oxybenzone, and titanium dioxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:13537-191
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
ISOSTEARYL NEOPENTANOATE (UNII: 411THY156Q)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
STARCH, CORN (UNII: O8232NY3SJ)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
MICA (UNII: V8A1AW0880)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
CARNAUBA WAX (UNII: R12CBM0EIZ)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
OCTYLDODECANOL (UNII: 461N1O614Y)
DIMETHICONE (UNII: 92RU3N3Y1O)
METHYLPARABEN (UNII: A2I8C7HI9T)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
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)
POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE (UNII: 9229XJ4V12)
CANDELILLA WAX (UNII: WL0328HX19)
YELLOW WAX (UNII: 2ZA36H0S2V)
CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)

#	Item Code	Package Description
Packaging
1	NDC:13537-191-16	1 in 1 BOX
1	NDC:13537-191-15	6 g in 1 BOTTLE

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH NOT FINAL	part352	03/06/2014

ESIKA 3-IN-1 PRO MAKE UP FOUNDATION SPF 20 BASE DE MAQUILLAJE PARA ROSTRO 3-EN-1 PRO FPS 20 (BEIGE 3) - BEIGE
octinoxate, oxybenzone, and titanium dioxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:13537-190
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
ISOSTEARYL NEOPENTANOATE (UNII: 411THY156Q)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
STARCH, CORN (UNII: O8232NY3SJ)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
MICA (UNII: V8A1AW0880)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
CARNAUBA WAX (UNII: R12CBM0EIZ)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
OCTYLDODECANOL (UNII: 461N1O614Y)
DIMETHICONE (UNII: 92RU3N3Y1O)
METHYLPARABEN (UNII: A2I8C7HI9T)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
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)
POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE (UNII: 9229XJ4V12)
CANDELILLA WAX (UNII: WL0328HX19)
YELLOW WAX (UNII: 2ZA36H0S2V)
CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)

#	Item Code	Package Description
Packaging
1	NDC:13537-190-18	1 in 1 BOX
1	NDC:13537-190-17	6 g in 1 BOTTLE

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH NOT FINAL	part352	03/06/2014

ESIKA 3-IN-1 PRO MAKE UP FOUNDATION SPF 20 BASE DE MAQUILLAJE PARA ROSTRO 3-EN-1 PRO FPS 20 (BEIGE 4) - BEIGE
octinoxate, oxybenzone, and titanium dioxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:13537-189
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
ISOSTEARYL NEOPENTANOATE (UNII: 411THY156Q)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
STARCH, CORN (UNII: O8232NY3SJ)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
MICA (UNII: V8A1AW0880)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
CARNAUBA WAX (UNII: R12CBM0EIZ)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
OCTYLDODECANOL (UNII: 461N1O614Y)
DIMETHICONE (UNII: 92RU3N3Y1O)
METHYLPARABEN (UNII: A2I8C7HI9T)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
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)
POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE (UNII: 9229XJ4V12)
CANDELILLA WAX (UNII: WL0328HX19)
YELLOW WAX (UNII: 2ZA36H0S2V)
CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)

#	Item Code	Package Description
Packaging
1	NDC:13537-189-20	1 in 1 BOX
1	NDC:13537-189-19	6 g in 1 BOTTLE

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH NOT FINAL	part352	03/06/2014

ESIKA 3-IN-1 PRO MAKE UP FOUNDATION SPF 20 BASE DE MAQUILLAJE PARA ROSTRO 3-EN-1 PRO FPS 20 (BEIGE 5) - BEIGE
octinoxate, oxybenzone, and titanium dioxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:13537-188
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
ISOSTEARYL NEOPENTANOATE (UNII: 411THY156Q)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
STARCH, CORN (UNII: O8232NY3SJ)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
MICA (UNII: V8A1AW0880)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
CARNAUBA WAX (UNII: R12CBM0EIZ)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
OCTYLDODECANOL (UNII: 461N1O614Y)
DIMETHICONE (UNII: 92RU3N3Y1O)
METHYLPARABEN (UNII: A2I8C7HI9T)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
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)
POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE (UNII: 9229XJ4V12)
CANDELILLA WAX (UNII: WL0328HX19)
YELLOW WAX (UNII: 2ZA36H0S2V)
CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)

#	Item Code	Package Description
Packaging
1	NDC:13537-188-22	1 in 1 BOX
1	NDC:13537-188-21	6 g in 1 BOTTLE

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH NOT FINAL	part352	03/06/2014

ESIKA 3-IN-1 PRO MAKE UP FOUNDATION SPF 20 BASE DE MAQUILLAJE PARA ROSTRO 3-EN-1 PRO FPS 20 (BEIGE 6) - BEIGE
octinoxate, oxybenzone, and titanium dioxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:13537-187
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
ISOSTEARYL NEOPENTANOATE (UNII: 411THY156Q)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
STARCH, CORN (UNII: O8232NY3SJ)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
MICA (UNII: V8A1AW0880)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
CARNAUBA WAX (UNII: R12CBM0EIZ)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
OCTYLDODECANOL (UNII: 461N1O614Y)
DIMETHICONE (UNII: 92RU3N3Y1O)
METHYLPARABEN (UNII: A2I8C7HI9T)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
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)
POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE (UNII: 9229XJ4V12)
CANDELILLA WAX (UNII: WL0328HX19)
YELLOW WAX (UNII: 2ZA36H0S2V)
CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)

#	Item Code	Package Description
Packaging
1	NDC:13537-187-24	1 in 1 BOX
1	NDC:13537-187-23	6 g in 1 BOTTLE

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH NOT FINAL	part352	03/06/2014

Labeler - Ventura Corporation LTD (602751344)

Name	Address	ID/FEI	Business Operations
Establishment
Bel Star S.A. (Colombia)		880160197	MANUFACTURE(13537-198, 13537-197, 13537-196, 13537-195, 13537-194, 13537-193, 13537-192, 13537-191, 13537-190, 13537-189, 13537-188, 13537-187)

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	NDC
1	13537-187-23
2	13537-187-24 (inactivated)
3	13537-188-21
4	13537-188-22 (inactivated)
5	13537-189-19
6	13537-189-20 (inactivated)
7	13537-190-17
8	13537-190-18 (inactivated)
9	13537-191-15
10	13537-191-16 (inactivated)
11	13537-192-13
12	13537-192-14 (inactivated)
13	13537-193-11
14	13537-193-12 (inactivated)
15	13537-194-09
16	13537-194-10 (inactivated)
17	13537-195-07
18	13537-195-08 (inactivated)
19	13537-196-05
20	13537-196-06 (inactivated)
21	13537-197-03
22	13537-197-04 (inactivated)
23	13537-198-01
24	13537-198-02 (inactivated)

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If this SPL contains inactivated NDCs listed by the FDA initiated compliance action, they will be specified as such.