DailyMed - ESIKA- octinoxate powder

Contains inactivated NDC Code(s)
NDC Code(s): 13537-317-01, 13537-317-02, 13537-318-01, 13537-318-02, view more
13537-319-01, 13537-319-02, 13537-320-01, 13537-320-02, 13537-321-01, 13537-321-02, 13537-322-01, 13537-322-02, 13537-323-01, 13537-323-02, 13537-324-01, 13537-324-02, 13537-325-01, 13537-325-02, 13537-326-01, 13537-326-02, 13537-327-01, 13537-327-02, 13537-328-01, 13537-328-02
Packager: Ventura Corporation (San Juan, P.R)

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 May 18, 2011

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

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Official Label (Printer Friendly)

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SPL UNCLASSIFIED SECTION

Drug Facts
Active Ingredients

Octinoxate (6%)
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 smoothly 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), coco-caprylate/caprate, ethylhexyl palmitate, glycerin, octyldodecanol, polymethyl methacrylate, cyclopentasiloxane, cetyl peg/ppg-10/1 dimethicone, polyglyceryl-4 isostearate, sodium chloride, talc, dimethicone, hexyl laurate, dimethicone/vinyl dimethicone crosspolymer, cyclomethicone, disteardimonium hectorite, cyclohexasiloxane, glycine soja protein (glycine soja (soybean) protein), microcrystalline wax, diazolidinyl urea, cetearyl dimethicone crosspolymer, methylparaben, propylparaben, tocopheryl acetate, petrolatum, dimethiconol, phospholipids, cholesterol, silica, bha, bht, candelilla cera (euphorbia cerifera (candelilla) wax), beeswax, cetearyl alcohol, cetearyl glucoside, copernicia cerifera cera (copernicia cerifera (carnauba) wax), polyglyceryl-2 dipolyhydroxystearate, glycosphingolipids, triethoxycaprylylsilane, ci 77891 (titanium dioxide ), ci 77492 (iron oxides), ci 77491( iron oxides), ci 77499 (iron oxides).
PRINCIPAL DISPLAY PANEL - 30 g Carton

ēsika

Hydrated Face Makeup Foundation SPF 15

30 g e (1 oz.)

INGREDIENTS AND APPEARANCE

ESIKA HYDRATED FACE MAKEUP FOUNDATION SPF 15
octinoxate powder

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:13537-317
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	0.06 g in 1 g

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
GLYCERIN (UNII: PDC6A3C0OX)
OCTYLDODECANOL (UNII: 461N1O614Y)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
TALC (UNII: 7SEV7J4R1U)
DIMETHICONE (UNII: 92RU3N3Y1O)
HEXYL LAURATE (UNII: 4CG9F9W01Q)
CYCLOMETHICONE (UNII: NMQ347994Z)
CYCLOMETHICONE 6 (UNII: XHK3U310BA)
SOYBEAN (UNII: L7HT8F1ZOD)
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)
METHYLPARABEN (UNII: A2I8C7HI9T)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
PETROLATUM (UNII: 4T6H12BN9U)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
CHOLESTEROL (UNII: 97C5T2UQ7J)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
BUTYLATED HYDROXYANISOLE (UNII: REK4960K2U)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
CANDELILLA WAX (UNII: WL0328HX19)
YELLOW WAX (UNII: 2ZA36H0S2V)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)
CARNAUBA WAX (UNII: R12CBM0EIZ)
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

#	Item Code	Package Description
Packaging
1	NDC:13537-317-02	1 in 1 BOX
1	NDC:13537-317-01	30 g in 1 JAR

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

ESIKA HYDRATED FACE MAKEUP FOUNDATION SPF 15
octinoxate powder

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:13537-318
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	0.06 g in 1 g

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
GLYCERIN (UNII: PDC6A3C0OX)
OCTYLDODECANOL (UNII: 461N1O614Y)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
TALC (UNII: 7SEV7J4R1U)
DIMETHICONE (UNII: 92RU3N3Y1O)
HEXYL LAURATE (UNII: 4CG9F9W01Q)
CYCLOMETHICONE (UNII: NMQ347994Z)
CYCLOMETHICONE 6 (UNII: XHK3U310BA)
SOYBEAN (UNII: L7HT8F1ZOD)
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)
METHYLPARABEN (UNII: A2I8C7HI9T)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
PETROLATUM (UNII: 4T6H12BN9U)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
CHOLESTEROL (UNII: 97C5T2UQ7J)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
BUTYLATED HYDROXYANISOLE (UNII: REK4960K2U)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
CANDELILLA WAX (UNII: WL0328HX19)
YELLOW WAX (UNII: 2ZA36H0S2V)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)
CARNAUBA WAX (UNII: R12CBM0EIZ)
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

#	Item Code	Package Description
Packaging
1	NDC:13537-318-02	1 in 1 BOX
1	NDC:13537-318-01	30 g in 1 JAR

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

ESIKA HYDRATED FACE MAKEUP FOUNDATION SPF 15
octinoxate powder

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:13537-319
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	0.06 g in 1 g

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
GLYCERIN (UNII: PDC6A3C0OX)
OCTYLDODECANOL (UNII: 461N1O614Y)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
TALC (UNII: 7SEV7J4R1U)
DIMETHICONE (UNII: 92RU3N3Y1O)
HEXYL LAURATE (UNII: 4CG9F9W01Q)
CYCLOMETHICONE (UNII: NMQ347994Z)
CYCLOMETHICONE 6 (UNII: XHK3U310BA)
SOYBEAN (UNII: L7HT8F1ZOD)
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)
METHYLPARABEN (UNII: A2I8C7HI9T)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
PETROLATUM (UNII: 4T6H12BN9U)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
CHOLESTEROL (UNII: 97C5T2UQ7J)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
BUTYLATED HYDROXYANISOLE (UNII: REK4960K2U)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
CANDELILLA WAX (UNII: WL0328HX19)
YELLOW WAX (UNII: 2ZA36H0S2V)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)
CARNAUBA WAX (UNII: R12CBM0EIZ)
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

#	Item Code	Package Description
Packaging
1	NDC:13537-319-02	1 in 1 BOX
1	NDC:13537-319-01	30 g in 1 JAR

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

ESIKA HYDRATED FACE MAKEUP FOUNDATION SPF 15
octinoxate powder

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:13537-320
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	0.06 g in 1 g

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
GLYCERIN (UNII: PDC6A3C0OX)
OCTYLDODECANOL (UNII: 461N1O614Y)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
TALC (UNII: 7SEV7J4R1U)
DIMETHICONE (UNII: 92RU3N3Y1O)
HEXYL LAURATE (UNII: 4CG9F9W01Q)
CYCLOMETHICONE (UNII: NMQ347994Z)
CYCLOMETHICONE 6 (UNII: XHK3U310BA)
SOYBEAN (UNII: L7HT8F1ZOD)
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)
METHYLPARABEN (UNII: A2I8C7HI9T)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
PETROLATUM (UNII: 4T6H12BN9U)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
CHOLESTEROL (UNII: 97C5T2UQ7J)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
BUTYLATED HYDROXYANISOLE (UNII: REK4960K2U)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
CANDELILLA WAX (UNII: WL0328HX19)
YELLOW WAX (UNII: 2ZA36H0S2V)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)
CARNAUBA WAX (UNII: R12CBM0EIZ)
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

#	Item Code	Package Description
Packaging
1	NDC:13537-320-02	1 in 1 BOX
1	NDC:13537-320-01	30 g in 1 JAR

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

ESIKA HYDRATED FACE MAKEUP FOUNDATION SPF 15
octinoxate powder

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:13537-321
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	0.06 g in 1 g

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
GLYCERIN (UNII: PDC6A3C0OX)
OCTYLDODECANOL (UNII: 461N1O614Y)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
TALC (UNII: 7SEV7J4R1U)
DIMETHICONE (UNII: 92RU3N3Y1O)
HEXYL LAURATE (UNII: 4CG9F9W01Q)
CYCLOMETHICONE (UNII: NMQ347994Z)
CYCLOMETHICONE 6 (UNII: XHK3U310BA)
SOYBEAN (UNII: L7HT8F1ZOD)
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)
METHYLPARABEN (UNII: A2I8C7HI9T)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
PETROLATUM (UNII: 4T6H12BN9U)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
CHOLESTEROL (UNII: 97C5T2UQ7J)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
BUTYLATED HYDROXYANISOLE (UNII: REK4960K2U)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
CANDELILLA WAX (UNII: WL0328HX19)
YELLOW WAX (UNII: 2ZA36H0S2V)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)
CARNAUBA WAX (UNII: R12CBM0EIZ)
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

#	Item Code	Package Description
Packaging
1	NDC:13537-321-02	1 in 1 BOX
1	NDC:13537-321-01	30 g in 1 JAR

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

ESIKA HYDRATED FACE MAKEUP FOUNDATION SPF 15
octinoxate powder

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:13537-322
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	0.06 g in 1 g

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
GLYCERIN (UNII: PDC6A3C0OX)
OCTYLDODECANOL (UNII: 461N1O614Y)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
TALC (UNII: 7SEV7J4R1U)
DIMETHICONE (UNII: 92RU3N3Y1O)
HEXYL LAURATE (UNII: 4CG9F9W01Q)
CYCLOMETHICONE (UNII: NMQ347994Z)
CYCLOMETHICONE 6 (UNII: XHK3U310BA)
SOYBEAN (UNII: L7HT8F1ZOD)
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)
METHYLPARABEN (UNII: A2I8C7HI9T)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
PETROLATUM (UNII: 4T6H12BN9U)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
CHOLESTEROL (UNII: 97C5T2UQ7J)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
BUTYLATED HYDROXYANISOLE (UNII: REK4960K2U)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
CANDELILLA WAX (UNII: WL0328HX19)
YELLOW WAX (UNII: 2ZA36H0S2V)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)
CARNAUBA WAX (UNII: R12CBM0EIZ)
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

#	Item Code	Package Description
Packaging
1	NDC:13537-322-02	1 in 1 BOX
1	NDC:13537-322-01	30 g in 1 JAR

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

ESIKA HYDRATED FACE MAKEUP FOUNDATION SPF 15
octinoxate powder

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:13537-323
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	0.06 g in 1 g

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
GLYCERIN (UNII: PDC6A3C0OX)
OCTYLDODECANOL (UNII: 461N1O614Y)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
TALC (UNII: 7SEV7J4R1U)
DIMETHICONE (UNII: 92RU3N3Y1O)
HEXYL LAURATE (UNII: 4CG9F9W01Q)
CYCLOMETHICONE (UNII: NMQ347994Z)
CYCLOMETHICONE 6 (UNII: XHK3U310BA)
SOYBEAN (UNII: L7HT8F1ZOD)
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)
METHYLPARABEN (UNII: A2I8C7HI9T)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
PETROLATUM (UNII: 4T6H12BN9U)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
CHOLESTEROL (UNII: 97C5T2UQ7J)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
BUTYLATED HYDROXYANISOLE (UNII: REK4960K2U)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
CANDELILLA WAX (UNII: WL0328HX19)
YELLOW WAX (UNII: 2ZA36H0S2V)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)
CARNAUBA WAX (UNII: R12CBM0EIZ)
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

#	Item Code	Package Description
Packaging
1	NDC:13537-323-02	1 in 1 BOX
1	NDC:13537-323-01	30 g in 1 JAR

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

ESIKA HYDRATED FACE MAKEUP FOUNDATION SPF 15
octinoxate powder

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:13537-324
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	0.06 g in 1 g

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
GLYCERIN (UNII: PDC6A3C0OX)
OCTYLDODECANOL (UNII: 461N1O614Y)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
TALC (UNII: 7SEV7J4R1U)
DIMETHICONE (UNII: 92RU3N3Y1O)
HEXYL LAURATE (UNII: 4CG9F9W01Q)
CYCLOMETHICONE (UNII: NMQ347994Z)
CYCLOMETHICONE 6 (UNII: XHK3U310BA)
SOYBEAN (UNII: L7HT8F1ZOD)
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)
METHYLPARABEN (UNII: A2I8C7HI9T)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
PETROLATUM (UNII: 4T6H12BN9U)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
CHOLESTEROL (UNII: 97C5T2UQ7J)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
BUTYLATED HYDROXYANISOLE (UNII: REK4960K2U)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
CANDELILLA WAX (UNII: WL0328HX19)
YELLOW WAX (UNII: 2ZA36H0S2V)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)
CARNAUBA WAX (UNII: R12CBM0EIZ)
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

#	Item Code	Package Description
Packaging
1	NDC:13537-324-02	1 in 1 BOX
1	NDC:13537-324-01	30 g in 1 JAR

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

ESIKA HYDRATED FACE MAKEUP FOUNDATION SPF 15
octinoxate powder

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:13537-325
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	0.06 g in 1 g

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
GLYCERIN (UNII: PDC6A3C0OX)
OCTYLDODECANOL (UNII: 461N1O614Y)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
TALC (UNII: 7SEV7J4R1U)
DIMETHICONE (UNII: 92RU3N3Y1O)
HEXYL LAURATE (UNII: 4CG9F9W01Q)
CYCLOMETHICONE (UNII: NMQ347994Z)
CYCLOMETHICONE 6 (UNII: XHK3U310BA)
SOYBEAN (UNII: L7HT8F1ZOD)
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)
METHYLPARABEN (UNII: A2I8C7HI9T)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
PETROLATUM (UNII: 4T6H12BN9U)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
CHOLESTEROL (UNII: 97C5T2UQ7J)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
BUTYLATED HYDROXYANISOLE (UNII: REK4960K2U)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
CANDELILLA WAX (UNII: WL0328HX19)
YELLOW WAX (UNII: 2ZA36H0S2V)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)
CARNAUBA WAX (UNII: R12CBM0EIZ)
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

#	Item Code	Package Description
Packaging
1	NDC:13537-325-02	1 in 1 BOX
1	NDC:13537-325-01	30 g in 1 JAR

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

ESIKA HYDRATED FACE MAKEUP FOUNDATION SPF 15
octinoxate powder

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:13537-326
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	0.06 g in 1 g

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
GLYCERIN (UNII: PDC6A3C0OX)
OCTYLDODECANOL (UNII: 461N1O614Y)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
TALC (UNII: 7SEV7J4R1U)
DIMETHICONE (UNII: 92RU3N3Y1O)
HEXYL LAURATE (UNII: 4CG9F9W01Q)
CYCLOMETHICONE (UNII: NMQ347994Z)
CYCLOMETHICONE 6 (UNII: XHK3U310BA)
SOYBEAN (UNII: L7HT8F1ZOD)
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)
METHYLPARABEN (UNII: A2I8C7HI9T)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
PETROLATUM (UNII: 4T6H12BN9U)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
CHOLESTEROL (UNII: 97C5T2UQ7J)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
BUTYLATED HYDROXYANISOLE (UNII: REK4960K2U)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
CANDELILLA WAX (UNII: WL0328HX19)
YELLOW WAX (UNII: 2ZA36H0S2V)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)
CARNAUBA WAX (UNII: R12CBM0EIZ)
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

#	Item Code	Package Description
Packaging
1	NDC:13537-326-02	1 in 1 BOX
1	NDC:13537-326-01	30 g in 1 JAR

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

ESIKA HYDRATED FACE MAKEUP FOUNDATION SPF 15
octinoxate powder

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:13537-327
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	0.06 g in 1 g

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
GLYCERIN (UNII: PDC6A3C0OX)
OCTYLDODECANOL (UNII: 461N1O614Y)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
TALC (UNII: 7SEV7J4R1U)
DIMETHICONE (UNII: 92RU3N3Y1O)
HEXYL LAURATE (UNII: 4CG9F9W01Q)
CYCLOMETHICONE (UNII: NMQ347994Z)
CYCLOMETHICONE 6 (UNII: XHK3U310BA)
SOYBEAN (UNII: L7HT8F1ZOD)
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)
METHYLPARABEN (UNII: A2I8C7HI9T)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
PETROLATUM (UNII: 4T6H12BN9U)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
CHOLESTEROL (UNII: 97C5T2UQ7J)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
BUTYLATED HYDROXYANISOLE (UNII: REK4960K2U)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
CANDELILLA WAX (UNII: WL0328HX19)
YELLOW WAX (UNII: 2ZA36H0S2V)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)
CARNAUBA WAX (UNII: R12CBM0EIZ)
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

#	Item Code	Package Description
Packaging
1	NDC:13537-327-02	1 in 1 BOX
1	NDC:13537-327-01	30 g in 1 JAR

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

ESIKA HYDRATED FACE MAKEUP FOUNDATION SPF 15
octinoxate powder

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:13537-328
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	0.06 g in 1 g

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
GLYCERIN (UNII: PDC6A3C0OX)
OCTYLDODECANOL (UNII: 461N1O614Y)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
TALC (UNII: 7SEV7J4R1U)
DIMETHICONE (UNII: 92RU3N3Y1O)
HEXYL LAURATE (UNII: 4CG9F9W01Q)
CYCLOMETHICONE (UNII: NMQ347994Z)
CYCLOMETHICONE 6 (UNII: XHK3U310BA)
SOYBEAN (UNII: L7HT8F1ZOD)
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)
METHYLPARABEN (UNII: A2I8C7HI9T)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
PETROLATUM (UNII: 4T6H12BN9U)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
CHOLESTEROL (UNII: 97C5T2UQ7J)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
BUTYLATED HYDROXYANISOLE (UNII: REK4960K2U)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
CANDELILLA WAX (UNII: WL0328HX19)
YELLOW WAX (UNII: 2ZA36H0S2V)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)
CARNAUBA WAX (UNII: R12CBM0EIZ)
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

#	Item Code	Package Description
Packaging
1	NDC:13537-328-02	1 in 1 BOX
1	NDC:13537-328-01	30 g in 1 JAR

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

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Label: ESIKA- octinoxate powder

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	NDC
1	13537-317-01
2	13537-317-02 (inactivated)
3	13537-318-01
4	13537-318-02 (inactivated)
5	13537-319-01
6	13537-319-02 (inactivated)
7	13537-320-01
8	13537-320-02 (inactivated)
9	13537-321-01
10	13537-321-02 (inactivated)
11	13537-322-01
12	13537-322-02 (inactivated)
13	13537-323-01
14	13537-323-02 (inactivated)
15	13537-324-01
16	13537-324-02 (inactivated)
17	13537-325-01
18	13537-325-02 (inactivated)
19	13537-326-01
20	13537-326-02 (inactivated)
21	13537-327-01
22	13537-327-02 (inactivated)
23	13537-328-01
24	13537-328-02 (inactivated)

Label: ESIKA- octinoxate powder

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More Info For This Drug

Drug Label Information

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ESIKA- octinoxate powder

Number of versions: 1

ESIKA- octinoxate powder

ESIKA- octinoxate powder

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ESIKA- octinoxate powder

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