Drug Facts

Active ingredients Purpose
TITANIUM DIOXIDE (6.24%) Sunscreen

ZINC OXIDE (4.9%) Sunscreen

OCTINOXATE (3.0%) Sunscreen

uses

Help prevents sunburn

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

Stop use and ask a doctor if rash occurs.

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.

Apply liberally and evenly 15 minutes before sun exposure.
Reapply at least every 2 hours.
Use a water resistant sunscreen if swimming or sweating.

Children under 6 months of age: Ask a doctor.

Inactive ingredients
MICA, POLYMETHYLSILSESQUIOXANE, HDI/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER, DIMETHICONE,
MAGNESIUM STEARATE, TRIMETHYLSILOXYSILICATE, ISOSTEARYL NEOPENTANOATE, HYDROGEN DIMETHICONE,
TOCOPHERYL ACETATE, PHENOXYETHANOL, ALUMINA, TRIETHOXYCAPRYLYLSILANE, PARFUM (FRAGRANCE),
CAPRYLYL GLYCOL, CERAMIDE 3, CHLORPHENESIN. MAY CONTAIN: CI 77492 (IRON OXIDES),
CI 77491 (IRON OXIDES), CI 77891 (TITANIUM DIOXIDE ), CI 77499 (IRON OXIDES).

PRINCIPAL DISPLAY PANEL - 10 g Cartridge Box - Claire 1-2-3

DIVINE

Polvos compactos doble uso FPS 15 edición de lujo dorado

Double use compact SPF 15 gold deluxe edition

Net Wt. 0.35 oz. e (10 g)

L'BEL

Claire 1-2-3

PRINCIPAL DISPLAY PANEL - 10 g Cartridge Box - Claire 4

DIVINE

Polvos compactos doble uso FPS 15 edición de lujo dorado

Double use compact SPF 15 gold deluxe edition

Net Wt. 0.35 oz. e (10 g)

L'BEL

Claire 4

PRINCIPAL DISPLAY PANEL - 10 g Cartridge Box - Medium 5

DIVINE

Polvos compactos doble uso FPS 15 edición de lujo dorado

Double use compact SPF 15 gold deluxe edition

Net Wt. 0.35 oz. e (10 g)

L'BEL

Medium 5

PRINCIPAL DISPLAY PANEL - 10 g Cartridge Box - Medium 6

DIVINE

Polvos compactos doble uso FPS 15 edición de lujo dorado

Double use compact SPF 15 gold deluxe edition

Net Wt. 0.35 oz. e (10 g)

L'BEL

Medium 6

PRINCIPAL DISPLAY PANEL - 10 g Cartridge Box - Medium 7

DIVINE

Polvos compactos doble uso FPS 15 edición de lujo dorado

Double use compact SPF 15 gold deluxe edition

Net Wt. 0.35 oz. e (10 g)

L'BEL

Medium 7

PRINCIPAL DISPLAY PANEL - 10 g Cartridge Box - Obscure 8-9

DIVINE

Polvos compactos doble uso FPS 15 edición de lujo dorado

Double use compact SPF 15 gold deluxe edition

Net Wt. 0.35 oz. e (10 g)

L'BEL

Obscure 8-9

LBEL DIVINE POLVOS COMPACTOS DOBLE USO FPS 15 EDICION DE LUJO DORADO/DOUBLE USE COMPACT SPF 15 GOLD DELUXE EDITION CLAIRE 1-2-3
titanium dioxide, zinc oxide, and octinoxate powder

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:14141-499
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP)	Titanium Dioxide	0.0624 g in 1 g
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z)	Zinc Oxide	0.049 g in 1 g
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	0.03 g in 1 g

Ingredient Name	Strength
Inactive Ingredients
MICA (UNII: V8A1AW0880)
DIMETHICONE (UNII: 92RU3N3Y1O)
MAGNESIUM STEARATE (UNII: 70097M6I30)
ISOSTEARYL NEOPENTANOATE (UNII: 411THY156Q)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
ALUMINUM OXIDE (UNII: LMI26O6933)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
CERAMIDE 3 (UNII: 4370DF050B)
CHLORPHENESIN (UNII: I670DAL4SZ)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)

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

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:14141-499-02	1 in 1 BOX	05/27/2013
1	NDC:14141-499-01	10 g in 1 CARTRIDGE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part352	05/27/2013

LBEL DIVINE POLVOS COMPACTOS DOBLE USO FPS 15 EDICION DE LUJO DORADO/DOUBLE USE COMPACT SPF 15 GOLD DELUXE EDITION CLAIRE 4
titanium dioxide, zinc oxide, and octinoxate powder

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:14141-500
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP)	Titanium Dioxide	0.0624 g in 1 g
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z)	Zinc Oxide	0.049 g in 1 g
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	0.03 g in 1 g

Ingredient Name	Strength
Inactive Ingredients
MICA (UNII: V8A1AW0880)
DIMETHICONE (UNII: 92RU3N3Y1O)
MAGNESIUM STEARATE (UNII: 70097M6I30)
ISOSTEARYL NEOPENTANOATE (UNII: 411THY156Q)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
ALUMINUM OXIDE (UNII: LMI26O6933)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
CERAMIDE 3 (UNII: 4370DF050B)
CHLORPHENESIN (UNII: I670DAL4SZ)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)

Product Characteristics
Color	RED (Rose lightly yellowish)	Score
Shape		Size
Flavor		Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:14141-500-02	1 in 1 BOX	05/27/2013
1	NDC:14141-500-01	10 g in 1 CARTRIDGE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part352	05/27/2013

LBEL DIVINE POLVOS COMPACTOS DOBLE USO FPS 15 EDICION DE LUJO DORADO/DOUBLE USE COMPACT SPF 15 GOLD DELUXE EDITION MEDIUM 5
titanium dioxide, zinc oxide, and octinoxate powder

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:14141-501
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP)	Titanium Dioxide	0.0624 g in 1 g
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z)	Zinc Oxide	0.049 g in 1 g
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	0.03 g in 1 g

Ingredient Name	Strength
Inactive Ingredients
MICA (UNII: V8A1AW0880)
DIMETHICONE (UNII: 92RU3N3Y1O)
MAGNESIUM STEARATE (UNII: 70097M6I30)
ISOSTEARYL NEOPENTANOATE (UNII: 411THY156Q)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
ALUMINUM OXIDE (UNII: LMI26O6933)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
CERAMIDE 3 (UNII: 4370DF050B)
CHLORPHENESIN (UNII: I670DAL4SZ)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)

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

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:14141-501-02	1 in 1 BOX	05/27/2013
1	NDC:14141-501-01	10 g in 1 CARTRIDGE; Type 1: Convenience Kit of Co-Package

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part352	05/27/2013

LBEL DIVINE POLVOS COMPACTOS DOBLE USO FPS 15 EDICION DE LUJO DORADO/DOUBLE USE COMPACT SPF 15 GOLD DELUXE EDITION MEDIUM 6
titanium dioxide, zinc oxide, and octinoxate powder

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:14141-502
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP)	Titanium Dioxide	0.0624 g in 1 g
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z)	Zinc Oxide	0.049 g in 1 g
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	0.03 g in 1 g

Ingredient Name	Strength
Inactive Ingredients
MICA (UNII: V8A1AW0880)
DIMETHICONE (UNII: 92RU3N3Y1O)
MAGNESIUM STEARATE (UNII: 70097M6I30)
ISOSTEARYL NEOPENTANOATE (UNII: 411THY156Q)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
ALUMINUM OXIDE (UNII: LMI26O6933)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
CERAMIDE 3 (UNII: 4370DF050B)
CHLORPHENESIN (UNII: I670DAL4SZ)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)

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

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:14141-502-02	1 in 1 BOX	05/27/2013
1	NDC:14141-502-01	10 g in 1 CARTRIDGE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part352	05/27/2013

LBEL DIVINE POLVOS COMPACTOS DOBLE USO FPS 15 EDICION DE LUJO DORADO/DOUBLE USE COMPACT SPF 15 GOLD DELUXE EDITION MEDIUM 7
titanium dioxide, zinc oxide, and octinoxate powder

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:14141-503
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP)	Titanium Dioxide	0.0624 g in 1 g
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z)	Zinc Oxide	0.049 g in 1 g
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	0.03 g in 1 g

Ingredient Name	Strength
Inactive Ingredients
MICA (UNII: V8A1AW0880)
DIMETHICONE (UNII: 92RU3N3Y1O)
MAGNESIUM STEARATE (UNII: 70097M6I30)
ISOSTEARYL NEOPENTANOATE (UNII: 411THY156Q)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
ALUMINUM OXIDE (UNII: LMI26O6933)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
CERAMIDE 3 (UNII: 4370DF050B)
CHLORPHENESIN (UNII: I670DAL4SZ)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)

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

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:14141-503-02	1 in 1 BOX	05/27/2013
1	NDC:14141-503-01	10 g in 1 CARTRIDGE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part352	05/27/2013

LBEL DIVINE POLVOS COMPACTOS DOBLE USO FPS 15 EDICION DE LUJO DORADO/DOUBLE USE COMPACT SPF 15 GOLD DELUXE EDITION OBSCURE 8-9
titanium dioxide, zinc oxide, and octinoxate powder

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:14141-504
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP)	Titanium Dioxide	0.0624 g in 1 g
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z)	Zinc Oxide	0.049 g in 1 g
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	0.03 g in 1 g

Ingredient Name	Strength
Inactive Ingredients
MICA (UNII: V8A1AW0880)
DIMETHICONE (UNII: 92RU3N3Y1O)
MAGNESIUM STEARATE (UNII: 70097M6I30)
ISOSTEARYL NEOPENTANOATE (UNII: 411THY156Q)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
ALUMINUM OXIDE (UNII: LMI26O6933)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
CERAMIDE 3 (UNII: 4370DF050B)
CHLORPHENESIN (UNII: I670DAL4SZ)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)

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

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:14141-504-02	1 in 1 BOX	05/27/2013
1	NDC:14141-504-01	10 g in 1 CARTRIDGE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part352	05/27/2013

Labeler - Bel Star S.A. (Colombia) (880160197)

Name	Address	ID/FEI	Business Operations
Establishment
Bel Star S.A. (Colombia)		880160197	MANUFACTURE(14141-499, 14141-500, 14141-501, 14141-502, 14141-503, 14141-504)

L'BEL DIVINE Polvos compactos doble uso FPS 15 edición de lujo dorado/Double use compact SPF 15 gold deluxe edition

PRINCIPAL DISPLAY PANEL - 10 g Cartridge Box - Claire 1-2-3

PRINCIPAL DISPLAY PANEL - 10 g Cartridge Box - Claire 4

PRINCIPAL DISPLAY PANEL - 10 g Cartridge Box - Medium 5

PRINCIPAL DISPLAY PANEL - 10 g Cartridge Box - Medium 6

PRINCIPAL DISPLAY PANEL - 10 g Cartridge Box - Medium 7

PRINCIPAL DISPLAY PANEL - 10 g Cartridge Box - Obscure 8-9

L'BEL
DIVINE Polvos compactos doble uso FPS 15 edición de lujo dorado/Double use compact SPF 15 gold deluxe edition