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 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 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 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 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 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

LBEL by

Drug Labeling and Warnings

LBEL by is a Otc medication manufactured, distributed, or labeled by Bel Star S.A. (Colombia). Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Drug Facts 

Active ingredients                            Purpose
TITANIUM DIOXIDE (6.24%)       Sunscreen

ZINC OXIDE (4.9%)                   Sunscreen

OCTINOXATE (3.0%)                  Sunscreen

PURPOSE

uses

• Help prevents sunburn

KEEP OUT OF REACH OF CHILDREN

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

STOP USE

Stop use and ask a doctor if rash occurs.

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.

DOSAGE & ADMINISTRATION

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 INGREDIENT

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

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

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

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

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

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

INGREDIENTS AND APPEARANCE

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

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
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

Inactive Ingredients
Ingredient Name	Strength
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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
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 Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
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

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
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

Inactive Ingredients
Ingredient Name	Strength
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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
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 Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
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

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
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

Inactive Ingredients
Ingredient Name	Strength
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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
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 Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
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

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
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

Inactive Ingredients
Ingredient Name	Strength
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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
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 Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
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

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
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

Inactive Ingredients
Ingredient Name	Strength
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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
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 Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
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

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
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

Inactive Ingredients
Ingredient Name	Strength
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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
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 Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	05/27/2013

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

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