LBEL DIVINE POLVOS COMPACTOS DOBLE USO FPS 15 EDICION DE LUJO PLATEADO/DOUBLE USE COMPACT SPF 15 SILVER DELUXE EDITION CLAIRE 1-2-3- titanium dioxide, zinc oxide, and octinoxate powder LBEL DIVINE POLVOS COMPACTOS DOBLE USO FPS 15 EDICION DE LUJO PLATEADO/DOUBLE USE COMPACT SPF 15 SILVER DELUXE EDITION CLAIRE 4- titanium dioxide, zinc oxide, and octinoxate powder LBEL DIVINE POLVOS COMPACTOS DOBLE USO FPS 15 EDICION DE LUJO PLATEADO/DOUBLE USE COMPACT SPF 15 SILVER DELUXE EDITION MEDIUM 5- titanium dioxide, zinc oxide, and octinoxate powder LBEL DIVINE POLVOS COMPACTOS DOBLE USO FPS 15 EDICION DE LUJO PLATEADO/DOUBLE USE COMPACT SPF 15 SILVER DELUXE EDITION MEDIUM 6- titanium dioxide, zinc oxide, and octinoxate powder LBEL DIVINE POLVOS COMPACTOS DOBLE USO FPS 15 EDICION DE LUJO PLATEADO/DOUBLE USE COMPACT SPF 15 SILVER DELUXE EDITION MEDIUM 7- titanium dioxide, zinc oxide, and octinoxate powder LBEL DIVINE POLVOS COMPACTOS DOBLE USO FPS 15 EDICION DE LUJO PLATEADO/DOUBLE USE COMPACT SPF 15 SILVER 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 Ventura International LTD., Bel Star S.A. (Colombia). Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredients

TITANIUM DIOXIDE (6.2393%), ZINC OXIDE (4.9%), OCTINOXATE (3.0%)

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.
• Apply lipstick following the curves of natural lip line. For added definition, use with a lip pencil.

Other information

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

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).

SPL UNCLASSIFIED SECTION

US: Dist by Ventura Int Ltd. DBA Belcorp USA, San Francisco, CA 94111.

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

DIVINE

Polvos compactos doble uso FPS 15 edición de lujo plateado

Double use compact SPF 15 silver deluxe edition

10 g e (.35 oz.)

L'BEL

PRINCIPAL DISPLAY PANEL - 10 g Cartridge Box - Claire 4

DIVINE

Polvos compactos doble uso FPS 15 edición de lujo plateado

Double use compact SPF 15 silver deluxe edition

10 g e (.35 oz.)

L'BEL

PRINCIPAL DISPLAY PANEL - 10 g Cartridge Box - Medium 5

DIVINE

Polvos compactos doble uso FPS 15 edición de lujo plateado

Double use compact SPF 15 silver deluxe edition

10 g e (.35 oz.)

L'BEL

PRINCIPAL DISPLAY PANEL - 10 g Cartridge Box - Medium 6

DIVINE

Polvos compactos doble uso FPS 15 edición de lujo plateado

Double use compact SPF 15 silver deluxe edition

10 g e (.35 oz.)

L'BEL

PRINCIPAL DISPLAY PANEL - 10 g Cartridge Box - Medium 7

DIVINE

Polvos compactos doble uso FPS 15 edición de lujo plateado

Double use compact SPF 15 silver deluxe edition

10 g e (.35 oz.)

L'BEL

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

DIVINE

Polvos compactos doble uso FPS 15 edición de lujo plateado

Double use compact SPF 15 silver deluxe edition

10 g e (.35 oz.)

L'BEL

INGREDIENTS AND APPEARANCE

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 14783-029
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP)	Titanium Dioxide	0.062393 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: 14783-029-02	1 in 1 BOX
1	NDC: 14783-029-01	10 g in 1 CARTRIDGE

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 PLATEADO/DOUBLE USE COMPACT SPF 15 SILVER DELUXE EDITION CLAIRE 4
titanium dioxide, zinc oxide, and octinoxate powder

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 14783-030
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP)	Titanium Dioxide	0.062393 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: 14783-030-02	1 in 1 BOX
1	NDC: 14783-030-01	10 g in 1 CARTRIDGE

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 PLATEADO/DOUBLE USE COMPACT SPF 15 SILVER DELUXE EDITION MEDIUM 5
titanium dioxide, zinc oxide, and octinoxate powder

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 14783-031
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP)	Titanium Dioxide	0.062393 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: 14783-031-02	1 in 1 BOX
1	NDC: 14783-031-01	10 g in 1 CARTRIDGE

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 PLATEADO/DOUBLE USE COMPACT SPF 15 SILVER DELUXE EDITION MEDIUM 6
titanium dioxide, zinc oxide, and octinoxate powder

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 14783-032
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP)	Titanium Dioxide	0.062393 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: 14783-032-02	1 in 1 BOX
1	NDC: 14783-032-01	10 g in 1 CARTRIDGE

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 PLATEADO/DOUBLE USE COMPACT SPF 15 SILVER DELUXE EDITION MEDIUM 7
titanium dioxide, zinc oxide, and octinoxate powder

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 14783-033
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP)	Titanium Dioxide	0.062393 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: 14783-033-02	1 in 1 BOX
1	NDC: 14783-033-01	10 g in 1 CARTRIDGE

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 PLATEADO/DOUBLE USE COMPACT SPF 15 SILVER DELUXE EDITION OBSCURE 8-9
titanium dioxide, zinc oxide, and octinoxate powder

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 14783-034
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP)	Titanium Dioxide	0.062393 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: 14783-034-02	1 in 1 BOX
1	NDC: 14783-034-01	10 g in 1 CARTRIDGE

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

Labeler - Ventura International LTD. (603192787)

Establishment
Name	Address	ID/FEI	Business Operations
Bel Star S.A. (Colombia)		880160197	MANUFACTURE(14783-029, 14783-030, 14783-031, 14783-032, 14783-033, 14783-034)