DOUBLE USE COMPACT SPF 15 GOLD DELUXE EDITION CLAIRE 1-2-3- octinoxate, titanium dioxide, zinc oxide powder DOUBLE USE COMPACT SPF 15 GOLD DELUXE EDITION CLAIRE 4- octinoxate, titanium dioxide, zinc oxide powder DOUBLE USE COMPACT SPF 15 GOLD DELUXE EDITION MEDIUM 5- octinoxate, titanium dioxide, zinc oxide powder DOUBLE USE COMPACT SPF 15 GOLD DELUXE EDITION MEDIUM 6- octinoxate, titanium dioxide, zinc oxide powder DOUBLE USE COMPACT SPF 15 GOLD DELUXE EDITION MEDIUM 7- octinoxate, titanium dioxide, zinc oxide powder

Double Use Compact SPF 15 gold deluxe edition Medium 7 by

Drug Labeling and Warnings

Double Use Compact SPF 15 gold deluxe edition Medium 7 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

Active ingredients Purpose

Octinoxate 3.00% Sunscreen

Titanium Dioxide 6.24% Sunscreen

Zinc Oxide 4.90 % Sunscreen

PURPOSE

Uses:

Helps prevent 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.

INDICATIONS & USAGE

Stop use and ask a doctor if rash occurs.

WARNINGS

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 prevent sunburn, not skin cancer or early skin aging.

• For external use only
• Do not use on damaged or broken skin
• When using this product, keep out of eyes. Rinse with water to remove.

DOSAGE & ADMINISTRATION

Directions:

• 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

OTHER SAFETY INFORMATION

Other information:

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

INACTIVE INGREDIENT

Inactive ingredients: Mica, polymethylsilsesquioxane, hdi/trimethylol hexyllactone crosspolymer, dimethicone, magnesium stearate, trimethylsiloxysilicate, isostearyl neopentanoate, hydrogen dimethicone, tocopheryl acetate, phenoxyethanol, alumina, triethoxycaprylylsilane, fragrance, caprylyl glycol, ceramide np, chlorphenesin, linalool, hydroxycitronellal, citronellol, geraniol, limonene, alpha-isomethyl ionone, May contain: Iron oxides, titanium dioxide

PRINCIPAL DISPLAY PANEL

L'BEL

Divine

Polvos Compactos doble uso FPS 15 edicion de lujo dorado

Double use compact SPF 15 gold deluxe edition

Tone: Claire 1-2-3

Net. Wt. 0.35 oz (10g)

PRINCIPAL DISPLAY PANEL

L'BEL

Divine

Polvos Compactos doble uso FPS 15 edicion de lujo dorado

Double use compact SPF 15 gold deluxe edition

Tone: Claire 4

Net. Wt. 0.35 oz (10g)

PRINCIPAL DISPLAY PANEL

L'BEL

Divine

Polvos Compactos doble uso FPS 15 edicion de lujo dorado

Double use compact SPF 15 gold deluxe edition

Tone: Medium 5

Net. Wt. 0.35 oz (10g)

PRINCIPAL DISPLAY PANEL

L'BEL

Divine

Polvos Compactos doble uso FPS 15 edicion de lujo dorado

Double use compact SPF 15 gold deluxe edition

Tone: Medium 6

Net. Wt. 0.35 oz (10g)

PRINCIPAL DISPLAY PANEL

L'BEL

Divine

Polvos Compactos doble uso FPS 15 edicion de lujo dorado

Double use compact SPF 15 gold deluxe edition

Tone: Medium 7

Net. Wt. 0.35 oz (10g)

INGREDIENTS AND APPEARANCE

DOUBLE USE COMPACT SPF 15 GOLD DELUXE EDITION CLAIRE 1-2-3 
octinoxate, titanium dioxide, zinc oxide powder

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 14141-201
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	4.9 g  in 100 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	6.24 g  in 100 g
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	3 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
CHLORPHENESIN (UNII: I670DAL4SZ)
ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)
CERAMIDE NP (UNII: 4370DF050B)
LINALOOL, (+/-)- (UNII: D81QY6I88E)
GERANIOL (UNII: L837108USY)
TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
ISOSTEARYL NEOPENTANOATE (UNII: 411THY156Q)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
HEXAMETHYLENE DIISOCYANATE/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER (UNII: WB5K9Y35Y9)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERRIC OXIDE RED (UNII: 1K09F3G675)
POLYMETHYLSILSESQUIOXANE (11 MICRONS) (UNII: Z570VEV8XK)
DIMETHICONE (UNII: 92RU3N3Y1O)
MAGNESIUM STEARATE (UNII: 70097M6I30)
HYDROXYCITRONELLAL (UNII: 8SQ0VA4YUR)
MICA (UNII: V8A1AW0880)
LIMONENE, (+)- (UNII: GFD7C86Q1W)
.BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)
HYDROGEN DIMETHICONE (13 CST) (UNII: 4QGR4P2YOI)
ALUMINUM OXIDE (UNII: LMI26O6933)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 14141-201-01	10 g in 1 BOTTLE; Type 0: Not a Combination Product	11/12/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	11/12/2020

DOUBLE USE COMPACT SPF 15 GOLD DELUXE EDITION CLAIRE 4 
octinoxate, titanium dioxide, zinc oxide powder

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 14141-202
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	4.9 g  in 100 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	6.24 g  in 100 g
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	3 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
CHLORPHENESIN (UNII: I670DAL4SZ)
ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)
CERAMIDE NP (UNII: 4370DF050B)
LINALOOL, (+/-)- (UNII: D81QY6I88E)
GERANIOL (UNII: L837108USY)
TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
ISOSTEARYL NEOPENTANOATE (UNII: 411THY156Q)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
HEXAMETHYLENE DIISOCYANATE/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER (UNII: WB5K9Y35Y9)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERRIC OXIDE RED (UNII: 1K09F3G675)
POLYMETHYLSILSESQUIOXANE (11 MICRONS) (UNII: Z570VEV8XK)
DIMETHICONE (UNII: 92RU3N3Y1O)
MAGNESIUM STEARATE (UNII: 70097M6I30)
HYDROXYCITRONELLAL (UNII: 8SQ0VA4YUR)
MICA (UNII: V8A1AW0880)
LIMONENE, (+)- (UNII: GFD7C86Q1W)
.BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)
HYDROGEN DIMETHICONE (13 CST) (UNII: 4QGR4P2YOI)
ALUMINUM OXIDE (UNII: LMI26O6933)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 14141-202-01	10 g in 1 BOTTLE; Type 0: Not a Combination Product	11/12/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	11/12/2020

DOUBLE USE COMPACT SPF 15 GOLD DELUXE EDITION MEDIUM 5 
octinoxate, titanium dioxide, zinc oxide powder

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 14141-203
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	4.9 g  in 100 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	6.24 g  in 100 g
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	3 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
CHLORPHENESIN (UNII: I670DAL4SZ)
ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)
CERAMIDE NP (UNII: 4370DF050B)
LINALOOL, (+/-)- (UNII: D81QY6I88E)
GERANIOL (UNII: L837108USY)
TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
ISOSTEARYL NEOPENTANOATE (UNII: 411THY156Q)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
HEXAMETHYLENE DIISOCYANATE/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER (UNII: WB5K9Y35Y9)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERRIC OXIDE RED (UNII: 1K09F3G675)
POLYMETHYLSILSESQUIOXANE (11 MICRONS) (UNII: Z570VEV8XK)
DIMETHICONE (UNII: 92RU3N3Y1O)
MAGNESIUM STEARATE (UNII: 70097M6I30)
HYDROXYCITRONELLAL (UNII: 8SQ0VA4YUR)
MICA (UNII: V8A1AW0880)
LIMONENE, (+)- (UNII: GFD7C86Q1W)
.BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)
HYDROGEN DIMETHICONE (13 CST) (UNII: 4QGR4P2YOI)
ALUMINUM OXIDE (UNII: LMI26O6933)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 14141-203-01	10 g in 1 BOTTLE; Type 0: Not a Combination Product	11/12/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	11/12/2020

DOUBLE USE COMPACT SPF 15 GOLD DELUXE EDITION MEDIUM 6 
octinoxate, titanium dioxide, zinc oxide powder

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 14141-204
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	4.9 g  in 100 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	6.24 g  in 100 g
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	3 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
CHLORPHENESIN (UNII: I670DAL4SZ)
ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)
CERAMIDE NP (UNII: 4370DF050B)
LINALOOL, (+/-)- (UNII: D81QY6I88E)
GERANIOL (UNII: L837108USY)
TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
ISOSTEARYL NEOPENTANOATE (UNII: 411THY156Q)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
HEXAMETHYLENE DIISOCYANATE/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER (UNII: WB5K9Y35Y9)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERRIC OXIDE RED (UNII: 1K09F3G675)
POLYMETHYLSILSESQUIOXANE (11 MICRONS) (UNII: Z570VEV8XK)
DIMETHICONE (UNII: 92RU3N3Y1O)
MAGNESIUM STEARATE (UNII: 70097M6I30)
HYDROXYCITRONELLAL (UNII: 8SQ0VA4YUR)
MICA (UNII: V8A1AW0880)
LIMONENE, (+)- (UNII: GFD7C86Q1W)
.BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)
HYDROGEN DIMETHICONE (13 CST) (UNII: 4QGR4P2YOI)
ALUMINUM OXIDE (UNII: LMI26O6933)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 14141-204-01	10 g in 1 BOTTLE; Type 0: Not a Combination Product	11/12/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	11/12/2020

DOUBLE USE COMPACT SPF 15 GOLD DELUXE EDITION MEDIUM 7 
octinoxate, titanium dioxide, zinc oxide powder

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 14141-205
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	4.9 g  in 100 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	6.24 g  in 100 g
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	3 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
CHLORPHENESIN (UNII: I670DAL4SZ)
ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)
CERAMIDE NP (UNII: 4370DF050B)
LINALOOL, (+/-)- (UNII: D81QY6I88E)
GERANIOL (UNII: L837108USY)
TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
ISOSTEARYL NEOPENTANOATE (UNII: 411THY156Q)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
HEXAMETHYLENE DIISOCYANATE/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER (UNII: WB5K9Y35Y9)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERRIC OXIDE RED (UNII: 1K09F3G675)
POLYMETHYLSILSESQUIOXANE (11 MICRONS) (UNII: Z570VEV8XK)
DIMETHICONE (UNII: 92RU3N3Y1O)
MAGNESIUM STEARATE (UNII: 70097M6I30)
HYDROXYCITRONELLAL (UNII: 8SQ0VA4YUR)
MICA (UNII: V8A1AW0880)
LIMONENE, (+)- (UNII: GFD7C86Q1W)
.BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)
HYDROGEN DIMETHICONE (13 CST) (UNII: 4QGR4P2YOI)
ALUMINUM OXIDE (UNII: LMI26O6933)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 14141-205-01	10 g in 1 BOTTLE; Type 0: Not a Combination Product	11/12/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	11/12/2020

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

Establishment
Name	Address	ID/FEI	Business Operations
Bel Star S.A. (Colombia)		880160197	manufacture(14141-201, 14141-202, 14141-203, 14141-204, 14141-205)