L'BEL DIVINE Double Use Compact SPF 15 gold deluxe edition

Active ingredients Purpose

Octinoxate 3.00% Sunscreen

Titanium Dioxide 6.24% Sunscreen

Zinc Oxide 4.90 % Sunscreen

Uses:

Helps prevent 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.

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.

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 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, fragrance, caprylyl glycol, ceramide np, chlorphenesin, linalool, hydroxycitronellal, citronellol, geraniol, limonene, alpha-isomethyl ionone, May contain: Iron oxides, titanium dioxide

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)

123

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)

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)

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)

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)

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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

Ingredient Name	Strength
Inactive Ingredients
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)

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

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

Ingredient Name	Strength
Inactive Ingredients
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)

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

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

Ingredient Name	Strength
Inactive Ingredients
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)

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

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

Ingredient Name	Strength
Inactive Ingredients
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)

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

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

Ingredient Name	Strength
Inactive Ingredients
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)

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

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

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

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