Drug Facts

Active Ingredients

Titanium Dioxide 5.75%

Zinc Oxide 4.90%

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 damaged 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.
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, dimethicone, polymethylsilsesquioxane, zinc stearate, hdi/trimethylol hexyllactone crosspolymer, trimethylsiloxysilicate, caprylic/capric triglyceride, perfluorohexylethyl triethoxysilane, tocopheryl acetate, hydrogen dimethicone, phenoxyethanol, cetyl peg/ppg-10/1 dimethicone, polyglyceryl-4 isostearate, alumina, hexyl laurate, fragrance, caprylyl glycol, crithmum maritimum extract, triethoxycaprylylsilane, chlorphenesin, ceramide np, hydroxycitronellal, linalool, citronellol, geraniol, alpha-isomethyl ionone, limonene.

May Contain: Iron oxides, titanium dioxide.

Product Packaging PERLA 100

perla 100

Product Packaging ARENA 200

arena 200

Product Packaging CARAMEL 200

caramel 200

Product Packaging SOLEI 200

solei 200

Product Packaging AVELLANA 200

avellana 200

Product Packaging GOLDEN 300

golden 300

LBEL FOREVER STAY POLVOS COMPACTOS DE LARGA DURACION FPS 15 LONG LASTING COMPACT SPF 15 PERLA 100
titanium dioxide, zinc oxide powder

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:14141-300
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	57.5 mg in 1 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	49 mg in 1 g

Ingredient Name	Strength
Inactive Ingredients
HYDROXYCITRONELLAL (UNII: 8SQ0VA4YUR)
GERANIOL (UNII: L837108USY)
ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)
HYDROGEN DIMETHICONE (13 CST) (UNII: 4QGR4P2YOI)
CRITHMUM MARITIMUM WHOLE (UNII: J7IHY79BKY)
CERAMIDE NP (UNII: 4370DF050B)
DIMETHICONE (UNII: 92RU3N3Y1O)
ALUMINUM OXIDE (UNII: LMI26O6933)
HEXYL LAURATE (UNII: 4CG9F9W01Q)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
LINALOOL, (+/-)- (UNII: D81QY6I88E)
LIMONENE, (+/-)- (UNII: 9MC3I34447)
FERRIC OXIDE RED (UNII: 1K09F3G675)
ZINC STEARATE (UNII: H92E6QA4FV)
HEXAMETHYLENE DIISOCYANATE/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER (UNII: WB5K9Y35Y9)
MICA (UNII: V8A1AW0880)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
PERFLUOROOCTYL TRIETHOXYSILANE (UNII: 814P46684U)
TRIMETHYLSILOXYSILICATE (M/Q 0.8-1.0) (UNII: 25LXE464L2)
.BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 5) (UNII: 035JKJ76MT)
CHLORPHENESIN (UNII: I670DAL4SZ)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:14141-300-01	1 in 1 BOX	08/03/2022
1		10 g in 1 CASE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	M020	08/03/2022

LBEL FOREVER STAY POLVOS COMPACTOS DE LARGA DURACION FPS 15 LONG LASTING COMPACT SPF 15 GOLDEN 300
titanium dioxide, zinc oxide powder

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:14141-305
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	57.5 mg in 1 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	49 mg in 1 g

Ingredient Name	Strength
Inactive Ingredients
HYDROXYCITRONELLAL (UNII: 8SQ0VA4YUR)
GERANIOL (UNII: L837108USY)
ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)
HYDROGEN DIMETHICONE (13 CST) (UNII: 4QGR4P2YOI)
CRITHMUM MARITIMUM WHOLE (UNII: J7IHY79BKY)
CERAMIDE NP (UNII: 4370DF050B)
ALUMINUM OXIDE (UNII: LMI26O6933)
HEXYL LAURATE (UNII: 4CG9F9W01Q)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
DIMETHICONE (UNII: 92RU3N3Y1O)
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
LINALOOL, (+/-)- (UNII: D81QY6I88E)
LIMONENE, (+/-)- (UNII: 9MC3I34447)
FERRIC OXIDE RED (UNII: 1K09F3G675)
ZINC STEARATE (UNII: H92E6QA4FV)
HEXAMETHYLENE DIISOCYANATE/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER (UNII: WB5K9Y35Y9)
MICA (UNII: V8A1AW0880)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
PERFLUOROOCTYL TRIETHOXYSILANE (UNII: 814P46684U)
TRIMETHYLSILOXYSILICATE (M/Q 0.8-1.0) (UNII: 25LXE464L2)
.BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 5) (UNII: 035JKJ76MT)
CHLORPHENESIN (UNII: I670DAL4SZ)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:14141-305-01	1 in 1 BOX	08/03/2022
1		10 g in 1 CASE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	M020	08/03/2022

LBEL FOREVER STAY POLVOS COMPACTOS DE LARGA DURACION FPS 15 LONG LASTING COMPACT SPF 15 ARENA 200
titanium dioxide, zinc oxide powder

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:14141-301
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	57.5 mg in 1 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	49 mg in 1 g

Ingredient Name	Strength
Inactive Ingredients
HYDROXYCITRONELLAL (UNII: 8SQ0VA4YUR)
GERANIOL (UNII: L837108USY)
ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)
HYDROGEN DIMETHICONE (13 CST) (UNII: 4QGR4P2YOI)
CRITHMUM MARITIMUM WHOLE (UNII: J7IHY79BKY)
CERAMIDE NP (UNII: 4370DF050B)
ALUMINUM OXIDE (UNII: LMI26O6933)
HEXYL LAURATE (UNII: 4CG9F9W01Q)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
DIMETHICONE (UNII: 92RU3N3Y1O)
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
LINALOOL, (+/-)- (UNII: D81QY6I88E)
LIMONENE, (+/-)- (UNII: 9MC3I34447)
FERRIC OXIDE RED (UNII: 1K09F3G675)
ZINC STEARATE (UNII: H92E6QA4FV)
HEXAMETHYLENE DIISOCYANATE/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER (UNII: WB5K9Y35Y9)
MICA (UNII: V8A1AW0880)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
PERFLUOROOCTYL TRIETHOXYSILANE (UNII: 814P46684U)
TRIMETHYLSILOXYSILICATE (M/Q 0.8-1.0) (UNII: 25LXE464L2)
.BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 5) (UNII: 035JKJ76MT)
CHLORPHENESIN (UNII: I670DAL4SZ)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:14141-301-01	1 in 1 BOX	08/03/2022
1		10 g in 1 CASE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	M020	08/03/2022

LBEL FOREVER STAY POLVOS COMPACTOS DE LARGA DURACION FPS 15 LONG LASTING COMPACT SPF 15 CARAMEL 200
titanium dioxide, zinc oxide powder

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:14141-302
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	57.5 mg in 1 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	49 mg in 1 g

Ingredient Name	Strength
Inactive Ingredients
HYDROXYCITRONELLAL (UNII: 8SQ0VA4YUR)
GERANIOL (UNII: L837108USY)
ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)
HYDROGEN DIMETHICONE (13 CST) (UNII: 4QGR4P2YOI)
CRITHMUM MARITIMUM WHOLE (UNII: J7IHY79BKY)
CERAMIDE NP (UNII: 4370DF050B)
ALUMINUM OXIDE (UNII: LMI26O6933)
HEXYL LAURATE (UNII: 4CG9F9W01Q)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
DIMETHICONE (UNII: 92RU3N3Y1O)
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
LINALOOL, (+/-)- (UNII: D81QY6I88E)
LIMONENE, (+/-)- (UNII: 9MC3I34447)
FERRIC OXIDE RED (UNII: 1K09F3G675)
ZINC STEARATE (UNII: H92E6QA4FV)
HEXAMETHYLENE DIISOCYANATE/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER (UNII: WB5K9Y35Y9)
MICA (UNII: V8A1AW0880)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
PERFLUOROOCTYL TRIETHOXYSILANE (UNII: 814P46684U)
TRIMETHYLSILOXYSILICATE (M/Q 0.8-1.0) (UNII: 25LXE464L2)
.BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 5) (UNII: 035JKJ76MT)
CHLORPHENESIN (UNII: I670DAL4SZ)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:14141-302-01	1 in 1 BOX	08/03/2022
1		10 g in 1 CASE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	M020	08/03/2022

LBEL FOREVER STAY POLVOS COMPACTOS DE LARGA DURACION FPS 15 LONG LASTING COMPACT SPF 15 SOLEI 200
titanium dioxide, zinc oxide powder

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:14141-303
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	57.5 mg in 1 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	49 mg in 1 g

Ingredient Name	Strength
Inactive Ingredients
HYDROXYCITRONELLAL (UNII: 8SQ0VA4YUR)
GERANIOL (UNII: L837108USY)
ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)
HYDROGEN DIMETHICONE (13 CST) (UNII: 4QGR4P2YOI)
CRITHMUM MARITIMUM WHOLE (UNII: J7IHY79BKY)
CERAMIDE NP (UNII: 4370DF050B)
ALUMINUM OXIDE (UNII: LMI26O6933)
HEXYL LAURATE (UNII: 4CG9F9W01Q)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
DIMETHICONE (UNII: 92RU3N3Y1O)
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
LINALOOL, (+/-)- (UNII: D81QY6I88E)
LIMONENE, (+/-)- (UNII: 9MC3I34447)
FERRIC OXIDE RED (UNII: 1K09F3G675)
ZINC STEARATE (UNII: H92E6QA4FV)
HEXAMETHYLENE DIISOCYANATE/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER (UNII: WB5K9Y35Y9)
MICA (UNII: V8A1AW0880)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
PERFLUOROOCTYL TRIETHOXYSILANE (UNII: 814P46684U)
TRIMETHYLSILOXYSILICATE (M/Q 0.8-1.0) (UNII: 25LXE464L2)
.BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 5) (UNII: 035JKJ76MT)
CHLORPHENESIN (UNII: I670DAL4SZ)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:14141-303-01	1 in 1 BOX	08/03/2022
1		10 g in 1 CASE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	M020	08/03/2022

LBEL FOREVER STAY POLVOS COMPACTOS DE LARGA DURACION FPS 15 LONG LASTING COMPACT SPF 15 AVELLANA 200
titanium dioxide, zinc oxide powder

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:14141-304
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	57.5 mg in 1 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	49 mg in 1 g

Ingredient Name	Strength
Inactive Ingredients
HYDROXYCITRONELLAL (UNII: 8SQ0VA4YUR)
GERANIOL (UNII: L837108USY)
ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)
HYDROGEN DIMETHICONE (13 CST) (UNII: 4QGR4P2YOI)
CRITHMUM MARITIMUM WHOLE (UNII: J7IHY79BKY)
CERAMIDE NP (UNII: 4370DF050B)
ALUMINUM OXIDE (UNII: LMI26O6933)
HEXYL LAURATE (UNII: 4CG9F9W01Q)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
DIMETHICONE (UNII: 92RU3N3Y1O)
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
LINALOOL, (+/-)- (UNII: D81QY6I88E)
LIMONENE, (+/-)- (UNII: 9MC3I34447)
FERRIC OXIDE RED (UNII: 1K09F3G675)
ZINC STEARATE (UNII: H92E6QA4FV)
HEXAMETHYLENE DIISOCYANATE/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER (UNII: WB5K9Y35Y9)
MICA (UNII: V8A1AW0880)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
PERFLUOROOCTYL TRIETHOXYSILANE (UNII: 814P46684U)
TRIMETHYLSILOXYSILICATE (M/Q 0.8-1.0) (UNII: 25LXE464L2)
.BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 5) (UNII: 035JKJ76MT)
CHLORPHENESIN (UNII: I670DAL4SZ)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:14141-304-01	1 in 1 BOX	08/03/2022
1		10 g in 1 CASE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	M020	08/03/2022

Labeler - BEL STAR S A (880160197)

L’BEL FOREVER STAY POLVOS COMPACTOS DE LARGA DURACIÓN FPS 15 LONG LASTING COMPACT POWDER SPF 15