Label: LBEL FOREVER STAY POLVOS COMPACTOS DE LARGA DURACION FPS 15 LONG LASTING COMPACT SPF 15 PERLA 100- titanium dioxide, zinc oxide powder
LBEL FOREVER STAY POLVOS COMPACTOS DE LARGA DURACION FPS 15 LONG LASTING COMPACT SPF 15 GOLDEN 300- titanium dioxide, zinc oxide powder
LBEL FOREVER STAY POLVOS COMPACTOS DE LARGA DURACION FPS 15 LONG LASTING COMPACT SPF 15 ARENA 200- titanium dioxide, zinc oxide powder
LBEL FOREVER STAY POLVOS COMPACTOS DE LARGA DURACION FPS 15 LONG LASTING COMPACT SPF 15 CARAMEL 200- titanium dioxide, zinc oxide powder
LBEL FOREVER STAY POLVOS COMPACTOS DE LARGA DURACION FPS 15 LONG LASTING COMPACT SPF 15 SOLEI 200- titanium dioxide, zinc oxide powder
LBEL FOREVER STAY POLVOS COMPACTOS DE LARGA DURACION FPS 15 LONG LASTING COMPACT SPF 15 AVELLANA 200- titanium dioxide, zinc oxide powder
-
NDC Code(s):
14141-300-01,
14141-301-01,
14141-302-01,
14141-303-01, view more14141-304-01, 14141-305-01
- Packager: BEL STAR S A
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated October 13, 2022
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Drug Facts
- Active Ingredients
- Purpose
- Uses
- Warnings
- Directions
- Other information
-
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.
- Company Information
- Product Packaging PERLA 100
- Product Packaging ARENA 200
- Product Packaging CARAMEL 200
- Product Packaging SOLEI 200
- Product Packaging AVELLANA 200
- Product Packaging GOLDEN 300
-
INGREDIENTS AND APPEARANCE
LBEL FOREVER STAY POLVOS COMPACTOS DE LARGA DURACION FPS 15 LONG LASTING COMPACT SPF 15 PERLA 100
titanium dioxide, zinc oxide powderProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:14141-300 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength 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 Inactive Ingredients Ingredient Name Strength 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) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 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 Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date 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 powderProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:14141-305 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength 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 Inactive Ingredients Ingredient Name Strength 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) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 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 Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date 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 powderProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:14141-301 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength 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 Inactive Ingredients Ingredient Name Strength 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) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 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 Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date 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 powderProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:14141-302 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength 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 Inactive Ingredients Ingredient Name Strength 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) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 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 Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date 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 powderProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:14141-303 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength 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 Inactive Ingredients Ingredient Name Strength 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) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 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 Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date 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 powderProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:14141-304 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength 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 Inactive Ingredients Ingredient Name Strength 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) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 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 Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final M020 08/03/2022 Labeler - BEL STAR S A (880160197)