Label: LBEL DIVINE POLVOS COMPACTOS DOBLE USO FPS 15 EDICION DE LUJO DORADO/DOUBLE USE COMPACT SPF 15 GOLD DELUXE EDITION CLAIRE 1-2-3- titanium dioxide, zinc oxide, and octinoxate powder
LBEL DIVINE POLVOS COMPACTOS DOBLE USO FPS 15 EDICION DE LUJO DORADO/DOUBLE USE COMPACT SPF 15 GOLD DELUXE EDITION CLAIRE 4- titanium dioxide, zinc oxide, and octinoxate powder
LBEL DIVINE POLVOS COMPACTOS DOBLE USO FPS 15 EDICION DE LUJO DORADO/DOUBLE USE COMPACT SPF 15 GOLD DELUXE EDITION MEDIUM 5- titanium dioxide, zinc oxide, and octinoxate powder
LBEL DIVINE POLVOS COMPACTOS DOBLE USO FPS 15 EDICION DE LUJO DORADO/DOUBLE USE COMPACT SPF 15 GOLD DELUXE EDITION MEDIUM 6- titanium dioxide, zinc oxide, and octinoxate powder
LBEL DIVINE POLVOS COMPACTOS DOBLE USO FPS 15 EDICION DE LUJO DORADO/DOUBLE USE COMPACT SPF 15 GOLD DELUXE EDITION MEDIUM 7- titanium dioxide, zinc oxide, and octinoxate powder
LBEL DIVINE POLVOS COMPACTOS DOBLE USO FPS 15 EDICION DE LUJO DORADO/DOUBLE USE COMPACT SPF 15 GOLD DELUXE EDITION OBSCURE 8-9- titanium dioxide, zinc oxide, and octinoxate powder
-
Contains inactivated NDC Code(s)
NDC Code(s): 14141-499-01, 14141-499-02, 14141-500-01, 14141-500-02, view more14141-501-01, 14141-501-02, 14141-502-01, 14141-502-02, 14141-503-01, 14141-503-02, 14141-504-01, 14141-504-02 - Packager: Bel Star S.A. (Colombia)
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not 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 November 19, 2019
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- KEEP OUT OF REACH OF CHILDREN
- STOP USE
-
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.
- DOSAGE & ADMINISTRATION
-
INACTIVE INGREDIENT
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). - PRINCIPAL DISPLAY PANEL - 10 g Cartridge Box - Claire 1-2-3
- PRINCIPAL DISPLAY PANEL - 10 g Cartridge Box - Claire 4
- PRINCIPAL DISPLAY PANEL - 10 g Cartridge Box - Medium 5
- PRINCIPAL DISPLAY PANEL - 10 g Cartridge Box - Medium 6
- PRINCIPAL DISPLAY PANEL - 10 g Cartridge Box - Medium 7
- PRINCIPAL DISPLAY PANEL - 10 g Cartridge Box - Obscure 8-9
-
INGREDIENTS AND APPEARANCE
LBEL DIVINE POLVOS COMPACTOS DOBLE USO FPS 15 EDICION DE LUJO DORADO/DOUBLE USE COMPACT SPF 15 GOLD DELUXE EDITION CLAIRE 1-2-3
titanium dioxide, zinc oxide, and octinoxate powderProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:14141-499 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP) Titanium Dioxide 0.0624 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:14141-499-02 1 in 1 BOX 05/27/2013 1 NDC:14141-499-01 10 g in 1 CARTRIDGE; Type 0: Not a Combination Product 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 DORADO/DOUBLE USE COMPACT SPF 15 GOLD DELUXE EDITION CLAIRE 4
titanium dioxide, zinc oxide, and octinoxate powderProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:14141-500 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP) Titanium Dioxide 0.0624 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:14141-500-02 1 in 1 BOX 05/27/2013 1 NDC:14141-500-01 10 g in 1 CARTRIDGE; Type 0: Not a Combination Product 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 DORADO/DOUBLE USE COMPACT SPF 15 GOLD DELUXE EDITION MEDIUM 5
titanium dioxide, zinc oxide, and octinoxate powderProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:14141-501 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP) Titanium Dioxide 0.0624 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:14141-501-02 1 in 1 BOX 05/27/2013 1 NDC:14141-501-01 10 g in 1 CARTRIDGE; Type 1: Convenience Kit of Co-Package 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 DORADO/DOUBLE USE COMPACT SPF 15 GOLD DELUXE EDITION MEDIUM 6
titanium dioxide, zinc oxide, and octinoxate powderProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:14141-502 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP) Titanium Dioxide 0.0624 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:14141-502-02 1 in 1 BOX 05/27/2013 1 NDC:14141-502-01 10 g in 1 CARTRIDGE; Type 0: Not a Combination Product 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 DORADO/DOUBLE USE COMPACT SPF 15 GOLD DELUXE EDITION MEDIUM 7
titanium dioxide, zinc oxide, and octinoxate powderProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:14141-503 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP) Titanium Dioxide 0.0624 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:14141-503-02 1 in 1 BOX 05/27/2013 1 NDC:14141-503-01 10 g in 1 CARTRIDGE; Type 0: Not a Combination Product 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 DORADO/DOUBLE USE COMPACT SPF 15 GOLD DELUXE EDITION OBSCURE 8-9
titanium dioxide, zinc oxide, and octinoxate powderProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:14141-504 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP) Titanium Dioxide 0.0624 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:14141-504-02 1 in 1 BOX 05/27/2013 1 NDC:14141-504-01 10 g in 1 CARTRIDGE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 05/27/2013 Labeler - Bel Star S.A. (Colombia) (880160197) Establishment Name Address ID/FEI Business Operations Bel Star S.A. (Colombia) 880160197 MANUFACTURE(14141-499, 14141-500, 14141-501, 14141-502, 14141-503, 14141-504)
