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
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Contains inactivated NDC Code(s)
NDC Code(s): 14783-056-01, 14783-056-02, 14783-057-01, 14783-057-02, view more14783-058-01, 14783-058-02, 14783-059-01, 14783-059-02, 14783-060-01, 14783-060-02, 14783-061-01, 14783-061-02 - Packager: Ventura International LTD.
- Category: HUMAN OTC DRUG LABEL
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 May 31, 2013
If you are a healthcare professional or from the pharmaceutical industry please visit this version.
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active Ingredients
- Purpose
- Uses
- Warnings
- Directions
- Other information
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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).
- SPL UNCLASSIFIED SECTION
- 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
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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:14783-056 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP) Titanium Dioxide 0.062393 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:14783-056-02 1 in 1 BOX 1 NDC:14783-056-01 10 g in 1 CARTRIDGE 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:14783-057 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP) Titanium Dioxide 0.062393 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:14783-057-02 1 in 1 BOX 1 NDC:14783-057-01 10 g in 1 CARTRIDGE 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:14783-058 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP) Titanium Dioxide 0.062393 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:14783-058-02 1 in 1 BOX 1 NDC:14783-058-01 10 g in 1 CARTRIDGE 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:14783-059 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP) Titanium Dioxide 0.062393 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:14783-059-02 1 in 1 BOX 1 NDC:14783-059-01 10 g in 1 CARTRIDGE 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:14783-060 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP) Titanium Dioxide 0.062393 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:14783-060-02 1 in 1 BOX 1 NDC:14783-060-01 10 g in 1 CARTRIDGE 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:14783-061 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP) Titanium Dioxide 0.062393 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:14783-061-02 1 in 1 BOX 1 NDC:14783-061-01 10 g in 1 CARTRIDGE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 05/27/2013 Labeler - Ventura International LTD. (603192787) Establishment Name Address ID/FEI Business Operations Bel Star S.A. (Colombia) 880160197 MANUFACTURE(14783-056, 14783-057, 14783-058, 14783-059, 14783-060, 14783-061)