Label: LBEL DIVINE POLVOS COMPACTOS DOBLE USO FPS 15 EDICION DE LUJO PLATEADO/DOUBLE USE COMPACT SPF 15 SILVER DELUXE EDITION CLAIRE 1-2-3- titanium dioxide, zinc oxide, and octinoxate powder
LBEL DIVINE POLVOS COMPACTOS DOBLE USO FPS 15 EDICION DE LUJO PLATEADO/DOUBLE USE COMPACT SPF 15 SILVER DELUXE EDITION CLAIRE 4- titanium dioxide, zinc oxide, and octinoxate powder
LBEL DIVINE POLVOS COMPACTOS DOBLE USO FPS 15 EDICION DE LUJO PLATEADO/DOUBLE USE COMPACT SPF 15 SILVER DELUXE EDITION MEDIUM 5- titanium dioxide, zinc oxide, and octinoxate powder
LBEL DIVINE POLVOS COMPACTOS DOBLE USO FPS 15 EDICION DE LUJO PLATEADO/DOUBLE USE COMPACT SPF 15 SILVER DELUXE EDITION MEDIUM 6- titanium dioxide, zinc oxide, and octinoxate powder
LBEL DIVINE POLVOS COMPACTOS DOBLE USO FPS 15 EDICION DE LUJO PLATEADO/DOUBLE USE COMPACT SPF 15 SILVER DELUXE EDITION MEDIUM 7- titanium dioxide, zinc oxide, and octinoxate powder
LBEL DIVINE POLVOS COMPACTOS DOBLE USO FPS 15 EDICION DE LUJO PLATEADO/DOUBLE USE COMPACT SPF 15 SILVER DELUXE EDITION OBSCURE 8-9- titanium dioxide, zinc oxide, and octinoxate powder

  • 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 May 29, 2013

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active Ingredients

    TITANIUM DIOXIDE (6.2393%), ZINC OXIDE (4.9%), OCTINOXATE (3.0%)

  • 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 damage 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.
    • Children under 6 months of age: Ask a doctor.
    • Reapply at least every 2 hours.
    • Use a water resistant sunscreen if swimming or sweating.
    • Apply lipstick following the curves of natural lip line. For added definition, use with a lip pencil.
  • 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, 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

    PUERTO RICO: Dist by Ventura Corp, Ltd., San Juan, Puerto Rico 00926. Made in Colombia.

  • PRINCIPAL DISPLAY PANEL - 10 g Cartridge Box - Claire 1-2-3

    DIVINE

    Polvos compactos doble uso FPS 15 edición de lujo plateado

    Double use compact SPF 15 silver deluxe edition

    10 g e (.35 oz.)

    L'BEL

    Principal Display Panel - 10 g Cartridge Box - Claire 1-2-3
  • PRINCIPAL DISPLAY PANEL - 10 g Cartridge Box - Claire 4

    DIVINE

    Polvos compactos doble uso FPS 15 edición de lujo plateado

    Double use compact SPF 15 silver deluxe edition

    10 g e (.35 oz.)

    L'BEL

    Principal Display Panel - 10 g Cartridge Box - Claire 4
  • PRINCIPAL DISPLAY PANEL - 10 g Cartridge Box - Medium 5

    DIVINE

    Polvos compactos doble uso FPS 15 edición de lujo plateado

    Double use compact SPF 15 silver deluxe edition

    10 g e (.35 oz.)

    L'BEL

    Principal Display Panel - 10 g Cartridge Box - Medium 5
  • PRINCIPAL DISPLAY PANEL - 10 g Cartridge Box - Medium 6

    DIVINE

    Polvos compactos doble uso FPS 15 edición de lujo plateado

    Double use compact SPF 15 silver deluxe edition

    10 g e (.35 oz.)

    L'BEL

    Principal Display Panel - 10 g Cartridge Box - Medium 6
  • PRINCIPAL DISPLAY PANEL - 10 g Cartridge Box - Medium 7

    DIVINE

    Polvos compactos doble uso FPS 15 edición de lujo plateado

    Double use compact SPF 15 silver deluxe edition

    10 g e (.35 oz.)

    L'BEL

    Principal Display Panel - 10 g Cartridge Box - Medium 7
  • PRINCIPAL DISPLAY PANEL - 10 g Cartridge Box - Obscure 8-9

    DIVINE

    Polvos compactos doble uso FPS 15 edición de lujo plateado

    Double use compact SPF 15 silver deluxe edition

    10 g e (.35 oz.)

    L'BEL

    Principal Display Panel - 10 g Cartridge Box - Obscure 8-9
  • INGREDIENTS AND APPEARANCE
    LBEL   DIVINE POLVOS COMPACTOS DOBLE USO FPS 15 EDICION DE LUJO PLATEADO/DOUBLE USE COMPACT SPF 15 SILVER DELUXE EDITION CLAIRE 1-2-3
    titanium dioxide, zinc oxide, and octinoxate powder
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13537-493
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP) Titanium Dioxide0.062393 g  in 1 g
    Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide0.049 g  in 1 g
    Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate0.03 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    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
    ColorRED (Rose) Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:13537-493-021 in 1 BOX
    1NDC:13537-493-0110 g in 1 CARTRIDGE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35205/27/2013
    LBEL   DIVINE POLVOS COMPACTOS DOBLE USO FPS 15 EDICION DE LUJO PLATEADO/DOUBLE USE COMPACT SPF 15 SILVER DELUXE EDITION CLAIRE 4
    titanium dioxide, zinc oxide, and octinoxate powder
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13537-494
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP) Titanium Dioxide0.062393 g  in 1 g
    Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide0.049 g  in 1 g
    Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate0.03 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    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
    ColorRED (Rose lightly yellowish) Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:13537-494-021 in 1 BOX
    1NDC:13537-494-0110 g in 1 CARTRIDGE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35205/27/2013
    LBEL   DIVINE POLVOS COMPACTOS DOBLE USO FPS 15 EDICION DE LUJO PLATEADO/DOUBLE USE COMPACT SPF 15 SILVER DELUXE EDITION MEDIUM 5
    titanium dioxide, zinc oxide, and octinoxate powder
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13537-495
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP) Titanium Dioxide0.062393 g  in 1 g
    Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide0.049 g  in 1 g
    Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate0.03 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    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
    ColorBROWN (Beige) Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:13537-495-021 in 1 BOX
    1NDC:13537-495-0110 g in 1 CARTRIDGE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35205/27/2013
    LBEL   DIVINE POLVOS COMPACTOS DOBLE USO FPS 15 EDICION DE LUJO PLATEADO/DOUBLE USE COMPACT SPF 15 SILVER DELUXE EDITION MEDIUM 6
    titanium dioxide, zinc oxide, and octinoxate powder
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13537-496
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP) Titanium Dioxide0.062393 g  in 1 g
    Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide0.049 g  in 1 g
    Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate0.03 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    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
    ColorBROWN (Yellowish Beige) Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:13537-496-021 in 1 BOX
    1NDC:13537-496-0110 g in 1 CARTRIDGE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35205/27/2013
    LBEL   DIVINE POLVOS COMPACTOS DOBLE USO FPS 15 EDICION DE LUJO PLATEADO/DOUBLE USE COMPACT SPF 15 SILVER DELUXE EDITION MEDIUM 7
    titanium dioxide, zinc oxide, and octinoxate powder
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13537-497
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP) Titanium Dioxide0.062393 g  in 1 g
    Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide0.049 g  in 1 g
    Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate0.03 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    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
    ColorBROWN (Light Reddish Beige) Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:13537-497-021 in 1 BOX
    1NDC:13537-497-0110 g in 1 CARTRIDGE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35205/27/2013
    LBEL   DIVINE POLVOS COMPACTOS DOBLE USO FPS 15 EDICION DE LUJO PLATEADO/DOUBLE USE COMPACT SPF 15 SILVER DELUXE EDITION OBSCURE 8-9
    titanium dioxide, zinc oxide, and octinoxate powder
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13537-498
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP) Titanium Dioxide0.062393 g  in 1 g
    Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide0.049 g  in 1 g
    Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate0.03 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    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
    ColorBROWN (Reddish Beige) Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:13537-498-021 in 1 BOX
    1NDC:13537-498-0110 g in 1 CARTRIDGE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35205/27/2013
    Labeler - Ventura Corporation LTD. (602751344)
    Establishment
    NameAddressID/FEIBusiness Operations
    Bel Star S.A. (Colombia)880160197MANUFACTURE(13537-493, 13537-494, 13537-495, 13537-496, 13537-497, 13537-498)
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