Label: DOUBLE USE COMPACT SPF 15 GOLD DELUXE EDITION CLAIRE 1-2-3- octinoxate, titanium dioxide, zinc oxide powder
DOUBLE USE COMPACT SPF 15 GOLD DELUXE EDITION CLAIRE 4- octinoxate, titanium dioxide, zinc oxide powder
DOUBLE USE COMPACT SPF 15 GOLD DELUXE EDITION MEDIUM 5- octinoxate, titanium dioxide, zinc oxide powder
DOUBLE USE COMPACT SPF 15 GOLD DELUXE EDITION MEDIUM 6- octinoxate, titanium dioxide, zinc oxide powder
DOUBLE USE COMPACT SPF 15 GOLD DELUXE EDITION MEDIUM 7- octinoxate, titanium dioxide, zinc oxide powder

  • 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 December 7, 2020

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  • ACTIVE INGREDIENT

    Active ingredients Purpose

    Octinoxate 3.00% Sunscreen

    Titanium Dioxide 6.24% Sunscreen

    Zinc Oxide 4.90 % Sunscreen

  • PURPOSE

    Uses:

    Helps prevent Sunburn

  • KEEP OUT OF REACH OF CHILDREN

    • Keep out of reach of children. If swallowed, get medical help, or contact a Poison Control Center right away.
  • INDICATIONS & USAGE

    Stop use and ask a doctor if rash occurs.

  • WARNINGS

    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 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.
  • DOSAGE & ADMINISTRATION

    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 SAFETY INFORMATION

    Other information:

    • Protect the product in this container from excessive heat and direct sun
  • INACTIVE INGREDIENT

    Inactive ingredients: Mica, polymethylsilsesquioxane, hdi/trimethylol hexyllactone crosspolymer, dimethicone, magnesium stearate, trimethylsiloxysilicate, isostearyl neopentanoate, hydrogen dimethicone, tocopheryl acetate, phenoxyethanol, alumina, triethoxycaprylylsilane, fragrance, caprylyl glycol, ceramide np, chlorphenesin, butylphenyl methylpropional, hydroxycitronellal, citronellol, geraniol, limonene, alpha-isomethyl ionone, May contain: Iron oxides, titanium dioxide

  • PRINCIPAL DISPLAY PANEL

    L'BEL

    Divine

    Polvos Compactos doble uso FPS 15 edicion de lujo dorado

    Double use compact SPF 15 gold deluxe edition

    Tone: Claire 1-2-3

    Net. Wt. 0.35 oz (10g)

    CJ 48351 Claire 1-2-3-

  • PRINCIPAL DISPLAY PANEL

    L'BEL

    Divine

    Polvos Compactos doble uso FPS 15 edicion de lujo dorado

    Double use compact SPF 15 gold deluxe edition

    Tone: Claire 4

    Net. Wt. 0.35 oz (10g)

    CJ 48351-B Claire 4

  • PRINCIPAL DISPLAY PANEL

    L'BEL

    Divine

    Polvos Compactos doble uso FPS 15 edicion de lujo dorado

    Double use compact SPF 15 gold deluxe edition

    Tone: Medium 5

    Net. Wt. 0.35 oz (10g)

    CJ-48351-B Medium 5

  • PRINCIPAL DISPLAY PANEL

    L'BEL

    Divine

    Polvos Compactos doble uso FPS 15 edicion de lujo dorado

    Double use compact SPF 15 gold deluxe edition

    Tone: Medium 6

    Net. Wt. 0.35 oz (10g)

    CJ-48351-B Medium 6

  • PRINCIPAL DISPLAY PANEL

    L'BEL

    Divine

    Polvos Compactos doble uso FPS 15 edicion de lujo dorado

    Double use compact SPF 15 gold deluxe edition

    Tone: Medium 7

    Net. Wt. 0.35 oz (10g)

    CJ-48351-B Medium 7

  • INGREDIENTS AND APPEARANCE
    DOUBLE USE COMPACT SPF 15 GOLD DELUXE EDITION CLAIRE 1-2-3 
    octinoxate, titanium dioxide, zinc oxide powder
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43596-0189
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE4.9 g  in 100 g
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE6.24 g  in 100 g
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE3 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)  
    CERAMIDE NP (UNII: 4370DF050B)  
    BUTYLPHENYL METHYLPROPIONAL (UNII: T7540GJV69)  
    GERANIOL (UNII: L837108USY)  
    TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    ISOSTEARYL NEOPENTANOATE (UNII: 411THY156Q)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    HEXAMETHYLENE DIISOCYANATE/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER (UNII: WB5K9Y35Y9)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    POLYMETHYLSILSESQUIOXANE (11 MICRONS) (UNII: Z570VEV8XK)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    HYDROXYCITRONELLAL (UNII: 8SQ0VA4YUR)  
    MICA (UNII: V8A1AW0880)  
    LIMONENE, (+)- (UNII: GFD7C86Q1W)  
    .BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)  
    HYDROGEN DIMETHICONE (13 CST) (UNII: 4QGR4P2YOI)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:43596-0189-110 g in 1 BOTTLE; Type 0: Not a Combination Product11/12/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35211/12/2020
    DOUBLE USE COMPACT SPF 15 GOLD DELUXE EDITION CLAIRE 4 
    octinoxate, titanium dioxide, zinc oxide powder
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43596-0190
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE4.9 g  in 100 g
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE6.24 g  in 100 g
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE3 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)  
    CERAMIDE NP (UNII: 4370DF050B)  
    BUTYLPHENYL METHYLPROPIONAL (UNII: T7540GJV69)  
    GERANIOL (UNII: L837108USY)  
    TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    ISOSTEARYL NEOPENTANOATE (UNII: 411THY156Q)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    HEXAMETHYLENE DIISOCYANATE/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER (UNII: WB5K9Y35Y9)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    POLYMETHYLSILSESQUIOXANE (11 MICRONS) (UNII: Z570VEV8XK)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    HYDROXYCITRONELLAL (UNII: 8SQ0VA4YUR)  
    MICA (UNII: V8A1AW0880)  
    LIMONENE, (+)- (UNII: GFD7C86Q1W)  
    .BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)  
    HYDROGEN DIMETHICONE (13 CST) (UNII: 4QGR4P2YOI)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:43596-0190-110 g in 1 BOTTLE; Type 0: Not a Combination Product11/12/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35211/12/2020
    DOUBLE USE COMPACT SPF 15 GOLD DELUXE EDITION MEDIUM 5 
    octinoxate, titanium dioxide, zinc oxide powder
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43596-0191
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE4.9 g  in 100 g
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE6.24 g  in 100 g
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE3 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)  
    CERAMIDE NP (UNII: 4370DF050B)  
    BUTYLPHENYL METHYLPROPIONAL (UNII: T7540GJV69)  
    GERANIOL (UNII: L837108USY)  
    TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    ISOSTEARYL NEOPENTANOATE (UNII: 411THY156Q)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    HEXAMETHYLENE DIISOCYANATE/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER (UNII: WB5K9Y35Y9)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    POLYMETHYLSILSESQUIOXANE (11 MICRONS) (UNII: Z570VEV8XK)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    HYDROXYCITRONELLAL (UNII: 8SQ0VA4YUR)  
    MICA (UNII: V8A1AW0880)  
    LIMONENE, (+)- (UNII: GFD7C86Q1W)  
    .BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)  
    HYDROGEN DIMETHICONE (13 CST) (UNII: 4QGR4P2YOI)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:43596-0191-110 g in 1 BOTTLE; Type 0: Not a Combination Product11/12/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35211/12/2020
    DOUBLE USE COMPACT SPF 15 GOLD DELUXE EDITION MEDIUM 6 
    octinoxate, titanium dioxide, zinc oxide powder
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43596-0192
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE4.9 g  in 100 g
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE6.24 g  in 100 g
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE3 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)  
    CERAMIDE NP (UNII: 4370DF050B)  
    BUTYLPHENYL METHYLPROPIONAL (UNII: T7540GJV69)  
    GERANIOL (UNII: L837108USY)  
    TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    ISOSTEARYL NEOPENTANOATE (UNII: 411THY156Q)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    HEXAMETHYLENE DIISOCYANATE/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER (UNII: WB5K9Y35Y9)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    POLYMETHYLSILSESQUIOXANE (11 MICRONS) (UNII: Z570VEV8XK)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    HYDROXYCITRONELLAL (UNII: 8SQ0VA4YUR)  
    MICA (UNII: V8A1AW0880)  
    LIMONENE, (+)- (UNII: GFD7C86Q1W)  
    .BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)  
    HYDROGEN DIMETHICONE (13 CST) (UNII: 4QGR4P2YOI)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:43596-0192-110 g in 1 BOTTLE; Type 0: Not a Combination Product11/12/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35211/12/2020
    DOUBLE USE COMPACT SPF 15 GOLD DELUXE EDITION MEDIUM 7 
    octinoxate, titanium dioxide, zinc oxide powder
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43596-0193
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE4.9 g  in 100 g
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE6.24 g  in 100 g
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE3 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)  
    CERAMIDE NP (UNII: 4370DF050B)  
    BUTYLPHENYL METHYLPROPIONAL (UNII: T7540GJV69)  
    GERANIOL (UNII: L837108USY)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    ISOSTEARYL NEOPENTANOATE (UNII: 411THY156Q)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    HEXAMETHYLENE DIISOCYANATE/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER (UNII: WB5K9Y35Y9)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    POLYMETHYLSILSESQUIOXANE (11 MICRONS) (UNII: Z570VEV8XK)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    HYDROXYCITRONELLAL (UNII: 8SQ0VA4YUR)  
    MICA (UNII: V8A1AW0880)  
    LIMONENE, (+)- (UNII: GFD7C86Q1W)  
    .BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)  
    HYDROGEN DIMETHICONE (13 CST) (UNII: 4QGR4P2YOI)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:43596-0193-110 g in 1 BOTTLE; Type 0: Not a Combination Product11/12/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35211/12/2020
    Labeler - Ventura Corporation LTD (602751344)
    Establishment
    NameAddressID/FEIBusiness Operations
    Bel Star S.A. (Colombia)880160197manufacture(43596-0189, 43596-0190, 43596-0191, 43596-0192, 43596-0193)
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