Label: 2 IN 1 POWDER MAKE-UP SPF 15- octinoxate titanium dioxide 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 11, 2012

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  • ACTIVE INGREDIENT

    SUNSCREEN ACTIVE INGREDIENT (SPF 15):
    OCTINOXATE, TITANIUM DIOXIDE/CI77891
  • PURPOSE

    PURPOSE: SUNSCREEN

  • INACTIVE INGREDIENT

    OTHER INGREDIENTS: TALC, HYDROGENATED LECITHIN, DIMETHICONE, OCTYLDODECYL LACTATE, METHYL METHACRYLATE CROSSPOLYMER, SILICA, ZINC STEARATE, OCTYLDODECYL STEAROYL STEARATE, METHYLPARABEN, DIISOSTEAROYL POLYGLYCERYL-3 DIISOSTEARATE, PROPYLPARABEN, SODIUM PCA, TOCOPHERYL ACETATE, TRIMETHYLSILOXYAMODIMETHICONE, MICA, DIAZOLIDINYL UREA  [MAY CONTAIN, +/-: IRON OXIDES/CI 77491/CI 77492/CI 77499]

  • INDICATIONS & USAGE

    CONTAINS SPF 15 TO HELP SHIELD AGAINST HARMFUL UV RAYS.

  • DOSAGE & ADMINISTRATION

    TO USE: APPLY WITH THE SPONGE FOR A LONG-LASTING VELVETY MATTE FINISH OR A POWDER BRUSH FOR A SHEER AND NATURAL FINISH.

  • WARNINGS

    DISCONTINUE USE IF IRRITATION OCCURS.

  • KEEP OUT OF REACH OF CHILDREN

    KEEP OUT OF REACH OF CHILDREN.

  • PRINCIPAL DISPLAY PANEL

    JAFRA

    TWO-IN-ONE POWDER MAKEUP SPF 15

    2-In-1 Powder M-U SPF-15_ART_BOX-FR_12g_20120502   2-In-1 Powder M-U SPF-15_ART_BOX-BK_12g_20120502   2-In-1 Powder M-U SPF-15_ART_LBL_12g_20120502

  • INGREDIENTS AND APPEARANCE
    2 IN 1 POWDER MAKE-UP  SPF 15
    octinoxate titanium dioxide powder
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68828-057
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE5 g  in 100 g
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE3.25 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    TALC (UNII: 7SEV7J4R1U)  
    HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    OCTYLDODECYL LACTATE (UNII: 8JKW8M5W35)  
    METHYL METHACRYLATE (UNII: 196OC77688)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    ZINC STEARATE (UNII: H92E6QA4FV)  
    OCTYLDODECYL STEAROYL STEARATE (UNII: 3D47Q6D93C)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    TRIMETHYLSILOXYSILICATE (M/Q 0.66) (UNII: 5041RX63GN)  
    MICA (UNII: V8A1AW0880)  
    DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
    SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)  
    ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68828-057-211 in 1 BOX
    1NDC:68828-057-2512 g in 1 JAR
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35204/24/2012
    Labeler - JAFRA COSMETICS INTERNATIONAL (041676479)
    Registrant - JAFRA COSMETICS INTERNATIONAL (041676479)
    Establishment
    NameAddressID/FEIBusiness Operations
    Jafra Manufacturing, S.A. de C.V.814732061manufacture
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