2 IN 1 POWDER MAKE-UP SPF 15 (OCTINOXATE TITANIUM DIOXIDE) POWDER [JAFRA COSMETICS INTERNATIONAL]

2 IN 1 POWDER MAKE-UP SPF 15 (OCTINOXATE TITANIUM DIOXIDE) POWDER [JAFRA COSMETICS INTERNATIONAL]
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NDC 68828-057-21, 68828-057-25
Set ID 2aeb3745-bf6e-49ae-a151-d5d633ac6bbc
Category HUMAN OTC DRUG LABEL
Packager JAFRA COSMETICS INTERNATIONAL
Generic Name
Product Class
Product Number
Application Number PART352
  • 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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