SUPERNATURAL PORELESS FLAWLESS TINTED SPF 15 (OCTISALATE AND TITANIUM DIOXIDE) CREAM [PHILOSOPHY, INC.]

SUPERNATURAL PORELESS FLAWLESS TINTED SPF 15 (OCTISALATE AND TITANIUM DIOXIDE) CREAM [PHILOSOPHY, INC.]
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NDC 50184-3800-1, 50184-3800-2
Set ID 146925bc-3619-45bc-9f49-d83f805d27e7
Category HUMAN OTC DRUG LABEL
Packager Philosophy, Inc.
Generic Name
Product Class
Product Number
Application Number PART352
  • ACTIVE INGREDIENT

    Active ingredients

    Octisalate 5% w/w

    Titanium Dioxide 4% w/w

  • INACTIVE INGREDIENT

    Cyclopentasiloxane   74.863% w/w

    Dimethicone Crosspolymer    6.25% w/w

    Dimethicone Vinyl Dimethicone crosspolymer   5.309% w/w

    Grossypium Herbaceum Cotton   1.48% w/w

    Phytosterols   0.037% w/w

    Tocotrienols   0.0160% w/w

    Tocopherol    0.0170% w/w

    Squalene   0.0150% w/w

    Oryza Sativa (Rice) Bran Wax   0.0150% w/w

    Retinyl Palmitate   0.100% w/w

    Simethicone   0.0025% w/w

    Alumina   0.0025% w/w

    Dimethicone   0.2400% w/w

    Silica   0.400% w/w

    Squalane   0.200% w/w

    Fragrance   0.1000% w/w

    Triethoxycaprylylsilane   0.0045% w/w

    Phenoxyethanol   0.2750% w/w

    Caprylyl Glycol   0.2250% w/w

    Iron Oxides   0.4485% w/w


  • ASK DOCTOR

    STOP USE AND ASK DOCTOR IF RASH OR IRRITATION DEVELOPS AND LASTS

  • GENERAL PRECAUTIONS

    WARNINGS: FOR EXTERNAL USE ONLY

  • WHEN USING

    WHEN USING THIS PRODUCT:

    KEEP OUT OF EYES.  RINSE WITH WATER TO REMOVE.

  • KEEP OUT OF REACH OF CHILDREN

    KEEP OUT OF REACH OF CHILDREN.

    IF SWALLOWED, GET MEDICAL HELP OR CONTACT A POISON CENTER RIGHT AWAY.

  • PURPOSE

    INDICATIONS:

    HELPS PREVENT SUNBURN

    HIGHER SPF GIVES MORE SUNBURN PROTECTION

  • INDICATIONS & USAGE

    INDICATIONS:

    HELPS PREVENT SUNBURN

    HIGHER SPF GIVES MORE SUNBURN PROTECTION



    DIRECTIONS: APPLY EVENLY OVER ENTIRE FACE AS A FOUNDATION OR PRIMER OR ALONE.  APPLY LIBERALLY BEFORE SUN EXPOSURE AND AS NEEDED.

  • PRINCIPAL DISPLAY PANEL

    image of box

  • INGREDIENTS AND APPEARANCE
    SUPERNATURAL PORELESS FLAWLESS TINTED SPF 15 
    octisalate and titanium dioxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50184-3800
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP) Titanium Dioxide40 mg  in 1 g
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE50 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    Cyclomethicone 5 (UNII: 0THT5PCI0R)  
    Levant Cotton Oil (UNII: N5CFT140R8)  
    .Beta.-Sitosterol (UNII: S347WMO6M4)  
    Alpha-Tocopherol (UNII: H4N855PNZ1)  
    Squalene (UNII: 7QWM220FJH)  
    Rice Germ Oil (UNII: D4H5GGS5JF)  
    Vitamin A Palmitate (UNII: 1D1K0N0VVC)  
    Aluminum Oxide (UNII: LMI26O6933)  
    Dimethicone (UNII: 92RU3N3Y1O)  
    Silicon Dioxide (UNII: ETJ7Z6XBU4)  
    Squalane (UNII: GW89575KF9)  
    Triethoxycaprylylsilane (UNII: LDC331P08E)  
    Phenoxyethanol (UNII: HIE492ZZ3T)  
    Caprylyl Glycol (UNII: 00YIU5438U)  
    Ferric Oxide Red (UNII: 1K09F3G675)  
    Ferric Oxide Yellow (UNII: EX438O2MRT)  
    Ferrosoferric Oxide (UNII: XM0M87F357)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50184-3800-21 in 1 CARTON12/01/2009
    1NDC:50184-3800-145.4 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35212/01/2009
    Labeler - Philosophy, Inc. (948102256)
    Establishment
    NameAddressID/FEIBusiness Operations
    Process Technologies and Packaging Inc.809172885manufacture(50184-3800)

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