Label: SUPERNATURAL SUPERBEAUTIFUL MAKEUP SPF 15- titanium dioxide and zinc oxide cream

  • 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 January 23, 2010

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  • ACTIVE INGREDIENT

    ACTIVE INGREDIENTS......

    TITANIUM DIOXIDE (4.5%)

    ZINC OXIDE (2.0%)


  • ASK DOCTOR

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

  • KEEP OUT OF REACH OF CHILDREN

    KEEP OUT OF REACH OF CHILDREN.  FOR EXTERNAL USE ONLY

  • WARNINGS

    WHEN USING THIS PRODUCT KEEP OUT OF EYES. RINSE WITH WARM WATER TO REMOVE.

  • PRINCIPAL DISPLAY PANEL

    image of box

  • INDICATIONS & USAGE

    Uses: helps protect against sunburn.

    Directions: apply with fingertips or brush, layer for more coverage.

  • INGREDIENTS AND APPEARANCE
    SUPERNATURAL SUPERBEAUTIFUL MAKEUP SPF 15 
    titanium dioxide and zinc oxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50184-6000
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium - UNII:D1JT611TNE) Titanium Dioxide45 mg  in 1 g
    Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Cation - UNII:13S1S8SF37) Zinc Oxide20 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    HELIANTHUS ANNUUS (UNII: BKJ0J3D1BP)  
    OLIVE OIL (UNII: 6UYK2W1W1E)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    Ceteth-20 (UNII: I835H2IHHX)  
    DIHEXADECYL PHOSPHATE (UNII: 2V6E5WN99N)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    OLETH-3 PHOSPHATE (UNII: 8Q0Z18J1VL)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    EGG PHOSPHOLIPIDS (UNII: 1Z74184RGV)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    POLYSORBATE 60 (UNII: CAL22UVI4M)  
    SQUALANE (UNII: GW89575KF9)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    SODIUM DEHYDROACETATE (UNII: 8W46YN971G)  
    .ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    OCTYLTRIETHOXYSILANE (UNII: LDC331P08E)  
    TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50184-6000-21 in 1 CARTON
    1NDC:50184-6000-136 g in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35212/01/2009
    Labeler - Philosophy, Inc. (948102256)