Label: FACE IT RADIANCE TWO WAY CAKE NB21- titanium dioxide, octinoxate, zinc oxide 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 September 1, 2011

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  • ACTIVE INGREDIENT


    TITANIUM DIOXIDE (12.8784%)
    OCTINOXATE (2%)
    ZINC OXIDE (1.4775%)
  • WARNINGS AND PRECAUTIONS

    For external use only

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. Is swallowed, get medical help or contact a Poison Control Center right away.
  • WHEN USING

    Keep out of eyes. Rinse with water to remove.

  • STOP USE

    Stop use if a rash or irritation develops and lasts.

  • PRINCIPAL DISPLAY PANEL


    FACE IT Radiance Two Way Cake NB21



    FACE IT RADIANCE TWO WAY CAKE



  • INGREDIENTS AND APPEARANCE
    FACE IT RADIANCE TWO WAY CAKE NB21 
    titanium dioxide, octinoxate, zinc oxide powder
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51523-112
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE12.8784 g  in 100 g
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE2 g  in 100 g
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE1.4775 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    MICA (UNII: V8A1AW0880)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    ALUMINUM DIMYRISTATE (UNII: J2KA067N9O)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
    BORON NITRIDE (UNII: 2U4T60A6YD)  
    DIISOPROPYL ADIPATE (UNII: P7E6YFV72X)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    LAUROYL LYSINE (UNII: 113171Q70B)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    BISMUTH OXYCHLORIDE (UNII: 4ZR792I587)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    BENZIMIDAZOLE (UNII: E24GX49LD8)  
    MEADOWFOAM SEED OIL (UNII: 412ZHA4T4Y)  
    SACCHARIDE ISOMERATE (UNII: W8K377W98I)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51523-112-021 in 1 BOX
    1NDC:51523-112-0111 g in 1 CONTAINER
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35209/01/2011
    Labeler - THEFACESHOP CO., LTD (688329416)
    Registrant - THEFACESHOP CO., LTD (688329416)
    Establishment
    NameAddressID/FEIBusiness Operations
    THEFACESHOP CO., LTD688329416manufacture
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