Label: FACE IT 4D PERPECT TWO-WAY CAKE NB23- titanium dioxide, octinoxate, zinc oxide powder

  • Category: HUMAN OTC DRUG LABEL

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 9, 2011

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  • ACTIVE INGREDIENT


    TITANIUM DIOXIDE (13.96843%)
    OCTINOXATE (3.5%)
    ZINC OXIDE (4.41%)
  • 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 4D PERPECT TWO-WAY CAKE NB23



    FACE IT 4D PERPECT TWO-WAY CAKE NB23



  • INGREDIENTS AND APPEARANCE
    FACE IT 4D PERPECT TWO-WAY CAKE NB23 
    titanium dioxide, octinoxate, zinc oxide powder
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51523-116
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE13.96843 g  in 100 g
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE3.5 g  in 100 g
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE4.41 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    MICA (UNII: V8A1AW0880)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    TALC (UNII: 7SEV7J4R1U)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    BARIUM SULFATE (UNII: 25BB7EKE2E)  
    HEXYL LAURATE (UNII: 4CG9F9W01Q)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    MAGNESIUM MYRISTATE (UNII: Z1917F0578)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    HAEMATOCOCCUS PLUVIALIS (UNII: 31T0FF0472)  
    WATER (UNII: 059QF0KO0R)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    ASTAXANTHIN (UNII: 8XPW32PR7I)  
    CHRYSANTHELLUM INDICUM TOP (UNII: STJ856D1Z0)  
    LONICERA JAPONICA FLOWER (UNII: 4465L2WS4Y)  
    NELUMBO NUCIFERA FLOWER (UNII: 61W322NLDV)  
    SAFFLOWER (UNII: 4VBL71TY4Y)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51523-116-021 in 1 BOX
    1NDC:51523-116-0112 g in 1 CONTAINER
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35209/09/2011
    Labeler - THEFACESHOP CO., LTD (688329416)
    Registrant - THEFACESHOP CO., LTD (688329416)
    Establishment
    NameAddressID/FEIBusiness Operations
    THEFACESHOP CO., LTD688329416manufacture