Label: FACE IT AQUA TINTED BB SPF 20 PA 01- titanium dioxide, octinoxate 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 September 2, 2011

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  • ACTIVE INGREDIENT

    TITANIUM DIOXIDE (5.8%)
    OCTINOXATE (5%)

    WATER, CYCLOMETHICONE 5, BUTYLENE GLYCOL, HEXYL LAURATE, POLYSORBATE 60, SQUALANE, GLYCERIN, BIOSACCHARIDE GUM-1, PHENOXYETHANOL, FERRIC OXIDE YELLOW, METHYLPARABEN, TALC, FERRIC OXIDE RED, ETHYLPARABEN, FERROSOFERRIC OXIDE, TRIETHOXYCAPRYLYLSILANE, BUTYLENE GLYCOL, PONCIRUS TRIFOLIATA FRUIT
  • PURPOSE

    Provides high protection against sunburn and tanning.

  • WHEN USING

    Avoid contact with eyes.
  • STOP USE

    Discontinue use if sign of irritation or rash appear.

  • DOSAGE & ADMINISTRATION

    Dispense an adequate amount and apply evenly. (At the final stage of basic skincare, dispense an adequate amount and apply evenly to desired parts)

  • PRINCIPAL DISPLAY PANEL

    FACE IT AQUA TINTED BB SPF 20 PA 01

    BB CREAM

  • INGREDIENTS AND APPEARANCE
    FACE IT AQUA TINTED BB SPF 20 PA 01 
    titanium dioxide, octinoxate cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51523-105
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE5.80 mL  in 100 mL
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE5 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    HEXYL LAURATE (UNII: 4CG9F9W01Q)  
    POLYSORBATE 60 (UNII: CAL22UVI4M)  
    SQUALANE (UNII: GW89575KF9)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    BIOSACCHARIDE GUM-1 (UNII: BB4PU4V09H)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    TALC (UNII: 7SEV7J4R1U)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    ETHYLPARABEN (UNII: 14255EXE39)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    PONCIRUS TRIFOLIATA FRUIT (UNII: 44445L49J2)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51523-105-021 in 1 BOX
    1NDC:51523-105-0140 mL in 1 CONTAINER
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35208/23/2011
    Labeler - THEFACESHOP CO., LTD (688329416)
    Registrant - THEFACESHOP CO., LTD (688329416)
    Establishment
    NameAddressID/FEIBusiness Operations
    THEFACESHOP CO., LTD688329416manufacture
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