Label: FACE IT HD PERFECT BB SPF30 PA 02- octinoxate, titanium dioxide, zinc oxide, betaine, talc 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 August 23, 2011

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  • ACTIVE INGREDIENT

    OCTINOXATE (6%)
    TITANIUM DIOXIDE (6.36%)
    ZINC OXIDE (2.88%)
    BETAINE (2%)
    TALC (0.684%)

    WATER, CYCLOMETHICONE, DIPROPYLENE GLYCOL, DIMETHICONE, GLYCERIN, MICA, TITANIUM DIOXIDE, ALUMINUM HYDROXIDE, STEARIC ACID, DIMETHICONE, MAGNESIUM SULFATE, TRIETHOXYCAPRYLYLSILANE, POLYGLYCERYL-4 ISOSTEARATE, HEXYL LAURATE, PHENOXYETHANOL, TRIETHOXYCAPRYLYLSILANE, METHYLPARABEN, DISTEARYLDIMONIUM CHLORIDE, STEARIC ACID, CAREX HUMILIS ROOT, ETHYLPARABEN, PROPYLPARABEN, MICA, TRIETHYLHEXANOIN, MARITIME PINE
  • 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 HD PERFECT BB SPF30 PA++ 02

    BB CREAM


  • INGREDIENTS AND APPEARANCE
    FACE IT HD PERFECT BB SPF30 PA 02 
    octinoxate, titanium dioxide, zinc oxide, betaine, talc cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51523-104
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE6 mL  in 100 mL
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE6.36 mL  in 100 mL
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE2.88 mL  in 100 mL
    BETAINE (UNII: 3SCV180C9W) (BETAINE - UNII:3SCV180C9W) BETAINE2 mL  in 100 mL
    TALC (UNII: 7SEV7J4R1U) (TALC - UNII:7SEV7J4R1U) TALC0.684 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    CYCLOMETHICONE (UNII: NMQ347994Z)  
    DIPROPYLENE GLYCOL (UNII: E107L85C40)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    MICA (UNII: V8A1AW0880)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    MAGNESIUM SULFATE, UNSPECIFIED (UNII: DE08037SAB)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)  
    HEXYL LAURATE (UNII: 4CG9F9W01Q)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    DISTEARYLDIMONIUM CHLORIDE (UNII: OM9573ZX3X)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    CAREX HUMILIS ROOT (UNII: QFR9QY5U3V)  
    ETHYLPARABEN (UNII: 14255EXE39)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    MICA (UNII: V8A1AW0880)  
    TRIETHYLHEXANOIN (UNII: 7K3W1BIU6K)  
    MARITIME PINE (UNII: 50JZ5Z98QY)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51523-104-021 in 1 BOX
    1NDC:51523-104-0140 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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