Label: FACE IT HD PERFECT BB SPF30 PA 01 - octinoxate, titanium dioxide, zinc oxide, betaine, talc cream

  • NDC Code(s): 51523-103-01, 51523-103-02
  • Packager: THEFACESHOP CO., LTD
  • 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
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  • PURPOSE

    Provides high protection against sunburn and tanning.

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  • WHEN USING

    Avoid contact with eyes. Close
  • STOP USE

    Discontinue use if sign of irritation or rash appear.

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  • 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)

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  • PRINCIPAL DISPLAY PANEL

    FACE IT HD PERFECT BB SPF30 PA++ 01

    BB CREAM


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  • INGREDIENTS AND APPEARANCE
    FACE IT HD PERFECT BB SPF30 PA 01 
    octinoxate, titanium dioxide, zinc oxide, betaine, talc cream
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:51523-103
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 6 mL  in 100 mL
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 6.36 mL  in 100 mL
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 2.88 mL  in 100 mL
    BETAINE (UNII: 3SCV180C9W) (BETAINE - UNII:3SCV180C9W) BETAINE 2 mL  in 100 mL
    TALC (UNII: 7SEV7J4R1U) (TALC - UNII:7SEV7J4R1U) TALC 0.684 mL  in 100 mL
    Inactive Ingredients
    Ingredient Name Strength
    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 Code Package Description Marketing Start Date Marketing End Date
    1 NDC:51523-103-02 1 in 1 BOX
    1 NDC:51523-103-01 40 mL in 1 CONTAINER
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part352 08/23/2011
    Labeler - THEFACESHOP CO., LTD (688329416)
    Registrant - THEFACESHOP CO., LTD (688329416)
    Establishment
    Name Address ID/FEI Business Operations
    THEFACESHOP CO., LTD 688329416 manufacture
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