FACE IT AQUA TINTED BB SPF 20 PA 01 (TITANIUM DIOXIDE, OCTINOXATE) CREAM [THEFACESHOP CO., LTD]

FACE IT AQUA TINTED BB SPF 20 PA 01 (TITANIUM DIOXIDE, OCTINOXATE) CREAM [THEFACESHOP CO., LTD]
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NDC 51523-105-01, 51523-105-02
Set ID ffa53d3f-0dfb-4f2e-a831-cc3085c3ef3b
Category HUMAN OTC DRUG LABEL
Packager THEFACESHOP CO., LTD
Generic Name
Product Class
Product Number
Application Number PART352
  • 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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