Label: FLEBEAUTE COLLAGENIC MAKE UP BASE SPF20 PA 01GREEN- titanium dioxide cream

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph 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 July 13, 2010

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  • ACTIVE INGREDIENT

    Active Ingredients: TITANIUM DIOXIDE, ZINC OXIDE

  • INACTIVE INGREDIENT

    Inactive Ingredients:

    WATER, CYCLOPENTASILOXANE, ETHYLHEXYL METHOXYCINNAMATE, CYCLOMETHICONE, BUTYLENE GLYCOL, DIMETHICONE, GLYCERIN, HYDROLYZED COLLAGEN, NATTO GUM, POLYMETHYLMETHACRYLATE, ARTEMISIA ABROTANUM FLOWER/LEAF/STEM EXTRACT, EUCOMMIA ULMOIDES EXTRACT, CROCUS SATIVUS FLOWER EXTRACT,
    HYDROGENATED LECITHIN, TOCOPHERYL ACETATE, DISTEARDIMONIUM HECTORITE, SILICA, TRIETHOXYCAPRYLYLSILANE, METHICONE, FRAGRANCE, METHYLPARABEN,
    BHT, ADENOSINE, DISODIUM EDTA
    (MAY CONTAIN) CHROMIUM OXIDE GREENS(CI77288), ULTRAMARINES(CI77007)

  • DESCRIPTION

    Warnings:
    When using this product
    Keep out of eyes. Rinse with water to remove.
    Stop use and ask a doctor if
    Rash or irritation develops and lasts.

    Directions:
    Apply evenly before sun exposure and as needed.
    Children under 6months of age; ask a doctor.

  • PRINCIPAL DISPLAY PANEL

    Image of carton

  • INGREDIENTS AND APPEARANCE
    FLEBEAUTE COLLAGENIC MAKE UP BASE  SPF20 PA 01GREEN
    titanium dioxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51523-006
    Route of AdministrationCUTANEOUS
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM - UNII:D1JT611TNE) TITANIUM DIOXIDE1.81 mL  in 35 mL
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC OXIDE1.41 mL  in 35 mL
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51523-006-0135 mL in 1 CARTON
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35207/01/2008
    Labeler - THEFACESHOP CO., LTD. (688329416)
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