Label: FLEBEAUTE COLLAGENIC TWO WAY CAKE SPF17 PA NB23- titanium dioxide powder

  • 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:

    MICA(CI 77019), TALC, SILICA, SQUALANE, ALUMINA, MAGNESIUM MYRISTATE, NYLON-12, BARIUM SULFATE, BORON NITRIDE, ETHYLHEXYL METHOXYCINNAMATE,
    DIMETHICONE, IRON OXIDES(CI 77492), LAUROYL LYSINE, VINYL DIMETHICONE/METHICONE SILSESQUIOXANE, CROSSPOLYMER, CAPRYLIC/CAPRIC TRIGLYCERIDE, METHICONE, MAGNESIUM STEARATE, IRON OXIDES(CI 77491), HYDROGENATED LECITHIN, METHYLPARABEN, FRAGRNACE(PARFUME), IRON OXIDES(CI 77499), BUTYLPARABEN, BUTYLENE GLYCOL, HYDROLYZED EXTENSIN, WATER, ULTRAMARINES(CI 77007), CROCUS SATIVUS FLOWER EXTRACT, PHENOXYETHANOL ARTEMISIA ABROTANUM FLOWER/LEAF/STEM EXTRACT, TRIETHOXYCAPRYLYLSILANE

  • 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.

  • PRINCIPAL DISPLAY PANEL

    Image of carton

  • INGREDIENTS AND APPEARANCE
    FLEBEAUTE COLLAGENIC TWO WAY CAKE  SPF17 PA NB23
    titanium dioxide powder
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51523-010
    Route of AdministrationCUTANEOUS
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM - UNII:D1JT611TNE) TITANIUM DIOXIDE0.93 g  in 12 g
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC OXIDE0.17 g  in 12 g
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51523-010-0112 g 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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