3CE FITTING CUSHION FOUNDATION 001 (TITANIUM DIOXIDE, OCTINOXATE, OCTISALATE) POWDER [NANDA CO., LTD]

3CE FITTING CUSHION FOUNDATION 001 (TITANIUM DIOXIDE, OCTINOXATE, OCTISALATE) POWDER [NANDA CO., LTD]
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NDC 60764-131-01, 60764-131-02
Set ID 1fca9d20-6a3c-40c8-8978-de46c5eb85fc
Category HUMAN OTC DRUG LABEL
Packager Nanda Co., Ltd
Generic Name
Product Class
Product Number
Application Number PART352
  • ACTIVE INGREDIENT

    Active Ingredient: Titanium Dioxide 14.1%, Ethylhexyl Methoxycinnamate 6.7%, Ethylhexyl Salicylate 4.0%

  • INACTIVE INGREDIENT

    Inactive Ingredients: Water, Cyclopentasiloxane, Trimethylsiloxysilicate, Butylene Glycol, PEG-8 Dimethicone, Butylene Glycol Dicaprylate/Dicaprate, Diphenylsiloxy Phenyl Trimethicone, Dipropylene Glycol, Niacinamide, Pentylene Glycol, Iron Oxides (CI 77492), C12-15 Alkyl Benzoate, Cetyl PEG/PPG-10/1 Dimethicone, Neopentyl Glycol Diheptanoate, PEG-8, Magnesium Sulfate, Synthetic Fluorphlogopite, Dimethicone, SorbitanIsostearate, Phenoxyethanol, DimethiconeCrosspolymer, DisteardimoniumHectorite, Stearic Acid, Alumina, Aluminum Hydroxide, Triethoxycaprylylsilane, Iron Oxides (CI 77491), Fragrance(Parfum), Iron Oxides (CI 77499), Hydrogenated Castor Oil Isostearate, Ethylhexylglycerin, Adenosine, Disodium EDTA, Methyl Methacrylate Crosspolymer, Hydrolyzed Hyaluronic Acid, AnastaticaHierochuntica Extract, Alcohol, AchilleaMillefolium Extract, Arnica Montana Flower Extract, Artemisia Absinthium Extract, GentianaLutea Root Extract, Lactobacillus Ferment, Potassium Sorbate

  • PURPOSE

    Purpose: Sunscreen

  • CAUTION

    CAUTION: 1. Discontinue use and consult a doctor when - your skin irritates, swells, itches, shows spots on areas applied - your skin reacts similarly with above when exposed to sunlight 2. Avoid applying on wounded, irritated, troubled areas 3. After the use - keep the cap closed - keep it out of children's reach - keep it away from expose to sunlight, high and low temperatures

  • DESCRIPTION

    INSTRUCTIONS: A Cushion compact foundation keeps your face looking perfectly just like the start of the day and prevents further darkening of skin. The lightweight, low-viscosity formula helps the foundation adhere to skin instantly while providing excellent coverage just like a liquid foundation.

    Directions: Take a small amount with the Ruby Cell Puff and spread evenly over face Please make sure to close the lid after use.

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    Image of carton

  • INGREDIENTS AND APPEARANCE
    3CE FITTING CUSHION FOUNDATION 001 
    titanium dioxide, octinoxate, octisalate powder
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:60764-131
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Titanium Dioxide (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) Titanium Dioxide1.69 g  in 12 g
    Octinoxate (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) Octinoxate0.80 g  in 12 g
    Octisalate (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) Octisalate0.48 g  in 12 g
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    Butylene Glycol (UNII: 3XUS85K0RA)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:60764-131-022 in 1 CARTON08/10/2016
    1NDC:60764-131-0112 g in 1 CONTAINER; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35208/10/2016
    Labeler - Nanda Co., Ltd (557816075)
    Registrant - Nanda Co., Ltd (557816075)
    Establishment
    NameAddressID/FEIBusiness Operations
    Nanda Co., Ltd557816075repack(60764-131)
    Establishment
    NameAddressID/FEIBusiness Operations
    Cosmax, Inc.689049693manufacture(60764-131)

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