3CE SHIMMER PINK (TITANIUM DIOXIDE) STICK [NANDA CO., LTD]

3CE SHIMMER PINK (TITANIUM DIOXIDE) STICK [NANDA CO., LTD]
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NDC 60764-013-01, 60764-013-02
Set ID afb948f6-64c3-4e20-822f-e42aef8b6a85
Category HUMAN OTC DRUG LABEL
Packager Nanda Co., Ltd
Generic Name
Product Class
Product Number
Application Number PART352
  • ACTIVE INGREDIENT

    Active Ingredient: Titanium Dioxide 4.0%

  • INACTIVE INGREDIENT

    Inactive Ingredients: Triethylhexanoin, Silica, Caprylic/Capric Triglyceride, Dimethicone, IsotridecylIsononanoate, Synthetic Fluorphlogopite, EthylhexylPalmitate, Ceresin, Ozokerite, Polyethylene, DiglycerylSebacate/Isopalmitate, VP/Hexadecene Copolymer, Hydrogenated Vegetable Oil, Microcrystalline Wax, HDI/TrimethylolHexyllactoneCrosspolymer, Hydroxyapatite, Silica Silylate, Methicone, Mica (CI 77019), Polyglyceryl-2 Triisostearate, Methylparaben, Iron Oxides (CI 77491), Iron Oxides (CI 77492), Iron Oxides (CI 77499), Tin Oxide (CI 77861), Propylparaben, Diisostearyl Malate, AstrocaryumMurumuru Seed Butter, TheobromaGrandiflorum Seed Butter, Aloe Barbadensis Leaf Juice, Dimethicone/Vinyl DimethiconeCrosspolymer, Polyurethane-40, Potassium Sorbate, Sodium Benzoate

  • 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: Shimmer stick that helps create a three-dimensional look with its subdued pearly light.

    Directions: Apply on T& C-zone, or other areas to highlight. Then pat around with your hands

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    Image of carton

  • INGREDIENTS AND APPEARANCE
    3CE SHIMMER PINK 
    titanium dioxide stick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:60764-013
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Titanium Dioxide (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) Titanium Dioxide0.4 g  in 10 g
    Inactive Ingredients
    Ingredient NameStrength
    Triethylhexanoin (UNII: 7K3W1BIU6K)  
    Dimethicone (UNII: 92RU3N3Y1O)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:60764-013-021 in 1 CARTON08/15/2016
    1NDC:60764-013-0110 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35208/15/2016
    Labeler - Nanda Co., Ltd (557816075)
    Registrant - Nanda Co., Ltd (557816075)
    Establishment
    NameAddressID/FEIBusiness Operations
    Nanda Co., Ltd557816075repack(60764-013)
    Establishment
    NameAddressID/FEIBusiness Operations
    Cosmax, Inc.689049693manufacture(60764-013)

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