3CE DUO COLOR FACE BLUSH CREME DE VIOLETTE (TITANIUM DIOXIDE) POWDER [NANDA CO., LTD]

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3CE DUO COLOR FACE BLUSH CREME DE VIOLETTE (TITANIUM DIOXIDE) POWDER [NANDA CO., LTD]
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NDC 60764-059-01, 60764-059-02
Set ID 5823e82f-06d5-44f5-add1-cf399666db77
Category HUMAN OTC DRUG LABEL
Packager Nanda Co., Ltd
Generic Name
Product Class
Product Number
Application Number PART352
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  • ACTIVE INGREDIENT

    Active Ingredient: Titanium Dioxide 5.6%

  • INACTIVE INGREDIENT

    Inactive Ingredients: Talc, Mica (CI 77019), Octyldodecyl Stearoyl Stearate, Phenyl Trimethicone, Nylon-12, Magnesium Myristate, Silica, Ultramarines (CI 77007), Propanediol, Triethoxycaprylylsilane, Magnesium Stearate, Red 30 (CI 73360), Dimethicone, Dimethiconol Stearate, Caprylic/Capric Triglyceride, Yellow 5 Lake (CI 19140), Methicone, Sodium Dehydroacetate, Tocopheryl Acetate, Red 7 (CI 15850:1), Tin Oxide (CI 77861)

  • 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: Achieve a beautiful flush on your skin with this pigmented blush.

    Directions: With a brush, dab on the center of both cheeks then follow with spreading out by dabbing around the face line

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    Image of carton

  • INGREDIENTS AND APPEARANCE
    3CE DUO COLOR FACE BLUSH CREME DE VIOLETTE 
    titanium dioxide powder
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:60764-059
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Titanium Dioxide (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) Titanium Dioxide0.28 g  in 5 g
    Inactive Ingredients
    Ingredient NameStrength
    Talc (UNII: 7SEV7J4R1U)  
    Mica (UNII: V8A1AW0880)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:60764-059-021 in 1 CARTON08/20/2016
    1NDC:60764-059-015 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 finalpart35208/20/2016
    Labeler - Nanda Co., Ltd (557816075)
    Registrant - Nanda Co., Ltd (557816075)
    Establishment
    NameAddressID/FEIBusiness Operations
    Nanda Co., Ltd557816075repack(60764-059)
    Establishment
    NameAddressID/FEIBusiness Operations
    Cosmax, Inc.689049693manufacture(60764-059)
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