3CE DUO COLOR FACE BLUSH RETRO DRIVE (TITANIUM DIOXIDE) POWDER [NANDA CO., LTD]

3CE DUO COLOR FACE BLUSH RETRO DRIVE (TITANIUM DIOXIDE) POWDER [NANDA CO., LTD]
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NDC 60764-061-01, 60764-061-02
Set ID a1356f98-d62a-4197-b82c-4b435e195093
Category HUMAN OTC DRUG LABEL
Packager Nanda Co., Ltd
Generic Name
Product Class
Product Number
Application Number PART352
  • ACTIVE INGREDIENT

    Active Ingredient: Titanium Dioxide 2.4%

  • INACTIVE INGREDIENT

    Inactive Ingredients: Mica (CI 77019), Talc, Octyldodecyl Stearoyl Stearate, Phenyl Trimethicone, Magnesium Myristate, Nylon-12, Magnesium Stearate, Red 6 (CI 15850), Yellow 5 Lake (CI 19140), Polyethylene, Silica, Iron Oxides (CI 77492), Propanediol, Triethoxycaprylylsilane, Dimethicone, PTFE, Ethylhexyl Methoxycinnamate, Iron Oxides (CI 77491), Sodium Dehydroacetate, Caprylic/Capric Triglyceride, Methicone

  • 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 RETRO DRIVE 
    titanium dioxide powder
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:60764-061
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Titanium Dioxide (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) Titanium Dioxide0.12 g  in 5 g
    Inactive Ingredients
    Ingredient NameStrength
    Mica (UNII: V8A1AW0880)  
    Talc (UNII: 7SEV7J4R1U)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:60764-061-021 in 1 CARTON08/20/2016
    1NDC:60764-061-015 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(60764-061)
    Establishment
    NameAddressID/FEIBusiness Operations
    Cosmax, Inc.689049693manufacture(60764-061)

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