3CE EYE SHADOW PALETTE SADDLE (TITANIUM DIOXIDE) POWDER [NANDA CO., LTD]

3CE EYE SHADOW PALETTE SADDLE (TITANIUM DIOXIDE) POWDER [NANDA CO., LTD]
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NDC 60764-065-01, 60764-065-02
Set ID 93d20d29-a4d5-45ce-8034-f254e5c262b5
Category HUMAN OTC DRUG LABEL
Packager Nanda Co., Ltd
Generic Name
Product Class
Product Number
Application Number PART352
  • ACTIVE INGREDIENT

    Active Ingredient: Titanium Dioxide 8.5%

  • INACTIVE INGREDIENT

    Inactive Ingredients:

    A) Mica (CI 77019), Talc, Iron Oxides (CI 77491), Nylon-12, Neopentyl Glycol Diethylhexanoate, Phenyl Trimethicone, Magnesium Myristate, Magnesium Stearate, Silica, Diisostearyl Malate, Dipentaerythrityl Hexahydroxystearate/Hexastearate/Hexarosinate, Octyldodecyl Stearoyl Stearate, Isostearyl Neopentanoate, Iron Oxides (CI 77492), Polybutene, Propanediol, Dimethicone, Iron Oxides (CI 77499), Triethoxycaprylylsilane, Sodium Dehydroacetate, Hydrogenated Lecithin, Tin Oxide (CI 77861)

    B)~D) Mica (CI 77019), Talc, Titanium Dioxide (CI 77891), Iron Oxides (CI 77491), Nylon-12, Neopentyl Glycol Diethylhexanoate, Phenyl Trimethicone, Magnesium Myristate, Magnesium Stearate, Silica, Diisostearyl Malate, Dipentaerythrityl Hexahydroxystearate/Hexastearate/Hexarosinate, Octyldodecyl Stearoyl Stearate, Isostearyl Neopentanoate, Iron Oxides (CI 77492), Polybutene, Propanediol, Dimethicone, Iron Oxides (CI 77499), Triethoxycaprylylsilane, Sodium Dehydroacetate, Hydrogenated Lecithin, Tin Oxide (CI 77861)

  • PURPOSE

    Purpose: Sunscreen

  • CAUTION

    CAUTION: 1. Keep it out of children's reach 2. Keep it away from expose to sunlight, high and low temperatures.

  • DESCRIPTION

    INSTRUCTIONS: Eye shadow palette with harmonious colors that magnify the hues and light.

    Directions: Gently apply on skin with its smooth sliding texture for a clean and luxurious finish

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    Image of carton

  • INGREDIENTS AND APPEARANCE
    3CE EYE SHADOW PALETTE SADDLE 
    titanium dioxide powder
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:60764-065
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Titanium Dioxide (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) Titanium Dioxide0.68 g  in 8 g
    Inactive Ingredients
    Ingredient NameStrength
    Mica (UNII: V8A1AW0880)  
    Talc (UNII: 7SEV7J4R1U)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:60764-065-021 in 1 CARTON08/20/2016
    1NDC:60764-065-018 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(60764-065)
    Establishment
    NameAddressID/FEIBusiness Operations
    Cosmax, Inc.689049693manufacture(60764-065)

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