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

3CE EYE SHADOW PALETTE SIENNA (TITANIUM DIOXIDE) POWDER [NANDA CO., LTD]
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NDC 60764-066-01, 60764-066-02
Set ID 6b8b51bf-439b-4522-92a5-10d2e6f4de8b
Category HUMAN OTC DRUG LABEL
Packager Nanda Co., Ltd
Generic Name
Product Class
Product Number
Application Number PART352
  • ACTIVE INGREDIENT

    Active Ingredient: Titanium Dioxide 5.9%

  • INACTIVE INGREDIENT

    Inactive Ingredients:

    A) Mica (CI 77019), Talc, Glass, Neopentyl Glycol Diethylhexanoate, Iron Oxides (CI 77491), Phenyl Trimethicone, Calcium Aluminum Borosilicate, Nylon-12, Diisostearyl Malate, Dipentaerythrityl Hexahydroxystearate/Hexastearate/Hexarosinate, Octyldodecyl Stearoyl Stearate, Isostearyl Neopentanoate, Magnesium Myristate, Magnesium Stearate, Carmine (CI 75470), Silica, Polybutene, Iron Oxides (CI 77499), Propanediol, Dimethicone, Ultramarines (CI 77007), Triethoxycaprylylsilane, Sodium Dehydroacetate, Hydrogenated Lecithin, Tin Oxide (CI 77861)

    B)~D) Mica (CI 77019), Talc, Glass, Titanium Dioxide (CI 77891), Neopentyl Glycol Diethylhexanoate, Iron Oxides (CI 77491), Phenyl Trimethicone, Calcium Aluminum Borosilicate, Nylon-12, Diisostearyl Malate, Dipentaerythrityl Hexahydroxystearate/Hexastearate/Hexarosinate, Octyldodecyl Stearoyl Stearate, Isostearyl Neopentanoate, Magnesium Myristate, Magnesium Stearate, Carmine (CI 75470), Silica, Polybutene, Iron Oxides (CI 77499), Propanediol, Dimethicone, Ultramarines (CI 77007), 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 SIENNA 
    titanium dioxide powder
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:60764-066
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Titanium Dioxide (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) Titanium Dioxide0.47 g  in 8 g
    Inactive Ingredients
    Ingredient NameStrength
    Mica (UNII: V8A1AW0880)  
    Talc (UNII: 7SEV7J4R1U)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:60764-066-021 in 1 CARTON08/20/2016
    1NDC:60764-066-018 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(60764-066)
    Establishment
    NameAddressID/FEIBusiness Operations
    Cosmax, Inc.689049693manufacture(60764-066)

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