Label: 3CE EYE SHADOW PALETTE BITTER SWEET- titanium dioxide powder

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated October 4, 2016

If you are a consumer or patient please visit this version.

  • ACTIVE INGREDIENT

    Active Ingredient: Titanium Dioxide 8.4%

  • INACTIVE INGREDIENT

    Inactive Ingredients:

    A) Talc, Glass, Mica (CI 77019), Neopentyl Glycol Diethylhexanoate, Phenyl Trimethicone, Nylon-12, Diisostearyl Malate, Dipentaerythrityl Hexahydroxystearate/Hexastearate/Hexarosinate, Octyldodecyl Stearoyl Stearate, Isostearyl Neopentanoate, Polybutene, Propanediol, Dimethicone, Magnesium Myristate, Iron Oxides (CI 77491), Triethoxycaprylylsilane, Yellow 6 Lake (CI 15985), Lauroyl Lysine, Tin Oxide (CI 77861), Sodium Dehydroacetate, Iron Oxides (CI 77492), Carmine (CI 75470), Red 30 (CI 73360)

    B)~D) Talc, Glass, Mica (CI 77019), Titanium Dioxide (CI 77891), Neopentyl Glycol Diethylhexanoate, Phenyl Trimethicone,Nylon-12, Diisostearyl Malate, Dipentaerythrityl Hexahydroxystearate/Hexastearate/Hexarosinate, Octyldodecyl Stearoyl Stearate, Isostearyl Neopentanoate, Polybutene, Propanediol, Dimethicone, Magnesium Myristate, Iron Oxides (CI 77491), Triethoxycaprylylsilane, Yellow 6 Lake (CI 15985), Lauroyl Lysine, Tin Oxide (CI 77861), Sodium Dehydroacetate, Iron Oxides (CI 77492), Carmine (CI 75470), Red 30 (CI 73360)

  • 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 BITTER SWEET 
    titanium dioxide powder
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:60764-064
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Titanium Dioxide (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) Titanium Dioxide0.67 g  in 8 g
    Inactive Ingredients
    Ingredient NameStrength
    Talc (UNII: 7SEV7J4R1U)  
    Mica (UNII: V8A1AW0880)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:60764-064-021 in 1 CARTON08/20/2016
    1NDC:60764-064-018 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(60764-064)
    Establishment
    NameAddressID/FEIBusiness Operations
    Cosmax, Inc.689049693manufacture(60764-064)