3CE LIP COLOR 807 HYPNOTIC (TITANIUM DIOXIDE) LIPSTICK [NANDA CO., LTD]

3CE LIP COLOR 807 HYPNOTIC (TITANIUM DIOXIDE) LIPSTICK [NANDA CO., LTD]
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NDC 60764-053-01, 60764-053-02
Set ID 22e63dc4-7eb3-4661-920c-4bbe13d435c4
Category HUMAN OTC DRUG LABEL
Packager Nanda Co., Ltd
Generic Name
Product Class
Product Number
Application Number PART352
  • ACTIVE INGREDIENT

    Active Ingredient: Titanium Dioxide 4.1%

  • INACTIVE INGREDIENT

    Inactive Ingredients: Diisostearyl Malate, Silica, Triethylhexanoin, IsononylIsononanoate, Microcrystalline Wax, Ceresin, Ozokerite, Red 7 (CI 15850:1), DiglycerylSebacate/Isopalmitate, EthylhexylHydroxystearate, Dicalcium Phosphate, Octyldodecanol, Polyglyceryl-2 Diisostearate, Polyglyceryl-2 Triisostearate, VP/Hexadecene Copolymer, SorbitanIsostearate, Euphorbia Cerifera (Candelilla) Wax, Polyethylene, Yellow 6 Lake (CI 15985), Silica Dimethyl Silylate, Iron Oxides (CI 77491), Tocopheryl Acetate, Blue 1 Lake (CI 42090), MangiferaIndica (Mango) Seed Butter, ButyrospermumParkii (Shea) Butter, Diamond powder, Water, Butylene Glycol, Amethyst Powder, Pearl Powder, Tourmaline, Methylparaben

  • 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: A rich color lipstick that moistly adheres to lips.

    Directions: Twist to dispense makeup and apply evenly to lips

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    Image of carton

  • INGREDIENTS AND APPEARANCE
    3CE LIP COLOR 807 HYPNOTIC 
    titanium dioxide lipstick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:60764-053
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Titanium Dioxide (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) Titanium Dioxide0.14 g  in 3.5 g
    Inactive Ingredients
    Ingredient NameStrength
    Diisostearyl Malate (UNII: QBS8A3XZGQ)  
    Triethylhexanoin (UNII: 7K3W1BIU6K)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:60764-053-021 in 1 CARTON08/01/2016
    1NDC:60764-053-013.5 g in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35208/01/2016
    Labeler - Nanda Co., Ltd (557816075)
    Registrant - Nanda Co., Ltd (557816075)
    Establishment
    NameAddressID/FEIBusiness Operations
    Nanda Co., Ltd557816075repack(60764-053)
    Establishment
    NameAddressID/FEIBusiness Operations
    Cosmax, Inc.689049693manufacture(60764-053)

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