3CE LIP COLOR 804 STAY BY ME (TITANIUM DIOXIDE) LIPSTICK [NANDA CO., LTD]

3CE LIP COLOR 804 STAY BY ME (TITANIUM DIOXIDE) LIPSTICK [NANDA CO., LTD]
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NDC 60764-055-01, 60764-055-02
Set ID c1a5de1b-4e24-41b9-80f6-ba64ac2efc40
Category HUMAN OTC DRUG LABEL
Packager Nanda Co., Ltd
Generic Name
Product Class
Product Number
Application Number PART352
  • ACTIVE INGREDIENT

    Active Ingredient: Titanium Dioxide 4.3%

  • INACTIVE INGREDIENT

    Inactive Ingredients: Diisostearyl Malate, Triethylhexanoin, EthylhexylHydroxystearate, IsononylIsononanoate, Silica, Microcrystalline Wax, Ceresin, Ozokerite, Polyglyceryl-2 Triisostearate, DiglycerylSebacate/Isopalmitate, Octyldodecanol, Alumina, Dicalcium Phosphate, VP/Hexadecene Copolymer, SorbitanIsostearate, Euphorbia Cerifera (Candelilla) Wax, Yellow 5 Lake (CI 19140), Red 28 Lake (CI 45410), Polyethylene, PentaerythritylTetraisostearate, Silica Dimethyl Silylate, Mica (CI 77019), Polyglyceryl-2 Diisostearate, Red 7 (CI 15850:1), Yellow 6 Lake (CI 15985), Tocopheryl Acetate, Iron Oxides (CI 77499), 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 804 STAY BY ME 
    titanium dioxide lipstick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:60764-055
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Titanium Dioxide (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) Titanium Dioxide0.15 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:60764-055-021 in 1 CARTON08/01/2016
    1NDC:60764-055-013.5 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(60764-055)
    Establishment
    NameAddressID/FEIBusiness Operations
    Cosmax, Inc.689049693manufacture(60764-055)

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