3CE CRE AMY LIP COLOR 05 DAZZLING (TITANIUM DIOXIDE) LIPSTICK [NANDA CO., LTD]

3CE CRE AMY LIP COLOR 05 DAZZLING (TITANIUM DIOXIDE) LIPSTICK [NANDA CO., LTD]
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NDC 60764-115-01, 60764-115-02
Set ID 5c3f37fe-f2db-45b1-b741-0a501855d950
Category HUMAN OTC DRUG LABEL
Packager Nanda Co., Ltd
Generic Name
Product Class
Product Number
Application Number PART352
  • ACTIVE INGREDIENT

    Active Ingredient: Titanium Dioxide 3.6%

  • INACTIVE INGREDIENT

    Inactive Ingredients: Squalane, Caprylic/Capric Triglyceride, Pentaerythrityl Tetraisostearate, Ethylhexyl Hydroxystearate, Butyloctyl Salicylate, Ozokerite, DiglycerylSebacate/Isopalmitate, Polyethylene, Phytosteryl/Isostearyl/Cetyl/Stearyl/Behenyl Dimer Dilinoleate, Hydrogenated Polyisobutene, Ceresin, Diisostearyl Malate, Microcrystalline Wax, Dicalcium Phosphate, VP/Eicosene Copolymer, VP/Hexadecene Copolymer, SorbitanIsostearate, Polyglyceryl-2 Triisostearate, Iron Oxides (CI 77491), Alumina, PhytosterylMacadamiate, Iron Oxides (CI 77492), Red 7 (CI 15850:1), Polyglyceryl-2 Diisostearate, GlycerylCaprylate, Caprylyl Glycol, Iron Oxides (CI 77499), Blue 1 Lake (CI 42090), ArganiaSpinosa Kernel Oil, TheobromaGrandiflorum Seed Butter

  • 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: Intense moisturizing lip color lipstick that blends into your lips as soon as it is applied.

    Directions: After applying a thin layer of lipstick, another layer of clear lip gloss will allow an additional transparency

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    Image of carton

  • INGREDIENTS AND APPEARANCE
    3CE CRE AMY LIP COLOR 05 DAZZLING 
    titanium dioxide lipstick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:60764-115
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Titanium Dioxide (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) Titanium Dioxide0.16 g  in 4.5 g
    Inactive Ingredients
    Ingredient NameStrength
    Squalane (UNII: GW89575KF9)  
    Pentaerythrityl Tetraisostearate (UNII: 9D7IK5483F)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:60764-115-021 in 1 CARTON08/10/2016
    1NDC:60764-115-014.5 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 finalpart35208/10/2016
    Labeler - Nanda Co., Ltd (557816075)
    Registrant - Nanda Co., Ltd (557816075)
    Establishment
    NameAddressID/FEIBusiness Operations
    Nanda Co., Ltd557816075repack(60764-115)
    Establishment
    NameAddressID/FEIBusiness Operations
    Cosmax, Inc.689049693manufacture(60764-115)

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