3CE CRE AMY LIP COLOR 13 VEG AS NIGHT (TITANIUM DIOXIDE) LIPSTICK [NANDA CO., LTD]

3CE CRE AMY LIP COLOR 13 VEG AS NIGHT (TITANIUM DIOXIDE) LIPSTICK [NANDA CO., LTD]
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NDC 60764-121-01, 60764-121-02
Set ID c81715ac-cdac-4b86-ae69-5545d780e264
Category HUMAN OTC DRUG LABEL
Packager Nanda Co., Ltd
Generic Name
Product Class
Product Number
Application Number PART352
  • ACTIVE INGREDIENT

    Active Ingredient: Titanium Dioxide 0.7%

  • INACTIVE INGREDIENT

    Inactive Ingredients: Squalane, Caprylic/Capric Triglyceride, Pentaerythrityl Tetraisostearate, Ethylhexyl Hydroxystearate, Butyloctyl Salicylate, Polyglyceryl-2 Triisostearate, Ozokerite, Ceresin, Diglyceryl Sebacate/Isopalmitate, Polyethylene, Phytosteryl/Isostearyl/Cetyl/Stearyl/Behenyl Dimer Dilinoleate, Hydrogenated Polyisobutene, Microcrystalline Wax, Red 6 (CI 15850), Dicalcium Phosphate, VP/Eicosene Copolymer, VP/Hexadecene Copolymer, Sorbitan Isostearate, Alumina, Diisostearyl Malate, Phytosteryl Macadamiate, Yellow 6 Lake (CI 15985), Glyceryl Caprylate, Caprylyl Glycol, Yellow 5 Lake (CI 19140), Argania Spinosa Kernel Oil, Theobroma Grandiflorum 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 13 VEG AS NIGHT 
    titanium dioxide lipstick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:60764-121
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Titanium Dioxide (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) Titanium Dioxide0.03 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:60764-121-021 in 1 CARTON08/10/2016
    1NDC:60764-121-014.5 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(60764-121)
    Establishment
    NameAddressID/FEIBusiness Operations
    Cosmax, Inc.689049693manufacture(60764-121)

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