3CE PORE SILKY BALM (TITANIUM DIOXIDE) POWDER [NANDA CO., LTD]

3CE PORE SILKY BALM (TITANIUM DIOXIDE) POWDER [NANDA CO., LTD]
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NDC 60764-014-01, 60764-014-02
Set ID bc0e5ec8-0ece-4022-807c-23e504c52875
Category HUMAN OTC DRUG LABEL
Packager Nanda Co., Ltd
Generic Name
Product Class
Product Number
Application Number PART352
  • ACTIVE INGREDIENT

    Active Ingredient: Titanium Dioxide 0.5%

  • INACTIVE INGREDIENT

    Inactive Ingredients: Dimethicone, Silica, Phenyl Trimethicone, IsotridecylIsononanoate, Methyl Methacrylate Crosspolymer, SorbitanOlivate, Microcrystalline Wax, Vinyl Dimethicone/MethiconeSilsesquioxaneCrosspolymer, Stearoyl Inulin, Polyethylene, Talc, Hydroxyapatite, Acetylated Sucrose Distearate, Diisostearyl Malate, Butylparaben, Fragrance(Parfum), Methicone, Polyglyceryl-2 Triisostearate, Yellow 5 Lake (CI 19140), Macadamia Integrifolia Seed Oil, ButyrospermumParkii (Shea) Butter, ArganiaSpinosa Kernel Oil, PolyvinylalcoholCrosspolymer, Nylon-12 Fluorescent Brightener 230 Salt

  • 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: Primer that conceals your rough, bumpy skin for a smooth canvas finish.

    Directions: Apply on concerned areas with wide pores then proceed to base make-up.

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    Image of carton

  • INGREDIENTS AND APPEARANCE
    3CE PORE SILKY BALM 
    titanium dioxide powder
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:60764-014
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Titanium Dioxide (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) Titanium Dioxide0.12 g  in 25 g
    Inactive Ingredients
    Ingredient NameStrength
    Dimethicone (UNII: 92RU3N3Y1O)  
    Phenyl Trimethicone (UNII: DR0K5NOJ4R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:60764-014-021 in 1 CARTON08/10/2016
    1NDC:60764-014-0125 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 finalpart35208/10/2016
    Labeler - Nanda Co., Ltd (557816075)
    Registrant - Nanda Co., Ltd (557816075)
    Establishment
    NameAddressID/FEIBusiness Operations
    Nanda Co., Ltd557816075repack(60764-014)
    Establishment
    NameAddressID/FEIBusiness Operations
    Cosmax, Inc.689049693manufacture(60764-014)

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