Label: 3CE FULL COVER CONCEALER 001- titanium dioxide liquid

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated October 12, 2016

If you are a consumer or patient please visit this version.

  • ACTIVE INGREDIENT

    Active Ingredient: Titanium Dioxide 13.0%

  • INACTIVE INGREDIENT

    Inactive Ingredients: Water, Cyclopentasiloxane, Methyl Methacrylate Crosspolymer, Butylene Glycol, CetylEthylhexanoate, Triethylhexanoin, Mica (CI 77019), Cetyl PEG/PPG-10/1 Dimethicone, Trimethylsiloxysilicate, Iron Oxides (CI 77492), DisteardimoniumHectorite, Dicaprylyl Carbonate, Beeswax, Polyglyceryl-4 Isostearate, Magnesium Sulfate, SorbitanIsostearate, Dimethicone/Vinyl DimethiconeCrosspolymer, Iron Oxides (CI 77491), Triethoxycaprylylsilane, Aluminum Hydroxide, Methylparaben, Chlorphenesin, Iron Oxides (CI 77499), Silica, Propylparaben, Disodium EDTA, Aloe Barbadensis Leaf Juice, PolyvinylalcoholCrosspolymer, Sodium Hyaluronate, GlycyrrhizaGlabra (Licorice) Root Extract, Natto Gum, Nylon-12 Fluorescent Brightener 230 Salt, Potassium Sorbate, Sodium Benzoate

  • 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 stick type concealer with sleek ends can be used on a variety of areas from narrow to wide areas on face.

    Directions: Apply on concerned area with rednesses, dark spot areas to brighten up.

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    Image of carton

  • INGREDIENTS AND APPEARANCE
    3CE FULL COVER CONCEALER 001 
    titanium dioxide liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:60764-098
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Titanium Dioxide (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) Titanium Dioxide0.65 g  in 5 mL
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    Butylene Glycol (UNII: 3XUS85K0RA)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:60764-098-021 in 1 CARTON08/20/2016
    1NDC:60764-098-015 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35208/20/2016
    Labeler - Nanda Co., Ltd (557816075)
    Registrant - Nanda Co., Ltd (557816075)
    Establishment
    NameAddressID/FEIBusiness Operations
    Nanda Co., Ltd557816075repack(60764-098)
    Establishment
    NameAddressID/FEIBusiness Operations
    Cosmax, Inc.689049693manufacture(60764-098)