Label: ESOPINIO FRESH AND CLEAR FOUNDATION SPF20- titanium dioxide cream

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph 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 August 29, 2011

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

  • ACTIVE INGREDIENT

    Active ingredient: TITANIUM DIOXIDE

  • INACTIVE INGREDIENT

    Inactive ingredients:

    Water, Cyclomethicone, Butylene Glycol, Dimethicone, Cetyl PEG/PPG-10/1 Dimethicone, Cyclomethicone/Dimethicone Crosspolymer, Butylene Glycol Dicaprylate/Dicaprate, Glycerin, Carbomer, Polysorbate 20, Palmitoyl Pentapeptide-4, Polyglyceryl-4-Isostearate, Silica, Ethylhexyl Methoxycinnamate, Micronized Titanium Dioxide Aluminum Hydroxide Stearic Acid, Sodium Chloride, Portulaca Oleracea Extract, Zinc Stearate, Betaine, Silica Dimethyl Silylate, Iron Oxide, Butyl Paraben, Methyl Paraben, Tocopheryl Acetate, Allantoin, Flavor, Anthemis Nobilis Flower Extract, Punica Granatum Extract, Vitis Vinifera(Grape) Seed Extract, Hematite Extract, Aluminum Silicate, Topaz, Amethyst Powder, Zeolite

  • PURPOSE

    Purpose: It protects the skin from UV rays, pollution and dust.

  • WARNINGS

    Warnings:
    In case of having following symptoms after using this, you're advised to stop using it immediately.  If you keep using it,  the  symptoms will get worse and need to consult a dermatologist.
    - In case of having problems such as red rash, swollenness, itching, stimulation during usage.
    - In case of having the same symptoms above on the part you put this product on by direct sunlight.
    You are banned to use it on the part where you have a scar, eczema, or dermatitis.
    In case of getting it into your eyes, you have to wash it immediately.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children:

    Keep out of the reach of babies and children.

  • INDICATIONS & USAGE

    Indications and usage:
    Tighten the lid after using it.
    Don't keep it in the place where the temperature is extremely hot or low and exposed the direct sunlight.
    Use it at the time before you're going out after applying the Animating Water Cream.

  • DOSAGE & ADMINISTRATION

    Dosage and administration:
    Take up about  0.3g - 0.5g of it  and smooth over the entire face.

  • PRINCIPAL DISPLAY PANEL

    Image of carton
  • INGREDIENTS AND APPEARANCE
    ESOPINIO FRESH AND CLEAR FOUNDATION  SPF20
    titanium dioxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:44781-140
    Route of AdministrationCUTANEOUS
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM - UNII:D1JT611TNE) TITANIUM DIOXIDE3.5 g  in 35 g
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    Cyclomethicone (UNII: NMQ347994Z)  
    Butylene Glycol (UNII: 3XUS85K0RA)  
    Dimethicone (UNII: 92RU3N3Y1O)  
    Glycerin (UNII: PDC6A3C0OX)  
    CARBOMER 934 (UNII: Z135WT9208)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    OCTINOXATE (UNII: 4Y5P7MUD51)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    ZINC STEARATE (UNII: H92E6QA4FV)  
    BETAINE (UNII: 3SCV180C9W)  
    BUTYLPARABEN (UNII: 3QPI1U3FV8)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    ALLANTOIN (UNII: 344S277G0Z)  
    CHAMAEMELUM NOBILE (UNII: 7NF3GE7IWR)  
    WINE GRAPE (UNII: 3GOV20705G)  
    ALUMINUM SILICATE (UNII: T1FAD4SS2M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:44781-140-0135 g in 1 CARTON
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35204/01/2010
    Labeler - ZION SYNTHETIC FIBER CO., LTD. (688011147)
    Registrant - ZION SYNTHETIC FIBER CO., LTD. (688011147)
    Establishment
    NameAddressID/FEIBusiness Operations
    ZION SYNTHETIC FIBER CO., LTD.688011147manufacture