Label: ESOPINIO SUN SHIELD PLUS SPF 35 PA- titanium dioxide cream

  • Category: HUMAN OTC DRUG LABEL

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 28, 2011

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  • ACTIVE INGREDIENT

    Active Ingredients: TITANIUM DIOXIDE, ZINC OXIDE

  • INACTIVE INGREDIENT

    Inactive ingredients:

    Water, Ethylhexyl Methoxycinnamate, Butylene Glycol, C12-15 Alkyl Benzoate, Cyclomethicone, Disteardimonium Hectorite, Glycerin, Cetyl PEG/PPG-10/1 Dimethicone,
    Butylene Glycol Dicaprylate/Dicaprate, Bis-Ethylhexyloxyphenol Methoxyphenyltriazine, 4-Methylbenzylidene Camphor, Betaine, Sodium Chloride, Polyglyceryl-4-Isostearate,
    Cetyl Dimethicone, Polymethyl Methacrylate, Dimethicone, Aluminum Hydroxide, Stearic Acid, Zinc Stearate, Portulaca Oleracea Extract, Methyl Paraben,
    Tocopheryl Acetate, Allantoin, Punica Granatum Fruit Extract, Solanum Lycopersicum (Tomato) Fruit Extract, Disodium EDTA, Aluminum Silicate,
    Zeolite, Topaz, Hematite Extract, Tourmaline, Flavor

  • PURPOSE

    Purpose:
    Protects your skin from Ultra-violet Rays.
    365 days with Esopinio Sun Shield Plus your skin will be safe.

  • 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 reach of 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.
    Please apply it an adequate quantity  evenly on face, throat, arms and legs at the last stage of basic makeup.
    Please apply it once again on your skin at the time when you're going out, sports activity, and any activities of outside.

  • DOSAGE & ADMINISTRATION

    Dosage and Administration:
    Take up about 1.2g - 1.5g of it and smooth over the entire face.

  • PRINCIPAL DISPLAY PANEL

    Image of carton

  • INGREDIENTS AND APPEARANCE
    ESOPINIO SUN SHIELD PLUS  SPF 35 PA
    titanium dioxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:44781-110
    Route of AdministrationCUTANEOUS
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM - UNII:D1JT611TNE) TITANIUM DIOXIDE2.55 mL  in 70 mL
    Zinc Oxide (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) Zinc Oxide1.4 mL  in 70 mL
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    OCTINOXATE (UNII: 4Y5P7MUD51)  
    Butylene Glycol (UNII: 3XUS85K0RA)  
    Cyclomethicone (UNII: NMQ347994Z)  
    Glycerin (UNII: PDC6A3C0OX)  
    Betaine (UNII: 3SCV180C9W)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    Dimethicone (UNII: 92RU3N3Y1O)  
    ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    ZINC STEARATE (UNII: H92E6QA4FV)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    ALLANTOIN (UNII: 344S277G0Z)  
    TOMATO (UNII: Z4KHF2C175)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    ALUMINUM SILICATE (UNII: T1FAD4SS2M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:44781-110-0170 mL 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