Label: BIOWHITE BRIGHTENING ESSENCE- dimethicone 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 April 22, 2011

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  • ACTIVE INGREDIENT

    Active Ingredient: DIMETHICONE

  • INACTIVE INGREDIENT

    Inactive Ingredients:
    Water, Diglycerin, Caprylic Capric Triglyceride, Palmitoyl Pentapeptide-4, C12-15 Alkyl Benzoate, Butylene Glycol, Cetearyl Olivate, Sorbitan Olivate, Propylene Glycol Dicaprylate Dicaprate, Morus Alba Root Extract, Lactoferrin, Glycerin, Tocopheryl Acetate, Beeswax, Glyceryl Stearate, Cetyl Alcohol, Limnanthes Alba (Meadowfoam)Seed Oil, Cyclomethicone, Hydrogenated Lecithin, Alpha-Bisabolol, Sodium Hyaluronate, Lauryl Laurate, Ubiquinone, Polysorbate 20, Sodium Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Betula Alba Juice, Portulaca Oleracea extract, Calendula Officinalis Flower Extact, Punica Granatum Fruit Extract, Angelica Keiskei Leaf/Stem Extract, Solanum Lycopersicum (Tomato) Fruit Extract, Polygonum Multiflorum Root Extract, Solanum Tuberosum (Potato) Pulp Extract, Artemisia Vulgaris Extract, Vigna Radiata Seed Extract, Gingko Biloba Leaf Extract, Chamomilla Recutita (Matricaria) Flower Extract,
    Hematite Extract, Aluminum Silicate, Topaz, Amethyst Powder, Zeolite, Isononyl Isononanoate, Triethanolamine, Allantoin, Carbomer, Dipotassium Glycyrrhizate, Disodium EDTA, Xanthan Gum, Methyl Paraben, Phenoxyethanol, Flavor

  • PURPOSE

    Purpose:
    It prevents skin's spots, blemishes, freckles, and thus, it effects to make skin whitening and brightening.

  • 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

    Indication 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 to the direct sunlight.
    Use it in the morning and evening, after using first Skin Softner and Essential Lotion.

  • DOSAGE & ADMINISTRATION

    Dosage and administration:
    Take up about 0.5g - 1.0g of it, and smooth over the entire face.

  • PRINCIPAL DISPLAY PANEL

    Image of carton

  • INGREDIENTS AND APPEARANCE
    BIOWHITE BRIGHTENING  ESSENCE
    dimethicone cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:44781-160
    Route of AdministrationCUTANEOUS
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE0.5 mL  in 50 mL
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    Butylene Glycol (UNII: 3XUS85K0RA)  
    Glycerin (UNII: PDC6A3C0OX)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    Cetyl Alcohol (UNII: 936JST6JCN)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:44781-160-0150 mL in 1 CARTON
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34704/01/2010
    Labeler - ZION SYNTHETIC FIBER CO., LTD. (688011147)
    Registrant - ZION SYNTHETIC FIBER CO., LTD. (688011147)
    Establishment
    NameAddressID/FEIBusiness Operations
    ZION SYNTHETIC FIBER CO., LTD.688011147manufacture