Label: BIOWHITE BEAUTY SERUM- allantoin 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

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  • ACTIVE INGREDIENT

    Active ingredient: ALLANTOIN

  • INACTIVE INGREDIENT

    Inactive ingredients:

    Water, Alpha Bisabolol, Dimethicone, Morus Alba Root Extract, Portulaca Oleracea Extract, Lactoferrin, Butylene Glycol, Alcohol, Glycerin, Chaenomeles Sinensis Fruit Extract, Ubiquinone, Sodium Hyaluronate, Phenoxyethanol, Sodium Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Caprylic Capric Triglyceride, Carbomer, Tocopheryl Acetate, Dipotassium Glycyrrhizate, Triethanolamine, Methyl Paraben, PEG-60 Hydrogenated Castor Oil, Hydrogenated Lecithin, Isohexadecane, Polysorbate 80, Disodium EDTA, Hematite Extract, Aluminum Silicate, Topaz, Amethyst Powder, Zeolite, Flavor

  • PURPOSE

    Purpose:
    It inhibits tyrosinase related to the production of melanin so that it provides whitening effect and provides bright and soft skin while suppressing the adsorption of pollutants caused by the sebum secretion.
    It helps skin's natural function for a resilient and the supple texture.

  • 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 to the direct sunlight.
    Use it in the morning and evening after applying the Skin Softner.

  • DOSAGE & ADMINISTRATION

    Dosage and administration:
    Take up about 2 - 3 drops of it, and smooth over the entire face, in the morning and evening.

  • PRINCIPAL DISPLAY PANEL

    Image of carton

  • INGREDIENTS AND APPEARANCE
    BIOWHITE BEAUTY SERUM 
    allantoin cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:44781-130
    Route of AdministrationCUTANEOUS
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALLANTOIN (UNII: 344S277G0Z) (ALLANTOIN - UNII:344S277G0Z) ALLANTOIN0.2 g  in 40 g
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    LEVOMENOL (UNII: 24WE03BX2T)  
    Dimethicone (UNII: 92RU3N3Y1O)  
    MORUS ALBA POLLEN (UNII: 3I9T68187H)  
    Butylene Glycol (UNII: 3XUS85K0RA)  
    Alcohol (UNII: 3K9958V90M)  
    Glycerin (UNII: PDC6A3C0OX)  
    UBIDECARENONE (UNII: EJ27X76M46)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    Phenoxyethanol (UNII: HIE492ZZ3T)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    CARBOMER 934 (UNII: Z135WT9208)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    POLYOXYL 60 HYDROGENATED CASTOR OIL (UNII: 02NG325BQG)  
    Polysorbate 80 (UNII: 6OZP39ZG8H)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    Aluminum Silicate (UNII: T1FAD4SS2M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:44781-130-0140 g 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