Label: BIOWHITE RESILIENT MASSAGE- dimethicone 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 January 11, 2012

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

  • ACTIVE INGREDIENT

    Active ingredient: DIMETHICONE 4.50%

  • INACTIVE INGREDIENT

    Inactive ingredients:
    Water, Argania Spinosa Kernel Oil, Squalane, Simmondsia Chinensis (Jojoba) Seed Oil, Butyrospermum Parkii(Shea Butter), Beeswax, Cethyl Ethylhexanoate (CEH), Olea Europaea (Olive) Fruit Oil, Butylene Glycol, Macadamis Ternifolia Seed Oil, Glycerin, Limnanthes Alba (Meadowfoam) Seed Oil, Hydrolyzed Pea Protein, Lecithin, Phytosterols, Stearyl Alcohol, Polysorbate 60, Hydrogenated Coconut Oil, Tocopheryl Acetate, Aloe Barbadensis Leaf Juice Powder, Glyceryl Stearate, Glycine Soja (Soybean) Oil, Stearic Acid, Bisabolol, Triethanolamine, Sorbitan Sesquiolate, Phenoxyethanol, Carbomer, Rosmarinus Officinalis (Rosemary) Leaf Extract, Sericin, Aesculus Hippocastanum (Horse Chestnut) Seed Extract, Methyl Paraben, Chaenomeles Sinensis Fruit Extract, Allantoin, Ceramide3, Hydrogenated Lecithin, Caprylic/Capric Triglyceride, Disodium EDTA, Xanthan Gum, Tourmaline, Aluminum Silicate, Topaz, Amethyst Powder, Zeolite, Sodium Hyaluronate, Sea Water, Butylated Hydroxytoluene(BHT), Flavor

  • PURPOSE

    Purpose: Skin Protectant

  • 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 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 evening after washing face.

  • DOSAGE & ADMINISTRATION

    Dosage and administration:
    Apply after washing face.
    Take a small amount of cream  about 1.0g-1.5g onto the fingertips and gently massage over the entire face.(cheeks, nostrils, mouth corners, forehead, and the around of eyes, even your hands)
    Blot face lightly with tissue, and may sleep without washing it.

  • PRINCIPAL DISPLAY PANEL

    Image of carton

  • INGREDIENTS AND APPEARANCE
    BIOWHITE RESILIENT MASSAGE 
    dimethicone cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:44781-210
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE4.27 g  in 95 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ARGAN OIL (UNII: 4V59G5UW9X)  
    SQUALANE (UNII: GW89575KF9)  
    JOJOBA OIL (UNII: 724GKU717M)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    YELLOW WAX (UNII: 2ZA36H0S2V)  
    OLIVE OIL (UNII: 6UYK2W1W1E)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    MEADOWFOAM SEED OIL (UNII: 412ZHA4T4Y)  
    LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
    STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
    POLYSORBATE 60 (UNII: CAL22UVI4M)  
    HYDROGENATED COCONUT OIL (UNII: JY81OXM1OM)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    SOYBEAN OIL (UNII: 241ATL177A)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:44781-210-0195 g in 1 CARTON
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34704/01/2011
    Labeler - ZION SYNTHETIC FIBER CO., LTD. (688011147)
    Registrant - ZION SYNTHETIC FIBER CO., LTD. (688011147)
    Establishment
    NameAddressID/FEIBusiness Operations
    ZION SYNTHETIC FIBER CO., LTD.688011147manufacture