Label: WHITENING MILK AND GREEN TEA SERUM FOR MEN- 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 September 20, 2011

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  • ACTIVE INGREDIENT

    Active ingredient: DIMETHICONE 1%

  • INACTIVE INGREDIENT

    Inactive ingredients:
    WATER, GLYCERETH-26, ISOHEXADECANE, ARBUTIN, ISOSTEARYL NEOPENTANOATE, DIETHOXYETHYL SUCCINATE, BIS-PEG-18 METHYL ETHER DIMETHYL SILANE, MILK PROTEIN, C14-22 ALCOHOLS, C12-20 ALKYL GLUCOSIDE, POLYSORBATE 80, SODIUM ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER, GLYCERYL STEARATE, CETEARYL ALCOHOL, TOCOPHERYL ACETATE, STEARIC ACID, DIPROPYLENE GLYCOL, HYDROGENATED LECITHIN, HONEY EXTRACT, HODROXYETHYL UREA, DIACETYL BOLDINE, CAPRYLIC/CAPRIC,  TRIGLYCERIDE, CAMELLIA SINENSIS LEAF EXTRACT, BUTYLENE GLYCOL, ALCOHOL DENAT., ARGININE, CARBOMER, DISODIUM EDTA, METHYLPARABEN, PROPYLPARABEN, PHENOXYETHANOL, FRAGRANCE

  • PURPOSE

    Purpose: This combination of cosmetics / OTC Drug is used for your basic skin care and gives a benefit for skin Brightening care.

  • WARNINGS

    Warnings:
    For external use only.
    Avoid contact with eyes.
    Discontinue use if signs of irritation appear.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children:
    Keep out of reach of children.

  • INDICATIONS & USAGE

    Indication and usage:
    Following toner, pour some on the palm of your hand and apply to skin gently. Press down lightly until absorbed.

  • DOSAGE & ADMINISTRATION

    Dosage and administration:
    Take appropriate amount according to your skin condition and apply every morning and night.

  • PRINCIPAL DISPLAY PANEL

    Image of carton

  • INGREDIENTS AND APPEARANCE
    WHITENING MILK AND GREEN TEA SERUM  FOR MEN
    dimethicone cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76214-020
    Route of AdministrationCUTANEOUS
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE0.35 mL  in 35 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    GLYCERETH-26 (UNII: NNE56F2N14)  
    ISOHEXADECANE (UNII: 918X1OUF1E)  
    ARBUTIN (UNII: C5INA23HXF)  
    C14-22 ALCOHOLS (UNII: B1K89384RJ)  
    C12-20 ALKYL GLUCOSIDE (UNII: K67N5Z1RUA)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    DIPROPYLENE GLYCOL (UNII: E107L85C40)  
    HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N)  
    HONEY (UNII: Y9H1V576FH)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    ARGININE (UNII: 94ZLA3W45F)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:76214-020-0135 mL in 1 CARTON
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34703/01/2011
    Labeler - SKINFOOD CO., LTD. (690324173)
    Registrant - SKINFOOD CO., LTD. (690324173)
    Establishment
    NameAddressID/FEIBusiness Operations
    SKINFOOD CO., LTD.690324173manufacture
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