Label: TOMATO WHITENING SERUM- 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 July 21, 2011

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  • ACTIVE INGREDIENT

    Active ingredient: DIMETHICONE

  • INACTIVE INGREDIENT

    Inactive ingredients:

    WATER, GLYCERETH-26, ISOHEXADECANE, ARBUTIN, SOLANUM LYCOPERSICUM (TOMATO) FRUIT/LEAF/STEM EXTRACT, ISOSTEARYL NEOPENTANOATE, DIETHOXYETHYL SUCCINATE, BIS-PEG-18 METHYL ETHER DIMETHYL SILANE, SODIUM ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER, POLYSORBATE 80, C14-22 ALCOHOLS, C12-20 ALKYL GLUCOSIDE, STEARIC ACID, HYDROGENATED LECITHIN, GLYCERYL STEARATE SE, CETEARYL ALCOHOL, PUNICA GRANATUM EXTRACT, HONEY EXTRACT, HYDROXYETHYL UREA, CHAENOMELES SINENSIS FRUIT EXTRACT, BUTYLENE GLYCOL, ALCOHOL DENAT., DIACETYL BOLDINE, ARGININE, CARBOMER, CAPRYLIC/CAPRIC TRIGLYCERIDE, DISODIUM EDTA, TOCOPHERYL ACETATE, METHYLPARABEN, PROPYLPARABEN, PHENOXYETHANOL, FRAGRANCE

  • PURPOSE

    Purpose:

    This combination of cosmetics 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
    TOMATO WHITENING SERUM 
    dimethicone cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76214-005
    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)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    C14-22 ALCOHOLS (UNII: B1K89384RJ)  
    C12-20 ALKYL GLUCOSIDE (UNII: K67N5Z1RUA)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    POMEGRANATE (UNII: 56687D1Z4D)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    HONEY (UNII: Y9H1V576FH)  
    HYDROXYETHYL UREA (UNII: MBQ7DDQ7AR)  
    CHAENOMELES SPECIOSA FRUIT (UNII: 6S5Q1Q537Z)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    ARGININE (UNII: 94ZLA3W45F)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:76214-005-0135 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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