Label: PLATINUM GRAPE CELL EMULSION- 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 July 27, 2011

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

  • ACTIVE INGREDIENT

    Active ingredient: DIMETHICONE 1.385%

  • INACTIVE INGREDIENT

    Inactive ingredients:

    WATER, CYCLOPENTASILOXANE, BUTYLENE GLYCOL, CAPRYLIC/CAPRIC TRIGLYCERIDE, GLYCERIN, PROPYLENE GLYCOL, ARBUTIN,  GLYCERYL STEARATE CITRATE,
    VITIS VINIFERA (GRAPE) FRUIT CELL EXTRACT, POLYMETHYL METHACRYLATE, DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER, POLYVINYL ALCOHOL, SODIUM POLYACRYLATE, POLYSORBATE 20, ALCOHOL DENAT., PALMITOYL PENTAPEPTIDE-4, CELLULOSE GUM, TRIDECETH-6, LECITHIN, C13-14 ISOPARAFFIN, LAURETH-7, POLYACRYLAMIDE, ISOMALT, TOCOPHERYL ACETATE, ADENOSINE, PEG/PPG-18/18 DIMETHICONE, DISODIUM EDTA, CARBOMER, COLLOIDAL PLATINUM, ACETYL TYROSINE, ADENOSINE TRIPHOSPHATE, CERAMIDE 3, CHOLESTEROL, DIACETYL BOLDINE, GLYCINE SOJA (SOYBEAN) PROTEIN, GLYCYRRHIZA GLABRA (LICORICE) ROOT EXTRACT, HYDROGENATED LECITHIN, HYDROLYZED RICE PROTEIN, HYDROLYZED VEGETABLE PROTEIN, OXIDO REDUCTASES, PROLINE, 1,2-HEXANEDIOL, CAPRYLYL GLYCOL, XANTHAN GUM, PALMITOYL OLIGOPEPTIDE, PALMITOYL TETRAPEPTIDE-7, TRIPEPTIDE-29, PHENOXYETHANOL, METHYLPARABEN, PROPYLPARABEN, FRAGRANCE

  • PURPOSE

    Purpose:

    This combination of cosmetics is used for your basic skin care and gives a benefit for Skin-Brightening and Anti-Wrinkle Effects.

  • 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:

    After toner or serum application, dispense an ample amount into the palm and apply onto the face in gentle upward and outward motions.

  • 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
    PLATINUM GRAPE CELL EMULSION 
    dimethicone cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76214-008
    Route of AdministrationCUTANEOUS
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE1.8 mL  in 130 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    ARBUTIN (UNII: C5INA23HXF)  
    GLYCERYL STEARATE CITRATE (UNII: WH8T92A065)  
    WINE GRAPE (UNII: 3GOV20705G)  
    POLYVINYL ALCOHOL (UNII: 532B59J990)  
    SODIUM POLYACRYLATE (2500000 MW) (UNII: 05I15JNI2J)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PALMITOYL PENTAPEPTIDE-4 (UNII: KK181SM5JG)  
    CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    TRIDECETH-6 (UNII: 3T5PCR2H0C)  
    LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
    C13-14 ISOPARAFFIN (UNII: E4F12ROE70)  
    LAURETH-7 (UNII: Z95S6G8201)  
    ISOMALT (UNII: S870P55O2W)  
    ADENOSINE (UNII: K72T3FS567)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    ADENOSINE TRIPHOSPHATE (UNII: 8L70Q75FXE)  
    CERAMIDE 3 (UNII: 4370DF050B)  
    CHOLESTEROL (UNII: 97C5T2UQ7J)  
    GLYCYRRHIZA GLABRA (UNII: 2788Z9758H)  
    HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N)  
    PROLINE (UNII: 9DLQ4CIU6V)  
    1,2-HEXANEDIOL (UNII: TR046Y3K1G)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    PALMITOYL OLIGOPEPTIDE (UNII: HO4ZT5S86C)  
    PALMITOYL TETRAPEPTIDE-7 (UNII: Q41S464P1R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:76214-008-01130 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