Label: FRESH JUICE C WHITENING CARE- 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 September 22, 2011

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  • ACTIVE INGREDIENT

    Active ingredient: DIMETHICONE 1%

  • INACTIVE INGREDIENT

    Inactive ingredients:
    WATER, BUTYLENE GLYCOL, ALCOHOL DENAT., ARBUTIN, HONEY EXTRACT, DIETHOXYETHYL SUCCINATE, BIS-PEG-18 METHYL ETHER DIMETHYL SILANE, ISOSTEARYL NEOPENTANOATE, LACTOBACILLUS FERMENT LYSATE FILTRATE, NIACINAMIDE, AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER , ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER, TRIETHANOLAMINE, HYDROGENATED LECITHIN, ACTINIDIA CHINENSIS (KIWI) FRUIT EXTRACT, CITRUS AURANTIUM DULCIS (ORANGE) FRUIT EXTRACT, CITRUS MEDICA LIMONUM (LEMON) FRUIT EXTRACT, FRAGARIA VESCA (STRAWBERRY) FRUIT EXTRACT, GLYCYRRHIZA GLABRA (LICORICE) ROOT EXTRACT, DISODIUM EDTA, CETEARYL ALCOHOL, GLYCOL STEARATE SE, STEARIC ACID, ASCORBYL TETRAISOPALMITATE, PEG-5 RAPESEED STEROL, PENTYLENE GLYCOL, ASPERGILLUS/SACCHAROMYCES/RICE FERMENT FILTRATE, BENZOPHENONE-5, CUCURBITA PEPO (PUMPKIN) SEED EXTRACT, PEG-150, LIMNANTHES ALBA (MEADOWFOAM) SEED OIL, RETINYL PALMITATE, TOCOPHERYL ACETATE, PEG-40 HYDROGENATED CASTOR OIL, PPG-26-BUTETH-26, BHT, METHYLPARABEN, PROPYLPARABEN, PHENOXYETHANOL, FRAGRANCE

  • PURPOSE

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

  • INGREDIENTS AND APPEARANCE
    FRESH JUICE C  WHITENING CARE
    dimethicone cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76214-023
    Route of AdministrationCUTANEOUS
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE0.5 g  in 50 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    ARBUTIN (UNII: C5INA23HXF)  
    HONEY (UNII: Y9H1V576FH)  
    NIACINAMIDE (UNII: 25X51I8RD4)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N)  
    KIWI FRUIT (UNII: 71ES77LGJC)  
    ORANGE (UNII: 5EVU04N5QU)  
    LEMON (UNII: 24RS0A988O)  
    GLYCYRRHIZA GLABRA (UNII: 2788Z9758H)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    POLYETHYLENE GLYCOL 7000 (UNII: Q0JET65GEL)  
    PENTYLENE GLYCOL (UNII: 50C1307PZG)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    PUMPKIN SEED (UNII: GH30P1VXK2)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    MEADOWFOAM SEED OIL (UNII: 412ZHA4T4Y)  
    VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
    POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:76214-023-0150 g in 1 BOTTLE
    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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