Label: FRESH JUICE E SERUM WRINKLE 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 5.3%

  • INACTIVE INGREDIENT

    Inactive ingredients:
    WATER, CYCLOPENTASILOXANE, BUTYLENE GLYCOL, ALCOHOL DENAT., DIPROPYLENE GLYCOL, GLYCERIN, TRISILOXANE, DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER, PEG-10 DIMETHICONE, TOCOPHERYL ACETATE, MACADAMIA TERNIFOLIA SEED OIL, SODIUM CHLORIDE, ASPARAGUS OFFICINALIS STEM EXTRACT, BRASSICA OLERACEA ITALICA (BROCCOLI) EXTRACT, SIMMONDSIA CHINENSIS (JOJOBA) SEED OIL, MEDICAGO SATIVA (ALFALFA) EXTRACT, PEG/PPG-17/6 COPOLYMER, SPINACIA OLERACEA (SPINACH) LEAF EXTRACT, DISTEARDIMONIUM HECTORITE, PEG/PPG-18/18 DIMETHICONE, PERSEA GRATISSIMA (AVOCADO) OIL, LECITHIN, PEG-150, PENTYLENE GLYCOL, POLYSORBATE 20, BENZOPHENONE-5, BHT, ADENOSINE, ASCORBYL TETRAISOPALMITATE, CARBOMER, HYDROGENATED LECITHIN, DISODIUM EDTA, LIMNANTHES ALBA (MEADOWFOAM) SEED OIL, PALMITOYL PENTAPEPTIDE-4, PEG-5 RAPESEED STEROL, RETINYL PALMITATE, PALMITOYL OLIGOPEPTIDE, PALMITOYL TETRAPEPTIDE-7, 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 bottle

  • INGREDIENTS AND APPEARANCE
    FRESH JUICE E SERUM  WRINKLE CARE
    dimethicone cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76214-024
    Route of AdministrationCUTANEOUS
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE2.65 mL  in 50 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    DIPROPYLENE GLYCOL (UNII: E107L85C40)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    TRISILOXANE (UNII: 9G1ZW13R0G)  
    MACADAMIA OIL (UNII: 515610SU8C)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    ASPARAGUS (UNII: Z1EJP3037Z)  
    BROCCOLI (UNII: UOI4FT57BZ)  
    ALFALFA SEED (UNII: 67PHZ58858)  
    SPINACH (UNII: 6WO75C6WVB)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    AVOCADO OIL (UNII: 6VNO72PFC1)  
    LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
    POLYETHYLENE GLYCOL 7000 (UNII: Q0JET65GEL)  
    PENTYLENE GLYCOL (UNII: 50C1307PZG)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    ADENOSINE (UNII: K72T3FS567)  
    HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    MEADOWFOAM SEED OIL (UNII: 412ZHA4T4Y)  
    PALMITOYL PENTAPEPTIDE-4 (UNII: KK181SM5JG)  
    PALMITOYL OLIGOPEPTIDE (UNII: HO4ZT5S86C)  
    PALMITOYL TETRAPEPTIDE-7 (UNII: Q41S464P1R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:76214-024-0150 mL 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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