Label: AGAVE CACTUS SERUM- 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 21, 2011

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  • ACTIVE INGREDIENT

    Active ingredient: DIMETHICONE

  • INACTIVE INGREDIENT

    Inactive ingredients:

    WATER, AGAVE TEQUILANA LEAF EXTRACT, ALCOHOL DENAT., BUTYLENE GLYCOL, GLYCERETH-26, MACADAMIA TERNIFOLIA SEED OIL, ARBUTIN,  BIS-PEG-18 METHYL ETHER DIMETHYL SILANE, GLYCERIN, LACTOBACILLUS FERMENT LYSATE FILTRATE, ERYTHRITOL, OPUNTIA FICUS-INDICA STEM EXTRACT, ISOHEXADECANE, HONEY EXTRACT, CEREUS GRANDIFLORUS (CACTUS) FLOWER EXTRACT, PALMITOYL OLIGOPEPTIDE, PALMITOYL TETRAPEPTIDE-7, HYDROLYZED VIOLA TRICOLOR EXTRACT, BISABOLOL, PALMITOYL PENTAPEPTIDE-4, ADENOSINE, MAACKIA FAURIEI STEM EXTRACT, CHOLESTEROL, PROPYLENE GLYCOL, ISOSTEARYL NEOPENTANOATE, LECITHIN, POLYSORBATE 20, TRIETHANOLAMINE, CARBOMER, ALLANTOIN, DISODIUM EDTA, HYDROGENATED LECITHIN,GLYCERYL POLYMETHACRYLATE, XANTHAN GUM, DIPOTASSIUM GLYCYRRHIZATE, TOCOPHERYL ACETATE, PHENOXYETHANOL, METHYLPARABEN, FRAGRANCE

  • PURPOSE

    Purpose:

    This combination of cosmetics is used for your basic skin care and gives a benefit for skin Anti-Wrinkle and 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
    AGAVE CACTUS SERUM 
    dimethicone cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76214-003
    Route of AdministrationCUTANEOUS
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE0.45 mL  in 45 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    AGAVE TEQUILANA LEAF (UNII: 05545M0E3M)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    GLYCERETH-26 (UNII: NNE56F2N14)  
    MACADAMIA OIL (UNII: 515610SU8C)  
    ARBUTIN (UNII: C5INA23HXF)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ERYTHRITOL (UNII: RA96B954X6)  
    HONEY (UNII: Y9H1V576FH)  
    OPUNTIA FICUS-INDICA STEM (UNII: MUD8892KHL)  
    ISOHEXADECANE (UNII: 918X1OUF1E)  
    MAACKIA FLORIBUNDA STEM (UNII: 84UXW52K8Y)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    ALLANTOIN (UNII: 344S277G0Z)  
    PALMITOYL OLIGOPEPTIDE (UNII: HO4ZT5S86C)  
    LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
    PALMITOYL TETRAPEPTIDE-7 (UNII: Q41S464P1R)  
    PALMITOYL PENTAPEPTIDE-4 (UNII: KK181SM5JG)  
    ADENOSINE (UNII: K72T3FS567)  
    HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    CHOLESTEROL (UNII: 97C5T2UQ7J)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:76214-003-0145 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