Label: AGAVE CACTUS HYDRATING- 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 22, 2011

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  • ACTIVE INGREDIENT

    Active ingredient: DIMETHICONE

  • INACTIVE INGREDIENT

    Inactive ingredients:

    WATER, AGAVE TEQUILANA LEAF EXTRACT, CYCLOPENTASILOXANE, GLYCERIN, ALCOHOL DENAT., CETYL ETHYLHEXANOATE, CYCLOHEXASILOXANE, PROPYLENE GLYCOL, ARBUTIN,  MINERAL OIL, BUTYLENE GLYCOL, CEREUS GRANDIFLORUS (CACTUS) FLOWER EXTRACT, CETEARYL ALCOHOL, GLYCERYL STEARATE, PEG-100 STEARATE, BEHENYL ALCOHOL, ADENOSINE, DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER, LACTOBACILLUS FERMENT LYSATE FILTRATE, OPUNTIA FICUS-INDICA STEM EXTRACT, POLYACRYLAMIDE, C13-14 ISOPARAFFIN, MAACKIA FAURIEI STEM EXTRACT, PALMITOYL OLIGOPEPTIDE, STEARETH-2, GLYCERYL POLYMETHACRYLATE, POLYSORBATE 20, HYDROLYZED VIOLA TRICOLOR EXTRACT, PEG-5 RAPESEED STEROL, PALMITOYL PENTAPEPTIDE-4, CARBOMER, PALMITOYL TETRAPEPTIDE-7, LAURETH-7, TOCOPHERYL ACETATE, XANTHAN GUM, LECITHIN, DISODIUM EDTA, TRIETHANOLAMINE, HYDROGENATED LECITHIN, CHOLESTEROL, DIPOTASSIUM GLYCYRRHIZATE, METHYLPARABEN, PROPYLPARABEN, PHENOXYETHANOL, FRAGRANCE

  • PURPOSE

    Purpose:

    This combination of cosmetics is used for your basic skin care and gives a benefit for 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 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 carton

  • INGREDIENTS AND APPEARANCE
    AGAVE CACTUS  HYDRATING
    dimethicone cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76214-006
    Route of AdministrationCUTANEOUS
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE0.9 g  in 45 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    AGAVE TEQUILANA LEAF (UNII: 05545M0E3M)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    CETYL ETHYLHEXANOATE (UNII: 134647WMX4)  
    CYCLOMETHICONE 6 (UNII: XHK3U310BA)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    ARBUTIN (UNII: C5INA23HXF)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    DOCOSANOL (UNII: 9G1OE216XY)  
    LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
    OPUNTIA FICUS-INDICA STEM (UNII: MUD8892KHL)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    C13-14 ISOPARAFFIN (UNII: E4F12ROE70)  
    MAACKIA FLORIBUNDA STEM (UNII: 84UXW52K8Y)  
    PALMITOYL OLIGOPEPTIDE (UNII: HO4ZT5S86C)  
    STEARETH-2 (UNII: V56DFE46J5)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    PALMITOYL PENTAPEPTIDE-4 (UNII: KK181SM5JG)  
    PALMITOYL TETRAPEPTIDE-7 (UNII: Q41S464P1R)  
    LAURETH-7 (UNII: Z95S6G8201)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    ADENOSINE (UNII: K72T3FS567)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N)  
    CHOLESTEROL (UNII: 97C5T2UQ7J)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:76214-006-0145 g 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