Label: OMIJA WHITENING- 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 22, 2011

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  • ACTIVE INGREDIENT

    Active ingredient: DIMETHICONE

  • INACTIVE INGREDIENT

    Inactive ingredients:

    WATER, SCHIZANDRA CHINENSIS FRUIT EXTRACT, CYCLOPENTASILOXANE, BUTYLENE GLYCOL, BIOSACCHARIDE GUM-1, PEG-10 DIMETHICONE, NIACINAMIDE, ISOTRIDECYL ISONONANOATE, SODIUM CHLORIDE, LACTOBACILLUS FERMENT LYSATE FILTRATE, SALIX NIGRA (WILLOW) BARK EXTRACT, SODIUM HYALURONATE, CAPRYLIC/CAPRIC TRIGLYCERIDE, DIACETYL BOLDINE, MAACKIA FAURIEI STEM EXTRACT, POLYSILICONE-11, SODIUM CITRATE, TOCOPHERYL ACETATE, SORBITOL, PROPYLENE GLYCOL, CHAMOMILLA RECUTITA (MATRICARIA) FLOWER EXTRACT, DISODIUM EDTA, CITRIC ACID, HYDROGENATED LECITHIN, SUCROSE LAURATE, ASCORBYL TETRAISOPALMITATE, ALCOHOL DENAT., MORUS ALBA ROOT EXTRACT, GLYCYRRHIZA GLABRA (LICORICE) ROOT EXTRACT, LYSOLECITHIN, CERAMIDE 3, SODIUM ASCORBYL PHOSPHATE, METHYLPARABEN, PHENOXYETHANOL, FRAGRANCE

  • PURPOSE

    Purpose:

    This combination of cosmetics 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 carton

  • INGREDIENTS AND APPEARANCE
    OMIJA WHITENING 
    dimethicone cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76214-007
    Route of AdministrationCUTANEOUS
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE2 g  in 50 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    SCHISANDRA CHINENSIS FRUIT (UNII: ABS794681C)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    BIOSACCHARIDE GUM-1 (UNII: BB4PU4V09H)  
    NIACINAMIDE (UNII: 25X51I8RD4)  
    ISOTRIDECYL ISONONANOATE (UNII: WEF51750MT)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    SALIX NIGRA BARK (UNII: QU52J3A5B3)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    MAACKIA FLORIBUNDA STEM (UNII: 84UXW52K8Y)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    SORBITOL (UNII: 506T60A25R)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    CHAMOMILE (UNII: FGL3685T2X)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N)  
    SUCROSE LAURATE (UNII: 05Q7CD0E49)  
    MORUS ALBA ROOT (UNII: CST1G9BZGD)  
    GLYCYRRHIZA GLABRA (UNII: 2788Z9758H)  
    CERAMIDE 3 (UNII: 4370DF050B)  
    SODIUM ASCORBYL PHOSPHATE (UNII: 836SJG51DR)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:76214-007-0150 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
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