Label: SOOSUL GINSENG- 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 November 27, 2014

If you are a consumer or patient please visit this version.

  • ACTIVE INGREDIENT

    Active Ingredient: DIMETHICONE 2.00%

  • INACTIVE INGREDIENT

    Inactive Ingredients:
    WATER, PHELLINUS LINTEUS EXTRACT, BUTYLENE GLYCOL, GLYCERIN, NEOPENTYL GLYCOL DIHEPTANOATE, MACADAMIA TERNIFOLIA SEED OIL, OCTYLDODECYL MYRISTATE, GLYCERYL POLYACRYLATE, BEESWAX, ISOHEXADECANE, BETAINE, CETEARYL ALCOHOL, GLYCOL STEARATE SE, POLYGLYCERYL-3 METHYLGLUCOSE, SQUALANE, STEARIC ACID, GLYCERYL STEARATE SE, HYDROGENATED LECITHIN, ALCOHOL, CHAMOMILLA RECUTITA (MATRICARIA), CUCUMIS SATIVUS(CUCUMBER), METHYLPARABEN, PINUS SYLVESTRIS BUD EXTRACT, SODIUM ACRYLATES COPOLYMER, SODIUM HYALURONATE, BUTYLPARABEN, CHLORPHENESIN, HELIANTHUS ANNUUS(SUNFLOWER) SEED OIL, HYDROGENATED POLYISOBUTENE, PHOSPHOLIPIDS, POLYGLYCERYL-10 STEARATE, ALLANTOIN, DISODIUM EDTA, TOCOPHERYL ACETATE, PHASEOLUS RADIATUS SEED EXTRACT, ANGELICA ACUTILOBA ROOT EXTRACT, BLETILLA STRIATA ROOT EXTRACT, TRICHOSANTHES KIRILOWII ROOT EXTRACT, POGOSTEMON CABLIN LEAF EXTRAC, CIMICIFUGA RACEMOSA ROOT EXTRACT, PAEONIA ALBIFLORA ROOT EXTRACT, RUBUS IDAEUS(RASPBERRY) FRUIT EXTRACT, ASTRAGALUS MEMBRANACEUS ROOT EXTRACT, FRAGRANCE, CALENDULA OFFICINALIS FLOWER EXTRACT

  • PURPOSE

    PURPOSE: SKIN PROTECTANT

  • Caution

    Caution: Discontinue use if skin irritation develops. Use only as directed. Store in a cool dark place, avoid high temperatures and exposure to strong sunlight. Keep out of reach of children and babies.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children and babies.

  • Indications

    Indications:
    Contains 15% of highly concentrated Sang-hwang mushroom extract, Korean Ginseng and various natural medicinal herbs, this nutrient-rich luxurious cream moisturizes, nourishes and calms your skin from within. It helps to erase the freckle, smoothen fine lines and revitalize youthfulness, promoting healthy looking skin and leaving it soft and supple.

  • How to use

    How to use: Apply appropriate amount on face and neck day and/or night. Gently massage from chin to forehead for better absorption. For optimal result, complete your skincare routine only with the Soosul Skincare products.

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    Image of carton

  • INGREDIENTS AND APPEARANCE
    SOOSUL GINSENG 
    dimethicone cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69351-020
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE1.2 g  in 60 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69351-020-0160 g in 1 CARTON
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34710/01/2014
    Labeler - Sang Hwang Mi-in Co., Ltd. (688396508)
    Registrant - Sang Hwang Mi-in Co., Ltd. (688396508)
    Establishment
    NameAddressID/FEIBusiness Operations
    Sang Hwang Mi-in Co., Ltd.688396508manufacture(69351-020)