Label: SOOSUL WHITENING SLEEPING PACK- 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 1.20%

  • INACTIVE INGREDIENT

    Inactive Ingredients:
    WATER, BUTYLENE GLYCOL, GLYCERIN, CETYL ETHYLHEXANOATE, PHELLINUS LINTEUS EXTRACT, NIACINAMIDE, POLYGLYCERYL-3 METHYLGLUCOSE DISTEARATE, CYCLOMETHICONE, POLYSORBATE 20, CYCLOPENTASILOXANE, DIMETHICONOL, DIMETHICONE / VINYL DIMETHICONE CROSSPOLYMER, ALOE BARBADENSIS LEAF JUICE, SODIUM HYALURONATE, BETA-GLUCAN, LUFFA CYLINDRICA FRUIT EXTRACT, MORUS ALBA BARK EXTRACT, GLYCYRRHIZA GLABRA (LICORICE) ROOT EXTRACT, ZANTHOXYLUM PIPERITUM FRUIT EXTRACT, PULSATILLA KOREANA EXTRACT, USNEA BARBATA (LICHEN) EXTRACT, TRIETHANOLAMINE, CARBOMER, SILICA, AMMONIUM ACRYLOYLDIMETHYLTAURATE/ VP COPOLYMER, FRAGRANCE, DISODIUM EDTA

  • 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:
    An intensive whitening mask formulated with organic Sang-hwang mushroom extracts, plant placenta and collagen extracts, arbutin etc. It suppresses melanin formation and prevent hyper-pigmentation while nourishing and hydrating skin while you are sleeping, leaving skin moist, soft resulting in balanced skin tone the next morning.
    - Paraben free and contains 3% of organic mushroom by Supercritical fluid extract method.

  • How to use

    How to use: After cleansing and toning at night, apply generously on face and neck. Gently massage until being absorbed, leave it on at least 30 minutes before going to bed and wash off in the morning. 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 WHITENING SLEEPING PACK 
    dimethicone cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69351-030
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE1.44 g  in 120 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69351-030-01120 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(69351-030)