Label: SPA MYSTIQUE SKIN RELIEF OATMEAL DAILY MOISTURIZING- dimethicone lotion

  • 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 August 4, 2014

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  • SPA MYSTIQUE SKIN RELIEF OATMEAL DAILY MOISTURIZING LOTION


  • Active Ingredient

    Dimethicone.............1.3%

  • Purpose

    Skin protectant

  • Use

    Help prevent and temporarily protects chafed, chapped, or cracked skin.

  • Warnings

    For external use only.

    When using this product

    avoid contact with eyes.  In case of eye contact, flush with water.

    Stop use and ask a doctor if

    condition worsens.  Symptoms last more than 7 days or clear up and occur again within a few days.

    Keep out of reach of children.

    If swallowed, get medical help or contact a Poison Control Center immediately.

  • Directions

    apply liberally as often as needed.

  • Other information

    Store at room temperature.

  • Inactive ingredients

    Water, Paraffinum Liquidum, Isopropyl Myristate, Glycerin, Glyceryl Stearate, Propylene Glycol, PEG-100 Stearate, Polyacrylamide, Cetyl Alcohol, Fragrance, DMDM Hydantoin, STearyl Alcohol, C13-14 Isoparaffin, Laureth-7, Disodium EDTA, Methylparaben, Propylparaben, Avena Sativa Kernel Extract.

  • PRINCIPAL DISPLAY PANEL

    SPA MYSTIQUE  Skin Relief Oatmeal Daily Moisturizing Lotion  dimethicone skin protectant with soothing oat essence  To protect and Relieve Dry Skin  8 fl. oz (235 mL)    MADE IN CHINA   Spa Mystique Vernon, CA 90058 USA   Spa Mystique is a trademark of Volume Brands International   Vist VolumeBrandIint.com

  • SPA MYSTIQUE SKIN RELIEF OATMEAL DAILY MOISTURIZING LOTION 8OZ/235ml (50523-100-08)

    Oatmeal Lotion

  • INGREDIENTS AND APPEARANCE
    SPA MYSTIQUE SKIN RELIEF OATMEAL DAILY MOISTURIZING 
    dimethicone lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50523-100
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE13 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    POLYQUATERNIUM-7 (70/30 ACRYLAMIDE/DADMAC; 1600000 MW) (UNII: 0L414VCS5Y)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    DMDM HYDANTOIN (UNII: BYR0546TOW)  
    STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
    C13-14 ISOPARAFFIN (UNII: E4F12ROE70)  
    LAURETH-7 (UNII: Z95S6G8201)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    OAT (UNII: Z6J799EAJK)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50523-100-081 in 1 CARTON
    1235 mL in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34706/20/2012
    Labeler - Volume Distributors, Inc. (002029544)
    Establishment
    NameAddressID/FEIBusiness Operations
    Ningbo Pulisi Daily Chemical Products Co.,Ltd.529047265manufacture(50523-100)
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