Label: HYDROMARINE EXTREME- octinoxate 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 January 21, 2012

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  • Active Ingredient

    Octinoxate 7.5%

  • Description

    Light-texture day/night cream with marine collagen, hyaluronic acid and reaffermine that provides a natural level of hydration and all the nutrients required to keep your skin working perfectly.

    200ml. 6.8 Fl.Oz.


  • Warning

    TOPICAL USE

    PROFESSIONAL ONLY

  • Instructions for use

    After applying COLLAGEN HYDROMARINE EXTREME SERUM, rub the CREAM in gently until absorbed.

  • PRINCIPAL DISPLAY PANEL

    Hydromarine Extreme

  • INGREDIENTS AND APPEARANCE
    HYDROMARINE  EXTREME
    octinoxate cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:42248-110
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE15 mL  in 200 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALOE (UNII: V5VD430YW9)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    TRICHLOROETHANE (UNII: 113C650IR1)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    WATER (UNII: 059QF0KO0R)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    PEG-8 STEARATE (UNII: 2P9L47VI5E)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    SOYBEAN (UNII: L7HT8F1ZOD)  
    CHONDRUS CRISPUS (UNII: OQS23HUA1X)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    BRONOPOL (UNII: 6PU1E16C9W)  
    HYDROLYZED GLYCOSAMINOGLYCANS (BOVINE; 50000 MW) (UNII: 997385V0VV)  
    METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    COLLAGEN, SOLUBLE, FISH SKIN (UNII: 8JC99XGU4W)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:42248-110-01200 mL in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35208/15/2011
    Labeler - Zenith Medicosm SL (464239694)
    Registrant - Zenith Medicosm SL (464239694)
    Establishment
    NameAddressID/FEIBusiness Operations
    Zenith Medicosm SL464239694manufacture
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