HYDROMARINE EXTREME (OCTINOXATE) CREAM [ZENITH MEDICOSM SL]

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HYDROMARINE EXTREME (OCTINOXATE) CREAM [ZENITH MEDICOSM SL]
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NDC 42248-110-01
Set ID 08aa016c-53af-47dc-9dd7-c497ea62b587
Category HUMAN OTC DRUG LABEL
Packager Zenith Medicosm SL
Generic Name
Product Class
Product Number
Application Number PART352
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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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