Label: REGEMARINE EXTREME- octinoxate cream

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not 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 January 21, 2012

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  • Active Ingredient

    Octinoxate 7.5%

  • Description

    The exclusive formula with marine collagen, algae and rosehip oil regenerates damaged tissue and helps firm and hydrate skin.  Specially designed for sagging and aged skin that requires progressive rejuvenation.

    50ml. 1.7 fl. Oz


  • Warning

    TOPICAL USE

  • PRINCIPAL DISPLAY PANEL

    REGEMARINEEXTREME
  • INGREDIENTS AND APPEARANCE
    REGEMARINE  EXTREME
    octinoxate cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:42248-107
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE3.75 mL  in 50 mL
    Inactive Ingredients
    Ingredient NameStrength
    MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    ROSA MOSCHATA OIL (UNII: J99W255AWF)  
    WATER (UNII: 059QF0KO0R)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    PEG-8 STEARATE (UNII: 2P9L47VI5E)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    SOYBEAN (UNII: L7HT8F1ZOD)  
    CHONDRUS CRISPUS (UNII: OQS23HUA1X)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
    CARBOMER 934 (UNII: Z135WT9208)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    COLLAGEN, SOLUBLE, FISH SKIN (UNII: 8JC99XGU4W)  
    ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)  
    PEG-6 STEARATE (UNII: 8LQC57C6B0)  
    PEG-32 STEARATE (UNII: 33GX5WQC0M)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    PANAX GINSENG FRUIT (UNII: E35T4MOI3E)  
    PEG/PPG-20/23 DIMETHICONE (UNII: XK68QT7HWY)  
    FUCUS VESICULOSUS (UNII: 535G2ABX9M)  
    PELVETIA CANALICULATA (UNII: 8U1M44KESN)  
    ALLANTOIN (UNII: 344S277G0Z)  
    VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:42248-107-021 in 1 BOX
    150 mL in 1 JAR
    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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