Label: VITA K- 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

    A cream containing Vitamin K, marine collagen, rosehip oil with anti-hemorrhagic,anti-inflammatory and regenerating properties that improves the appearance of skin with circulation problems (dilated capillaries, rosacea). Indicated for all kinds of skin and recommended as both a pre-laser and preventive treatment.

    50ml. 1.7 fl. Oz


  • Warning

    TOPICAL USE

  • PRINCIPAL DISPLAY PANEL

    VITAK
  • INGREDIENTS AND APPEARANCE
    VITA  K
    octinoxate cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:42248-103
    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
    PEG-2 STEARATE (UNII: 94YQ11Y95F)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    GLYCOL STEARATE (UNII: 0324G66D0E)  
    ROSA MOSCHATA OIL (UNII: J99W255AWF)  
    WATER (UNII: 059QF0KO0R)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    PEG-8 STEARATE (UNII: 2P9L47VI5E)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    THYME (UNII: CW657OBU4N)  
    KIWI FRUIT (UNII: 71ES77LGJC)  
    PHYTONADIONE (UNII: A034SE7857)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    COLLAGEN, SOLUBLE, FISH SKIN (UNII: 8JC99XGU4W)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    EPILOBIUM ANGUSTIFOLIUM LEAF (UNII: 7NV86426N2)  
    GINKGO (UNII: 19FUJ2C58T)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:42248-103-021 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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