Label: CALCIUM REPAIR- 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

    Cream with excellent repairing effect containing calcium, marine collagen and hyaluronic acid. The extra calcium content helps recover skin density and support, and restructure and fight the premature signs of skin thinning typical of menopause. Indicated for all skin types.

    50ml. 1.7 fl. Oz


  • Warning

    TOPICAL USE

  • PRINCIPAL DISPLAY PANEL

    CALCIUMREPAIR
  • INGREDIENTS AND APPEARANCE
    CALCIUM  REPAIR
    octinoxate cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:42248-104
    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)  
    SOY ISOFLAVONES (UNII: 71B37NR06D)  
    CALCIUM GLUCONATE (UNII: SQE6VB453K)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    HYALURONIC ACID (UNII: S270N0TRQY)  
    CARBOMER 934 (UNII: Z135WT9208)  
    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)  
    FUCUS VESICULOSUS (UNII: 535G2ABX9M)  
    ALLANTOIN (UNII: 344S277G0Z)  
    VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
    METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
    FD&C RED NO. 4 (UNII: X3W0AM1JLX)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:42248-104-021 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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