Label: NEOVA DNA DAMAGE CONTROL - SILC SHEER SPF 45- octinoxate, titanium dioxide emulsion

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph 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 9, 2012

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  • Directions for use:

    Apply evenly to face. Reapply
    as needed. For optimal results, use daily with Neova
    [DNA + Copper] products.

  • Supplied

    in a 2.5 fl. oz. / 74 mL bottle.

  • Active Ingredients:

    Titanium Dioxide 3.5%, Octinoxate 6.5%.

  • Inactive Ingredients:

    Camellia Sinensis Leaf Extract,
    Aloe Barbadensis Extract, Octyl Stearate, Cyclomethicone,
    Isopropyl Palmitate, Helianthus Annuus (Sunflower)
    Seed Oil, Lauryl PEG-9 Polydimethylsiloxyethyl
    Dimethicone, Micrococcus Lysate, Plankton Extract,
    Xanthophyll, Rosmarinus Officinalis (Rosemary) Leaf
    Extract, Squalane, Lecithin, Silica, Hydrated Silica,
    Microcrystalline Wax, Cetyl Dimethicone, Hydrogenated
    Castor Oil, Sodium Chloride, Phenoxyethanol, Iodopropynyl
    Butylcarbamate, Melanin, Caramel, Iron Oxides,
    CI 77499, CI 77491, CI 77492.

  • Image of package insert, package, and pouch

    PkgInsertUniversalpg1.jpgPackage Insert page 1 PkgInsertUniversalpg2.jpgPackage Insert page 2 AmpuleSHEER.jpgAmpule PouchSHEER.jpgPouch

  • INGREDIENTS AND APPEARANCE
    NEOVA DNA DAMAGE CONTROL - SILC SHEER   SPF 45
    octinoxate, titanium dioxide emulsion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62362-149
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate6.5 mL  in 100 mL
    Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP) Titanium Dioxide3.5 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    Green Tea Leaf (UNII: W2ZU1RY8B0)  
    Aloe Vera Leaf (UNII: ZY81Z83H0X)  
    Octyl Stearate (UNII: 772Y4UFC8B)  
    Cyclomethicone (UNII: NMQ347994Z)  
    Isopropyl Palmitate (UNII: 8CRQ2TH63M)  
    Sunflower Oil (UNII: 3W1JG795YI)  
    Lutein (UNII: X72A60C9MT)  
    Rosemary (UNII: IJ67X351P9)  
    Squalane (UNII: GW89575KF9)  
    Egg Phospholipids (UNII: 1Z74184RGV)  
    Silicon Dioxide (UNII: ETJ7Z6XBU4)  
    Hydrated Silica (UNII: Y6O7T4G8P9)  
    Microcrystalline Wax (UNII: XOF597Q3KY)  
    Hydrogenated Castor Oil (UNII: ZF94AP8MEY)  
    Sodium Chloride (UNII: 451W47IQ8X)  
    Phenoxyethanol (UNII: HIE492ZZ3T)  
    Iodopropynyl Butylcarbamate (UNII: 603P14DHEB)  
    Caramel (UNII: T9D99G2B1R)  
    Ferrosoferric Oxide (UNII: XM0M87F357)  
    Ferric Oxide Red (UNII: 1K09F3G675)  
    Ferric Oxide Yellow (UNII: EX438O2MRT)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:62362-149-031 in 1 POUCH
    1NDC:62362-149-022 mL in 1 POUCH
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35201/09/2012
    Labeler - PhotoMedex, Inc. (054503875)
    Establishment
    NameAddressID/FEIBusiness Operations
    PhotoMedex, Inc.054503875manufacture
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