Label: NEOVA DNA DAMAGE CONTROL - ACTIVE SPF 45- zinc oxide, octinoxate, octisalate emulsion

  • Category: HUMAN OTC DRUG LABEL

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Drug Label Information

Updated January 6, 2012

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  • Directions for use:

    Apply liberally to exposed skin every two hours. Reapply as needed. For optimal results, use daily with Neova [DNA + Copper] products.

  • Supplied

    in a 3.0 fl. oz. / 89 mL tube.

  • Active Ingredients:

    Zinc Oxide 8.0%, Octinoxate 7.5%, Octisalate 3.0%.

  • Inactive Ingredients:

    Water (Aqua), Cyclopentasiloxane,
    Ethyl Hexyl Isononanoate, Micrococcus Lysate, Plankton
    Extract, L-ergothioneine, Dimethicone, Dimethicone/
    PEG-10/15 Crosspolymer, Lauryl PEG-9 Polymethylsiloxyethyl
    Dimethicone, Dimethicone/Vinyl Dimethicone
    Crosspolymer, Retinyl Palmitate, Ascorbyl Palmitate
    (Vitamin C), Sodium Chloride, Phenoxyethanol, Butylene
    Glycol, Iodopropynyl Butylcarbamate, Citric Acid,
    Sodium Hydroxide.

  • Image of package, pouch, and package insert

    AmpuleActive.jpgPackage PouchActive.jpgPouch PkgInsertUniversalpg1.jpgPackage Insert page 1 PkgInsertUniversalpg2.jpgPackage Insert page 2

  • INGREDIENTS AND APPEARANCE
    NEOVA DNA DAMAGE CONTROL - ACTIVE   SPF 45
    zinc oxide, octinoxate, octisalate emulsion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62362-129
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide8 mL  in 100 mL
    Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate7.5 mL  in 100 mL
    Octisalate (UNII: 4X49Y0596W) (Octisalate - UNII:4X49Y0596W) Octisalate3 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    Cyclomethicone 5 (UNII: 0THT5PCI0R)  
    Ethylhexyl Isononanoate (UNII: I6KB4GE3K4)  
    Micrococcus Luteus (UNII: LV6L29Z6AX)  
    Ergothioneine (UNII: BDZ3DQM98W)  
    Dimethicone (UNII: 92RU3N3Y1O)  
    Vitamin A Palmitate (UNII: 1D1K0N0VVC)  
    Ascorbyl Palmitate (UNII: QN83US2B0N)  
    Sodium Chloride (UNII: 451W47IQ8X)  
    Phenoxyethanol (UNII: HIE492ZZ3T)  
    Butylene Glycol (UNII: 3XUS85K0RA)  
    Iodopropynyl Butylcarbamate (UNII: 603P14DHEB)  
    Citric Acid (UNII: 2968PHW8QP)  
    Sodium Hydroxide (UNII: 55X04QC32I)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:62362-129-031 in 1 POUCH
    1NDC:62362-129-022 mL in 1 PACKAGE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35201/06/2012
    Labeler - PhotoMedex, Inc. (054503875)
    Establishment
    NameAddressID/FEIBusiness Operations
    PhotoMedex, Inc.054503875manufacture
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