Label: NEOVA DNA DAMAGE CONTROL - EVERYDAY SPF 43- zinc oxide, octinoxate, octisalate 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 6, 2012

If you are a consumer or patient please visit this version.

View All Sections
  • Directions for use:

    Apply every morning to face, neck, décolletage
    and hands. Reapply as needed. For optimal results, use daily
    with Neova [DNA + Copper] products.

  • Supplied

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

  • Active Ingredients:

    Zinc Oxide 7.5%, Octinoxate 7.5%, Octisalate 2.5%.

  • Inactive Ingredients:

    Water (Aqua), Isopropyl Palmitate,
    Octyl Stearate, Ethyl Hexyl Isononanoate, Cyclopentasiloxane,
    Cetearyl Glucoside, Micrococcus Lysate,
    Plankton Extract, L-ergothioneine, Dimethicone,
    Glycereth-26, Sodium Hyaluronate, Panthenol, Allantoin,
    Tocopheryl Acetate, Ascorbyl Palmitate (Vitamin C),
    Oleth-3 Phosphate, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl
    Taurate Copolymer, Polyisobutene, PEG-7
    Trimethylolpropane Coconut Ether, Lecithin, Polyether-1,
    Phenoxyethanol, Butylene Glycol, Citric Acid, Iodopropynyl
    Butylcarbamate, Triethoxycaprylylsilane.

  • Image of package insert, package, and pouch

    PkgInsertUniversalpg1.jpgPackage Insert page 1 PkgInsertUniversalpg2.jpgPackage Insert page 2 AmpuleEday.jpgAmpule PouchEday.jpgPouch

  • INGREDIENTS AND APPEARANCE
    NEOVA DNA DAMAGE CONTROL - EVERYDAY  SPF 43
    zinc oxide, octinoxate, octisalate emulsion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62362-139
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide7.5 mL  in 100 mL
    Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate7.5 mL  in 100 mL
    Octisalate (UNII: 4X49Y0596W) (Octisalate - UNII:4X49Y0596W) Octisalate2.5 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    Isopropyl Palmitate (UNII: 8CRQ2TH63M)  
    Octyl Stearate (UNII: 772Y4UFC8B)  
    Ethylhexyl Isononanoate (UNII: I6KB4GE3K4)  
    Cyclomethicone 5 (UNII: 0THT5PCI0R)  
    Cetearyl Glucoside (UNII: 09FUA47KNA)  
    Ergothioneine (UNII: BDZ3DQM98W)  
    Dimethicone (UNII: 92RU3N3Y1O)  
    Glycereth-26 (UNII: NNE56F2N14)  
    Hyaluronate Sodium (UNII: YSE9PPT4TH)  
    Panthenol (UNII: WV9CM0O67Z)  
    Allantoin (UNII: 344S277G0Z)  
    Alpha-Tocopherol Acetate (UNII: 9E8X80D2L0)  
    Ascorbyl Palmitate (UNII: QN83US2B0N)  
    Oleth-3 Phosphate (UNII: 8Q0Z18J1VL)  
    Polyisobutylene (1300 MW) (UNII: 241BN7J12Y)  
    Egg Phospholipids (UNII: 1Z74184RGV)  
    Butylene Glycol (UNII: 3XUS85K0RA)  
    Citric Acid (UNII: 2968PHW8QP)  
    Iodopropynyl Butylcarbamate (UNII: 603P14DHEB)  
    Triethoxycaprylylsilane (UNII: LDC331P08E)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:62362-139-031 in 1 POUCH
    1NDC:62362-139-022 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
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!