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

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  • Active Ingredients

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

  • PURPOSE

    Sunscreen

  • INDICATIONS & USAGE

    • Helps prevent sunburn. • Higher SPF gives
    more sunburn protection. • Retains SPF after 80 minutes
    of activity in the water or perspiring.

  • Warnings

    • For external use only.
    • When using this product keep out of eyes. Rinse with water to remove.
    • Stop use and ask a doctor if rash or irritation develops and lasts.
    • Keep out of reach of children. If swallowed, contact a Poison Control Center immediately or get medical help right away.
  • When using this product

    Keep out of eyes. Rinse with water to remove.

  • Stop use and ask a doctor if

    Rash or irritation develops and lasts.

  • Keep out of reach of children

    If swallowed, contact a Poison Control Center immediately or get medical help right away.

  • Directions

    • Apply every morning to face, neck
    and décolletage. • Reapply as needed or after towel
    drying, swimming or perspiring.
    • Children under 6 months of age: ask a doctor.

  • Other Information

    High protection sun product.
    Sun Alert: Limiting sun exposure, wearing protective
    clothing, and using sunscreens may reduce the risks
    of skin aging, skin cancer, and other harmful effects
    of the sun.
    Serious side effects associated with use of this product
    may be reported to this number: 888-966-1010.

  • 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 box and label

    DNADamageControlEday.jpgLabel DNADConEDAYBox.jpgBox

  • 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)  
    Phenoxyethanol (UNII: HIE492ZZ3T)  
    Butylene Glycol (UNII: 3XUS85K0RA)  
    Citric Acid (UNII: 2968PHW8QP)  
    Iodopropynyl Butylcarbamate (UNII: 603P14DHEB)  
    Triethoxycaprylylsilane (UNII: LDC331P08E)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:62362-139-011 in 1 BOX
    1NDC:62362-139-7474 mL in 1 TUBE
    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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