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

  • 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 5, 2012

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  • Active Ingredients

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

  • Purpose

    Zinc Oxide - sunscreen, Octinoxate - sunscreen, Octisalate - sunscreen

  • Uses

    • 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.

  • Directions

    Apply liberally before sun exposure.
    • 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), 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 Box and Label


    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)  
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:62362-129-011 in 1 BOX
    1NDC:62362-129-8989 mL in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35201/05/2012
    Labeler - PhotoMedex, Inc. (054503875)
    NameAddressID/FEIBusiness Operations
    PhotoMedex, Inc.054503875manufacture