Label: NEOVA DNA DAMAGE CONTROL - ACTIVE BROAD SPECTRUM SPF 43- octinoxate, zinc oxide cream

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated October 10, 2023

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

  • Active Ingredients

    Octinoxate 7.5%, Zinc Oxide 9.0%

  • Purpose

    Sunscreen

  • Uses

    • Helps prevent sunburn
    • If used as directed and with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin again caused by the sun.
  • Warnings

    For external use only

  • DO NOT USE

    Do not useon damaged or broken skin.

  • WHEN USING

    When using this productkeep out of eyes. Rinse with water to remove.

  • STOP USE

    Stop use and ask a doctor ifrash occurs.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.If product is swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    • Apply liberally 15 minutes before sun exposure.
    • Reapply:

         °After 80 minutes of swimming or sweating.

         °Immediately after towel drying.

         °At least every two hours.

    • Children under 6 months of age: ask a doctor.
    • Sun Protection Measures.Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a broad spectrum SPF of 15 or higher and other sun protection measures including:

        °Limit time in the sun, especially from 10 a.m. - 2 p.m.

        °Wear long-sleeve shirts, pants, hats, and sunglasses.

  • Inactive Ingredients

    Ascorbyl Palmitate, Butylene Glycol, Citric Acid, Cyclopentasiloxane, Dimethicone, Dimethicone/PEG-10/15 Crosspolymer, Dimethicone/Vinyldimethicone Crosspolymer, Ergothioneine, Ethyl Hexyl Isononanoate,Iodopropynyl Butylcarbamate, Lauryl PEG-9 Polymethylsiloxyethyl Dimethicone, Lecithin, Microcoous Lysate, Phenoxyethanol, Plankton Extract, Purified Water, Retinyl Palmitate, Sodium Chloride, Sodium Hydroxide, Triethanoxycaprylylsilane.

  • Other Information

    Protect this product from excessive heat and direct sun.

  • Questions or Comments?

    Call toll free 1-888-966-1010.

  • Priduct Label

    Neova DNA Damage Control
    Active SPF 43
    3.0 fl. oz. (89mL)

    image description

  • INGREDIENTS AND APPEARANCE
    NEOVA DNA DAMAGE CONTROL - ACTIVE  BROAD SPECTRUM SPF 43
    octinoxate, zinc oxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72251-003
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE7.5 g  in 100 mL
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE9 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    ASCORBYL PALMITATE (UNII: QN83US2B0N)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)  
    ERGOTHIONEINE (UNII: BDZ3DQM98W)  
    ETHYLHEXYL ISONONANOATE (UNII: I6KB4GE3K4)  
    IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)  
    LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: 25G622K2RA)  
    EGG PHOSPHOLIPIDS (UNII: 1Z74184RGV)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    WATER (UNII: 059QF0KO0R)  
    VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    MICROCOCCUS LUTEUS (UNII: LV6L29Z6AX)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72251-003-891 in 1 BOX04/19/2018
    189 mL in 1 TUBE; Type 1: Convenience Kit of Co-Package
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02010/08/2012
    Labeler - PHARMA COSMETICS, INC (080622701)
    Establishment
    NameAddressID/FEIBusiness Operations
    Swiss-American CDMO, LLC080170933manufacture(72251-003)