Label: NEOVA DNA DAMAGE CONTROL - EVERYDAY BROAD SPECTRUM SPF 44- octinoxate, octisalate, zinc oxide emulsion

  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated October 10, 2023

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

  • Active Ingredients

    Octinoxate 6.5%, Octisalate 2.5% Zinc Oxide 8.5%

  • 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.
    • Use a water resistant sunscreen if swimming or sweating.
    • Reapply at least every 2 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

    Allantoin, Ascorbyl Palmitate, Butylene Glycol, Cetearyl Glucoside, Citric Acid, Cyclopentasiloxane, Dimethicone, Ergothioneine, Ethyl Hexyl Isononanoate, Glycereth-26, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Iodopropynyl Butylcarbamate, Isopropyl Palmitate, Lecithin, Micrococcus Lysate, Octyl Sterate, Oleth-3 Phosphate, Panthenol, PEG-7 Trimethylolprpopane Coconut Ether, Phenoxyethanol, Plankton Extract, Polyether-1, Polyisobutene, Purified Water, Retinyl Palmitate, Sodium Hyaluronate, Sodium Hydroxide, Tocopherol Acetate, Triethoxycaprylysilane.

  • Other Information

    Protect this product from excessive heat and direct sun.

  • Questions or Comments?

    Call toll free 1-888-966-1010.

  • Product Label

    Neova DNA Damage Control
    Everyday SPF 44
    2.5 fl. oz. (74mL) label and box

    everyday

  • INGREDIENTS AND APPEARANCE
    NEOVA DNA DAMAGE CONTROL - EVERYDAY  BROAD SPECTRUM SPF 44
    octinoxate, octisalate, zinc oxide emulsion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72251-002
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE6.5 g  in 100 mL
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE2.5 g  in 100 mL
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE8.5 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALLANTOIN (UNII: 344S277G0Z)  
    ASCORBYL PALMITATE (UNII: QN83US2B0N)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    ERGOTHIONEINE (UNII: BDZ3DQM98W)  
    ETHYLHEXYL ISONONANOATE (UNII: I6KB4GE3K4)  
    GLYCERETH-26 (UNII: NNE56F2N14)  
    HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (45000 MPA.S AT 1%) (UNII: 86FQE96TZ4)  
    IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)  
    ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)  
    EGG PHOSPHOLIPIDS (UNII: 1Z74184RGV)  
    OCTYL STEARATE (UNII: 772Y4UFC8B)  
    OLETH-3 PHOSPHATE (UNII: 8Q0Z18J1VL)  
    PANTHENOL (UNII: WV9CM0O67Z)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    POLYETHYLENE GLYCOL 8000 (UNII: Q662QK8M3B)  
    DODOXYNOL-5 (UNII: CSH59YN3D0)  
    VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    POLYISOBUTYLENE (1300 MW) (UNII: 241BN7J12Y)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72251-002-7474 mL in 1 BOTTLE; Type 1: Convenience Kit of Co-Package04/19/2018
    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(72251-002)