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

  • Category: HUMAN OTC DRUG LABEL

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 2, 2014

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  • 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 use on damaged or broken skin.

  • WHEN USING

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

  • STOP USE

    Stop use and ask a doctor if rash 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.

  • Neova DNA Damage ControlEveryday SPF 442.5 fl. oz. (74mL) label and box

    DNADamageControlEveryday2-5ozLabel.jpglabel DNADamageControlEveryday2-5ozBox.jpgbox

  • 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:62362-159
    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)  
    Water (UNII: 059QF0KO0R)  
    Vitamin A Palmitate (UNII: 1D1K0N0VVC)  
    Hyaluronate Sodium (UNII: YSE9PPT4TH)  
    Sodium Hydroxide (UNII: 55X04QC32I)  
    .Alpha.-Tocopherol Acetate (UNII: 9E8X80D2L0)  
    Triethoxycaprylylsilane (UNII: LDC331P08E)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:62362-159-011 in 1 BOX
    1NDC:62362-159-7474 mL in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35210/08/2012
    Labeler - PhotoMedex, Inc. (054503875)
    Establishment
    NameAddressID/FEIBusiness Operations
    PhotoMedex, Inc.054503875manufacture(62362-159)
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