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

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not 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 April 20, 2018

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 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.
    • 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 not finalpart35210/08/2012
    Labeler - PHARMA COSMETICS, INC (080622701)
    Establishment
    NameAddressID/FEIBusiness Operations
    Swiss-American CDMO, LLC080170933manufacture(72251-003)