Label: NEOVA DNA DAMAGE CONTROL - SILC SHEER SPF 45- octinoxate, titanium dioxide emulsion

  • Category: HUMAN OTC DRUG LABEL
  • 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 6, 2012

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  • Active Ingredients

    Octinoxate 6.5%, Titanium Dioxide 3.5%

  • Purpose

    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 every morning to face, neck
    and décolletage. • 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

    Camellia Sinensis Leaf
    Extract, Aloe Barbadensis Extract, Octyl Stearate,
    Cyclomethicone, Isopropyl Palmitate, Helianthus Annuus
    (Sunflower) Seed Oil, Lauryl PEG-9 Polydimethylsiloxyethyl
    Dimethicone, Micrococcus Lysate, Plankton
    Extract, Xanthophyll, Rosmarinus Officinalis (Rosemary)
    Leaf Extract, Squalane, Lecithin, Silica, Hydrated Silica,
    Microcrystalline Wax, Cetyl Dimethicone, Hydrogenated
    Castor Oil, Sodium Chloride, Phenoxyethanol, Iodopropynyl
    Butylcarbamate, Melanin, Caramel, Iron Oxides, CI 77499,
    CI 77491, CI 77492.

  • Image of box and label

    DNADControlSHEERBox.jpgBox DNADControlSHEERLabel.jpgLabel

  • INGREDIENTS AND APPEARANCE
    NEOVA DNA DAMAGE CONTROL - SILC SHEER  SPF 45
    octinoxate, titanium dioxide emulsion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62362-149
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate6.5 mL  in 100 mL
    Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP) Titanium Dioxide3.5 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    Green Tea Leaf (UNII: W2ZU1RY8B0)  
    Aloe Vera Leaf (UNII: ZY81Z83H0X)  
    Octyl Stearate (UNII: 772Y4UFC8B)  
    Cyclomethicone (UNII: NMQ347994Z)  
    Isopropyl Palmitate (UNII: 8CRQ2TH63M)  
    Sunflower Oil (UNII: 3W1JG795YI)  
    Lutein (UNII: X72A60C9MT)  
    Rosemary (UNII: IJ67X351P9)  
    Squalane (UNII: GW89575KF9)  
    Egg Phospholipids (UNII: 1Z74184RGV)  
    Silicon Dioxide (UNII: ETJ7Z6XBU4)  
    Hydrated Silica (UNII: Y6O7T4G8P9)  
    Microcrystalline Wax (UNII: XOF597Q3KY)  
    Hydrogenated Castor Oil (UNII: ZF94AP8MEY)  
    Sodium Chloride (UNII: 451W47IQ8X)  
    Phenoxyethanol (UNII: HIE492ZZ3T)  
    Iodopropynyl Butylcarbamate (UNII: 603P14DHEB)  
    Caramel (UNII: T9D99G2B1R)  
    Ferrosoferric Oxide (UNII: XM0M87F357)  
    Ferric Oxide Red (UNII: 1K09F3G675)  
    Ferric Oxide Yellow (UNII: EX438O2MRT)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:62362-149-011 in 1 BOX
    1NDC:62362-149-7474 mL in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35201/06/2012
    Labeler - PhotoMedex, Inc. (054503875)
    Establishment
    NameAddressID/FEIBusiness Operations
    PhotoMedex, Inc.054503875manufacture
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