Label: NOEVIR N5- zinc oxide, octinoxate, titanium dioxide powder

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

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Drug Label Information

Updated December 8, 2009

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  • Drug Facts

    Drug Facts
    Active Ingredients                       Purpose
    ZINC OXIDE  14.25%                  Sunscreen
    OCTINOXATE  7.5%                   Sunscreen
    TITANIUM DIOXIDE 2.07%         Sunscreen

    Uses
    • Helps prevent sunburn.
    • Higher SPF gives more sunburn protection.
    • Provides high protection against sunburn.
    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, get medical help or contact a Poison Control Center right away.
    Directions
    • Apply evenly before sun exposure.
    • Children under 6 months of age ask a doctor.
    • Reapply as needed or after towel drying, swimming or sweating.
    Other Information
    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.
  • PRINCIPAL DISPLAY PANEL

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  • INGREDIENTS AND APPEARANCE
    NOEVIR N5 
    zinc oxide, octinoxate, titanium dioxide powder
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62908-012
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE144 mg  in 100 g
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE2000 mg  in 100 g
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE13800 mg  in 100 g
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:62908-012-021 in 1 BOX
    1NDC:62908-012-0112 g in 1 TRAY
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other01/01/2010
    Labeler - NOEVIR USA INC (018593293)
    Registrant - NOEVIR USA INC (018593293)
    Establishment
    NameAddressID/FEIBusiness Operations
    NOEVIR CO Ltd690620521manufacture
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