Label: NOEVIR N5- zinc oxide, octinoxate, titanium dioxide powder
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Contains inactivated NDC Code(s)
NDC Code(s): 62908-012-01, 62908-012-02 - Packager: NOEVIR USA INC
- Category: HUMAN OTC DRUG LABEL
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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.
For external use only.
When using this product
- Keep out of eyes. Rinse with water to remove.
- Rash or irritation develops and lasts.
- If swallowed, get medical help or contact a Poison Control Center right away.
- Apply evenly before sun exposure.
- Children under 6 months of age ask a doctor.
- Reapply as needed or after towel drying, swimming or sweating.
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.
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INGREDIENTS AND APPEARANCE
NOEVIR N5
zinc oxide, octinoxate, titanium dioxide powderProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:62908-012 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 144 mg in 100 g OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 2000 mg in 100 g TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 13800 mg in 100 g Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:62908-012-02 1 in 1 BOX 1 NDC:62908-012-01 12 g in 1 TRAY Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 01/01/2010 Labeler - NOEVIR USA INC (018593293) Registrant - NOEVIR USA INC (018593293) Establishment Name Address ID/FEI Business Operations NOEVIR CO Ltd 690620521 manufacture