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NOEVIR RAYSELA

Dosage form: cream
Ingredients: ZINC OXIDE 14250mg in 100g, OCTINOXATE 7500mg in 100g, TITANIUM DIOXIDE 2070mg in 100g
Labeler: NOEVIR USA INC
NDC Code: 62908-011

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

Drug Facts

Drug FactsDrug 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.




NOEVIR RAYSELA 
zinc oxide, octinoxate, titanium dioxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62908-011
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (ZINC OXIDE) ZINC OXIDE14250 mg  in 100 g
OCTINOXATE (OCTINOXATE) OCTINOXATE7500 mg  in 100 g
TITANIUM DIOXIDE (TITANIUM DIOXIDE) TITANIUM DIOXIDE2070 mg  in 100 g
Packaging
#Item CodePackage Description
1NDC:62908-011-021 TUBE (TUBE) in 1 BOX
1NDC:62908-011-0135 g in 1 TUBE
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/FEIOperations
NOEVIR USA INC018593293manufacture

Revised: 11/2009
Document Id: 7eebb3b0-6583-47fe-8679-e894f1740645
Set id: f63dd9ef-a65a-4d0a-abb9-981f5fd4979c
Version: 1
Effective Time: 20091112
 
NOEVIR USA INC

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

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