NOEVIR RAYSELA - zinc oxide, octinoxate, titanium dioxide cream 
NOEVIR USA INC

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.

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Drug Facts

Drug Facts

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

Uses
Warnings
For external use only.
When using this product
Stop use and ask a doctor if
Keep out of reach of children
Directions
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.

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NOEVIR RAYSELA 
zinc oxide, octinoxate, titanium dioxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62908-011
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE14250 mg  in 100 g
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE7500 mg  in 100 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE2070 mg  in 100 g
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:62908-011-021 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/FEIBusiness Operations
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