NOEVIR RAYSELA- zinc oxide, octinoxate, titanium dioxide cream

NOEVIR RAYSELA by

Drug Labeling and Warnings

NOEVIR RAYSELA by is a Otc medication manufactured, distributed, or labeled by NOEVIR USA INC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

INGREDIENTS AND APPEARANCE

NOEVIR RAYSELA 
zinc oxide, octinoxate, titanium dioxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 62908-011
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	14250 mg  in 100 g
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	7500 mg  in 100 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	2070 mg  in 100 g

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 62908-011-02	1 in 1 BOX
1	NDC: 62908-011-01	35 g in 1 TUBE

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 USA INC		018593293	manufacture