ZINC OXIDE, OCTOCRYLENE, OCTINOXATE, OCTISALATE

FDA Drug Profile — Vivier Sheer SPF 45, Sheer Broad Spectrum SPF45

Drug Details

Generic Name
ZINC OXIDE, OCTOCRYLENE, OCTINOXATE, OCTISALATE
Brand Names
Vivier Sheer SPF 45, Sheer Broad Spectrum SPF45
Application Number
M020
Sponsor
Vivier Pharma, Inc.
NDC Codes
2
Dosage Forms
LOTION
Routes
TOPICAL
Active Ingredients
OCTINOXATE, OCTISALATE, OCTOCRYLENE, ZINC OXIDE

Indications and Usage

USES • Helps prevent sunburn and provides a sun protection factor of 45. • Ideal for daily use; can be applied under makeup.

Warnings

For external use only • The sun may cause sunburn, premature aging of the skin and skin cancer. Avoiding the sun, wearing protective clothing and regular use of sunscreens over the years may reduce the chance of these harmful effects. When using this product • Avoid contact with eyes. If contact occurs, rinse thoroughly with water. • Do not use on damaged or broken skin. 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.