Zinc Oxide and Octinoxate

FDA Drug Profile — Replenix Tinted Sunscreen SPF 50, Essential Defense Everyday Clear Broad Spectrum SPF 47 Sunscreen

Drug Details

Generic Name
Zinc Oxide and Octinoxate
Brand Names
Replenix Tinted Sunscreen SPF 50, Essential Defense Everyday Clear Broad Spectrum SPF 47 Sunscreen
Application Number
M020
Sponsor
Topiderm, Inc.
NDC Codes
2
Dosage Forms
LOTION
Routes
TOPICAL
Active Ingredients
OCTINOXATE, ZINC OXIDE

Indications and Usage

Uses Helps prevent sunburn If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun.

Warnings

Warnings For external use only Do not use on damaged or broken skin When using this product keep out of eyes. Rinse with warm water to remove Stop use and ask a physician if rash occurs If product is swallowed, get medical help or contact a Poison Control Center right away