zinc oxide and octinoxate sunscreen

FDA Drug Profile — EltaMD UV Shield SPF45, EltaMD UV Clear Tinted SPF46, EltaMD UV SPF 30 Plus, EltaMD UV Daily SPF40, EltaMD UV Daily Tinted SPF40

Drug Details

Generic Name
zinc oxide and octinoxate sunscreen
Brand Names
EltaMD UV Shield SPF45, EltaMD UV Clear Tinted SPF46, EltaMD UV SPF 30 Plus, EltaMD UV Daily SPF40, EltaMD UV Daily Tinted SPF40, EltaMD UV Facial SPF30 Plus, EltaMD UV Lip Balm SPF31
Application Number
M020
Sponsor
CP Skin Health Group, Inc.
NDC Codes
7
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 Stop use and ask a physician if rash occurs Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.