ZINC OXIDE, OCTINOXATE, OCTISALATE, OCTISALATE

FDA Drug Profile — JACKET SPF 50

Drug Details

Generic Name
ZINC OXIDE, OCTINOXATE, OCTISALATE, OCTISALATE
Brand Names
JACKET SPF 50
Application Number
M020
Sponsor
Balshi MD Dermaceuticals
NDC Codes
1
Dosage Forms
CREAM
Routes
TOPICAL
Active Ingredients
OCTINOXATE, OCTISALATE, OXYBENZONE, 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 water to remove Stop use and consult physician if irritation or rash develops Keep out if reach of children. If product is swallowed, get medical attention or contact poison control center immediately.