Octocrylene and Octisalate Cream

FDA Drug Profile — Tone Control Morning Cream SPF 15

Drug Details

Generic Name
Octocrylene and Octisalate Cream
Brand Names
Tone Control Morning Cream SPF 15
Application Number
M020
Sponsor
Bentley Laboratories, LLC
NDC Codes
1
Dosage Forms
CREAM
Routes
TOPICAL
Active Ingredients
OCTISALATE, OCTOCRYLENE

Indications and Usage

Uses: Helps prevent sunburn.

Warnings

Warnings • Skin Cancer/Skin Aging Alert : Spending too much time in the sun increases your risk of skin cancer and early skin aging. This product has been shown to only help prevent sunburn, not skin cancer or early skin aging. • 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 ask a doctor if rash occurs.