octinoxate and oxybenzone

FDA Drug Profile — Land Shark SPF 8

Drug Details

Generic Name
octinoxate and oxybenzone
Brand Names
Land Shark SPF 8
Application Number
M020
Sponsor
Tropical Seas, Inc.
NDC Codes
2
Dosage Forms
OIL, LOTION
Routes
TOPICAL
Active Ingredients
OCTINOXATE, OXYBENZONE

Indications and Usage

Uses helps prevent sunburn

Warnings

Warnings Skin Cancer/Skin Aging Alert: Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown to 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 Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.