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 protect against sunburn and chapped lips.

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 only to help prevent sunburn, not skin cancer or early skin aging. For external use only. Do not use on damaged or broken skin. Stop use and consult a doctor if rash occurs. Avoid contact with eyes. If in eyes, rinse with warm water to remove. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center.