PETROLATUM, OXYBENZONE, OCTINOXATE, AVOBENZONE

FDA Drug Profile — EIGHT HOUR LIP PROTECTANT SPF 15

Drug Details

Generic Name
PETROLATUM, OXYBENZONE, OCTINOXATE, AVOBENZONE
Brand Names
EIGHT HOUR LIP PROTECTANT SPF 15
Application Number
M020
Sponsor
REVLON
NDC Codes
1
Dosage Forms
LIPSTICK
Routes
TOPICAL
Active Ingredients
AVOBENZONE, OCTINOXATE, OXYBENZONE, PETROLATUM

Indications and Usage

Helps prevent sunburn Temporarily protects and helps relieve chapping peeling or flaking due to minor sunburn windburn cracked lips

Warnings

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 prevent sunburn, not skin cancer or early skin aging. For external use only Do not use on damaged or broken skin Stop use and ask a doctor if rash occurs or if condition lasts more than 7 days. Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.