AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE LIP BALM

FDA Drug Profile — NATUREWELL HYDRASUN LIP BALM SPF30 MINT BREEZE SPF 30, NATUREWELL HYDRASUN LIP BALM SPF30 CITRUS SPRITZ

Drug Details

Generic Name
AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE LIP BALM
Brand Names
NATUREWELL HYDRASUN LIP BALM SPF30 MINT BREEZE SPF 30, NATUREWELL HYDRASUN LIP BALM SPF30 CITRUS SPRITZ
Application Number
M020
Sponsor
Port Jervis Laboratories, Inc.
NDC Codes
2
Dosage Forms
LIPSTICK
Routes
TOPICAL
Active Ingredients
AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE

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. Flammable. Keep away from heat or flame. 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 or irritation occurs.