ESSENTIALS Face and Body Sunscreen

AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE TOPICAL HUMAN OTC DRUG

ESSENTIALS Face and Body Sunscreen is an FDA drug label for the active ingredient AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE manufactured by Rodan & Fields administered by TOPICAL. This page reproduces the FDA-approved indications and usage, dosage, contraindications, warnings, and adverse reactions exactly as published in the drug label. Data source: openFDA (U.S. FDA), label effective 20200402.

Generic name
AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE
Manufacturer
Rodan & Fields
Product type
HUMAN OTC DRUG
Route
TOPICAL
Dosage form
N/A
NDC
14222-0002
Application
M020
Label effective
20200402

Active ingredients

Active Ingredients (w/w) Avobenzone 2.8%, Homosalate 9.6%, Octisalate 4.8%, Octocrylene 9.6%

Indications & Usage

Uses Helps prevent sunburn. When used as directed with other sun protection measures (see Directions ), decreases the risk of skin cancer and early skin aging caused by the sun.

Dosage & Administration

Directions Apply liberally 15 minutes before sun exposure. Reapply at least every 2 hours. Reapply after 80 minutes of swimming or sweating. Reapply immediately after towel drying Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a broad spectrum SPF value of 15 or higher and other sun protection measures including: Limit time in the sun, especially from 10 a.m.-2 p.m. Wear long-sleeve shirts, pants, hats and sunglasses. Children under 6 months: Ask a doctor.

Contraindications

Not available.

Warnings

Warnings 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 doctor if rash occurs Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away

Adverse Reactions

Not available.

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