SEVEN MINERALS Skin Friendly SPF 50

AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE TOPICAL HUMAN OTC DRUG

SEVEN MINERALS Skin Friendly SPF 50 is an FDA drug label for the active ingredient AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE manufactured by Seven Minerals NA LLC 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 20231111.

Generic name
AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE
Manufacturer
Seven Minerals NA LLC
Product type
HUMAN OTC DRUG
Route
TOPICAL
Dosage form
N/A
NDC
73609-221
Application
M020
Label effective
20231111

Active ingredients

Active Ingredients Avobenzone 3.00%, Homosalate 10.00% Octisalate 5.00%, Octocrylene 10.00% Purpose Sunscreen

Indications & Usage

USES: • Helps prevent sunburn. • Higher SPF gives more sunburn protection. • Retains SPF after 80 minutes of swimming or sweating. • If used as directed with other sun protection measures (see ), decreases the risk of skin cancer and early skin aging caused by the sun. Directions

Dosage & Administration

DIRECTIONS: • Apply liberally 15 minutes before sun exposure and as needed. • Children under 6 months of age: ask a doctor. • Reapply: • after 80 minutes of swimming or sweating • immediately after towel drying • at least every 2 hours. • Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use sunscreen with broad spectrum protection and an SPF rating of 15 or higher, along with other sun protection measures including: • Limit time in the sun, especially between 10am and 2pm. • Wear long sleeve shirts, pants, hats and sunglasses. SUN PROTECTION MEASURES:

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 a doctor if rash or irritation develops and lasts. Keep out of reach of children. If product is swallowed, get medical attention or contact poison control center immediately.

Adverse Reactions

Not available.

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