DERMATONE SPF50 Sunscreen

DERMATONE SPF50 Sunscreen is an FDA-registered drug product whose active ingredient is AVABENZONE 3% HOMOSALATE 10% OCTISALATE 5%. It is labelled by Dermatone Labs LLC taken by topical and marketed as a human otc drug product. Identifiers on file: NDC 54414-028, application M020, label effective 20260511. It is one of 2 FDA drug label records sharing the active ingredient AVABENZONE 3% HOMOSALATE 10% OCTISALATE 5%. This page reproduces the FDA-approved label text so you can check what a product is, who makes it and how it is supplied before discussing it with a pharmacist or prescriber.

Across FDA labelling, products containing AVABENZONE 3% HOMOSALATE 10% OCTISALATE 5% are most often described in connection with: helps prevent. Wording differs between labels, and the full indications section on this page takes precedence when it is present.

Uses •helps prevent sunburn•

Directions • spray liberally and spread evenly by hand 15 minutes before sun exposure• reapply: • after 80 minutes of swimming or sweating • immediately after towel drying • at least every 2 hours • hold container 4 to 6 inches from the skin to apply • do not spray directly into face. Spray on hands then apply to face • do not apply in windy conditions • use in a well-ventilated area • Sun Protection Measures. Spending tme 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 of 15 or higher and other sun protection measures including: • limit time in the sun, especially from 10 a.m. - 2. p.m. • wear a long-sleeve shirt, pants, hats, and sunglasses. • children under 6 months: Ask a doctor.

Warnings For external use only. Flammable: Do not use near heat, flame or while smoking.

FDA lists 2 drug label records with AVABENZONE 3% HOMOSALATE 10% OCTISALATE 5% as the active ingredient. The most common dosage forms and the manufacturers with the most records are summarised below; strengths, pack sizes and inactive ingredients can still differ between apparently similar products.

What is DERMATONE SPF50 Sunscreen used for?
Uses •helps prevent sunburn•

Who makes DERMATONE SPF50 Sunscreen?
Dermatone Labs LLC is the labeler of record for DERMATONE SPF50 Sunscreen. 2 FDA label records share the active ingredient AVABENZONE 3% HOMOSALATE 10% OCTISALATE 5%, so generic and branded versions may come from different companies; the manufacturer named on your pack is the one that matters for any enquiry.

What form does DERMATONE SPF50 Sunscreen come in?
administered by topical. Strengths and pack sizes vary by label, so compare the NDC on your pack with the identifier listed on this page.

Is DERMATONE SPF50 Sunscreen prescription or over-the-counter?
The FDA label for this product is recorded as human otc drug. Marketing status can differ between strengths and countries, so check the dispensing rules where you live.

Are there other products containing AVABENZONE 3% HOMOSALATE 10% OCTISALATE 5%?
Yes. 2 FDA drug label records list AVABENZONE 3% HOMOSALATE 10% OCTISALATE 5% as the active ingredient. Products with the same active ingredient can usually be substituted only when a prescriber or pharmacist confirms it is appropriate.

Has DERMATONE SPF50 Sunscreen been recalled?
No FDA recall record in our database matches this product name or manufacturer. Recall data is updated periodically, so a very recent notice may not appear here yet.

Where does this information come from?
All content is reproduced from FDA Structured Product Labelling data via openFDA. It is provided for identification and reference only and is not medical advice.