ProtecTINT 20C

ProtecTINT 20C is an FDA-registered drug product whose active ingredient is HOMOSALATE, OCTISALATE, ZINC OXIDE. It is labelled by PML NYC, LLC taken by topical and marketed as a human otc drug product. Identifiers on file: NDC 59735-906, application M020, label effective 20260414. It is one of 3 FDA drug label records sharing the active ingredient HOMOSALATE, OCTISALATE, ZINC OXIDE. 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 HOMOSALATE, OCTISALATE, ZINC OXIDE are most often described in connection with: ask doctor, rash occurs. Wording differs between labels, and the full indications section on this page takes precedence when it is present.

Stop use and ask a doctor if rash occurs

Directions Apply generously and evenly 15 minutes before sun exposure Reapply at least every 2 hours Use a water resistant sunscreen if swimming or sweating 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-sleeved shirts, pants, hats, and sunglasses Children under 6 months: Ask a doctor

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

FDA lists 3 drug label records with HOMOSALATE, OCTISALATE, ZINC OXIDE 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 ProtecTINT 20C used for?
Stop use and ask a doctor if rash occurs

Who makes ProtecTINT 20C?
PML NYC, LLC is the labeler of record for ProtecTINT 20C. 3 FDA label records share the active ingredient HOMOSALATE, OCTISALATE, ZINC OXIDE, 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 ProtecTINT 20C 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 ProtecTINT 20C 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 HOMOSALATE, OCTISALATE, ZINC OXIDE?
Yes. 3 FDA drug label records list HOMOSALATE, OCTISALATE, ZINC OXIDE 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 ProtecTINT 20C 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.