SPF 50 Kids Sunscreen

SPF 50 Kids Sunscreen is an FDA-registered drug product whose active ingredient is HOMOSALATE 10% OCTISALATE 5% AVOBENZONE 3%. It is labelled by Coconut Caliente Costa Rica LLC taken by topical and marketed as a human otc drug product. Identifiers on file: NDC 85033-002, application M020, label effective 20260507. It is one of 6 FDA drug label records sharing the active ingredient HOMOSALATE 10% OCTISALATE 5% AVOBENZONE 3%. 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 10% OCTISALATE 5% AVOBENZONE 3% 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 pply evenly to face and neck 15 minutes before sun exposure reapply: After 80 minutes of swimming or sweating . Immediately after towel drying . At least every 2 hours • 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 10a.m.– 2p.m. . Wear long-sleeve shirts, pants, hats, and sunglasses. . Children under 6 months: Ask a doctor.

Warnings For external use only. Do not useon damaged or broken skin. When using this product• keep out of eyes. Rinse with water to remove. Stop use and ask a doctor ifrash occurs.

FDA lists 6 drug label records with HOMOSALATE 10% OCTISALATE 5% AVOBENZONE 3% 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 SPF 50 Kids Sunscreen used for?
Uses Helps prevent sunburn

Who makes SPF 50 Kids Sunscreen?
Coconut Caliente Costa Rica LLC is the labeler of record for SPF 50 Kids Sunscreen. 6 FDA label records share the active ingredient HOMOSALATE 10% OCTISALATE 5% AVOBENZONE 3%, 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 SPF 50 Kids 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 SPF 50 Kids 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 HOMOSALATE 10% OCTISALATE 5% AVOBENZONE 3%?
Yes. 6 FDA drug label records list HOMOSALATE 10% OCTISALATE 5% AVOBENZONE 3% 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 SPF 50 Kids 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.