COOLA Classic Body Sunscreen Fragrance-Free SPF 50

COOLA Classic Body Sunscreen Fragrance-Free SPF 50 is an FDA-registered drug product whose active ingredient is AVOBENZONE HOMOSALATE OCTISALATE OCTOCRYLENE. It is labelled by Bentley Laboratories, LLC taken by topical and marketed as a human otc drug product. Identifiers on file: NDC 54111-145, application M020, label effective 20231219. It is one of 3 FDA drug label records sharing the active ingredient AVOBENZONE HOMOSALATE OCTISALATE OCTOCRYLENE. 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 AVOBENZONE HOMOSALATE OCTISALATE OCTOCRYLENE are most often described in connection with: helps prevent, sun protection, measures see, directions decreases, risk skin, aging caused. Wording differs between labels, and the full indications section on this page takes precedence when it is present.

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

Directions • apply liberally 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 of 15 or higher and after 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

Warnings For external use only.

FDA lists 3 drug label records with AVOBENZONE HOMOSALATE OCTISALATE OCTOCRYLENE 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 COOLA Classic Body Sunscreen Fragrance-Free SPF 50 used for?
Uses • helps prevent sunburn • if used as directed with other sun protection measures (see Directions ) decreases the risk of skin cancer and early skin aging caused by the sun.

Who makes COOLA Classic Body Sunscreen Fragrance-Free SPF 50?
Bentley Laboratories, LLC is the labeler of record for COOLA Classic Body Sunscreen Fragrance-Free SPF 50. 3 FDA label records share the active ingredient AVOBENZONE HOMOSALATE OCTISALATE OCTOCRYLENE, 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 COOLA Classic Body Sunscreen Fragrance-Free SPF 50 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 COOLA Classic Body Sunscreen Fragrance-Free SPF 50 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 AVOBENZONE HOMOSALATE OCTISALATE OCTOCRYLENE?
Yes. 3 FDA drug label records list AVOBENZONE HOMOSALATE OCTISALATE OCTOCRYLENE 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 COOLA Classic Body Sunscreen Fragrance-Free SPF 50 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.