COOLA Refreshing Water Mist SPF 18

COOLA Refreshing Water Mist SPF 18 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 54111-148, application M020, label effective 20231219. It is one of 105 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 • shake well • apply liberally 15 minutes before sun exposure • reapply: •after 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 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 long-sleeved shirts, pants, hats, and sunglasses • children under 6 months: Ask a doctor

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 doctor if skin rash occurs

FDA lists 105 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 Refreshing Water Mist SPF 18 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 Refreshing Water Mist SPF 18?
Bentley Laboratories, LLC is the labeler of record for COOLA Refreshing Water Mist SPF 18. 105 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 Refreshing Water Mist SPF 18 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 Refreshing Water Mist SPF 18 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. 105 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 Refreshing Water Mist SPF 18 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.