PRIDEFUL SPF 15 LIP BALM-melon

PRIDEFUL SPF 15 LIP BALM-melon is an FDA-registered drug product whose active ingredient is HOMOSALATE, OCTISALATE, OCTOCRYLENE, AVOBENZONE. It is labelled by PRIDEFUL LLC taken by topical and marketed as a human otc drug product. Identifiers on file: NDC 82866-003, application M020, label effective 20231026. It is one of 9 FDA drug label records sharing the active ingredient HOMOSALATE, OCTISALATE, OCTOCRYLENE, AVOBENZONE. 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, OCTOCRYLENE, AVOBENZONE 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.

Use Helps prevent sunburn.

Directions Apply liberally 15 minutes before sun exposure; Use a water resistant sunscreen if swimming or swimming or sweating Reapply at least every 2 hours; Children under 6 month: Ask a doctor.

Warnings For external use only. Do not use on damaged or broken skin. Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to help prevent sunrbun, not skin cancer or early skin aging. Skin Cancer/Skin Aging Alert When using this product Keep out of eyes. Rinse with water to remove. Stop use and ask doctor if rash occurs. Keep out of reach of children If swallowed, get medical help or contact a Poison Control Center right away.

FDA lists 9 drug label records with HOMOSALATE, OCTISALATE, OCTOCRYLENE, AVOBENZONE 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 PRIDEFUL SPF 15 LIP BALM-melon used for?
Use Helps prevent sunburn.

Who makes PRIDEFUL SPF 15 LIP BALM-melon?
PRIDEFUL LLC is the labeler of record for PRIDEFUL SPF 15 LIP BALM-melon. 9 FDA label records share the active ingredient HOMOSALATE, OCTISALATE, OCTOCRYLENE, AVOBENZONE, 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 PRIDEFUL SPF 15 LIP BALM-melon 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 PRIDEFUL SPF 15 LIP BALM-melon 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, OCTOCRYLENE, AVOBENZONE?
Yes. 9 FDA drug label records list HOMOSALATE, OCTISALATE, OCTOCRYLENE, AVOBENZONE 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 PRIDEFUL SPF 15 LIP BALM-melon 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.