Lip Balm SPF 15

Lip Balm SPF 15 is an FDA-registered drug product whose active ingredient is AVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENE. It is labelled by Skin Script, LLC taken by topical and marketed as a human otc drug product. Identifiers on file: NDC 83657-600, application M020, label effective 20260819. It is one of 6 FDA drug label records sharing the active ingredient AVOBENZONE, OCTINOXATE, 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, OCTINOXATE, OCTISALATE, OCTOCRYLENE 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 apply liberally 15 minutes before sun exposure Use a water resistant sunscreen if swimming or sweating Reapply at least every 2 hours Children under 6 months of age: Ask a doctor 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 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 sleeved shirts, pants, hats, and sunglasses.

Warnings For External Use Only Do not use on damaged or broken skin Stop and ask a doctor if rash occurs When using this product keep out of eyes. Rinse with water to remove.

FDA lists 6 drug label records with AVOBENZONE, OCTINOXATE, 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 Lip Balm SPF 15 used for?
Uses Helps prevent sunburn

Who makes Lip Balm SPF 15?
Skin Script, LLC is the labeler of record for Lip Balm SPF 15. 6 FDA label records share the active ingredient AVOBENZONE, OCTINOXATE, 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 Lip Balm SPF 15 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 Lip Balm SPF 15 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, OCTINOXATE, OCTISALATE, OCTOCRYLENE?
Yes. 6 FDA drug label records list AVOBENZONE, OCTINOXATE, 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 Lip Balm SPF 15 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.