PoutScreen Lip Treatment Lemon Meringue

PoutScreen Lip Treatment Lemon Meringue is an FDA-registered drug product whose active ingredient is AVOBENZONE, OCTINOXATE, OCTOCRYLENE. It is labelled by NAKED SUNDAYS PTY LTD taken by topical and marketed as a human otc drug product. Identifiers on file: NDC 81104-603, application M020, label effective 20260710. It is one of 4 FDA drug label records sharing the active ingredient AVOBENZONE, OCTINOXATE, 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, OCTOCRYLENE are most often described in connection with: helps prevent, sun protection, measures see, directions decreases, risk skin, ageing caused. Wording differs between labels, and the full indications section on this page takes precedence when it is present.

Use: • Helps prevent sunburn. • If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin ageing caused by the sun

Directions: • Apply liberally and evenly 15 minutes before sun exposure. • Re-apply at least every 80 minutes or immediately after swimming, sweating or towel drying. • Use a water-resistant sunscreen if swimming or sweating. 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 a Broad Spectrum SPF value of 15 or higher and other sun protection measures including: • Limit time in the sun, especially from 10.00AM - 2.00PM • Wear long-sleeved shirts, pants, hats, and sunglasses

Warnings: For external use only. • Do not use on damaged or broken skin.

FDA lists 4 drug label records with AVOBENZONE, OCTINOXATE, 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 PoutScreen Lip Treatment Lemon Meringue used for?
Use: • Helps prevent sunburn. • If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin ageing caused by the sun

Who makes PoutScreen Lip Treatment Lemon Meringue?
NAKED SUNDAYS PTY LTD is the labeler of record for PoutScreen Lip Treatment Lemon Meringue. 4 FDA label records share the active ingredient AVOBENZONE, OCTINOXATE, 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 PoutScreen Lip Treatment Lemon Meringue 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 PoutScreen Lip Treatment Lemon Meringue 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, OCTOCRYLENE?
Yes. 4 FDA drug label records list AVOBENZONE, OCTINOXATE, 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 PoutScreen Lip Treatment Lemon Meringue 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.