Image MD Restoring Lip Enhancer SPF15

Image MD Restoring Lip Enhancer SPF15 is an FDA-registered drug product whose active ingredient is SUNSCREEN. It is labelled by Swiss-American CDMO, LLC taken by topical and marketed as a human otc drug product. Identifiers on file: NDC 60232-3537, application M020, label effective 20231106. It is one of 10 FDA drug label records sharing the active ingredient SUNSCREEN. 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 SUNSCREEN are most often described in connection with: sun protection, directions apply, liberally minutes, water-resistant sunscreen, swimming sweating, reapply least, measures spending, risk skin. Wording differs between labels, and the full indications section on this page takes precedence when it is present.

Directions Apply liberally 15 minutes before sun exposure. Use a water-resistant sunscreen if swimming or sweating. Reapply 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 other sun protection measures including: limit time in the sun, especially from 10 am to 2 pm. Wear long-sleeve shirts, pants, hats, and sunglasses. Children under 6 months: ask a physician.

Directions Apply liberally 15 minutes before sun exposure. Use a water-resistant sunscreen if swimming or sweating. Reapply 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 other sun protection measures including: limit time in the sun, especially from 10 am to 2 pm. Wear long-sleeve shirts, pants, hats, and sunglasses. Children under 6 months: ask a physician.

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 rash occurs. If swallowed get medical help or contact a Poison Control Center right away.

FDA lists 10 drug label records with SUNSCREEN 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 Image MD Restoring Lip Enhancer SPF15 used for?
Directions Apply liberally 15 minutes before sun exposure. Use a water-resistant sunscreen if swimming or sweating. Reapply 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 other sun protection measures including: limit …

Who makes Image MD Restoring Lip Enhancer SPF15?
Swiss-American CDMO, LLC is the labeler of record for Image MD Restoring Lip Enhancer SPF15. 10 FDA label records share the active ingredient SUNSCREEN, 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 Image MD Restoring Lip Enhancer SPF15 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 Image MD Restoring Lip Enhancer SPF15 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 SUNSCREEN?
Yes. 10 FDA drug label records list SUNSCREEN 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 Image MD Restoring Lip Enhancer SPF15 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.