Physical Sunscreen SPF50 80 min WR 159-100

Physical Sunscreen SPF50 80 min WR 159-100 is an FDA-registered drug product whose active ingredient is TITANIUM DIOXIDE, TITANIUM DIOXIDE SUNSCREEN. It is labelled by Swiss-American CDMO, LLC taken by topical and marketed as a human otc drug product. Identifiers on file: NDC 60232-0044, application M020, label effective 20231109. 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 TITANIUM DIOXIDE, TITANIUM DIOXIDE SUNSCREEN are most often described in connection with: helps prevent, sun protection, measure 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 measure (See Directions), decreases the risk of skin cancer and early skin aging caused by the sun.

Directions Apply liberally 15 minutes before sun exposure. Reapply after 80 minutes of swimming or sweating, immediately after towel drying and 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 a physician if rash occurs. If product is swallowed get medical help or contact a Poison Control Center right away.

What is Physical Sunscreen SPF50 80 min WR 159-100 used for?
Uses Helps prevent sunburn. If used as directed with other sun protection measure (See Directions), decreases the risk of skin cancer and early skin aging caused by the sun.

Who makes Physical Sunscreen SPF50 80 min WR 159-100?
Swiss-American CDMO, LLC is the labeler of record for Physical Sunscreen SPF50 80 min WR 159-100.

What form does Physical Sunscreen SPF50 80 min WR 159-100 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 Physical Sunscreen SPF50 80 min WR 159-100 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.

Has Physical Sunscreen SPF50 80 min WR 159-100 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.