Image Prevention Refiner Primer SPF50

Image Prevention Refiner Primer SPF50 is an FDA-registered drug product whose active ingredient is ZINC OXIDE, 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 60232-1830, application M020, label effective 20231106. It is one of 2 FDA drug label records sharing the active ingredient ZINC OXIDE, TITANIUM DIOXIDE 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 ZINC OXIDE, TITANIUM DIOXIDE SUNSCREEN are most often described in connection with: helps prevent, sun protection, measures 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 measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun.

Directions Apply generously 15 minutes before sun exposure. Children under 6 months of age: ask a doctor. Reapply at least every 2 hours. Use a water resistant sunscreen if swimming or sweating. Immediately after towel drying. At least every 2 hours. Use a water resistant sunscreen when swimming or sweating, immediately after towel drying, at least every two 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 value of 15 or higher and other sun protection measures including: limit time in the sun, especially from 10am to 2pm, wear long-sleeved shirts, pants, hats and sunglasses.

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

FDA lists 2 drug label records with ZINC OXIDE, TITANIUM DIOXIDE 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 Prevention Refiner Primer SPF50 used for?
Uses Helps prevent sunburn. If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun.

Who makes Image Prevention Refiner Primer SPF50?
Swiss-American CDMO, LLC is the labeler of record for Image Prevention Refiner Primer SPF50. 2 FDA label records share the active ingredient ZINC OXIDE, TITANIUM DIOXIDE 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 Prevention Refiner Primer SPF50 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 Prevention Refiner Primer SPF50 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 ZINC OXIDE, TITANIUM DIOXIDE SUNSCREEN?
Yes. 2 FDA drug label records list ZINC OXIDE, TITANIUM DIOXIDE 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 Prevention Refiner Primer SPF50 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.