Max Mineral

Max Mineral is an FDA-registered drug product whose active ingredient is TITANIUM DIOXIDE, ZINC OXIDE. It is labelled by Peter Thomas Roth Labs, LLC taken by topical and marketed as a human otc drug product. Identifiers on file: NDC 54031-020, application M020, label effective 20231114. It is one of 84 FDA drug label records sharing the active ingredient TITANIUM DIOXIDE, ZINC OXIDE. 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, ZINC OXIDE are most often described in connection with: helps prevent, sun protection, measures see, directions decreases, risk skin, early skinaging. Wording differs between labels, and the full indications section on this page takes precedence when it is present.

Uses helps prevent sunburn lf used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skinaging caused by the sun

Directions apply liberally 15 minutes before sun exposure reapply at least every 2 hours use a water•resistant sunscreen if swimming or sweating 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 a.m. to 2 p.m. wear long•sleeved shirts, pants, hats, and sunglasses children under 6 months of age: ask a doctor

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 aska doctor if rash occurs. Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.

FDA lists 84 drug label records with TITANIUM DIOXIDE, ZINC OXIDE 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 Max Mineral used for?
Uses helps prevent sunburn lf used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skinaging caused by the sun

Who makes Max Mineral?
Peter Thomas Roth Labs, LLC is the labeler of record for Max Mineral. 84 FDA label records share the active ingredient TITANIUM DIOXIDE, ZINC OXIDE, 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 Max Mineral 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 Max Mineral 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 TITANIUM DIOXIDE, ZINC OXIDE?
Yes. 84 FDA drug label records list TITANIUM DIOXIDE, ZINC OXIDE 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 Max Mineral 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.