EXTREME PROTECT SPF 30

EXTREME PROTECT SPF 30 is an FDA-registered drug product whose active ingredient is OCTINOXATE, ZINC OXIDE. It is labelled by SCIENCE OF SKINCARE LLC taken by topical and marketed as a human otc drug product. Identifiers on file: NDC 69219-103, application M020, label effective 20260501. It is one of 3 FDA drug label records sharing the active ingredient OCTINOXATE, 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 OCTINOXATE, ZINC OXIDE 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 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: o limit time in the sun, especially from 10 a.m.-2 p.m. o wear long-sleeve shirts, pants, hats, and sunglasses • Children under 6 months: Ask a doctor

WARNINGS • For external use only

FDA lists 3 drug label records with OCTINOXATE, 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 EXTREME PROTECT SPF 30 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 EXTREME PROTECT SPF 30?
SCIENCE OF SKINCARE LLC is the labeler of record for EXTREME PROTECT SPF 30. 3 FDA label records share the active ingredient OCTINOXATE, 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 EXTREME PROTECT SPF 30 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 EXTREME PROTECT SPF 30 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 OCTINOXATE, ZINC OXIDE?
Yes. 3 FDA drug label records list OCTINOXATE, 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 EXTREME PROTECT SPF 30 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.