Cream

Cream is an FDA-registered drug product whose active ingredient is ZINC OXIDE. It is labelled by Oxygen Development LLC taken by topical and marketed as a human otc drug product. Identifiers on file: NDC 61354-115, application M020, label effective 20231026. It is one of 404 FDA drug label records sharing the active ingredient 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 ZINC OXIDE are most often described in connection with: help prevent, sun protection, measures see, directions decreases, risk skin, agung caused. Wording differs between labels, and the full indications section on this page takes precedence when it is present.

Uses Help prevent sunburn. If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin agung caused by the sun.

Directions Apply liberally 15 minutes before sun exposure. Use water resistant sunscreen if swimming or sweating. Reapply at least every 2 hours. Sun protection measures: Spending time in the sun increases 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 10 am-2 pm. -wear long-sleeved shirts, pants, hats and sunglasses. -children under 6 months of age: Ask a doctor.

Warnings For external use only.

FDA lists 404 drug label records with 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.

5 FDA recall record(s) match this product name or manufacturer. A match means the firm or product name appears in the enforcement report; confirm lot numbers and dates against the official FDA notice before acting.

What is Cream used for?
Uses Help prevent sunburn. If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin agung caused by the sun.

Who makes Cream?
Oxygen Development LLC is the labeler of record for Cream. 404 FDA label records share the active ingredient 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 Cream 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 Cream 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?
Yes. 404 FDA drug label records list 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 Cream been recalled?
5 FDA recall record(s) match this product name or manufacturer. Review the recall and safety notices section on this page and confirm lot numbers against the official FDA enforcement report.

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.