Pure Haven Essentials

Pure Haven Essentials is an FDA-registered drug product whose active ingredient is TITANIUM DIOXIDE, ZINC OXIDE. It is labelled by Pure Haven LLC taken by topical and marketed as a human otc drug product. Identifiers on file: NDC 71355-819, application M020, label effective 20231111. 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, 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. Reapply: - At least every tow-hours. - Immediately after swimming, sweating or towel drying. Spending time in the sun increase your risk of skin cancer and early skin aging . To decrease this risk, regularly use sunscreen with broad spectrum protection and an SPF rating of 15 or higher, along with other sun protection measures including: Sun protection measures. - Limit time in the sun, especially between 10am and 2pm. - Wear long sleeve shirts, pants, hats and sunglasses. - For childre under 6-months, consult with a physician.

Warnings: For external use 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 consult physician if irritation or rash develops. Keep out of reach of children. If product is swallowed, get medical attention or contact poison control center immediately.

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 Pure Haven Essentials 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 Pure Haven Essentials?
Pure Haven LLC is the labeler of record for Pure Haven Essentials. 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 Pure Haven Essentials 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 Pure Haven Essentials 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 Pure Haven Essentials 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.