Ultra Violette Sheen Screen Broad Spectrum Hydrating Lip Balm Dusk

Ultra Violette Sheen Screen Broad Spectrum Hydrating Lip Balm Dusk is an FDA-registered drug product whose active ingredient is SPF50. It is labelled by Grace And Fire USA Inc. taken by topical and marketed as a human otc drug product. Identifiers on file: NDC 84803-104, application M020, label effective 20261001. It is one of 2 FDA drug label records sharing the active ingredient SPF50. 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 SPF50 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 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 value of 15 or higher and other sun protection measures including: * Limit time in the sun, especially from 10a.m.- 2p.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

FDA lists 2 drug label records with SPF50 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 Ultra Violette Sheen Screen Broad Spectrum Hydrating Lip Balm Dusk 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 Ultra Violette Sheen Screen Broad Spectrum Hydrating Lip Balm Dusk?
Grace And Fire USA Inc. is the labeler of record for Ultra Violette Sheen Screen Broad Spectrum Hydrating Lip Balm Dusk. 2 FDA label records share the active ingredient SPF50, 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 Ultra Violette Sheen Screen Broad Spectrum Hydrating Lip Balm Dusk 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 Ultra Violette Sheen Screen Broad Spectrum Hydrating Lip Balm Dusk 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 SPF50?
Yes. 2 FDA drug label records list SPF50 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 Ultra Violette Sheen Screen Broad Spectrum Hydrating Lip Balm Dusk 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.