ULTRA VIOLETTE Fave Screen Broad Spectrum SPF 50
ULTRA VIOLETTE Fave Screen Broad Spectrum SPF 50 is an FDA drug label for the active ingredient AVOBENZONE, BEMOTRIZINOL, OCTISALATE manufactured by Grace and Fire USA administered by TOPICAL. This page reproduces the FDA-approved indications and usage, dosage, contraindications, warnings, and adverse reactions exactly as published in the drug label. Data source: openFDA (U.S. FDA), label effective 20260901.
- Generic name
- AVOBENZONE, BEMOTRIZINOL, OCTISALATE
- Manufacturer
- Grace and Fire USA
- Product type
- HUMAN OTC DRUG
- Route
- TOPICAL
- Dosage form
- N/A
- NDC
- 84803-117
- Application
- M020
- Label effective
- 20260901
About this product
ULTRA VIOLETTE Fave Screen Broad Spectrum SPF 50 is an FDA-registered drug product whose active ingredient is AVOBENZONE, BEMOTRIZINOL, OCTISALATE. It is labelled by Grace and Fire USA taken by topical and marketed as a human otc drug product. Identifiers on file: NDC 84803-117, application M020, label effective 20260901. 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.
What it is used for
Across FDA labelling, products containing AVOBENZONE, BEMOTRIZINOL, OCTISALATE are most often described in connection with: helps prevent, sun protection, measures see, directions decreases, risk skin, aging casued. Wording differs between labels, and the full indications section on this page takes precedence when it is present.
Active ingredients
Indications & Usage
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 casued by the sun
Dosage & Administration
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 years of age: ask a doctor
Warnings
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 ask a doctor if rash occurs Keep out of reach of children. If swallowed, call a poison control center or get medical help right away.
Frequently asked questions
What is ULTRA VIOLETTE Fave Screen Broad Spectrum SPF 50 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 casued by the sun
Who makes ULTRA VIOLETTE Fave Screen Broad Spectrum SPF 50?
Grace and Fire USA is the labeler of record for ULTRA VIOLETTE Fave Screen Broad Spectrum SPF 50.
What form does ULTRA VIOLETTE Fave Screen Broad Spectrum SPF 50 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 Fave Screen Broad Spectrum SPF 50 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.
Has ULTRA VIOLETTE Fave Screen Broad Spectrum SPF 50 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.
This page reproduces FDA Structured Product Labelling data for identification and reference. It is not medical advice, does not diagnose or treat any condition, and does not sell or price any medicine.