ULTRA VIOLETTE Unblock Screen SPF 50 Sunscreen
ULTRA VIOLETTE Unblock Screen SPF 50 Sunscreen is an FDA drug label for the active ingredient BEMOTRIZINOL, OCTOCRYLENE, ZINC OXIDE manufactured by Grace and Fire USA Inc. 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 20260809.
- Generic name
- BEMOTRIZINOL, OCTOCRYLENE, ZINC OXIDE
- Manufacturer
- Grace and Fire USA Inc.
- Product type
- HUMAN OTC DRUG
- Route
- TOPICAL
- Dosage form
- N/A
- NDC
- 84803-116
- Application
- M020
- Label effective
- 20260809
About this product
ULTRA VIOLETTE Unblock Screen SPF 50 Sunscreen is an FDA-registered drug product whose active ingredient is BEMOTRIZINOL, OCTOCRYLENE, ZINC OXIDE. It is labelled by Grace and Fire USA Inc. taken by topical and marketed as a human otc drug product. Identifiers on file: NDC 84803-116, application M020, label effective 20260809. 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 BEMOTRIZINOL, OCTOCRYLENE, ZINC OXIDE are most often described in connection with: helps prevent, sun protection, measures see, directions decreases, risk early, skin aging. 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 with other sun protection measures (see Directions), decreases the risk of early skin aging caused 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 decrase this risk, regularly use a Broad-Spectrum SPF value of 15 or higher and other sun protection measures including: limit time in the sun, especially from 10am - 2pm wear long-sleeved shirts, pants, hats, and sunglasses children under 6 months 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 Unblock Screen SPF 50 Sunscreen used for?
Uses Helps prevent sunburn If used with other sun protection measures (see Directions), decreases the risk of early skin aging caused by the sun
Who makes ULTRA VIOLETTE Unblock Screen SPF 50 Sunscreen?
Grace and Fire USA Inc. is the labeler of record for ULTRA VIOLETTE Unblock Screen SPF 50 Sunscreen.
What form does ULTRA VIOLETTE Unblock Screen SPF 50 Sunscreen 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 Unblock Screen SPF 50 Sunscreen 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 Unblock Screen SPF 50 Sunscreen 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.