Ultra Violette Preen Screen Broad Spectrum SPF 50

AVONBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENE TOPICAL HUMAN OTC DRUG

Ultra Violette Preen Screen Broad Spectrum SPF 50 is an FDA drug label for the active ingredient AVONBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENE 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 20260601.

Generic name
AVONBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENE
Manufacturer
Grace and Fire USA Inc.
Product type
HUMAN OTC DRUG
Route
TOPICAL
Dosage form
N/A
NDC
84803-101
Application
M020
Label effective
20260601

About this product

Ultra Violette Preen Screen Broad Spectrum SPF 50 is an FDA-registered drug product whose active ingredient is AVONBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENE. It is labelled by Grace and Fire USA Inc. taken by topical and marketed as a human otc drug product. Identifiers on file: NDC 84803-101, application M020, label effective 20260601. 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 AVONBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENE are most often described in connection with: skin cancer, helps prevent, sun protection, measures see, directions decreases, aging caused. Wording differs between labels, and the full indications section on this page takes precedence when it is present.

Active ingredients

AVONBENZONE 3% HOMOSALATE 10% OCTISALATE 5% OCTOCRYLENE 6%

Indications & Usage

HELPS PREVENT SUNBURN If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer of skin cancer and early skin aging caused by the sun

Dosage & Administration

Hold container 4 to 6 inches from skin to apply. Spray on hands then apply to face. Do not apply in windy conditions. Use in a well-ventilated area and avoid inhalation. Apply liberally 15 minuts 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 sungasses. Children under 6 months of age: Ask a doctor.

Warnings

For external use only Do not use on damaged or broken skin 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, get medical help or contact a Poison Control Center right away

Frequently asked questions

What is Ultra Violette Preen Screen Broad Spectrum SPF 50 used for?
HELPS PREVENT SUNBURN If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer of skin cancer and early skin aging caused by the sun

Who makes Ultra Violette Preen Screen Broad Spectrum SPF 50?
Grace and Fire USA Inc. is the labeler of record for Ultra Violette Preen Screen Broad Spectrum SPF 50.

What form does Ultra Violette Preen 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 Preen 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 Preen 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.