Sunscreen SPF 50

AVOBENZONE 3% HOMOSALATE 10% OCTOCRYLENE 5% TOPICAL HUMAN OTC DRUG

Sunscreen SPF 50 is an FDA drug label for the active ingredient AVOBENZONE 3% HOMOSALATE 10% OCTOCRYLENE 5% manufactured by Worthy Promotional Products 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 20260706.

Generic name
AVOBENZONE 3% HOMOSALATE 10% OCTOCRYLENE 5%
Manufacturer
Worthy Promotional Products
Product type
HUMAN OTC DRUG
Route
TOPICAL
Dosage form
N/A
NDC
52260-018
Application
M020
Label effective
20260706

About this product

Sunscreen SPF 50 is an FDA-registered drug product whose active ingredient is AVOBENZONE 3% HOMOSALATE 10% OCTOCRYLENE 5%. It is labelled by Worthy Promotional Products taken by topical and marketed as a human otc drug product. Identifiers on file: NDC 52260-018, application M020, label effective 20260706. It is one of 2 FDA drug label records sharing the active ingredient AVOBENZONE 3% HOMOSALATE 10% OCTOCRYLENE 5%. 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 3% HOMOSALATE 10% OCTOCRYLENE 5% are most often described in connection with: helps prevent. Wording differs between labels, and the full indications section on this page takes precedence when it is present.

Active ingredients

Active Ingredients Purpose Avobenzone 3.0%, Homosalate 10 %, Octisalate 5.0%,,,,,,,,,,,,,,,,,,,,,,,,,,,.............Sunscreen

Indications & Usage

Uses · helps prevent sunburn

Dosage & Administration

Directions Shake well before usng · spray liberally and spread evenly by hand 15 minutes before sun exposure · reapply: · after 80 minutes of swimming or sweating · immediately after towel drying · at least every 2 hours · hold container 4 tob 6 inches from the skin to apply · do not spray directly into face. Spray on hands then apply to face · do not apply in windy conditions · use in a well-ventilated area. · 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 of 15 or higher and other sun protection measures including · limit time in the sun, especially from 10 a.m. - 2 p.m. · wear a long-sleeved shirts, pants, hats, and sunglasses. · children under 6 months: Ask a doctor.

Warnings

Warnings For external use only. Flammable :Do not use near heat, flame or while smoking. Do not use on damaged or broken skin. When using this product · keep out of eyes . Rinse with water to remove. · Do not puncture or incinerate. Contents under pressure. Do not store at temperatures above 1200F. Stop use and ask doctor ifr ash occurs.

How products containing AVOBENZONE 3% HOMOSALATE 10% OCTOCRYLENE 5% compare

FDA lists 2 drug label records with AVOBENZONE 3% HOMOSALATE 10% OCTOCRYLENE 5% 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.

Dosage formProductsManufacturerProducts
— — Worthy Promotional Products 2
— — — —
— — — —
— — — —
— — — —

Recall and safety notices

5 FDA recall record(s) match this product name or manufacturer. A match means the firm or product name appears in the enforcement report; confirm lot numbers and dates against the official FDA notice before acting.

RecallProductFirmClassStatusReported
D-0193-2026 Elixir by Coco March Mineral Sunscreen SPF 50, Zinc Oxide 21%, 2.1 oz (62g) per bottle, Distributed by: VitaTienda Co U.S.A., San Juan, PR 00646. NDC: 35192-048-17, UPC 8 10145 82007 0 CA BOTANA International, Inc. Class II Ongoing 20251203
D-0190-2026 Gabriel Mineral Sunscreen SPF 50, Zinc Oxide 21%, 2.1 oz, Net 61 g per tube, Dist. By: Gabriel Cosmetics, Inc., Redmond, WA USA 98052, NDC: 35192-044-01, UPC 7 07060 9592 1 CA BOTANA International, Inc. Class II Ongoing 20251203
D-0194-2026 Elixir by Coco March Tinted Mineral Sunscreen SPF 50, Zinc Oxide 21%, 2.1 oz (62g) per bottle, Distributed by: VitaTienda Co U.S.A., San Juan, PR 00646. NDC: 35192-050-17, UPC 6 7229 99913 8 CA BOTANA International, Inc. Class II Ongoing 20251203
D-0192-2026 Sugared+Bronzed Tinted Mineral Sunscreen SPF 50, Zinc Oxide 21%, Net WT 3.3 OZ (93 G) per tube, Dist. By: Sugared+Bronzed, 929 Montana Ave, Santa Monica, CA 90403. NDC: 35192-055-18, UPC 8 50047 92223 6 CA BOTANA International, Inc. Class II Ongoing 20251203
D-0183-2026 Doctor. D. Schwab Mineral Sunscreen SPF 50, Zinc Oxide 21%, 4 oz./ 113.4 g per tube, Manufactured by CA Botana, San Diego, CA 92123. NDC: 35192-042-02 CA BOTANA International, Inc. Class II Ongoing 20251203

Frequently asked questions

What is Sunscreen SPF 50 used for?
Uses · helps prevent sunburn

Who makes Sunscreen SPF 50?
Worthy Promotional Products is the labeler of record for Sunscreen SPF 50. 2 FDA label records share the active ingredient AVOBENZONE 3% HOMOSALATE 10% OCTOCRYLENE 5%, 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 Sunscreen 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 Sunscreen 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.

Are there other products containing AVOBENZONE 3% HOMOSALATE 10% OCTOCRYLENE 5%?
Yes. 2 FDA drug label records list AVOBENZONE 3% HOMOSALATE 10% OCTOCRYLENE 5% 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 Sunscreen SPF 50 been recalled?
5 FDA recall record(s) match this product name or manufacturer. Review the recall and safety notices section on this page and confirm lot numbers against the official FDA enforcement report.

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.