Private Label Sunscreen SPF35 40min WR RE126-202

HOMOSALATE, ZINC OXIDE SUNSCREEN TOPICAL HUMAN OTC DRUG

Private Label Sunscreen SPF35 40min WR RE126-202 is an FDA drug label for the active ingredient HOMOSALATE, ZINC OXIDE SUNSCREEN manufactured by Swiss-American CDMO, LLC 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 20231109.

Generic name
HOMOSALATE, ZINC OXIDE SUNSCREEN
Manufacturer
Swiss-American CDMO, LLC
Product type
HUMAN OTC DRUG
Route
TOPICAL
Dosage form
N/A
NDC
60232-0036
Application
M020
Label effective
20231109

About this product

Private Label Sunscreen SPF35 40min WR RE126-202 is an FDA-registered drug product whose active ingredient is HOMOSALATE, ZINC OXIDE SUNSCREEN. It is labelled by Swiss-American CDMO, LLC taken by topical and marketed as a human otc drug product. Identifiers on file: NDC 60232-0036, application M020, label effective 20231109. 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 HOMOSALATE, ZINC OXIDE SUNSCREEN are most often described in connection with: helps prevent, sun protection, measure 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.

Active ingredients

Active Ingredients Homosalate 9.0% Sunscreen Zinc Oxide 10.0% Sunscreen Octisalate 5.0% Sunscreen

Indications & Usage

uses Helps prevent sunburn. If used as directed with other sun protection measure (See Directions), decreases the risk of skin cancer and early skin aging caused by the sun.

Dosage & Administration

Directions Apply liberally 15 minutes before sun exposure. Reapply after 40 minutes of swimming or sweating, immediately after towel drying and at least every 2 hours. 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 am to 2 pm. Wear long-sleeve shirts, pants, hats, and sunglasses. Children under 6 months: ask a physician.

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 physician if rash occurs. If product is swallowed get medical help or contact a Poison Control Center right away.

Frequently asked questions

What is Private Label Sunscreen SPF35 40min WR RE126-202 used for?
uses Helps prevent sunburn. If used as directed with other sun protection measure (See Directions), decreases the risk of skin cancer and early skin aging caused by the sun.

Who makes Private Label Sunscreen SPF35 40min WR RE126-202?
Swiss-American CDMO, LLC is the labeler of record for Private Label Sunscreen SPF35 40min WR RE126-202.

What form does Private Label Sunscreen SPF35 40min WR RE126-202 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 Private Label Sunscreen SPF35 40min WR RE126-202 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 Private Label Sunscreen SPF35 40min WR RE126-202 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.