Homosalate, Octisalate, Zinc oxide

HOMOSALATE, OCTISALATE, ZINC OXIDE TOPICAL HUMAN OTC DRUG

Homosalate, Octisalate, Zinc oxide is an FDA drug label for the active ingredient HOMOSALATE, OCTISALATE, ZINC OXIDE manufactured by Aldi 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 20260824.

Generic name
HOMOSALATE, OCTISALATE, ZINC OXIDE
Manufacturer
Aldi Inc
Product type
HUMAN OTC DRUG
Route
TOPICAL
Dosage form
N/A
NDC
64024-957
Application
M020
Label effective
20260824

About this product

Homosalate, Octisalate, Zinc oxide is an FDA-registered drug product whose active ingredient is HOMOSALATE, OCTISALATE, ZINC OXIDE. It is labelled by Aldi Inc taken by topical and marketed as a human otc drug product. Identifiers on file: NDC 64024-957, application M020, label effective 20260824. It is one of 3 FDA drug label records sharing the active ingredient HOMOSALATE, OCTISALATE, ZINC OXIDE. 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, OCTISALATE, ZINC OXIDE are most often described in connection with: helps prevent, sun protection, measures 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 10% Octisalate 5% Zinc Oxide 6.3%

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 caused by the sun

Dosage & Administration

Directions apply liberally {and evenly} 15 minutes before sun exposure apply to all skin exposed to the sun 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 10 a.m.–2 p.m. wear long-sleeved shirts, pants, hats and sunglasses children under 6 months of age: Ask a doctor

Warnings

Warnings For external use only

Adverse Reactions

Adverse Reactions DIST. & SOLD EXCLUSIVELY BY: ALDI, BATAVIA, IL 60510 www.ALDI.us 844-484-0332

More products with the same ingredient

HOMOSALATE, OCTISALATE, ZINC OXIDE

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SEAWEED BATH CO Cooling Mist SPF-60 Sport

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How products containing HOMOSALATE, OCTISALATE, ZINC OXIDE compare

FDA lists 3 drug label records with HOMOSALATE, OCTISALATE, ZINC OXIDE 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
— — Aldi Inc 1
— — PML NYC, LLC 1
— — The Seaweed Bath Co. 1
— — — —
— — — —

Frequently asked questions

What is Homosalate, Octisalate, Zinc oxide 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 caused by the sun

Who makes Homosalate, Octisalate, Zinc oxide?
Aldi Inc is the labeler of record for Homosalate, Octisalate, Zinc oxide. 3 FDA label records share the active ingredient HOMOSALATE, OCTISALATE, ZINC OXIDE, 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 Homosalate, Octisalate, Zinc oxide 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 Homosalate, Octisalate, Zinc oxide 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 HOMOSALATE, OCTISALATE, ZINC OXIDE?
Yes. 3 FDA drug label records list HOMOSALATE, OCTISALATE, ZINC OXIDE 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 Homosalate, Octisalate, Zinc oxide 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.