Baby Butz

ZINC OXIDE TOPICAL HUMAN OTC DRUG

Baby Butz is an FDA drug label for the active ingredient ZINC OXIDE manufactured by Olen Skin Care Corporation 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 20260610.

Generic name
ZINC OXIDE
Manufacturer
Olen Skin Care Corporation
Product type
HUMAN OTC DRUG
Route
TOPICAL
Dosage form
N/A
NDC
52358-0001
Application
M016
Label effective
20260610

About this product

Baby Butz is an FDA-registered drug product whose active ingredient is ZINC OXIDE. It is labelled by Olen Skin Care Corporation taken by topical and marketed as a human otc drug product. Identifiers on file: NDC 52358-0001, application M016, label effective 20260610. It is one of 404 FDA drug label records sharing the active ingredient 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 ZINC OXIDE are most often described in connection with: diaper rash, helps treat, protects chafed, skin due. Wording differs between labels, and the full indications section on this page takes precedence when it is present.

Active ingredients

Active Ingredients Zinc Oxide 30%

Indications & Usage

Use Helps treat and prevent diaper rash Protects chafed skin due to diaper rash Helps seal out wetness

Dosage & Administration

Directions Change wet or soiled diapers promptly. Cleanse the diaper area and allow to dry. Apply cream liberally as often as necessary with each diaper change especially at bedtime or any time exposure to wet diaper my be prolonged.

Warnings

Warnings For External Use Only

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How products containing ZINC OXIDE compare

FDA lists 404 drug label records with 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
— — Ilia, Inc. 30
— — COSMAX USA, CORP 24
— — Colorescience 16
— — Allure Labs Inc 9
— — Raw Elements LLC 9

Frequently asked questions

What is Baby Butz used for?
Use Helps treat and prevent diaper rash Protects chafed skin due to diaper rash Helps seal out wetness

Who makes Baby Butz?
Olen Skin Care Corporation is the labeler of record for Baby Butz. 404 FDA label records share the active ingredient 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 Baby Butz 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 Baby Butz 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 ZINC OXIDE?
Yes. 404 FDA drug label records list 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 Baby Butz 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.