BABIES KIDSSUN PROTECTION

MINERAL SUNSCREEN TOPICAL HUMAN OTC DRUG

BABIES KIDSSUN PROTECTION is an FDA drug label for the active ingredient MINERAL SUNSCREEN manufactured by PANERGYTEK 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 20260620.

Generic name
MINERAL SUNSCREEN
Manufacturer
PANERGYTEK USA INC
Product type
HUMAN OTC DRUG
Route
TOPICAL
Dosage form
N/A
NDC
85950-001
Application
M020
Label effective
20260620

About this product

BABIES KIDSSUN PROTECTION is an FDA-registered drug product whose active ingredient is MINERAL SUNSCREEN. It is labelled by PANERGYTEK USA INC taken by topical and marketed as a human otc drug product. Identifiers on file: NDC 85950-001, application M020, label effective 20260620. It is one of 4 FDA drug label records sharing the active ingredient MINERAL SUNSCREEN. 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 MINERAL SUNSCREEN are most often described in connection with: sun protection, apply liberally, sunexposure reapply, minutes ofswimming, sweating immediatelyafter, towel drying, measures spending, increasesyour risk. Wording differs between labels, and the full indications section on this page takes precedence when it is present.

Active ingredients

Titanium dioxide-19.5% Zinc oxide-24%

Indications & Usage

Apply liberally 15 minutes before sunexposure. Reapply: After 80 minutes ofswimming or sweating. immediatelyafter towel drying.At least every 2 hours.Sun Protection Measures.Spending time in the sun increasesyour risk of skin cancer and early skinaging. To decrease this risk, regularlyuse a sunscreen with a broadspectrum SPF value of 15 or higher.And other sun protection measuresincluding: Limit time in the sun,especially from 10am-2pm. wearlong-sleeved shirts, pants, hats andsunglasses. Children under 6months of age: ask a doctor

Dosage & Administration

Apply liberally 15 minutes before sunexposure. Reapply: After 80 minutes ofswimming or sweating. immediatelyafter towel drying.At least every 2 hours.Sun Protection Measures.Spending time in the sun increasesyour risk of skin cancer and early skinaging. To decrease this risk, regularlyuse a sunscreen with a broadspectrum SPF value of 15 or higher.And other sun protection measuresincluding: Limit time in the sun,especially from 10am-2pm. wearlong-sleeved shirts, pants, hats andsunglasses. Children under 6months of age: ask a doctor

Warnings

For external use only.Do not use on damaged or broken skinWhen using this product keep out ofeyes. Rinse with water to remove.Stop use and ask a doctor if rash occursKeep out of reach of children. lfproducts swallowed. get medical helpor contact a Poison Control Center rightaway.

More products with the same ingredient

MINERAL SUNSCREEN

Mineral Sunscreen SPF 50

ALAINA HEALTHCARE PRIVATE LIMITED View label

Mineral sunscreen

Guangzhou Origin Beauty Cosmetics Co., Ltd. View label

doTERRA Sun Body

doTERRA International, LLC View label

How products containing MINERAL SUNSCREEN compare

FDA lists 4 drug label records with MINERAL SUNSCREEN 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
— — ALAINA HEALTHCARE PRIVATE LIMITED 1
— — Guangzhou Origin Beauty Cosmetics Co., Ltd. 1
— — PANERGYTEK USA INC 1
— — doTERRA International, LLC 1
— — — —

Frequently asked questions

What is BABIES KIDSSUN PROTECTION used for?
Apply liberally 15 minutes before sunexposure. Reapply: After 80 minutes ofswimming or sweating. immediatelyafter towel drying.At least every 2 hours.Sun Protection Measures.Spending time in the sun increasesyour risk of skin cancer and early skinaging. To decrease this risk, regularlyuse a sunscreen with a broadspectrum SPF value of 15 or higher.And other sun protection measuresincluding: Limit …

Who makes BABIES KIDSSUN PROTECTION?
PANERGYTEK USA INC is the labeler of record for BABIES KIDSSUN PROTECTION. 4 FDA label records share the active ingredient MINERAL SUNSCREEN, 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 BABIES KIDSSUN PROTECTION 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 BABIES KIDSSUN PROTECTION 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 MINERAL SUNSCREEN?
Yes. 4 FDA drug label records list MINERAL SUNSCREEN 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 BABIES KIDSSUN PROTECTION 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.