ELROEL Pang Pang Sun Cushion S7

ZINC OXIDE, TITANIUM DIOXIDE, OCTINOXATE, OCTISALATE TOPICAL HUMAN OTC DRUG

ELROEL Pang Pang Sun Cushion S7 is an FDA drug label for the active ingredient ZINC OXIDE, TITANIUM DIOXIDE, OCTINOXATE, OCTISALATE manufactured by MONOGLOT HOLDINGS 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 20260417.

Generic name
ZINC OXIDE, TITANIUM DIOXIDE, OCTINOXATE, OCTISALATE
Manufacturer
MONOGLOT HOLDINGS Inc.
Product type
HUMAN OTC DRUG
Route
TOPICAL
Dosage form
N/A
NDC
83154-003
Application
M020
Label effective
20260417

About this product

ELROEL Pang Pang Sun Cushion S7 is an FDA-registered drug product whose active ingredient is ZINC OXIDE, TITANIUM DIOXIDE, OCTINOXATE, OCTISALATE. It is labelled by MONOGLOT HOLDINGS Inc. taken by topical and marketed as a human otc drug product. Identifiers on file: NDC 83154-003, application M020, label effective 20260417. 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, TITANIUM DIOXIDE, OCTINOXATE, OCTISALATE 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

ZINC OXIDE 9.70% OCTINOXATE 7.00% OCTISALATE 3.00% TITANIUM DIOXIDE 1.52%

Indications & Usage

Helps prevent sunburn

Dosage & Administration

For sunscreen use: ■ apply liberally 15 minutes before sun exposure ■ reapply at least every two 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

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 using and ask a doctor if rash occurs.

Frequently asked questions

What is ELROEL Pang Pang Sun Cushion S7 used for?
Helps prevent sunburn

Who makes ELROEL Pang Pang Sun Cushion S7?
MONOGLOT HOLDINGS Inc. is the labeler of record for ELROEL Pang Pang Sun Cushion S7.

What form does ELROEL Pang Pang Sun Cushion S7 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 ELROEL Pang Pang Sun Cushion S7 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 ELROEL Pang Pang Sun Cushion S7 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.