Essential Moisturizing Sunscreen

ZINC OXIDE, OCTINOXATE TOPICAL HUMAN OTC DRUG

Essential Moisturizing Sunscreen is an FDA drug label for the active ingredient ZINC OXIDE, OCTINOXATE manufactured by Topiderm, 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 20230209.

Generic name
ZINC OXIDE, OCTINOXATE
Manufacturer
Topiderm, Inc.
Product type
HUMAN OTC DRUG
Route
TOPICAL
Dosage form
N/A
NDC
51326-122
Application
M020
Label effective
20230209

About this product

Essential Moisturizing Sunscreen is an FDA-registered drug product whose active ingredient is ZINC OXIDE, OCTINOXATE. It is labelled by Topiderm, Inc. taken by topical and marketed as a human otc drug product. Identifiers on file: NDC 51326-122, application M020, label effective 20230209. It is one of 5 FDA drug label records sharing the active ingredient ZINC OXIDE, OCTINOXATE. 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, OCTINOXATE 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 ingredient Purpose Zinc Oxide 14.8% Sunscreen Octinoxate 7.5% Sunscreen

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 to face and neck and spread evenly 15 minutes before sun exposure Re-apply after swimming, excessive perspiring, or anytime after towel drying Use a water resistant sunscreen if swimming or sweating Use on children under 6 months of age: consult a doctor.

Warnings

Warnings For external use only. When using this product keep out of eyes, rinse with water to remove. Stop use if signs of irritation or rash appear. If irritation or rash persists consult a doctor. Keep out of reach of children. In case of accidental ingestion, seek professional assistance or contact a Poison Control Center immediately.

More products with the same ingredient

ZINC OXIDE, OCTINOXATE

Broad Spectrum SPF45

Drmtlgy, LLC View label

Dr.Denese SPF 30 Defense Day

SkinScience Labs, Inc View label

Sheer Defense Tinted Broad Spectrum Sunscreen SPF 50

Private Label Skin Care View label

Sheer Defense Tinted SPF 46

Private Label Skin Care View label

How products containing ZINC OXIDE, OCTINOXATE compare

FDA lists 5 drug label records with ZINC OXIDE, OCTINOXATE 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
— — Private Label Skin Care 2
— — Drmtlgy, LLC 1
— — SkinScience Labs, Inc 1
— — Topiderm, Inc. 1
— — — —

Frequently asked questions

What is Essential Moisturizing Sunscreen 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 Essential Moisturizing Sunscreen?
Topiderm, Inc. is the labeler of record for Essential Moisturizing Sunscreen. 5 FDA label records share the active ingredient ZINC OXIDE, OCTINOXATE, 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 Essential Moisturizing Sunscreen 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 Essential Moisturizing Sunscreen 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, OCTINOXATE?
Yes. 5 FDA drug label records list ZINC OXIDE, OCTINOXATE 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 Essential Moisturizing Sunscreen 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.