SIMPLI DAY All In One SmartCream SPF 42

ZINC OXIDE, OCTISALATE, OCTOCRYLENE, ENSULIZOLE TOPICAL HUMAN OTC DRUG

SIMPLI DAY All In One SmartCream SPF 42 is an FDA drug label for the active ingredient ZINC OXIDE, OCTISALATE, OCTOCRYLENE, ENSULIZOLE manufactured by SIMPLI SKIN MD LLC 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 20231111.

Generic name
ZINC OXIDE, OCTISALATE, OCTOCRYLENE, ENSULIZOLE
Manufacturer
SIMPLI SKIN MD LLC
Product type
HUMAN OTC DRUG
Route
TOPICAL
Dosage form
N/A
NDC
82733-294
Application
M020
Label effective
20231111

About this product

SIMPLI DAY All In One SmartCream SPF 42 is an FDA-registered drug product whose active ingredient is ZINC OXIDE, OCTISALATE, OCTOCRYLENE, ENSULIZOLE. It is labelled by SIMPLI SKIN MD LLC taken by topical and marketed as a human otc drug product. Identifiers on file: NDC 82733-294, application M020, label effective 20231111. 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, OCTISALATE, OCTOCRYLENE, ENSULIZOLE are most often described in connection with: helps prevent, sun protection, measures see, 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 Zinc Oxide 5% Octisalate 5% Octocrylene 5% Ensulizole 4% Purpose Sunscreen

Indications & Usage

Uses Helps prevent sunburn. If used as directed with other sun protection measures (see ), decreases the risk of skin cancer and early skin aging caused by the sun. Directions

Dosage & Administration

Directions Apply liberally each morning 15 minutes before sun exposure. During sun exposure, reapply: after 80 minutes of swimming or sweating immediately after towel drying at least every 2 hours 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 of 15 or higher and other sun protection measures including: Sun Protection Measures: limit time in the sun, especially from 10 a.m. - 2 p.m. wear long-sleeve shirts, pants, hats, and sunglasses Children under 6 months: ask a doctor

Warnings

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 use and ask doctor if rash or irritation occurs Keep out of each of children. If swallowed, get medical help or contact a Poison Control Center right away

Frequently asked questions

What is SIMPLI DAY All In One SmartCream SPF 42 used for?
Uses Helps prevent sunburn. If used as directed with other sun protection measures (see ), decreases the risk of skin cancer and early skin aging caused by the sun. Directions

Who makes SIMPLI DAY All In One SmartCream SPF 42?
SIMPLI SKIN MD LLC is the labeler of record for SIMPLI DAY All In One SmartCream SPF 42.

What form does SIMPLI DAY All In One SmartCream SPF 42 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 SIMPLI DAY All In One SmartCream SPF 42 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 SIMPLI DAY All In One SmartCream SPF 42 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.