Image Skincare Prevention Plus Daily Ultimate Protection

HOMOSALATE, OCTISALATE, OCTOCRYLENE, ZINC OXIDE SUNSCREEN TOPICAL HUMAN OTC DRUG

Image Skincare Prevention Plus Daily Ultimate Protection is an FDA drug label for the active ingredient HOMOSALATE, OCTISALATE, OCTOCRYLENE, ZINC OXIDE SUNSCREEN manufactured by Swiss-American CDMO, 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 20231106.

Generic name
HOMOSALATE, OCTISALATE, OCTOCRYLENE, ZINC OXIDE SUNSCREEN
Manufacturer
Swiss-American CDMO, LLC
Product type
HUMAN OTC DRUG
Route
TOPICAL
Dosage form
N/A
NDC
60232-1022
Application
M020
Label effective
20231106

About this product

Image Skincare Prevention Plus Daily Ultimate Protection is an FDA-registered drug product whose active ingredient is HOMOSALATE, OCTISALATE, OCTOCRYLENE, ZINC OXIDE SUNSCREEN. It is labelled by Swiss-American CDMO, LLC taken by topical and marketed as a human otc drug product. Identifiers on file: NDC 60232-1022, application M020, label effective 20231106. It is one of 2 FDA drug label records sharing the active ingredient HOMOSALATE, OCTISALATE, OCTOCRYLENE, ZINC OXIDE 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 HOMOSALATE, OCTISALATE, OCTOCRYLENE, ZINC OXIDE SUNSCREEN 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 Ingredients Homosalate 10.0% Sunscreen Octisalate 5.0% Sunscreen Octocrylene 6.0% Sunscreen Zinc Oxide 9.0% 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 for Sunscreen Use Apply generously 15 minutes before sun exposure. Children under 6 months of age: ask a doctor. Reapply at least every 2 hours. Use a water resistant sunscreen if swimming or sweating. Immediately after towel drying. At least every 2 hours. 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 10am to 2pm, wear long-sleeved shirts, pants, hats and sunglasses.

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 a doctor if rash occurs. If swallowed, get medical help or contact a Poison Control Center right away.

More products with the same ingredient

HOMOSALATE, OCTISALATE, OCTOCRYLENE, ZINC OXIDE SUNSCREEN

Image Prevention Plus Professional Ultimate Protection Moisturizer SPF50

Swiss-American CDMO, LLC View label

How products containing HOMOSALATE, OCTISALATE, OCTOCRYLENE, ZINC OXIDE SUNSCREEN compare

FDA lists 2 drug label records with HOMOSALATE, OCTISALATE, OCTOCRYLENE, ZINC OXIDE 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
— — Swiss-American CDMO, LLC 2
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Frequently asked questions

What is Image Skincare Prevention Plus Daily Ultimate Protection 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 Image Skincare Prevention Plus Daily Ultimate Protection?
Swiss-American CDMO, LLC is the labeler of record for Image Skincare Prevention Plus Daily Ultimate Protection. 2 FDA label records share the active ingredient HOMOSALATE, OCTISALATE, OCTOCRYLENE, ZINC OXIDE 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 Image Skincare Prevention Plus Daily Ultimate 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 Image Skincare Prevention Plus Daily Ultimate 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 HOMOSALATE, OCTISALATE, OCTOCRYLENE, ZINC OXIDE SUNSCREEN?
Yes. 2 FDA drug label records list HOMOSALATE, OCTISALATE, OCTOCRYLENE, ZINC OXIDE 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 Image Skincare Prevention Plus Daily Ultimate 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.