FITISH SPF 50 FACE

FITISH SPF 50 FACE CUTANEOUS HUMAN OTC DRUG

FITISH SPF 50 FACE is an FDA drug label for the active ingredient FITISH SPF 50 FACE manufactured by Fitish Holdings, LLC administered by CUTANEOUS. 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 20260714.

Generic name
FITISH SPF 50 FACE
Manufacturer
Fitish Holdings, LLC
Product type
HUMAN OTC DRUG
Route
CUTANEOUS
Dosage form
N/A
NDC
84417-002
Application
N/A
Label effective
20260714

About this product

FITISH SPF 50 FACE is an FDA-registered drug product whose active ingredient is FITISH SPF 50 FACE. It is labelled by Fitish Holdings, LLC taken by cutaneous and marketed as a human otc drug product. Identifiers on file: NDC 84417-002, label effective 20260714. 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 FITISH SPF 50 FACE 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

Active Ingredient(s) Octocrylene 8.0% Ethylhexyl Salicylate 5.0% Ethylhexyl Methoxycinnamate 7.5 %

Indications & Usage

Use USES Helps prevent sunburn

Dosage & Administration

Directions Apply directly to clean skin 15 minutes before sun exposure and anywhere you want extra glow. Reapply after 40 minutes of swimming or sweating, immediately after towel drying and at least every 2 hours. Can be used on body as well. 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 limiting time in the sun, especially from 10 a.m.-2 p.m. and wear long-sleeved shirts, pants, hats and sunglasses

Warnings

Warnings WARNINGS For external use only.

Frequently asked questions

What is FITISH SPF 50 FACE used for?
Use USES Helps prevent sunburn

Who makes FITISH SPF 50 FACE?
Fitish Holdings, LLC is the labeler of record for FITISH SPF 50 FACE.

What form does FITISH SPF 50 FACE come in?
administered by cutaneous. Strengths and pack sizes vary by label, so compare the NDC on your pack with the identifier listed on this page.

Is FITISH SPF 50 FACE 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 FITISH SPF 50 FACE 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.