FDA Establishment Registration & Drug Listing for Sunscreens: Step by Step

Before a sunscreen can be legally sold in the United States, two back-office steps have to be done: the facility has to be registered, and the product has to be listed. They're less visible than the label, but skip them and the product isn't legal to distribute. Here's how they work.

Step 1: Establishment registration

Every facility that manufactures, packages, or labels the OTC drug must register with the FDA. Registration identifies who is making the product and where. Foreign establishments must also designate a U.S. Agent as part of this step, and registration is renewed annually.

Step 2: Get a labeler code and NDC

Each product needs a National Drug Code (NDC), built from a labeler code assigned by the FDA. The NDC uniquely identifies your product in the U.S. drug system.

Step 3: Drug listing via SPL

Listing is submitted electronically in Structured Product Labeling (SPL) format — a standardized electronic file that carries your product and labeling information to the FDA. Each product you market must be listed, and listings are kept up to date as products change.

Timing matters

None of this is instant. Appointing a U.S. Agent, registering establishments, obtaining a labeler code, and preparing SPL all take time — which is exactly why the bemotrizinol exclusivity window is an opportunity, not a delay. Use it to get registered and listed so you're ready to sell the day your market opens.

Get the checklist

Registration and listing are core sections of our Bemotrizinol (BEMT) U.S. Market-Entry Compliance Checklist. Download the free checklist → Or let Axentra handle registration, listing, and SPL for you through the U.S. Market Entry Package.

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Frequently asked questions

What's the difference between registration and listing?

Registration identifies the facility making the drug; listing identifies the specific product (via NDC and SPL). You generally need both.

What is SPL?

Structured Product Labeling is the standardized electronic format used to submit drug listing and labeling information to the FDA.

When should I start registration and listing?

Well before your intended launch — the steps take time, and a U.S. Agent must be in place before a foreign establishment can complete registration.