Start a Sunscreen Brand: FDA Rules, SPF Testing and What It Costs

Sunscreen is an over-the-counter drug in the United States, so a new SPF brand starts with FDA registration, drug listing and lab testing, not with packaging. Asaya Skincare puts in vitro SPF testing at $2,000 to $8,000 per product and in vivo testing at $15,000 to $35,000 per product, as of 17 February 2026. Supergoop! and Vacation show what funded brands in this space have done, but neither story shows what a small launch costs.

Is sunscreen a cosmetic or a drug in the US?

Sunscreen is regulated as a drug. Certified Cosmetics describes sunscreen products as over-the-counter drugs, not cosmetics, tied to their intended use of preventing sunburn and reducing skin cancer risk. The FDA says sunscreens must satisfy the safety and efficacy standards for nonprescription drug products.

That changes the whole launch. The formula, the factory and the label are all judged against drug rules. A brand that files under the cosmetics system has filed under the wrong one, because a cosmetic facility registration does not satisfy the OTC drug obligations.

What must a sunscreen brand register and renew each year?

A sunscreen manufacturer needs drug establishment registration, drug listing, cGMP compliance and label compliance. Liberty Management Group lists these as the core FDA drug requirements for sunscreen makers, dated 27 May 2025.

Renewal runs from 1 October to 31 December each year, and it includes a blanket listing submission and the OMUFA fee, according to Liberty Management Group. No public OMUFA fee amount was found, so a budget should include it as a line to be confirmed with the FDA.

Does MoCRA apply to a sunscreen brand?

No. The Modernization of Cosmetics Regulation Act of 2022 (MoCRA) covers cosmetics and hybrid products with dual claims, not sunscreens. Cosmereg states that MoCRA is relevant only for those products, not sunscreens.

This matters for budgeting. Founders who read "cosmetics law" and file only a MoCRA-style registration have skipped the drug steps that carry the cost.

How much does SPF testing cost per product?

Testing is the largest quoted cost. Every figure below has a named source and a date.

Asaya sells sunscreen, so its prices are a competitor's view. Solésence is a testing company quoting its own package, so its figure is self-reported. Innacos Labs also says that any adjustment to a formula requires re-testing, which means one reformulation can repeat the cost.

Can a small brand fund this from $5,000?

Mostly no. A single in vivo test starts at $15,000, three times a $5,000 budget. The low end of in vitro testing, $2,000, fits inside that budget, but the standard regulatory package starts at $16,000, which does not.

Adding one SPF effectiveness round and one subject testing round from the 2021 Innacos figures gives $7,500 before any other cost. Those are quotes from labs, not market averages, and they are four or five years old. A reader with $5,000 can afford to test a formula, but not to finish a US launch at these quoted prices.

Which funded sunscreen brands show the path?

Two brands in the sources have outside money or an exit. The table lists the documented events.

Cosmetics Business reports that Vacation was founded to make sunscreen "fun". GCI Magazine frames the Series A as money to reach more US retail and hire staff. The copyable part of these stories is the regulatory checklist. The part that took money, retail reach and hiring is not something a solo founder can repeat.

What's still unclear?

• Supergoop! funding. Public sources report different round counts and totals, so this post gives no total. The stake date comes from Bloomberg, which reports a majority stake, not a full acquisition.
• Vacation valuation and total raised. These come from a single aggregator, so they are left out.
• Price dates. The Innacos figures date from 2021. The Asaya and Solésence figures are vendor quotes, and no public full price list was found.
• Missing costs. Facility registration, OMUFA fee amounts, formulation, label printing and first production runs are not priced in any source checked, so the startup budget is incomplete.
• Weakest point. The argument rests on vendor quotes and two funded brands. It shows the cost floor for testing and registration, not what a typical small brand spends or earns.

This is research, not legal, tax or financial advice.