How to Develop a Sunscreen Product for the U.S. Market

Unlike most skincare products, sunscreen is generally regulated as an over-the-counter (OTC) drug in the United States rather than as an ordinary cosmetic. As a result, developing a sunscreen product involves more than creating an effective formula—it also requires early planning around ingredients, testing, labeling, and manufacturing. Understanding these requirements early can help brands reduce redevelopment and bring products to market more efficiently.

Developing a sunscreen for the U.S. market is often more complex than many beauty brands expect. A formula that performs well in one market may not be suitable for another, and decisions about formulation, testing, packaging, and product claims are more closely connected than they are for most skincare products. Taking these factors into account from the beginning helps brands reduce unnecessary revisions, improve development efficiency, and prepare for a smoother product launch.

Why Are U.S. Sunscreen Regulations Different?

Unlike most countries, the United States generally regulates sunscreen as an over-the-counter (OTC) drug rather than a cosmetic. This classification is based on the product’s intended purpose—to help prevent sunburn and protect the skin from harmful UV radiation. As a result, sunscreen products are subject to a different regulatory framework than ordinary skincare products, with specific requirements for active ingredients, labeling, and performance claims.

What Ingredients Can Be Used in U.S. Sunscreens?

Choosing UV filters is one of the earliest decisions in U.S. sunscreen development. Unlike many other markets, the United States permits only specific UV filters for sunscreen products marketed under the FDA’s OTC sunscreen regulatory framework. For brands developing products for the U.S. market, understanding these requirements early helps avoid unnecessary reformulation, repeated testing, and delays before commercialization.

Examples are provided for reference only. The availability and permitted conditions of use for sunscreen active ingredients are governed by the applicable FDA OTC sunscreen framework and may be updated over time.

Use FDA-Permitted UV Filters

Only sunscreen active ingredients recognized under the FDA’s OTC sunscreen regulatory framework can be used in products marketed in the United States. Each ingredient is subject to specific conditions, including permitted concentrations and intended use. Rather than adapting an existing formula later, brands should confirm that their UV filter system is suitable for the U.S. market before formulation begins.

Define Your Target Market Before Formulation

A sunscreen formula developed for one market may not be suitable for another. The United States and the European Union regulate sunscreen differently, particularly with regard to approved UV filters and product claims.

One question we hear frequently is whether a sunscreen formula developed for Europe can also be be sold in the U.S. In practice, the answer depends on factors such as the UV filter system, intended claims, and applicable regulatory requirements.

We’ve found that defining the target market at the start of a project makes formulation decisions more straightforward and helps reduce redevelopment later in the process. Building the formula around the intended market from day one is typically more efficient than modifying an existing product after development is complete.

What Testing Is Required for U.S. Sunscreens?

Testing requirements depend on the claims a brand intends to make. Any sunscreen displaying an SPF value must have supporting test data, while Broad Spectrum and Water Resistance claims require additional testing. Defining the product’s claim strategy early helps brands plan testing more efficiently and avoid unnecessary redevelopment later in the project.

SPF, Broad Spectrum, and Water Resistance Testing

Each claim requires its own supporting evaluation. SPF testing verifies the labeled protection level, while Broad Spectrum testing confirms UVA and UVB protection. Water Resistance testing is only required when the product will make a corresponding claim. Because these evaluations are performed on the finished formulation, even small formula changes may require additional testing.

Plan Testing as Part of Product Development

Rather than treating testing as the final step before launch, it should be incorporated into the product development process. Planning testing requirements alongside formulation and product positioning helps reduce delays, improve development efficiency, and ensure label claims are supported before commercialization.

Third-Party Testing Support

We work with qualified third-party testing laboratories to support sunscreen performance evaluations based on each product’s intended claims. Independent test reports provide objective data for claims such as SPF, Broad Spectrum, and Water Resistance, helping brands assess product performance before commercial production.

Example of an independent third-party SPF test report used during sunscreen product development. Client-specific information has been redacted for confidentiality.

What Are the FDA Labeling Requirements for Sunscreen?

For U.S. sunscreen products, labeling is more than a packaging requirement—it reflects the product’s formulation, performance testing, and regulatory positioning. Every claim displayed on the label should be supported by appropriate testing and the product’s intended formulation.

Most OTC sunscreen products include a standardized Drug Facts panel, along with claims such as SPF, Broad Spectrum, or Water Resistant, where supported by appropriate testing. Because these elements directly influence packaging design, brands should plan labeling alongside formulation and testing to help minimize revisions before commercial production.

Common Challenges Brands Face When Developing Sunscreen for the U.S. Market

Through our experience supporting sunscreen development projects, we have found that many delays are not caused by formulation alone. They often result from decisions about target markets, testing, claims, and packaging being made too late or without enough coordination. The following are some of the most common challenges we see when brands prepare sunscreen products for the U.S. market.

Treating Regulatory Planning as a Final Step

Some brands begin with formulation and review U.S. requirements only after the formula is nearly complete. Because active ingredients, intended claims, testing, labeling, and packaging are closely connected, late regulatory planning can lead to reformulation, repeated testing, and artwork revisions.

Assuming One Formula Can Be Used in Every Market

We often see brands planning to use the same sunscreen formula across the U.S., Europe, and other regions. However, differences in permitted UV filters and regulatory requirements may make this impractical. Defining the intended market before formulation begins usually creates a more efficient development path.

Finalizing Claims or Packaging Before Testing

Another common issue is confirming marketing claims or packaging artwork before performance testing is complete. Since claims such as SPF, Broad Spectrum, and Water Resistance depend on supporting data, final decisions should be made only after the relevant results are available.

How Blackbird Supports Sunscreen Product Development for the U.S. Market

At Blackbird, sunscreen development starts with the market the product is intended for. We first clarify the brand’s target SPF, desired claims, product format, texture, intended use, and positioning. These decisions help define the formula direction and identify the packaging, testing, and production considerations that may need to be addressed later.

Depending on the project, brands can either develop a new formula or build on one of our existing sunscreen formulations created for the U.S. market. These established formulas provide a practical starting point and can be further customized around texture, skin feel, product positioning, and performance goals. This approach can shorten early development timelines while still allowing the final product to reflect the brand’s identity.

As the project progresses, we support formulation, sampling, packaging selection, and production planning. When requested by the client, we can also assist with coordinating qualified third-party laboratories for evaluations such as SPF, Broad Spectrum, or Water Resistance testing. The specific testing program depends on the product’s intended claims and the brand’s commercialization needs.

By considering formulation, claims, packaging, testing requirements, and manufacturing as connected stages, we help reduce unnecessary redevelopment and keep the project moving toward scalable production.

Developing a sunscreen product for the U.S. market involves more than achieving a target SPF. Ingredient selection, intended claims, testing, labeling, packaging, and manufacturing decisions are closely connected and should be planned together from the beginning. A coordinated development process can help brands reduce unnecessary reformulation, avoid packaging revisions, and prepare more efficiently for commercial production.

Planning a sunscreen product for the U.S. market?

Talk with our team about your project requirements and development goals.

FAQs