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

To develop a sunscreen product for the U.S. market, brands should plan around FDA requirements from the beginning—not just SPF. This includes selecting compliant UV filters, defining product claims, planning performance evaluation, preparing compliant labeling, and aligning manufacturing with U.S. regulatory expectations.

Developing a sunscreen product for the U.S. market is often more complex than many beauty brands expect. Unlike ordinary skincare products, sunscreen development involves more than formulation alone. Decisions about ingredients, intended claims, performance evaluation, labeling, packaging, and manufacturing are closely connected, making early planning essential for an efficient development process.

This guide explains the key considerations brands should understand when developing sunscreen products for the U.S. market, helping reduce unnecessary redevelopment and prepare products for commercial production more efficiently.

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 and the market where the product will be sold. Evaluations may include the labeled SPF value, UVA or PA performance, and Broad Spectrum protection, including critical wavelength assessment where applicable. Water Resistance claims require separate supporting testing and should be planned carefully because they may involve additional development time, cost, and formula risk.

SPF, UVA, and Broad Spectrum Evaluations

SPF testing evaluates the product’s labeled sun protection level, while UVA-related evaluations assess protection across the UVA range. Depending on the intended market and claim strategy, this may include a PA rating or other UVA performance measures. For U.S. Broad Spectrum claims, critical wavelength evaluation is an important part of demonstrating protection across both UVA and UVB wavelengths.

Because these evaluations are performed on the finished formulation, meaningful changes to the formula may affect previous results and require reassessment.

Plan Testing Before Finalizing Claims and Packaging

Testing should be planned alongside formulation and product positioning rather than treated as a final step before launch. Defining the intended SPF, UVA, and Broad Spectrum claims early helps brands plan development timelines, budgets, and packaging more realistically.

Performance Evaluation Support

Depending on the project’s requirements, we can support performance evaluations related to SPF, UVA/PA, and Broad Spectrum or critical wavelength claims as part of the development process. The resulting data can help brands assess formula performance and identify whether further optimization may be needed before commercial production.

Example of an independent 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.

Because label claims influence packaging artwork and marketing communication, they should be reviewed before packaging is finalized.

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.

In many projects, these challenges are interconnected rather than isolated. Addressing them together early in development is typically more efficient than solving them individually after the formula has been finalized.

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

For sunscreen products intended for the U.S. market, development begins with clearly defining the target SPF, product positioning, texture, intended claims, and consumer expectations. These decisions establish the formulation direction and help guide the development process from the outset.

In our experience, many projects can be developed more efficiently by building on an established sunscreen formulation platform. This approach helps reduce early development risk while still allowing the formula to be customized around texture, skin feel, product positioning, and brand requirements.

We’ve also found that sunscreen development is often more efficient when product priorities are clearly defined. Projects that combine multiple complex objectives—such as very high SPF, water resistance, mineral-only UV filters, reef-friendly positioning, and an ultra-light texture—typically require additional formulation work and optimization. Establishing clear priorities early usually leads to a smoother development process.

Throughout development, we support formulation refinement, sample development, packaging selection, manufacturing planning, and production preparation. By treating these stages as a connected process rather than separate tasks, we help brands move more efficiently from concept to scalable manufacturing.

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?

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