US sunscreen reform: New bill targets accelerated product innovation

US lawmakers have introduced a bill to reform how the FDA evaluates and approves over-the-counter (OTC) sun protection. The SAFE Sunscreen Standards Act would increase the availability of sunscreen options in the US to align with global standards.

Representatives Dave Joyce, John Joyce, Debbie Dingell, and Deborah Ross back the bipartisan bill. “The US lacks many of the sun protection options already available in other countries,” says Dingell.

John Joyce adds that scientific advances in photoprotection cannot “continue to be stalled by outdated regulatory processes.”

In the US, sunscreens are an FDA-regulated drug product, meaning they must meet standards related to the safety and effectiveness of this categorization. The SAFE Sunscreen Standards Act aims to modernize the FDA’s sunscreen ingredient review process, which has been scrutinized for not approving a new filter since the 1990s. The bill also requires the administration to provide updates on pending sunscreen ingredients.

The lawmakers call for the FDA to use real-world evidence and nontraditional scientific data to assess safety and effectiveness, which aligns more with traditional cosmetics approvals. 

“The current government narrative is a very US-first attitude, which in turn influences its individualistic approach to competing in markets and carving its own identity,” Innova Market Insights’ project lead for Beauty Personal Care tells Personal Care Insights.

“When that is the case, it is vital that a sector like sunscreen, which is rapidly turning into an essential operative domain, is pushed forward in alignment with current trends. The biggest motivation for this step forward is to bring the US into line with the pace of the sunscreen sector.”

Battling animal testing

The SAFE Sunscreen Standards Act also supports the use of non-animal testing methods. The bill mandates that the Department of Health and Human Services publish annual reports on the FDA’s progress and adoption of alternative testing.

New bill supports cruelty-free testing methods and aims to align American sun care innovation with global trends.“Cruelty-free is not just a marketable strategy or additional claim to your product anymore — this is what brands must understand first. ‘No animal testing’ cannot be relegated to the back benches – it is a ‘given’ expectation in the consumer’s psyche,” says the Innova project lead.

“Cruelty-free is not a fad or a trend — it is a way of life, choice, and ethical decision-making of the end-user, which must be given its proper due to make a proper mark in personal care, whether you are a regulatory body, an ingredient manufacturer, or a brand.”

Delayed drug testing system

Sunscreen ingredients currently have a drug approval system requiring clinical trials and animal testing. This stance contrasts with the cosmetics-based approach in other regions, such as Europe and Asia.

The Innova analyst says that sunscreens being treated as OTC drugs instead of cosmetics is a “major reason for inhibited regulatory pathways.” She explains that this prevents the US from being able to compete with the fast innovation cycles in the personal care industry.

The FDA has approved 16 sunscreen-related ingredients, but only two fall under the scope of GRASE (Generally Recognized as Safe & Effective): zinc oxide and titanium dioxide.

In the EU, 48 filters are available. Japan has the highest number of approved sunscreen ingredients at over 40, with regular updates. Following, Australia and South Korea have over 30 approved ingredients for UV filter actives. 

This reality underscores the limited access to advanced filters in the US, such as bemotrizinol and bisoctrizole, which have been proven safe and effective abroad. The act comes at a time when innovation in photoprotection is advancing globally.

“The difference is, all of these countries and regions are working alongside the real-time pace of the market and its drive to expand the sunscreen domains by commercializing the ingredients as cosmetics and quasi-drugs, without the red tape of OTC and pharmacological narratives,” says the Innova project lead.

“We are standing at the precipice of evolution when it comes to sun care, and this can be both promising and incredibly challenging. The world is a global village now… competition comes from participants inside and outside of the US, and herein, fast-tracked approvals by regulatory reforms can change the rules of the game.”

Lawmakers propose the SAFE Sunscreen Standards Act to modernize FDA approval of UV filters.Long-standing criticism

The proposed legislation responds to criticism that the FDA has not approved a new sunscreen filter since 1999, causing it to fall behind international benchmarks. 

House Representative Alexandria Ocasio-Cortez (AOC) previously challenged the FDA’s regulations on sunscreen in 2023. She vocalized a need to expand the list of approved ingredients to improve UV protection after claiming that the FDA regulations on sunblock limit US citizens’ access to higher-performance UV filters allowed in other countries.

“AOC’s involvement was the catalyst to bring forward the conversation about rethinking sunscreen regulations, especially regarding a more forward and relevant restructuring. Couple that with socio-political pressures to democratize safety in sunscreen formulas and make them more accessible to end-users, and this can be a key motivation for fast-tracking approvals for new UV actives,” says the Innova analyst.

The FDA previously told Personal Care Insights that it welcomes and encourages the introduction of more sunscreen options to the US market, but said they must meet regulatory standards.

“While some countries regulate sunscreens differently (for instance, as cosmetics), in the US, sunscreens are an FDA-regulated drug product, which means they must meet standards related to the safety and effectiveness of OTC drug products in the US,” it said.

The filters currently approved in the US provide UVB protection, which is essential for preventing sunburn. However, many fall short in UVA defense, which is critical for guarding against aging and skin cancer.

The US currently lags behind Europe and Asia in approved sunscreen ingredients, limiting access to advanced UVA protection.Need for protection

The new bill emphasizes the importance of sunscreens in skin cancer prevention. Studies have shown that fewer than half of American sunscreens meet EU standards for UVA protection.

Skin cancer remains the most diagnosed form of cancer in the US.

The American Academy of Dermatology (AAD) recently found that 96% of Americans believe sun protection is important. Yet, 67% of Americans tanned their skin in 2024, up from 54% in 2020.

“The recent survey findings from the AAD show that despite user awareness toward sunscreens, there is a steep incline in sun damage in the US, wherein awareness essentially is not translating to actual and regular usage,” says the Innova analyst.

“There can be multiple drivers for this occurrence, and the FDA’s lack of updates for approved ingredients does not make this easier since user trust and believability in sunscreen ingredients is not bolstered enough to garner actual usage in everyday life.”

“This expansion is much needed, as sunscreen usage is now stretching beyond a good habit into an everyday essential.”