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As regulatory and testing requirements mount, developing new sunscreens is more time-consuming and challenging.
November 3, 2025
By: Raymond Sullivan-Bojorquez
MS Chemistry | Business Development Manager with Lucas Meyer Cosmetics, by Clariant
Sunscreens are slow to reach the market. Delays stem from more than just formulation complexities. As regulatory and testing requirements mount, developing new sunscreens is more time-consuming and challenging.
The problem is twofold: US sunscreens take years to develop because SPF and water-resistance claims
require in-vivo testing (human subjects), and new UV filters are stalled by ongoing regulatory hurdles that push for systemic testing. A key distinction is that UV filters, the active ingredients that absorb or block UV radiation, must be treated as drugs in the US. Therefore, any new UV filter requires FDA drug approval, a process that is lengthy and still requires animal testing.1 Even when using a pre-approved UV filter, sunscreens still take 12–36 months to develop because they must undergo FDA-regulated claim substantiation, such as SPF validation and water resistance testing. Formulators are also limited to a narrow roster of UV filters and must adhere to standard formats like lotions, sprays or sticks.
In contrast, the European Union classifies sunscreens as cosmetics instead of non-prescription OTC drugs. As a result, they have been able to introduce triple the UV filters over the last two decades without imposing the formidable barriers the FDA requires. Moreover, the EU earlier this year introduced in-vitro testing as a method of validating SPFs in 2025.2
Since the US still requires animal testing, the level of regulatory scrutiny can exceed that applied to certain areas of oncology research. This is particularly striking given that the FDA advanced cancer research by embracing more human-relevant, non-animal methods. Meanwhile, sunscreen innovation remains stalled under outdated requirements, despite being a far less complex and lower-risk field than cancer therapeutics. Accelerated by advancements in monoclonal antibody research during the Covid-19 pandemic, the FDA is now recognizing the advantages of approving studies without animal testing. This shift emerged first in oncology and biotech research, but OTC still needs to adopt these modernized guidelines.
In addition, experts have long noted that animal models are poor predictors of human physiological responses. As a result, momentum is building around New Approach Methodologies (NAMs) with the FDA, which offer more reliable and efficient approval pathways.3
While the FDA announced in 2025 plans to phase out animal testing for monoclonal antibodies and other drugs using “AI modeling, human organ models, and real-world data,” they reaffirmed that animal testing is still required for all sunscreens. That’s why US sunscreens all use the same ~16 UV filters in the past 25 years: it’s just faster and cheaper to innovate through formulation and delivery systems rather than new filters. Unfortunately, no new sunscreen filters have been approved for use in the US since 1999, and the eight modern UV filters submitted under the 2014 Sunscreen Innovation Act (SIA)have yet to receive full approval.4
The 2014 Sunscreen Innovation Act (SIA) was intended to streamline the approval process for new UV filters and set a five-year timeline for review. In practice, however, the FDA deferred final decisions back to manufacturers once that limit expired, requesting additional data (often requiring animal testing) before classifying the filters as GRASE (Generally Recognized as Safe and Effective). Faced with high R&D costs, long timelines, anti-animal testing policies and no guarantee of eventual approval, manufacturers largely pulled back, leaving many promising filters stuck in regulatory limbo for years.
In contrast, the EU allows any filter approved under the Cosmetics Regulation Annex VI to be used, which currently boasts 48 allowed UV filters—triple the US list.5 In the EU, sunscreens are classified as cosmetic ingredients (not drugs), and with animal testing for cosmetics banned, R&D timelines are much more favorable. The EU banned animal testing for cosmetics in 2013. Instead, the EU invested in advancing human-organ model testing to demonstrate the safety and efficacy of novel UV filters, positioning the region as a pioneer in sunscreen development and skin protection using organ-on-chip technology.6
Notably, animal testing may still occur under EU law if mandated by REACH for safety assessments unrelated to cosmetics. The key difference between systems is that EU manufacturers “are permitted to perform animal testing, as a last resort,” whereas in the US it has historically been a requirement. This paradigm shift in regulatory philosophy enabled the EU to drive innovation and deliver more advanced suncare options for consumers during the past two decades.7 Moreover, the EU recently adopted a new ISO standard that allow for in-vitro SPF testing. This new Double Plate Method (DPM) marks a pivotal shift from traditional in-vivo assessments.2
The FDA requires that the safety and efficacy of ingredients be demonstrated at a level sufficient to support inclusion in a monograph or approval through a New Drug Application (NDA). To the agency’s credit, it has signaled openness to non-animal testing methods, particularly since the 2018 US federal law (FDA Modernization Act 2.0, updated in 2022) eliminated the blanket requirement for animal data in NDAs. Upon further testing, results show that when sunscreen is applied to the skin, even a single application, all six tested active ingredients and all of the formulations, resulted in measurable blood levels of the active ingredient.8 However, the fact that an ingredient is absorbed through the skin and into the body does not mean that the ingredient is unsafe, rather the agency calls for more robust systemic safety data. The most reliable way to generate this according to the FDA remains animal testing in combination with human pharmacokinetic studies.1,8
This regulatory landscape has created an innovation bottleneck, with almost no new UV filters added in decades. US brands have had to focus innovation on textures, delivery systems and claims, such as water resistance, tinted formulas and mineral blends. The challenge has even increased recently, with the FDA issuing warning letters to Supergoop and Vacation for using mousse and foam formats to deliver sunscreen ingredients.9 The only sunscreen formats approved in the US by the FDA include “oil, lotion, cream, gel, butter, paste, ointment, stick, spray, and powder,” and anything outside of those formats requires an NDA. With the current environment, this is ending up to require over 10+ years of research, exorbitant testing costs, and animal testing requirements—all of which create an undesirable space to enter for most brands or manufacturers.
As it turns out, there’s a notable loophole that tech-savvy consumers have exploited in recent years. While US retailers like CVS, Target, Sephora and Ulta can only sell sunscreens that comply with the FDA OTC monograph, there is little regulatory oversight for online imports through third-party resellers such as Amazon. This allows products containing “EU-only filters” like Tinosorb S/M, Mexoryl XL and Uvasorb HEB to be purchased online, even though they are technically illegal to be sold in the US and certainly not available on US shelves.
To address this, the FDA recently ended the de minimis exemption for shipments valued at $800 or less effective in July 2025, giving the agency authority to review all packages containing regulated items like sunscreens. However, whether this will effectively crack down on non-FDA approved sunscreens in the long-term is yet to be seen, as EU sunscreens are readily-available on Amazon to this day.10,11 On the other hand, the directive may slow already long R&D timelines for materials, rather than enhancie consumer protection depending on how quickly the FDA is able to crack down on this suncare black market. While the law is intended to safeguard consumers from unregulated suncare ingredients, the current environment creates additional hurdles for US manufacturers and emerging brands trying to innovate in the sunscreen market instead.
Some brands, such as La Roche-Posay, successfully navigated the US regulatory system using an NDA for their Anthelios launch.12 This allowed La Roche-Posay (L’Oréal) to include European filters like Mexoryl SX or XL (Terephthalylidene Dicamphor Sulfonic Acid and Drometrizole Trisiloxane), which are not FDA-approved under the OTC monograph, by submitting an NDA for each specific Anthelios formula containing Mexoryl SX. The NDA pathway works because the FDA treats the product as a new drug, requiring the company to provide safety data (toxicology, systemic absorption, phototoxicity), efficacy data (SPF and broad-spectrum testing), and stability and formulation data. However, the NDA is ingredient and formulation-specific, meaning approval applies only to that exact formula. As a result, the US market ends up with limited SPF options due to the cost and time required to receive approval for each formula vs the EU market.A 2025 review published in the Boston College Law Review notes that since the FDA approved ecamsule (Mexoryl SX) for use in Anthelios in 2006, no new sunscreens have been approved through NDAs for over-the-counter (OTC) use in the US, and more broadly, no new UV filters have been approved since 1999.13
The SAFE Sunscreen Standards Act (H.R. 3686) aims to address these challenges and was introduced in the US House of Representatives on June 3, 2025.14 The bill has been referred to the House Committee on Energy and Commerce, with next steps including committee review, potential markup sessions, a House vote, and then referral to the Senate if passed. This key sunscreen reform is being considered as part of the over-the-counter monograph user fee (OMUFA) reauthorization legislation, which is set to expire on September 30. The Senate HELP Committee has unanimously approved the OMUFA reauthorization language, including the SAFE Sunscreen Standards Act. If enacted, Congress will have the opportunity to modernize US sunscreen R&D and regulations, moving away from one of the slowest approval standards in the world.
Unfortunately, previous attempts to amend the OTC monograph for nonprescription drugs such as sunscreens, in 2019 and 2021, were unsuccessful.15
Raymond Sullivan-Bojorquez is business development manager at Lucas Meyer Cosmetics by Clariant. Email: rsull002@ucr.edu
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