Sunscreen Under Scrutiny: A Brand's Fight Against Outdated FDA Rules

MURRIETA, CA – May 26, 2026 – A message once confined to health blogs and environmental reports is now flashing across a billboard in Times Square, posing a direct challenge to federal regulators: Is your sunscreen safe? The question comes from Primally Pure, a non-toxic skincare brand that has launched a national campaign, "Trust the Sun. Question Your Sunscreen.," aimed at forcing a long-overdue conversation about the chemicals millions of Americans apply to their skin daily.

The campaign thrusts into the spotlight a complex issue that has been simmering for years within scientific and regulatory circles: the U.S. Food and Drug Administration's (FDA) decades-old safety standards for sunscreen. While the agency has acknowledged the need for updates, progress has been glacial, leaving consumers in a state of uncertainty and challenger brands like Primally Pure sensing an opportunity to demand change.

A Regulatory Limbo Decades in the Making

At the heart of the controversy is the regulatory framework governing sunscreens, which are classified as over-the-counter (OTC) drugs. This requires their active ingredients to be Generally Recognized as Safe and Effective (GRASE). The FDA's last significant update to these standards was in 1999, a time before the widespread availability of high-speed internet and the rise of the modern wellness movement.

In 2019, the FDA issued a proposed rule that sent shockwaves through the industry. The agency found that of the 16 active sunscreen ingredients then in use, only two—the mineral filters zinc oxide and titanium dioxide—had sufficient data to be designated as GRASE. For 12 other common chemical filters, including oxybenzone, octinoxate, and avobenzone, the FDA stated there was not enough safety data to make a determination and called on the industry to provide it. Two other ingredients were deemed not safe.

More than seven years later, that proposed rule has not been finalized. The 2020 CARES Act shifted the OTC review process to a new administrative order system intended to be more efficient, but a final order on sunscreens has yet to materialize. This has left the 12 ingredients in question on the market in a state of regulatory limbo, permitted for use while their definitive safety profile remains unconfirmed by the FDA's own standards.

"Consumers are paying attention now," said Bethany McDaniel, founder of Primally Pure, in a statement. "They're reading labels, asking questions and looking beyond marketing claims. They deserve transparency... This campaign is our invitation to raise the bar for our industry and for regulators."

From Lab to Bloodstream: The Science of Absorption

The FDA's call for more data wasn't arbitrary. It was fueled by growing evidence of systemic absorption—the process by which chemicals enter the bloodstream through the skin. The agency's own funded study, published in the Journal of the American Medical Association (JAMA) in 2019, found that several chemical filters were absorbed into the body at levels far exceeding the threshold at which the FDA requires additional safety testing.

Oxybenzone, a particularly scrutinized ingredient, was found in participants' bloodstreams at concentrations more than 400 times the FDA's safety testing limit. While the FDA has stressed that absorption does not equal harm, it maintains that the findings necessitate further investigation into potential long-term health effects, including possible endocrine disruption. Advocacy groups like the Environmental Working Group (EWG) and Breast Cancer Prevention Partners have long raised concerns about these chemicals, recommending consumers opt for mineral-based alternatives.

This scientific uncertainty is a cornerstone of Primally Pure's campaign. "All we're saying is: do the same thing with your sunscreen," McDaniel stated. "Just read the label. Ask if those ingredients have been proven safe. And if they haven't, ask why they're still there."

A Tale of Two Ecosystems: From Coral Reefs to Human Skin

The debate extends beyond human health to environmental impact. Several of the same chemical filters under FDA review have already been banned in popular tourist destinations like Hawaii, Palau, and the U.S. Virgin Islands. These jurisdictions acted after scientific studies demonstrated the chemicals' devastating effects on marine ecosystems, particularly their role in coral bleaching.

The juxtaposition is stark and serves as a powerful talking point for critics: chemicals deemed too toxic for coral reefs remain approved for daily application on human skin nationwide. This dual concern for personal and planetary health has galvanized a segment of consumers who are now seeking "reef-safe" products, a market that has grown significantly in recent years.

A Farm-to-Face Brand Takes on Washington

Primally Pure's campaign is a calculated move from a brand built on challenging industry norms. Founded by McDaniel on her family's regenerative farm, the company began by making skincare from tallow rendered from grass-fed cattle, positioning itself as an antithesis to mass-produced, lab-formulated products. Its foray into sun care, using non-nano zinc oxide in a simple, less-than-ten-ingredient formula, is presented as proof that effective, safe sun protection is possible without a complex list of synthetic chemicals.

To amplify its message, the brand has launched a multi-pronged offensive. Beyond the high-profile billboards, it has created a Change.org petition calling on the FDA to modernize its standards and developed a free online ingredient checker for consumers to research their own sunscreens. This strategy of education and empowerment is characteristic of the modern direct-to-consumer playbook, building a community around a shared mission and turning customers into advocates.

This brand-led activism taps into a broader market shift toward "clean beauty," where transparency and ingredient integrity are paramount. It also highlights the legislative inertia in Washington. While the Sunscreen Innovation Act of 2014 failed to bring new, potentially safer ingredients from overseas to the U.S. market, newer bipartisan proposals like the SAFE Sunscreen Standards Act aim to modernize the review process itself. This legislative push underscores a growing consensus that for millions of Americans who apply sunscreen daily, the demand for both safety and certainty can no longer be ignored.