Major Developments in Sunscreen Safety: Regulatory Concerns and Hidden Ingredients

In recent weeks, sunscreen safety has come under intense scrutiny due to significant developments from the U.S. Food and Drug Administration (FDA) and the Journal of the American Academy of Dermatology (JAAD). These concerns revolve around the compliance of certain sunscreen formats and the presence of undisclosed active ingredients, emphasizing the need for increased transparency in sunscreen formulation.

FDA Warnings on Unapproved Sunscreen Forms

On August 6, 2025, the FDA issued warning letters to several popular sunscreen brands, including Supergoop!, Vacation Inc., and others. The FDA’s concerns center on the use of mousse, whipped, and foam formats, which do not comply with the approved dosage forms outlined in the OTC Monograph M020. Such products are considered misbranded under current regulations.

Key Takeaways:

• Non-Compliant Formats: Only oil, lotion, cream, gel, butter, paste, ointment, stick, spray, and powder forms are currently permissible.
• Risk of Misleading Packaging: Vacation Inc.’s whipped cream canister design has been highlighted as particularly deceptive, posing risks of accidental ingestion.

Expert Opinions on Sunscreen Regulations

Sunscreen formulation experts have reacted to these regulatory changes with mixed feelings. Industry expert Kelly Dobos shared her concerns on social media, stating:

"I think there may be legitimate concerns about the dispersion of the actives and even application, especially with particulates like ZnO…"

Experts suggest this situation is an opportunity for the FDA to revisit and modernize the Monograph, especially given the popularity of newer sunscreen formats.

Uncovering Hidden UV Filters

A recent study published in JAAD revealed alarming findings about undisclosed UV filters in widely used sunscreen products. An analysis of 150 sunscreen products showed:

• Over 50 products containing butyloctyl salicylate
• 19 products with diethylhexyl syringylidenemalonate (DESM)
• 12 products featuring ethylhexyl methoxycrylene (EHMC)
• 4 products containing ethyl ferulate

Why This Matters

• Regulatory Oversight: Many of these chemicals are not listed on the FDA Monograph as approved sunscreens.
• Performance: Butyloctyl salicylate is noted as an SPF booster but does not contribute the necessary SPF units to be labeled a sunscreen on its own.

Understanding ‘Sunscreen Doping’

The issues discussed extend to what some term “sunscreen doping.” According to a report from Pavise, initiated by biomedical engineer Sophie Bai, there’s a crucial distinction between acceptable SPF boosters and undisclosed UV filters:

• SPF Boosters: These are inactive ingredients enhancing sunscreen effectiveness without requiring FDA approval.
• Doping: This refers to the hidden use of equivalent but unapproved UV filters, often included in formulations claiming to be "100% mineral."

Concerns Over Consumer Safety

While these hidden ingredients may make for a more aesthetically pleasing product, they pose serious safety concerns. Some sunscreens marketed as mineral-only contain these banned filters, thus risking consumer safety and compliance with existing regulations.

The Role of Transparency and Compliance

This evolving scenario underscores the increasing responsibilities of sunscreen formulators:

• Regulatory Compliance: New sunscreen formats must adhere to existing FDA standards.
• Ingredient Transparency: Proper disclosure of active ingredients is vital for consumer safety.

Moving Forward

As the sunscreen market rapidly evolves, these recent warnings serve as a call for both improved compliance and transparency. Regulatory agencies like the FDA must adapt to new formulations while ensuring public health standards are rigorously upheld.

Conclusion

The latest developments in sunscreen safety highlight the critical importance of compliance in formulation and the need for transparency regarding active ingredients. As awareness increases, both manufacturers and consumers must prioritize safety to promote effective sun protection strategies.

For further insights, you can read more about FDA regulations and the findings from the Journal of the American Academy of Dermatology.