I begin my column with a personal story. Two weeks ago, I went for my annual checkup with my dermatologist. He checked me thoroughly from head to toe. Lo and behold, he discovered an unusually dark mole on the top of my head. He showed me the picture.  Technically, I have been a sunscreen expert for years, and I know my ABCDE (Asymmetry/Border irregularity/Color variation/Diameter>6 mm/Evolving) of skin cancer detection. The mole met all five criteria.  

My dermatologist needed a biopsy to rule out malignant melanoma (MM). He did not mention that perhaps it could be the two other less invasive and manageable skin cancers, namely basal cell carcinoma (BCC) or squamous cell carcinoma (SCC). Of course, I had three sleepless nights awaiting the results of the biopsy.

Thank God, the results showed that it was none of these cancers. Phew!  It was a benign seborrheic keratosis, a common non-cancerous skin growth that appears as a brown or black spot on the skin as a person ages.

The Most Common Cancer

Fortunately, I’m saved from the agony of the treatment and follow-up care for skin cancers but, unfortunately, over five million Americans are not so lucky and are afflicted by skin cancers every single year. Here are some of the statistics:

1. Skin cancer is the most common cancer in the US. The primary cause is sun exposure.
2. The US represents 1/3 of all global skin cancer diagnoses.
3. Over five million Americans are treated for skin cancer each year at a cost of over $8.1 billion.
4. The estimated number of new melanomas, potentially deadly cases, diagnosed in 2025 is projected to increase 5.9% topping 200,000 cases a year.
5. Nearly 10,000 people are diagnosed with skin cancer every single day, and more than two people die of the disease every hour in the US.
6. According to the World Health Organization (WHO) four out of five cases of skin cancer can be prevented by adopting sun safe practices.
7. In 2014 Congress passed the Sunscreen Innovation Act (SIA) to establish a process for review and approval of new active sunscreen ingredients.
8. Despite this, it has been more than 20 years since the FDA approved of any new sunscreen actives.

The US Is a Skin Cancer Capital

This personal introduction brings me to the current state of sunscreen regulations in the US. We represent a third of the world’s skin cancer diagnoses. It is the most common cancer in the country. More people are diagnosed with skin cancer each year than all other cancers combined. Think about that for a minute.

I played golf last week and mentioned my brief encounter with potential skin cancer to my playing partners. Both immediately showed me their moles, and the surgery that they had undertaken recently due to skin cancer. One of them told me that he has had a basal cell carcinoma mole removed almost every other year!

How do we combat this horrible, rampant disease? Obviously, it helps to stay away from the sun altogether, or at least from 11:00am to 2:00pm. That’s not always practical. However, we can wear large- \brimmed hats, put on SPF protective clothing, wear proper sunglasses, use an umbrella, or stay in the shade.  Are we forgetting that sunscreen lotions are one of the best methods of sun protection if applied properly and frequently?

The US Lags the World

The sunscreens that we have in the US today, despite their elegance and ease of application and convenience, fall short of great protection, especially if not applied correctly and often. UVA protection is crucial but is not optimal in today’s American sunscreens.

In addition, the most important function in a sunscreen product is the superior ultraviolet (UV) filter in the product. Have you noticed that the US sunscreen industry relies on only six UV filters; namely, avobenzone, octisalate, homosalate, octocrylene, zinc oxide and titanium dioxide for UVA, UVB or broad-spectrum protection. Do you believe that those six UV filters are the best for sun protection? What about the other superior filters that are allowed use in Europe, Asia and the rest of the world?

We tried so hard at the PASS Coalition for more than a decade, through Congress, to get the FDA to approve those European filters, but to no avail. The FDA has not even finalized its Sunscreen Monograph that was issued in 1978, almost 50 years ago.

PASS Coalition’s Efforts

In 2014, the PASS Coalition, of which I am a member, lobbied hard to address all the issues that confront sunscreen usages, especially through the introduction of the SIA Act of 2014. Unfortunately, this legislation was abandoned before addressing any of the sunscreen issues preventing superior, safe protection for US consumers. On June 4, 2025, however, the US House Skin Cancer Caucus co-chairs, Representatives John Joyce (R-PA), Dave Joyce (R-OH), Debbie Dingell (D-MI) and Deborah Ross (D-NC) introduced the SAFE  Sunscreen Standards Act (Supporting Accessible, Flexible and Effective Sunscreen Act (HR 3686).¹ If passed, this bipartisan legislation will streamline FDA review of non-prescription sunscreens. It will amend section 505G of the Federal Food, Drug and Cosmetic Acts (21 USC.355 H) to improve the regulatory review process, to determine the safety and effectiveness of non-prescription sunscreen active ingredients, and for a variety of other purposes.

The legislation uses interesting statements such as the use of “real world evidence to demonstrate safety and effectiveness,” and the use of “observational studies” (from global use?) to ensure Americans have access to safe, effective and innovative sunscreens that align with global standards. Hopefully, all these statements imply the adoption of the superior European UV filters. They also recommend the use of non-animal testing methods.

All of this is wonderful news, but we must wait and see if any of the suggested provisions will be adopted by the FDA soon. Not only will this allow for the approval of more effective UV filters in the US, it may also lead to the issuing of the Final Monograph. Amen!

Stay tuned. Stay hopeful.

References

1. H.R.3686 – To amend the Federal Food, Drug, and Cosmetic Act to improve the regulatory review process to determine the safety and effectiveness of nonprescription sunscreen active ingredients, and for other purposes. https://www.congress.gov/bill/119th-congress/house-bill/3686