Complicated routes to registration

Remember when the United States passed the ‘Sunscreen Innovation Act’ in 2014? Supporters of the legislation thought that newer potentially better, sunscreens used elsewhere around the world would soon be available in the U.S. 

Nearly eight years later, the law has not lived up to its name, much to the frustration of sunscreen manufacturers and ingredient companies worldwide. The industry continues to face its share of challenges in the U.S., as regulators scrutinise certain ingredients and ask for more data on currently approved organic UV filters.

In many other countries, where sunscreens are considered cosmetics, manufacturers have dozens of effective ingredients from which to choose. These divergent regulatory frameworks create barriers to the international trade of sunscreens, including the need for reformulation, U.S.-specific labels, and potentially duplicate testing.

Customers’ claims

At the same time, consumers worldwide not only want safe and effective products but also those that offer better textures, formats and performance with preferences often varying by geography.

For example, in Asia, consumers are looking for light-weight gels that feel cool and slippery to the touch. They avoid products that leave a gunky feeling on the surface of the skin or too much of a whitening film. In Europe, natural and mineral-based sunscreens are in demand, with light airy textures and easy-to-spread cream formats. In North America, people want products with a high sun protection factor (SPF) that are waterproof and easy to apply, which explains the popularity of sprays.

What is also driving the sun care category is the need to be inclusive of all skin tones because everyone deserves to have affordable access to skin health and cancer prevention.

For years, unfortunately, brands did not pay attention to the diversity of their customers and reflect that in their offering. Mineral sunscreens were notorious for leaving behind a white cast that made people look like ghosts. Tinted options did not exist to match multiple skin colours and tones, and thankfully, those days are behind us.

You are missing a big opportunity if you are not thinking of inclusive skin care.

Satisfying consumers and regulators

More than ever, innovation is needed to stay ahead of consumer trends and navigate regulatory complexity. New solutions will require building partnerships through industry associations and collaborating with suppliers, customers, distributors and research and development experts on new formulations and new molecules to move the industry forward.

The industry will have to work together with regulators to ensure a consumer-centred approach because people seek multifunctional products that protect against skin cancer, sunburns, dark spots, and wrinkles while also moisturising or providing additional beauty benefits.

The Hawaii case

A good case study is how brands pivoted (rightly or wrongly) to comply with new environmental regulations in Hawaii that banned sunscreens containing oxybenzone and octyl-methoxycinnamate. Hawaii’s goal was to encourage the industry to change by substituting new ingredients and offering more mineral-based sunscreens.

Despite concerns about the limitations of the scientific evidence on which the Hawaii ban was based, formulators, ingredient makers, distributors and lab experts worked to develop alternatives to meet existing SPF levels. With the filters avail-able in the market, they were able to create efficacious formulas that provide sensory benefits and protect people from UV radiation.

Several companies created new sunscreen formulations for the Hawaii market. Brands also turned to ingredient experts for support because of their access to a large base of suppliers and the technical know-how in their global solution centres. 

Sluggish approval in U.S.

Sunscreen makers want to create more choice in the U.S. market, but regulators don’t make it easy. Even though melanoma rates have risen on average 1.2% each year from 2010 to 2019, the U.S. sun-screen market has the weakest collection of UVA filters in the world. Even environmental and consumer-protection groups, which have been at odds with the industry, agree on that.

Avobenzone, which offers strong protection against UVA rays, was the last over-the-counter ingredient approved by the FDA, and that was over 20 years ago. Several other UVA filters are available in the global market, but not in the U.S.

For instance, bemotrizinol, an oil-soluble organic compound that is highly photostable, has been approved for use in sunscreen in the European Union since 2000 and in some other parts of the world, including Australia. The broadband filter was submitted to the FDA for approval in 2019, but approval has still not been granted.

Prominent American media outlets, such as The Atlantic and Bloomberg, have begun to question why consumers in Europe and Asia have more sunscreen choices than people in the U.S.

The FDA’s proposed order amending the sunscreen monograph also is creating negative publicity for ingredients that have long been used in formulations around the world. The Cosmetics Europe trade association has called out the disconnect between science and the proposed policy changes. According to the association, the proposed order would only allow about half of the UV filters considered safe and effective worldwide in the U.S. market.