FDA green-lights popular sunscreen ingredient

Driving the news: Regulators added bemotrizinol to the list of permitted sunscreen active ingredients, following up on a proposal issued last year.

• The substance offers protection against both ultraviolet A and B rays and has low levels of absorption through the skin.
• The FDA regulates sunscreen as an over-the-counter drug, and international brands like those made in Korea had to be modified or reformulated to meet U.S. regulations.

The Dutch brand DSM-Firmenich is expected to begin selling a bemotrizinol product under the Parsol Shield brand later this year and will have an 18-month market exclusivity.

• The American Academy of Dermatology said the FDA action "marks an important public health step" and noted many other countries have nearly twice as many approved sunscreen ingredients.
• Congress late last year passed legislation requiring the agency to update its process for testing UV filters and allow for the use of real-world evidence to demonstrate safety and effectiveness.