FDA Approves New Sunscreen Ingredient Bemotrizinol After 20 Years
Dermatologists say bemotrizinol
offers advantages over other compounds in sunscreens currently on the market.
·
The Food and Drug Administration (FDA) has
approved Bemotrizinol for use in
over-the-counter sunscreens in the United States.
·
Bemotrizinol is the first
new sunscreen ingredient approved by the FDA in 20 years.
How Bemotrizinol Works
·
The ingredient protects against both:
o
Ultraviolet A (UVA) rays, which
contribute to skin aging and wrinkles.
o
Ultraviolet B (UVB) rays, which
cause sunburn.
·
This broad-spectrum protection helps reduce skin
damage from sun exposure.
Advantages
Over Existing Sunscreen Ingredients
·
Dermatologists highlighted several benefits of bemotrizinol:
o
Provides effective UVA and UVB protection.
o
Does not leave a chalky or white residue on the
skin.
o
Offers a more cosmetically appealing finish
compared to many mineral sunscreens.
o
Is less likely to cause skin irritation, making it
suitable for sensitive skin.
o
Remains stable and effective for longer periods in
sunlight.
Potential
Safety Benefits
·
Bemotrizinol is a
large molecule that remains on the skin's surface rather than being absorbed
into the bloodstream.
·
This characteristic may address concerns about
systemic absorption associated with some existing sunscreen ingredients.
·
The FDA classified bemotrizinol
as "Generally Recognized as Safe and Effective" (GRASE),
allowing its use without additional testing requirements.
Why
Approval Took So Long
·
Sunscreens are regulated as drugs in the
United States, unlike many other countries where they are regulated as
cosmetics.
·
This regulatory approach requires extensive safety
and efficacy testing, making approvals more time-consuming and costly.
·
Bemotrizinol has
already been widely used in sunscreen products across Europe and Asia for many
years.
Industry
Impact
·
The approval followed a request from DSM
Nutritional Products LLC to add bemotrizinol to
the list of approved sunscreen ingredients.
·
U.S. manufacturers may take time to develop new
formulations, but international companies could introduce existing bemotrizinol-based products into the U.S. market more
quickly.
Key
Takeaway
·
The FDA's approval of bemotrizinol
expands sunscreen options for American consumers by introducing a
broad-spectrum UV filter that is effective, skin-friendly, photostable, and
cosmetically elegant.
·
Experts note that while the new ingredient offers
advantages, currently available sunscreens remain highly effective, and
consistent sunscreen use remains the most important factor in sun protection.
The
Food and Drug Administration cleared a new ingredient for sunscreens on Tuesday,
paving the way for American companies to begin using a compound that has long been
a part of popular sunscreens in Europe and Asia.
The
ingredient, bemotrizinol, works by blocking ultraviolet
radiation. It filters out two kinds of ultraviolet rays: ultraviolet A, which contributes
to wrinkles and skin aging, and ultraviolet B, which causes sunburns.
Dermatologists
said bemotrizinol offers a few advantages over other sunscreen
compounds currently available. The ingredient fills “a need in the field,” Dr. Elisabeth
Pedersen, a dermatologist at University of Michigan Health, said.
Dr.
Jennifer Stein, a dermatologist at N.Y.U. Langone Health, said sunscreens with bemotrizinol were more “cosmetically elegant.” Many sun protection
products already on the market are mineral or physical sunscreens, which leave a
chalky, white film on the skin — “really thick and pasty, kind of like the zinc
on the lifeguard’s nose that you stereotypically see,” Dr. Pedersen said. Bemotrizinol, by contrast, rubs into the skin without leaving
a cast.
Bemotrizinol is also better for sensitive skin than some
other sunscreen ingredients are, with a lower risk of causing irritation, said Dr.
Victor Quan, an assistant professor of dermatology at the Northwestern Feinberg
School of Medicine. And it can last longer in the sun without breaking down, he
said.
Unlike
ingredients in some other sunscreens, bemotrizinol is
a large molecule that sits on top of the skin and does not get absorbed into the
bloodstream. Scientists are not sure how concerned to be about the safety of sunscreens
that do enter the bloodstream. “It just left a question mark,” Dr. Stein said. “It
doesn’t mean that they’re not safe, it just means we don’t know and that more testing
needs to be done to prove that it is safe.”
Bemotrizinol is the first new ingredient for over-the-counter
sunscreens the agency has greenlit in 20 years, Health Secretary Robert F. Kennedy
Jr. wrote in a statement announcing the move. Sunscreens are regulated in the United
States as drugs, rather than as cosmetic products, as they are in other countries,
which is why it can take so long for new ingredients to be authorized, Dr. Pedersen
said. “It takes a lot more rigorous testing, and it’s expensive for companies.”
The
F.D.A. said it considered bemotrizinol to be “generally
recognized as safe and effective” — a designation that means an ingredient can be
used without additional testing. A company called DSM Nutritional Products LLC requested
that the F.D.A. add bemotrizinol to the list of allowed
over-the-counter sunscreen ingredients.
It
may take some time for American companies to formulate products with the new ingredient.
But international manufacturers that have long made sunscreens with bemotrizinol may just move some of them over to the U.S. market,
dermatologists said.
The
options without bemotrizinol that are currently on the
market are still very effective and will work well for many people, Dr. Quan said.
“Big
picture,” he said, “the best sunscreen is the one that you like using.”