FDA RATINGS FOR SUNSCREENS
FDA proposes new rules for
27 August, 2007:
The United States Food and Drug
Administration (FDA) has proposed a
new rating system for sunscreens that
would, for the first time, alert
consumers as to how well they block
dangerous ultraviolet A (UVA) rays.
At present, most commercial sunscreens
only screen out ultraviolet B (UVB),
not UVA, which is associated with
longer and more serious damage deep
within the skin.
Labels would have up to four stars
indicating their effectiveness against
UVA rays, the FDA said.
Both UVA and UVB increase skin cancer
risks and skin aging.
The changes proposed by the FDA are
undergoing a 90-day period of public
comment before being published in a
final draft form. According to the
FDA, those rules would only go into
effect 18 months later.
Dr Douglas C Throckmorton, deputy
director of FDA’s Center for Drug
Evaluation and Research, said the US
health regulator has long been
attempting to make recommendations on
UVA protection. Only now has the
agency settled on which tests it will
accept for rating UVA protection.
The new rating – called ‘extra UVA
protection’ – would be in addition to
the sun protection factor (SPF), which
is already on sunscreens. SPF measures
the effectiveness of the product in
preventing sunburn from UVB rays.
UVB radiation causes sunburn, but UVA
can damage skin tissue below the
surface. Both UVA and UVB cause skin
cancer and aging such as wrinkles and
FDA officials say the agency considers
that protection from both UVB and UVA
radiation is equally important at this
time, because scientific data
demonstrates that both have harmful
effects on the skin.
The proposed ratings system for UVA
sunscreens would rate them on a scale
of one to four stars – one star for
low UVA protection, two stars for
medium protection, three stars for
high protection, and four stars for
the highest protection available in an
If a sunscreen does not have at least
‘one star’ of protection, the FDA
would require that the product have a
‘no UVA protection’ marking on the
label near the SPF value.
Ratings for UVA would be based on two
tests: The first measures the
sunscreen’s ability to reduce the
amount of UVA radiation that passes
through it. The second measures a
product’s ability to prevent tanning.
This test would be similar to the SPF
test used to determine the
effectiveness of sunscreens to block
Sunscreens would carry a ‘warnings’
statement in the ‘Drug Facts’ box. The
warning will say that “UV exposure
from the sun increases the risk of
skin cancer, premature skin aging, and
other skin damage. It is important to
decrease UV exposure by limiting time
in the sun, wearing protective
clothing, and using a sunscreen.”
Besides, the label would also warn
that “UV exposure from the sun
increases the risk of skin cancer,
premature skin aging and other skin
damage. It is important to decrease UV
exposure by limiting time in the sun,
wearing protective clothing, and using
Directions would tell people to
reapply sunscreen at least every 2
The warning is intended to alert
consumers that sunscreen is only a
part of protecting yourself from sun
exposure, according to the FDA.
The proposal has guidelines for
testing that manufacturers need to do
to support their claims. Under the
rule, sunscreens could have a maximum
SPF of 50+ unless test data shows that
a higher number is warranted.
In addition, the definition of SPF
would change from ‘sun protection
factor’ to ‘sunburn protection
factor.’ This change will prevent “the
impression of solar invincibility and
a false sense of security,” according
to the FDA’s proposal.