special report

FDAs sunscreen
recommendations
The US Senate just approved a bill to
speed up the FDAs approval of sunscreen
ingredients. Heres guidance, cautions,
and SPFs, decoded.
MARY BETH NIERENGARTEN, MA

The need to protect the skin from

excessive sun exposure from ultra
violet radiation (UVR) is now well
established based on studies show
ing a clear causal link between
excessive UVR exposure and dam
age to the skin that raises the risk of
skin cancer and leads to premature
aging.1 Despite this known causal
link, the rate of skin cancer contin
ues to grow at a rapid pace.
Data show that the incidence of
the most serious type of skin cancer,
melanoma, has been doubling every
10 years in many countries and is
expected to continue to rise over the
next 10 to 20 years.1 In the United
States, skin cancer is the most com
mon cancer and it is estimated that
1 in 5 persons will be diagnosed
with a skin cancer during his or her
lifetime.1
Protecting children against sun
overexposure is particularly impor
tant to prevent or reduce the life
time chance of developing skin
cancer and other skin damage.
Epidemiologic data show a higher
incidence of melanoma in persons
with a history of sunburns during
childhood, and data from a pro
spective, population-based study
indicate that more than 50% of chil
dren experience a sunburn before
36

highlight the importance of using

other prim ary preventive mea
sures to provide the best protection
against the sun as described. Finally,
the article briefly mentions several
issues that have raised some con
cerns regarding the potential harm
of sunscreens, including systemic
toxicity and vitamin D deficiency,
as well as issues that await more
clear FDA direction such as the
safety of sunscreen sprays.

age 11 years followed by another

R e c e n t F D A g u id a n c e
sunburn a few years later.2
o
n s u n s c re e n u se
Pediatricians can play a pivotal
With the growing number of sun
role in reducing the adverse effects
screens on the market with vary
of sun damage by educating children
ing information on sun protection
and their parents on ways to avoid
claims, the FDA proposed new reg
overexposure to the sun, including
ulations to sunscreen manufactur
the appropriate and regular use of
ers to establish standards for testing
sunscreen. When used along with
the effectiveness of over-theother primary preventive mea
counter (OTC) sunscreen
sures, the appropriate use
products.3 Implemented
FAST FACT
of sunscreen can provide
1
in
5
persons
w
ill
i
in July 2012, the new
the necessary protection i
be
diagnosed
w
ith
regulations require that
to prevent and reduce
a skin cancer in his y
all sunscreen products
the rising incidence of
or her lifetim e.1
be labeled to provide
skin cancer.2
accurate
information on
This article is a brief
the products effectiveness.4,5
overview of current efforts to
Key terms and their descriptions
provide guidance on the proper use
used in labeling based on these new
of sunscreen in children. The article
FDA regulations are listed in Table
first describes recent efforts by the
l .5,6
US Food and Drug Administration
Important to highlight is the label
(FDA) to provide guidance to con
telling
consumers that the prod
sumers on how to evaluate the
uct reduces the risk of all types of
effectiveness of different sunscreen
sun damage, including skin cancer.
products based on mandating new
These products are labeled as broad
regulations to sunscreen manufac
spectrum with a sun protection
turers on labeling requirements.
factor (SPF) of 15 or greater, and
Pediatricians and other healthcare
the labeling further indicates that:
providers can help their patients
If used as directed with other sun
understand these labels to ensure
protection measures, this product
the appropriate and best selection
reduces the risk of skin cancer and
and use of these products.
early skin aging, as well as helps
Along with sunscreen use, the
prevent sunburn.5
FDA and other organizations

CONTEMPORARYPEDIATRICS.COM

OCTOBER

2014

special report
TABLE

t ERMS

TERM

IN SUNSCREEN LABELING RASED ON FDA REGULATIONS

DESCRIPTION

FDA REGULATION

SPF

M a x im u m cla im fo r SPF a llo w e d on a p ro d u c t: SPF 50+.

N o e v id e n c e s u b s ta n tia te s a d d itio n a l sun p ro te c tio n in
p ro d u c ts SPF >50.
S u n s c re e n s w ith SPF >15 are m ore p ro te c tiv e th a n th o s e
<15.

Broad spectrum

B ro a d s p e c tru m can o n ly be used on a la b e l if th e p ro d u c t

p ro v id e s p ro te c tio n o f b o th U VA ra d ia tio n and UVB
w a v e le n g th s , and p ro te c ts a g a in s t >90% o f UV s p e c tru m
(290 -4 0 0 nm).
N o n -b ro a d s p e c tru m p ro d u c ts or broad s p e c tru m w ith SPF
o f 2 -1 4 m u s t be labeled: "T h e s e p ro d u c ts have n o t been
s h o w n to p ro te c t a g a in s t skin c a n c e r and e a rly skin aging.
T h e y have been sh o w n o n ly to help p re v e n t su n b u rn ."

SPF p ro vid e s n u m e ric m e a s u re m e n t o f h o w

e ffe c tiv e su n scre e n is in p re v e n tin g su n b u rn ,
and ty p ic a lly ran g e s fro m 2 to >100. The
a ssu m p tio n is th a t h ig h e r SPFs (ie, 30 vs 15)
pro vid e s u b s ta n tia lly b e tte r sun p ro te c tio n ,
b u t th is m ay n o t be a c c u ra te .
P ro te c tio n a g a in s t b o th U VA and U V B is
im p o rta n t fo r s u n s c re e n e ffe c tiv e n e s s .
H is to ric a lly , m a n y s u n s c re e n p ro d u c ts o n ly
p ro te c te d a g a in s t U V B , w h ic h p ro te c ts
a g a in s t s u n b u rn . P ro te c tio n a g a in s t UVA
and U VB is n e c e s s a ry to p ro te c t a g a in s t skin
c a n c e r and p re m a tu re skin aging.

B road s p e c tru m p ro d u c ts w ith SPF >15 m ay be labeled:

" I f used as d ire c te d w ith o th e r sun p ro te c tio n m e a su re s,
th is p ro d u c t re d u c e s th e ris k o f skin c a n c e r and e a rly skin
a g in g , as w e ll as h e lp s p re v e n t s u n b u rn ."

Water
resistance

P ro d u c ts n e e d in g to be re a p p lie d a fte r 40 m in o f
s w im m in g o r s w e a tin g , o r im m e d ia te ly a fte r d ry in g o ff,
s h o u ld be la b e le d w a te r re s is ta n t.
P ro d u c t n e e d in g to be re a p p lie d a fte r 80 m in o f s w im m in g
o r s w e a tin g , o r im m e d ia te ly a fte r d ry in g o ff, s h o u ld be
la b e le d v e ry w a te r re s is ta n t.

Waterproof or
sweatproof

C a n n o t be used on labels.

Immediate use
or prolonged
protection >2 hr

N e ith e r label can be used u n le ss d a ta to s u p p o rt cla im

are s u b m itte d to and a p p ro ve d by th e FDA.

P ro d u c ts a re d iffe re n tia te d as w a te r
re s is ta n t o r v e ry w a te r re s is ta n t based
on h o w w e ll th e y re ta in s ta te d SPF a fte r
u n d e rg o in g im m e rs io n te s tin g .

Abbreviations: FOA, US Food and Drug Administration; nm, nanometer; SPF, sun protection factor; UV, ultraviolet; UVA, ultraviolet A; UVB, ultraviolet B.
Food and Drug Administration5; US Food and Drug Administration.6

P re v e n tiv e m e a s u re s
u s e d w it h s u n s c re e n s
Along w ith selecting an appropri
ate sunscreen to prevent sun d am
age, children and their parents should
be advised to follow several simple
instructions that can m inim ize the
risk of sun damage. Several organiza
tions, including the FDA, emphasize
the need for adhering to other preven
tive m ethods along with sunscreen
use to provide the best sun protection.
Most of these measures prioritize the
38

need to reduce sun exposure particu

larly during midday when UV inten
sity is at its peak and emphasize the
need to cover up with appropriate
clothing while in the sun; regular use
of ample sunscreen while in the sun;
and application of a sunscreen suffi
cient to protect the skin. Table 2 lists
recom m endations for prim ary pre
vention of overexposure to the sun
by the FDA, the Centers for Disease
C ontrol and Prevention, and the
American Academy of Pediatrics.6'9

CONTEMPORARYPEDIATRICS.COM

OCTOBER

2014

Ms Nierengarten, a m edica l w r ite r in S t. Paul.

M in n e s o ta , has o ver 25 y ears o f m edical
w ritin g expe rience, c o a u th o rin g a rtic le s fo r

Lancet Oncology, Lancet Neurology, Lancet

Infectious Diseases, and M e d sca p e . The
a u th o r has n o th in g to d isclo se in re gard to
a ffilia tio n s w ith or fin a n c ia l in te re s ts in any
o rg a n iza tio n s th a t m ay have an in te re s t in
any p a rt o f th is a rtic le .

More sunscreen guidance at

bit.ly/sunscreen-update

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