Sunscreen labeling requirements

NEWS 05/12/1993 Sunscreen labeling requirements
P93-16                                 Food and Drug Administration
FOR IMMEDIATE RELEASE                  Mike Shaffer (301) 443-3285

   The Food and Drug Administration today proposed sunscreen labeling
requirements designed to help sunbathers better protect their skin
from sun damage. The proposals would require that: 
   -- sun protective factors (SPFs) be limited to a maximum of 30;
   -- cosmetic products for tanning that contain no sunscreen display
a warning that they do not protect against sunburn; and
   -- all sunscreen and suntan products bear statements about the
sun's potential harm and about the product's ability to protect
users.
     One statement that FDA proposes to require on sunscreens reads: 
"Sun Alert: The sun causes skin damage.  Regular use of sunscreens
over the years may reduce the chance of skin damage, some types of
skin cancer and other harmful effects due to the 
sun."
   "There is overwhelming evidence that overexposure to radiation
from the sun is a health hazard," said FDA Commissioner David A.
Kessler, M.D.  "Consumers should not have to guess how much
protection, if any, they'll 
get from the sunscreen and tanning products on the market." 
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                                      Page 2, P93-16, Sunscreens
   If finalized, the new document -- known as a monograph -- would
revise and update sunscreen standards originally proposed in 1978 and
reviewed again at a public meeting in 1988. Since the late 1970s,
considerable advances have been made in understanding the effects of
radiation from the sun on the body, while the number of doctors'
office visits for skin cancer has increased more than 50 percent. 
Skin cancers in which ultraviolet radiation from the sun plays an
important role are the most common form of cancer. 
   Hundreds of comments have been received over the years from
industry, professional and consumer groups and individuals about
sunscreens. Twenty active ingredients, some already in use, are being
proposed as safe and effective for use in sunscreen products.
   The proposal increases to 30 the highest number of permissible sun
protection factors, a value twice as high as was stated in the
standards proposed in 1978.  SPF numbers above 30, which have since
then appeared on some products, may be used until a final  regulation
becomes effective, but such values are not considered necessary for
most consumers.  SPF is an indication of how long users who apply the
sunscreen properly can expect to safely stay in the sun without
burning. The higher the SPF number, the more protection is provided.
   According to the proposal, labeling will advise that products used
on children between six months and two years of age should provide a
minimum SPF of four, and that parents should consult a 
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                                        Page 3, P93-16, Sunscreens
physician about using sunscreen on children under six months old.
   Any product that refers to an SPF or makes other sunscreen claims
would be considered a drug and subject to the full sunscreen
requirements.  Although FDA considers all products, including
cosmetics such as lipsticks and shampoos that make sunscreen claims,
to be drugs, alternative labeling would be allowed to distinguish
between products intended for everyday use and those intended to
protect against prolonged and intense exposure to the sun.
    Among other issues discussed in the proposal are claims that a
product is waterproof or water resistant and claims for sunless
tanning, tanning pills and tanning accelerators.
   FDA is one of the eight Public Health Service agencies within HHS. 
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