I
106TH CONGRESS
1ST SESSION
H. R. 2658
To provide that the Commissioner of Food and Drugs shall by regulation
require over the counter drug sunscreen products to include an expiration
date and storage recommendations on their label.
IN THE HOUSE OF REPRESENTATIVES
JULY 30, 1999
Mr. CROWLEY (for himself, Mrs. MALONEY of New York, Mr. MCNULTY, Ms.
MCKINNEY, Mr. MCGOVERN, and Ms. LEE) introduced the following bill;
which was referred to the Committee on Commerce
A BILL
To provide that the Commissioner of Food and Drugs shall
by regulation require over the counter drug sunscreen
products to include an expiration date and storage rec-
ommendations on their label.
Be it enacted by the Senate and House of Representa-
tives of the United States of America in Congress assembled,
SECTION 1. SHORT TITLE.
This Act may be cited as the ‘‘Safe Sunscreen,
Healthy Skin Act’’.
SEC. 2. FINDINGS.
The Congress finds the following:
(1) According to the American Cancer Society,
over 800,000 new skin cancer cases of highly curable
basal cell or squamous cell cancers are diagnosed per
year.
(2) In 1995, over 34,100 persons were diag-
nosed with melanoma, the most serious type of skin
cancer. Since 1973, the incidence rate of melanoma
has increased about 4 percent per year. An addi-
tional 16,000 invasive nonmelanoma skin cancer
cases occurred in 1995, mostly sarcomas, including
Kaposi’s sarcoma.
(3) Approximately 9,300 deaths occurred in
1995, 7,200 from malignant melanoma and 2,100
due to other skin cancers. According to the Amer-
ican Cancer Society’s ‘‘Cancer Facts & Figures—
1995’’ the best ways to prevent skin cancer are as
follows: ‘‘The sun’s ultraviolet rays are the strongest
between 10 a.m. and 3 p.m., exposure at these times
should be avoided, and protective clothing should be
worn.’’
(4) Because of the possible link between severe
sunburns in childhood and greatly increased risk of
melanoma in later life, children, in particular, should
be protected from the sun.
(5) Considering that half of all new cancers are
skin cancers, malignant melanoma, the deadliest
form of skin cancer, will claim over 7,300 lives this
year, 1,200 people will die from other forms of skin
cancer, and an estimated 1,000,000 new cases of
skin cancer were diagnosed in the United States in
1996, this Act takes on a special urgency.
(6) Sunscreen products have an effectiveness
life of 3 to 5 years. In light of how important these
products are in combating skin cancer, it is appro-
priate that the consumer know that sunscreen is not
protective against the sun’s rays after a certain
point. This especially becomes true with children’s
sunscreen, as young people tend to be more severely
burned and are in greater danger than adults.
SEC. 3. LABELING.
(a) EXPIRATION DATE AND STORAGE RECOMMENDA-
TIONS.—The Commissioner of Food and Drugs shall re-
quire over the counter drug sunscreen products which are
designed to screen the ultra violet rays of the sun on indi-
viduals who use the products to include on the label of
the products a date beyond which the product is not an
effective screen of such rays and recommendations for the
storage of the products to avoid reducing the effectiveness
of the products.
(b) ENFORCEMENT.—For purposes of the Federal
Food, Drug, and Cosmetic Act, an over the counter drug
sunscreen product which does not contain the date and
storage recommendations required by regulations under
subsection (a) shall be considered to be a misbranded
drug.
SEC. 4. EFFECTIVE DATE.
This Act shall take effect on the first day of January
next succeeding the date of its enactment.
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