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T99-23 Print Media: 301-827-6242
May 21, 1999
Consumer Inquiries: 888-INFO-FDA
SUNSCREEN REGULATIONS FINALIZED
The Food and Drug Administration today finalized its
regulations for over-the-counter (OTC) sunscreen drug
products. The regulations (referred to as a "final
monograph") list the sunscreen active ingredients that can
be used in these products as well as labeling and testing
requirements. The regulations provide for uniform,
streamlined labeling for all OTC products intended for use
as sunscreens to assist consumers in making decisions on sun
protection.
FDA has been involved with the development of
regulations for OTC drug products since 1972, and sunscreens
is just one of many categories of OTC drug products for
which "monographs" have been finalized.
Highlights of the new regulations include the
following:
- Similar labeling requirements for all OTC
products intended for use as sunscreens (including
sunscreen-cosmetic combinations such as makeup products
carrying sun protection claims) to provide good, useful
information to consumers.
- Uniform, streamlined labeling for all sunscreens.
Accommodations in labeling will be made for sunscreens
that are labeled for use only on specific small areas
of the face (e.g., lips, nose, ears, and/or around
eyes).
- A list of 16 allowed sunscreen active
ingredients, with zinc oxide and avobenzone being the
two most recent additions.
- Both required and optional label claims,
warnings, and directions.
- Required sun protection factor (SPF) testing.
The higher the SPF the more sunburn protection.
- A new SPF category of "30" plus (or "30+") for SPF
values above 30.
- Simplification of the previously proposed five
product sun protection categories to "minimum,"
"moderate," or "high," plus optional claims to help
consumers with selection of sunscreen products.
- A "Sun Alert" statement that reflects the
important role sunscreens play in a total program to
reduce the harmful effects of the sun (i.e., "Sun
alert: Limiting sun exposure, wearing protective
clothing, and using sunscreens may reduce the risks of
skin aging, skin cancer, and other harmful effects of
the sun.")
- Cessation of unsupported, absolute, and/or
misleading and confusing terms such as "sunblock,"
"waterproof," "all-day protection," and "visible and/or
infrared light protection".
- In addition to these changes new cosmetic
regulations developed during the sunscreen rulemaking
require tanning preparations that do not contain a
sunscreen ingredient to display the following
warning:
"Warning--this product does not contain a
sunscreen and does not protect against sunburn.
Repeated exposure of unprotected skin while
tanning may increase the risk of skin aging, skin
cancer, and other harmful effects to the skin
even if you do not burn."
Because of the testing requirements for and seasonal nature of
sunscreen products, manufacturers of sunscreens will have 24
months to comply with the new requirements. Manufacturers of
cosmetic tanning preparations that do not contain a
sunscreen will have 12 months to include the required
warning statement on their products. However, all
manufacturers are encouraged to provide the new labeling as
soon as possible.
Claims concerning ultraviolet A (UVA) protection will
continue as previously proposed until the agency further
evaluates this issue.
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