US FDA: FDA Proposes New Rule for Sunscreen

Products Highlights Include New UVA Rating

System, Sun Warning Information
Publication info: M2 Presswire ; Coventry [Coventry]24 Aug 2007: 1.

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ABSTRACT (ABSTRACT)
"For more than 30 years, consumers have been able to identify the level of UVB protection provided by sunscreens
using only sunburn protection factor or SPF values," said Andrew C. von Eschenbach, M.D., Commissioner of Food
and Drugs. "Under today's proposal, consumers will also now know the level of UVA protection in sunscreens,
which will help them make informed decisions about protecting themselves and their children against the harmful
effects of the sun."
The proposed regulation creates a consumer-friendly rating system for UVA products designed to help consumers
identify the level of UVA protection offered by a product. The FDA proposal provides a ratings system for UVA
sunscreen products on a scale of one to four stars. One star would represent low UVA protection, two stars would
represent medium protection, three stars would represent high protection, and four stars would represent the
highest UVA protection available in an OTC sunscreen product. If a sunscreen product does not provide at least a
low level (one star) of protection, FDA is proposing to require that the product bear a "no UVA protection" marking
on the front label near the SPF value.
When finalized, the proposed regulation would amend the existing OTC sunscreen rule published in 1999 that
established regulations related to UVB light and mandated that OTC UVB sunscreen products be labeled with a
SPF. FDA also is amending its existing 1999 rule to increase the SPF from SPF30+ to SPF50+. Previously, FDA had
recognized SPF values up to 30+.

FULL TEXT
M2 PRESSWIRE-August 24, 2007-US FDA: FDA Proposes New Rule for Sunscreen Products Highlights Include New
UVA Rating System, Sun Warning Information (C)1994-2007 M2 COMMUNICATIONS LTD
The U.S. Food and Drug Administration today proposed a new regulation that sets standards for formulating,
testing and labeling over-the-counter (OTC) sunscreen drug products with ultraviolet A (UVA) and ultraviolet B
(UVB) protection.
"For more than 30 years, consumers have been able to identify the level of UVB protection provided by sunscreens
using only sunburn protection factor or SPF values," said Andrew C. von Eschenbach, M.D., Commissioner of Food
and Drugs. "Under today's proposal, consumers will also now know the level of UVA protection in sunscreens,
which will help them make informed decisions about protecting themselves and their children against the harmful
effects of the sun."
Sunlight is composed of the visible light that we can see, and ultraviolet (UV) light that we can not. There are two
types of UV light, UVA and UVB. UVA light is responsible for tanning and UVB for sunburn. Both can damage the
skin and increase the risk of skin cancer.
The proposed regulation creates a consumer-friendly rating system for UVA products designed to help consumers
identify the level of UVA protection offered by a product. The FDA proposal provides a ratings system for UVA
sunscreen products on a scale of one to four stars. One star would represent low UVA protection, two stars would
represent medium protection, three stars would represent high protection, and four stars would represent the
highest UVA protection available in an OTC sunscreen product. If a sunscreen product does not provide at least a

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low level (one star) of protection, FDA is proposing to require that the product bear a "no UVA protection" marking
on the front label near the SPF value.
Ratings would be derived from two tests the FDA proposes to assess the effectiveness of sunscreens in providing
protection against UVA light. The first test measures a product's ability to reduce the amount of UVA radiation that
passes through it.
The second test measures a product's ability to prevent tanning. This test is nearly identical to the SPF test used
to determine the effectiveness of UVB sunscreen products.
In addition, a "Warnings" statement in the "Drug Facts" box will be required of all sunscreen product
manufacturers. The warning will say: "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." The warning is intended to increase awareness that sunscreens are only one part of a sun protection
program.
"Many consumers incorrectly believe that the only way to protect themselves from skin damage caused by the sun
is to apply sunscreens," said Douglas Throckmorton, M.D., deputy director of FDA's Center for Drug Evaluation and
Research.
"The labeling being proposed today strengthens the existing labeling for sunscreens by educating consumers on
the added importance of limiting their time in the sun and wearing protective clothing as part of a sun protection
regimen."
When finalized, the proposed regulation would amend the existing OTC sunscreen rule published in 1999 that
established regulations related to UVB light and mandated that OTC UVB sunscreen products be labeled with a
SPF. FDA also is amending its existing 1999 rule to increase the SPF from SPF30+ to SPF50+. Previously, FDA had
recognized SPF values up to 30+.
Under the proposed amendment, the range would be SPF2 to SPF50+. SPF50 provides more UVB protection than
lower SPF values. Additionally, the proposed rule:
* revises the existing SPF (UVB) testing procedures;
* allows new combinations of active ingredients; and
* asks for comments on the issue of nanoparticles.
FDA is accepting comments on the new rule for 90 days until November 26, 2007. Comments must be identified
with Docket No.
1978N-0038 and can be submitted electronically or in written form. Electronic submissions can be submitted at
the following Web sites:
Federal eRulemaking Portal: www.regulations.gov FDA Web site: www.fda.gov/dockets/ecomments
Written submissions can be submitted by fax or mail: Division of Dockets Management Food and Drug
Administration 5630 Fishers Lane, Room 1061 Rockville, MD 20852 Fax: 301-827-6870
For more information: FDA Web site for OTC drug products
Consumer Article: FDA Aims to Upgrade Sunscreen Labeling
CONTACT: Rita Chappelle, Media Inquiries, US FDA
Tel: +1 301 827 6242
((M2 Communications Ltd disclaims all liability for information provided within M2 PressWIRE. Data supplied by
named party/parties. Further information on M2 PressWIRE can be obtained at http:// www.presswire.net on the
world wide web. Inquiries to info@m2.com)).

DETAILS

Company / organization: Name: Food &Drug Administration; NAICS: 922190; SIC: 9400; DUNS: 13-818-2175

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 Publication title: M2 Presswire; Coventry

First page: 1

Number of pages: 0

Publication year: 2007

Publication date: Aug 24, 2007

Publisher: Normans Media Ltd

Place of publication: Coventry

Country of publication: United Kingdom, Coventry

Publication subject: Communications

Source type: Wire Feeds

Language of publication: English

Document type: WIRE FEED

ProQuest document ID: 444637334

Document URL: https://search.proquest.com/docview/444637334?accountid=31562

Copyright: (Copyright M2 Communications Ltd. 24, 2007)

Last updated: 2010-06-30

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