Sunscreen, cancer, UVA and UVB - ZHION.COM
July 4, 2011 Send your comment to zhion@zhion.com
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Science
According to a recent study, Boise has 51 clear summer days and for every 100,000 people
in Ada County, 3.9 people die from skin cancer and another 27.3 are diagnosed with skin
cancer. [KTVB.COM, July 3, 2011]

Some people do not apply sun screen on their skin, when it is a cloudy day.

Two thirds of people in UK never wear sun cream when in the UK because they think the
cloud cover will protect them. Anne Jackson, CEO of the North West Cancer Research Fund,
said dangerous UVA and UVB rays still make their way through the clouds and dramatically
increase the risk of developing skin cancer. [Daily Mail, 5th July 2011]

Both UVB and UVA radiation contribute to sunburn, skin cancer, and premature skin aging.
However, sunburn is primarily caused by UVB radiation. "Broad spectrum" generally means
the product protects against both forms of skin-damaging ultra violent light, while "sun
tanning lotions" are likely protect only against one form of UV light. So, you may want to avoid
purchasing some tanning lotions, if you would like to have a better protection for your skin
from the sun.  [newsfeedresearcher.com Jun-23-2011]

Applying sunscreen onto the skin and wearing wide-brimmed hats and tight-knit clothing can
lower not only the risk of skin cancer but also premature wrinkles. To ensure the protective
effect, please, reapply sunscreen every few hours. Apply it more frequent if swimming or
sweating heavily. [SJ-R.com, Jul 03, 2011]

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The Food and Drug Administration (FDA) is taking steps to help protect consumers
from skin damage caused by excessive sun exposure.

The new measures include the following:

* final regulations that establish standards for testing the effectiveness of sunscreen products
and require labeling that accurately reflects test results
* a proposed regulation that would limit the maximum SPF value on sunscreen labeling to
“SPF 50+”
* a data request for safety and effectiveness information for sunscreen products formulated
in certain dosage forms (e.g., sprays)
* a draft guidance for sunscreen manufacturers on how to test and label their products in light
of these new measures.

These measures are necessary, says Lydia Velazquez, PharmD, in FDA’s Division of
Nonprescription Regulation Development, because “our scientific understanding has grown.
We want consumers to understand that not all sunscreens are created equal.”

“This new information will help consumers know which products offer the best protection from
the harmful rays of the sun,” Velazquez says.  “It is important for consumers to read the entire
label, both front and back, in order to choose the appropriate sunscreen for their needs.”

Everyone is potentially susceptible to sunburn and the other detrimental effects of exposure
to UV radiation.

FDA's Final Regulations

The final regulations, which become effective in one year, establish a standard test for over-
the-counter (sold without a prescription) sunscreen products that will determine which
products are allowed to be labeled as “Broad Spectrum.”

Products that pass this test will provide protection against both ultraviolet B radiation (UVB)
and ultraviolet A radiation (UVA).  Sunburn is primarily caused by UVB.  Both UVB and UVA
can cause sunburn, skin cancer, and premature skin aging.  A certain percentage of a broad
spectrum product’s total protection is against UVA.

Under the new regulations, sunscreen products that protect against all types of sun-induced
skin damage will be labeled "Broad Spectrum" and “SPF 15” (or higher) on the front.

The new labeling will also tell consumers on the back of the product that sunscreens labeled
as both “Broad Spectrum” and “SPF 15” (or higher) not only protect against sunburn, but, if
used as directed with other sun protection measures, can reduce the risk of skin cancer and
early skin aging. For these broad spectrum products, higher SPF (Sun Protection Factor)
values also indicate higher levels of overall protection.

By contrast, any sunscreen not labeled as “Broad Spectrum” or that has an SPF value
between 2 and 14, has only been shown to help prevent sunburn.

Reynold Tan, a scientist in FDA’s Division of Nonprescription Regulation Development,
notes that FDA has been developing testing and labeling requirements for sunscreen
products for decades. However, only recently have the data become sufficient to establish an
accurate and reliable test for broad spectrum UV protection, he says.

To help consumers select and use sunscreens appropriately, the final regulations include
these additional labeling provisions:

* Sunscreen products that are not broad spectrum or that are broad spectrum with SPF
values from 2 to14 will be labeled with a warning that reads: “Skin Cancer/Skin Aging Alert:  
Spending time in the sun increases your risk of skin cancer and early skin aging. This
product has been shown only to help prevent sunburn, not skin cancer or early skin aging.”

* Water resistance claims on the product's front label must tell how much time a user can
expect to get the declared SPF level of protection while swimming or sweating, based on
standard testing. Two times will be permitted on labels: 40 minutes or 80 minutes.

* Manufacturers cannot make claims that sunscreens are “waterproof” or “sweatproof, or
identify their products as “sunblocks.”   Also, sunscreens cannot claim protection
immediately on application (for example, “instant protection”) or protection for more than two
hours without reapplication, unless they submit data and get approval from FDA.

FDA Proposed Regulations, Data Requests, and a Draft Guidance

In addition to the final regulations, FDA is proposing a regulation that would require
sunscreen products that have SPF values higher than 50 to be labeled as “SPF 50+.” FDA
does not have adequate data demonstrating that products with SPF values higher than 50
provide additional protection compared to products with SPF values of 50.

FDA is requesting data and information on different dosage forms of sunscreen products.  
The agency currently considers sunscreens in the form of oils, creams, lotions, gels, butters,
pastes, ointments, sticks, and sprays to be eligible for potential inclusion in the OTC
sunscreen monograph – meaning that they can be marketed without individual product
approvals.

The agency currently considers wipes, towelettes, powders, body washes, and shampoo not
eligible for the monograph. Therefore, they cannot be marketed without an approved
application.

For sunscreen spray products, the agency requests additional data to establish
effectiveness and to determine whether they present a safety concern if inhaled
unintentionally.  These requests arise because sprays are applied differently from other
sunscreen dosage forms, such as lotions and sticks.

FDA is also issuing a draft guidance to help sunscreen manufacturers understand how to
label and test their products in light of the final and proposed regulations and the data
request on dosage forms. Tan says the FDA hopes that manufacturers will implement the
new rules well before their effective date.

Sun Safety Tips

Spending time in the sun increases the risk of skin cancer and early skin aging.  To reduce
this risk, consumers should regularly use sun protection measures including:

* Use sunscreens with broad spectrum SPF values of 15 or higher regularly and as directed.
* Limit time in the sun, especially between the hours of 10 a.m. and 2 p.m., when the sun’s
rays are most intense.
* Wear clothing to cover skin exposed to the sun; for example, long-sleeved shirts, pants,
sunglasses, and broad-brimmed hats.
* Reapply sunscreen at least every 2 hours, more often if you’re sweating or jumping in and
out of the water.

This article appears on FDA's Consumer Updates page, which features the latest on all FDA-
regulated products.

Reference: FDA Website June 14, 2011