FDA to Ban Misleading Sunscreen Labels; Dermagenics Predicts 90% of Sunscreen Products Will be Pulled Off Shelf Within One Year

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Under the new FDA regulation, supported by Dermagenics, the agency has proposed that sunscreen labeling be expanded to provide a four-star rating system that informs consumers how well the product protects them against Ultraviolet A (UVA) light, the major cause of skin cancer.

Our cutting edge formulation technology has allowed us to use safe and proven ingredients to create an effective physical barrier sunscreen that provides 95% protection against UVA and UVB rays.

The FDA is taking action to require sunscreen labels to accurately rate the protection offered against the sun’s harmful rays. Under the new regulation, supported by Dermagenics, the agency has proposed that sunscreen labeling be expanded to provide a four-star rating system that informs consumers how well the product protects them against Ultraviolet A (UVA) light, the major cause of skin cancer.

According to Mike Koenig from the FDA’s non-prescription regulation development team, the FDA has been working on the regulation since 2007, stating “The final rule has been written for the new regulation and is now with the office of management and budget. The final rule should be approved in the next few months. Once published, the new regulations will take one year to go into effect. The rule will require all sunscreens to provide information on the label regarding protection against UVA rays in addition to UVB rays.”

Currently, sunscreen labels are only required to carry “Sunburn Protection Factor” (SPF) value that informs potential users how well the product protects against UVB rays. Most of these sunscreens fail to offer adequate protection against UVA rays, which penetrate deeper than UVB rays, causing skin cancer, premature aging and wrinkles. These misleading labels mean that consumers think they are protecting themselves from the sun, when they are actually completely exposed to the UVA spectrum.

Noted Orange County dermatologist Dr. Manu Seyfzadeh explains, “The most important advice in terms of sun exposure is to avoid sunburns, because sunburns are associated with melanoma. However, even sun exposure without sunburn can lead to certain kinds of non-melanoma skin cancer and pre-mature skin aging. Therefore, I recommend using a physical sunblock for optimal protection. Physical barrier sunblocks use zinc oxide and titanium dioxide to provide full spectrum protection from the sun, which is superior to the partial spectrum protection offered by chemical varieties. These ingredients actually prevent most of the sun’s rays from reaching the skin, rather than absorbing a limited spectrum, as with chemical sunscreens.”

The sun’s rays also penetrate the windows of cars, offices, and homes, making all day protection important every day of the week. Although glass blocks UVB rays, it does not block harmful UVA rays. Consumers are beginning to realize that sun protection should be a daily, year round activity, not just used on beach days.

Some sunscreens even claim broad-spectrum UVA and UVB protection, while only absorbing a small spectrum of the UVA rays. Further, many consumers are fooled by the manufacturers claims for SPF ratings of 45, 60, or even 100.

However, the FDA does not recognize an SPF above 30, because accurate testing is not available for higher SPF levels. The FDA has stated that these higher SPF ratings are “inherently misleading”. It is estimated that an SPF of 15 provides a 95% UVB protection and SPF 30 provides only 1% more. Experts consider high-level SPF ratings to be a marketing ploy used to trick consumers into thinking they will be better protected from the sun.

Fortunately, the FDA has taken note of this alarming trend and is taking action to protect consumers by requiring UVA protection ratings on sunscreen labels. This will likely result in a large percentage of sunscreen products being removed from the shelves, because most sunscreens do not adequately protect skin from UVA rays.

There are a limited number of physical sunscreens already available that effectively block both UVA and UVB rays, such as Dermagenics Sun Savvy Solar Shield. Dermagenics sunscreen effectively provides 95% UVA/UVB protection, without the typical white residue left by zinc sunscreen.

Dermagenics CEO Debbye McGlothen explains, “Our cutting edge formulation technology has allowed us to use safe and proven ingredients to create an effective physical barrier sunscreen that provides 95% protection against UVA and UVB rays. Using a sophisticated reverse emulsion process, which suspends the zinc oxide and titanium dioxide on the skin’s surface, Dermagenics provides all day protection with no white residue or clogged pores. Our sunscreen does not contain common sunscreen chemicals such as oxybenzone, alcohols or PABA, and doesn’t run when wet, sting the eyes, or irritate the skin.”

For media inquiries, please contact Jason Barbaria: jb(at)dermagenics(dot)com, or 888-988-3376.

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Jason Barbaria
Dermagenics
888-988- 3376
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