FDA 2019 sunscreen proposal

For the first time in over 40 years, the Food and Drug Administration (FDA) has announced a new sunscreen safety proposal that could significantly impact the dosage and ingredients of over-the-counter sunscreens. One thing that will not be affected by the new proposal, however, is the importance of wearing sunscreen and our team of Fort Collins skincare specialists agrees.

Sunscreen is one of the most highly recommended skincare products as it provides the most effective protection against the harmful UV rays of the sun. The primary purpose of this new proposal is to ensure that sunscreen continues to be both safe and beneficial by reviewing its active ingredients, dosage, sun protection factor (SPF), broad-spectrum requirements and product labeling.

The Purpose of This New Proposal

The new Sunscreen Safety Proposal is the final set of regulations for over-the-counter sunscreen products required by the Sunscreen Innovation Act of 2014. SIA was enacted with the intent of reviewing both the safety and effectiveness of nonprescription active ingredients commonly found in sunscreen. FDA Commissioner Scott Gottlieb, M.D. best described the intent behind this years’ sunscreen safety proposal in this news release. He stated that:

“Broad spectrum sunscreens with SPF values of at least 15 are critical to the arsenal of tools for preventing skin cancer and protecting the skin from damage caused by the sun’s rays, yet some of the essential requirements for these preventive tools haven’t been updated in decades. Since the initial evaluation of these products, we know much more about the effects of the sun and about sunscreen’s absorption through the skin. Sunscreen usage has changed, with more people using these products more frequently and in larger amounts. At the same time, sunscreen formulations have evolved as companies innovated. Today’s action is an important step in the FDA’s ongoing efforts to take into account modern science to ensure the safety and effectiveness of sunscreens. The proposal we’ve put forward would improve quality, safety and efficacy of the sunscreens Americans use every day. We will continue to work with industry, consumers and public health stakeholders to ensure that we’re striking the right balance. To further advance these goals, we’re also working toward comprehensive OTC reform, which will help foster OTC product innovation as well as facilitate changes necessary for the FDA to keep pace with evolving science and new safety data.”

The recommendations within the proposal will surely lead to a number of changes for the sunscreen industry, and many companies may find themselves forced to reformulate their products.

Active Ingredients

The biggest impact from this new proposal will come from changes to approved ingredients. Out of the 16 active ingredients currently found in sunscreen, the FDA has determined that only two are safe for use: zinc oxide and titanium dioxide. Research for the proposal also determined that there is not enough scientific data on another 12 ingredients to fully determine if they are safe or harmful, so the FDA has requested that additional testing be done by the sunscreen industry. Two final active ingredients, PABA and trolamine salicylate, were determined to not be safe for use. However, the FDA believes they are not used in any sunscreens currently on the market. You can read more about the effect on sunscreen ingredients by clicking here.

SPF

The proposal suggests that the maximum SPF value labeled on sunscreens be raised from SPF 50+ to SPF 60+. It also suggests that sunscreens with an SPF of 15 or higher be required to provide broad-spectrum protection. Likewise, it recommends that as SPF increases, so should the level of protection against UVA radiation through broad-spectrum protection.

Label Requirements

The proposal creates stricter labeling requirements for over-the-counter sunscreens. It proposes that

  • Active ingredients be clearly outlined on the front of the package
  • A skin cancer/skin aging alert be added to the front label of sunscreens that have not been proven to help reduce the risk of skin cancer
  • The format be revised for identifying SPF, broad spectrum, and water resistance

A Call for Further Testing

While the proposal recommends several significant changes on its own, the FDA intends to continue testing and researching ingredients. Click here to read more about the FDA’s new proposal for skincare regulations.

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