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New FDA Sunscreen Regulations

New FDA Sunscreen Regulations: What This Means for Sun Protection

The Food and Drug Administration (FDA) has tightened up its regulations around over-the-counter (OTC) sunscreen products, calling for more research on non-prescription sunscreen ingredients. They’ve recommended a new rule that would update regulatory requirements for most sunscreen products in the United States.

These proposed regulations are in response to new research on the common ingredients of OTC sunscreen. According to these findings, only two out of the 16 ingredients (zinc oxide and titanium dioxide) are considered to be generally safe and effective per FDA standards. However, there's more to the story than that. Two other components – para-aminobenzoic acid (PABA) and trolamine salicylate – are now deemed unsafe for use in sunscreen. The FDA notes that there is not enough research to determine the safety and effectiveness of the other 12 ingredients.

The Proposition

So, what exactly is the proposition in question? NBC News reported that "[new regulations have] been issued to establish conditions under which some sunscreen drug products can be sold without FDA-approved marketing applications." The FDA proposal also revealed the alarming fact that many broad-spectrum sunscreens had not been updated in decades. To combat this, FDA Commissioner Scott Gottlieb suggested a new rule that, as the SPF in broad-spectrum products increases, “the magnitude of protection against UVA radiation also increases.” This rule will ensure that products provide consumers with the labeled-protection they believe they are purchasing.

Per the new regulations, the FDA stated that the only dosage forms that are “generally recognized as safe and effective” (GRASE) for use as sunscreens are sprays, oils, lotions, creams, gels, butters, pastes, ointments, and sticks. Meanwhile, sunscreen options that combine SPF with insect repellents will not fall into the GRASE category. These products will have to go through the process of being “new [and approved] drugs.”

Powders, however, will be “eligible for inclusion” if additional data is presented. The FDA also suggested that wipes, towelettes, body washes, shampoos, and other dosage forms should be categorized as new drugs due to a lack of data.

More Details From the FDA

On the FDA website, Gottlieb continued to clarify on this proposal, stating that it would “improve [the] quality, safety, and efficacy of the sunscreens Americans use every day.” The FDA insisted that they will continue to collaborate with industry stakeholders, public health professionals, and consumers to ensure that efforts are balanced. They will also work toward “comprehensive OTC reform” to help foster research and product development.

It has been many years – decades, in fact – since the current OTC sunscreen products were updated. And today, we know much more about their ingredients as well as the sun’s effects on the skin. More importantly, sunscreen usage has changed. Today, people use these products more frequently and in larger amounts.

What Now?

Both the FDA and the American Academy of Dermatology Association (AADA) are encouraging the public to continue protecting themselves from the sun’s harmful rays by using their preferred sunscreen option. It is important to note that, until the FDA’s proposal passes, the current ingredients in sunscreen are considered safe and effective.

The AADA recommends a comprehensive sun protection plan for every individual that spends time outside. It includes (but is not limited to) seeking shade, wearing UPF 50+ clothing, and applying broad-spectrum, water-resistant sunscreen with an SPF of 30 or higher to all exposed skin.

That being said, it’s more important now than ever to ramp up your sun safety routine. And Cabana Life is here to help you stay protected. Browse our new arrivals to find stylish sun-protective clothing for the whole family!