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Shedding Light on Possible New FDA Sunscreen Regulations

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With Memorial Day Weekend marking the unofficial start of summer, millions of Americans are now enjoying warmer weather and more time outdoors. As consumers restock their beach bags and picnic baskets, the Food & Drug Administration continues to take a closer look at a summer essential likely to be in all of them: sunscreen.

On February 21, 2019, the FDA announced it was advancing new proposed regulation designed to ensure that sunscreens are safe and effective. The proposed regulation would update requirements for nonprescription, over-the-counter (OTC) sunscreens marketed without FDA approval. According to the FDA’s press release, the proposed regulation “addresses sunscreen active ingredient safety, dosage forms and sun protection factor (SPF) and broad-spectrum requirements.”

At Reed Tech, we’re keeping a close eye on yet another provision: proposed changes to sunscreen product labeling.

Proposed new regulations

Citing a goal of helping consumers more easily identify key information, the FDA is considering requiring all OTC sunscreens to add active ingredients on the front of the package to bring these product labels in line with other OTC drugs. If enacted, the new regulation would mandate a front-label notification for consumers to read the skin cancer/skin aging alert for products not shown to help prevent skin cancer. It would also require revised formats for statements about SPF, broad spectrum and water resistance.

In short, manufacturers of sunscreens – and, potentially, any OTC product that contains sunscreen active ingredients – such as lip balm, cosmetics, and hand creams – could be facing the need to overhaul their product labels.

The Sunscreen Innovation Act (SIA) enacted November 2014 calls for the FDA to issue a final OTC sunscreen monograph to be effective within five years of enactment of the SIA – in other words, by November 26, 2019. Assuming the FDA meets the deadline, companies will need to act swiftly and effectively to make the packaging revisions – and update their product listings with the FDA.

What’s next?

At Reed Tech, we’re monitoring this ruling, and we stand ready to help affected manufacturers – many of whom may have limited experience with the FDA’s electronic Drug Registration and Listing (eDRL) process using Structured Product Labeling (SPL) submissions. We offer an SPL preparation and data maintenance product, outsourced SPL conversion services and SPL submission services all supported by our expert staff to help guide you through the process with guaranteed 100% accuracy. So while we can’t promise that addressing all the proposed changes will be a day at the beach, we’re here to make the eDRL SPL process as fast and smooth as possible.

For questions about SPL solutions and services, get in touch with Reed Tech by email at Pharma@ReedTech.com

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