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OTC Sunscreen manufacturers can expect to see some major changes coming their way soon, with the announcement of some brand-new rules coming from the FDA late Friday afternoon. The proposed order discusses changes to label requirements and major changes to active ingredients that are allowed in OTC sunscreen products. This proposed rule is an update to the 2019 proposed rule and has a 45-day public comment period.

One of the major label changes is regarding the maximum labeled SPF that can be on the product. Currently, there is no maximum SPF value that must be on a label; however, the proposed rule states that all products with an SPF over 60 (SPF 80 products, for example) should simply just state SPF 60+. The agency also proposes that the dosage form of the product be put on the label, as well as a “Skin Cancer/Skin Aging alert” on products that have not been clinically proven to help prevent skin cancer.[1]

In addition to these major label changes, the most daunting change of all is regarding the active ingredients for OTC sunscreen products. Currently, 16 active ingredients are generally recognized as safe and effective (GRASE) – meaning any product formulated with at least one of these ingredients can be marketed without the burden of a new drug application. Under this proposed rule, the FDA has trimmed the list of GRASE OTC sunscreen active ingredients down to just two: zinc oxide and titanium dioxide. Beyond that, the FDA is removing GRASE status from aminobenzoic acid (PABA) and trolamine salicylate due to safety concerns.1

Finally, the last major change in the proposed rule would force manufacturers to beef up their record-keeping and maintenance requirements. This includes keeping records of final formulation testing and other manufacturing batch/lot records. The writing on this wall for this proposed rule is that the Agency is slowly trying to force OTC manufacturers to migrate towards a more robust QMS requirement than they are currently used to.

Although these changes may seem daunting, they don’t have to be resource-intensive with EMMA International on your side. The team of FDA Compliance experts at EMMA International can help guide you through the various Regulatory Affairs, Quality, and Compliance hurdles that come with major changes like this. Give us a call at 248-987-4497 or email info@emmainternational.com to get connected with us today!


[1] FDA, HHS (Sep 2021) Amending Over The Counter Monograph M020: Sunscreen Proposed Order retrieved on 09/26/2021 from: https://www.federalregister.gov/documents/2021/09/27/2021-20780/amending-over-the-counter-monograph-m020-sunscreen-drug-products-for-over-the-counter-human-use-over

Madison Wheeler

Madison Wheeler

Director of Technical Operations - Ms. Wheeler serves as EMMA International’s Director of Technical Operations. She has experience in technical writing, nonconforming product management, issue evaluations, and implementing corrective and preventative actions in the pharmaceuticals and medical device industries. She has experience cross-functionally between R&D, lean manufacturing operations, and RA compliance. Ms. Wheeler also has academic and work experience with human health-risk engineering controls, physiological biophysics, and clinical research. Ms. Wheeler holds a Bachelor of Science in Biosystems Engineering with a concentration in Biomedical Engineering from Michigan State University. She is also a Certified Quality Auditor (CQA), and is currently pursuing her M.S. in Quality Management.

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