Here is a simplified breakdown of what has changed and what it means for your product labels:

Sunscreen Monograph Updates:

• Nano Ingredients Recognized: The monographs now explicitly include data on nano titanium dioxide and nano zinc oxide, covering acceptable quantities, dosage forms, and specifications.
• New Filters Added: Bemotrizinol and Bisoctrizole have been added to the Secondary Sunscreen monograph.
• Testing Standards: New in vitro methods for SPF and broad-spectrum testing (e.g., ISO 23675, ISO 23698) are now referenced.
• PA Ratings (UVA Protection): For NHPs and Non-prescription Drugs (NPDs), PA ratings are now permitted as “additional information” on the label. For NPDs, data must be provided to support any additional information regarding the PA rating prior to its use on labels. The PA rating is acceptable as additional information on the label for NHPs containing Zinc Oxide or a combination of Zinc Oxide and Titanium Dioxide. It does not apply to Titanium Dioxide alone (due to lower efficacy against long-wave UVA).

Acne Therapy Monograph Updates:

• More flexibility for marketing claims (expanded terminology): You are no longer restricted to just “acne pimples.” The monograph now allows interchangeable terms such as “zits,” “blemishes,” “spots,” “blackheads,” “whiteheads,” and “comedones.”
• New Performance Claims: Added support for claims regarding mechanism of action, such as “Penetrates pores to eliminate most acne pimples” or “For the management of acne breakouts.”
• Quantity Labeling: You now have the option to express quantity as % w/w or % w/v, depending on your specific formulation.

General Updates for Both Categories:

• Product Facts Table: A standardized Product Facts Table has been added for NHPs in these categories to improve consumer readability.
• Dosage Forms: An updated list of acceptable dosage forms is now included.

The NNHPD has indicated that under this Monograph Update Project, no modifications are anticipated that would necessitate mandatory product license amendments or label revisions. Essentially, these updates are intended to offer more flexibility and modernization rather than forcing a compliance overhaul of existing products. However, if you are launching new products, you should align with these new standards immediately.

Need help navigating these changes? Do you have questions about how these monograph updates affect your specific formulations or labeling strategies? Feel free to reach out to us.

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This proposal highlights the effectiveness of the OTC Monograph Order Request (OMOR) pathway. Initiated by a request from DSM Nutritional Products LLC, the FDA is proposing the inclusions of bemotrizinol at concentrations up to 6% without requiring a full New Drug Application. The FDA’s review confirmed that the ingredient meets high safety standards, offering broad spectrum (UVA/UVB) protection with low skin absorption and a favorable tolerability profile.

The FDA is currently inviting public feedback on this proposal via the OTC Monograph@FDA portal. If the agency ultimately concludes that bemotrizinol is generally recognized as safe and effective (GRASE), it will issue a final order formally adding the ingredient to he OTC Monograph M020.

The post 📢 FDA Modernization in Action: The Bemotrizinol Proposal & The Future of OTC Monograph Reform appeared first on Focal Point.

Sunscreen is measured in SPF, but what does that mean exactly? SPF stands for Sun Protection Factor. The number indicates how long the UV rays would normally have taken to redden your skin if you had not applied the sunscreen as directed. For example, if you apply an SPF 15, it will take 15 times longer for your skin to burn than if you hadn’t applied the sunscreen.  

There are two types of sunscreen ingredients; chemical and physical ingredients. Chemical ingredients, such as avobenzone and octisalate, absorb UV rays before they can damage your skin. While physical ingredients, such as titanium dioxide and zinc oxide, block and scatter the UV rays before they can damage the skin. Neither is better than the other. With this being said, it should be noted that governing bodies have sunscreen monographs in place to protect the public, such as the FDA Sunscreen Monograph and the Canada Sunscreen Monograph. 

For more information, please contact Focal Point Research Inc. We are leading North American Regulatory and New Product Consultants for Medical Devices, Natural Health Products, OTC Drugs, Cosmetics, and other consumer products regulated by Health Canada and the U.S. FDA. 

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