How would you like to be on the Personal Care Products Council and the Consumer Healthcare Products Association Sunscreen Task Force? This body of people have been assigned the task of figuring out the requirement for human absorption of sunscreen agents according to actual use. This new task has been added to the list provided by the FDA in 2016 issuing guidance for manufacturers to outline safety data for OTC sunscreen active ingredients as GRASE (generally recognized as safe and effective). The existing list included clinical and nonclinical safety testing, data about human irritation, sensitization, and photosafety studies. Systemic carcinogenicity, animal developmental and reproductive toxicity studies and studies regarding safety in children were on the list.
What is the bottom line for the consumer? Most likely this process will lead to fewer sunscreen products for consumers to choose from and almost certainly at a higher cost. It could take up to 5 years before the FDA gives its imprimatur to sunscreens according April 2019 Cutis.
So, we’ve copied and pasted the recent proposed rule outlining several proposals:
- Of the 16 currently marketed active sunscreen ingredients, only 2—zinc oxide and titanium dioxide—are considered GRASE. Two ingredients—trolamine salicylate and para-aminobenzoic acid—are considered non-GRASE, but there is not enough information at this time to determine if the remaining 12 ingredients are GRASE. The FDA is working with manufacturers to obtain sufficient information to make this determination.
- Approved dosage formulations include sprays, oils, lotions, creams, gels, butters, pastes, ointments, and sticks. Further information is needed regarding powders before they can be considered.
- The maximum SPF will be increased from 50+ to 60+.
- Sunscreens with an SPF of 15 or higher are required to provide broad-spectrum protection commensurate with the SPF, expanding on critical wavelength testing.
- There are new labeling changes, including a requirement that active ingredients be listed on the front of the packaging.
- Sunscreen products that contain insect repellents are considered non-GRASE.
Reference:
DeLeo, VA. Sunscreen regulations and advice for your patients. Cutis website. https://www.mdedge.com/dermatology/article/199055/melanoma/sunscreen-regulations-and-advice-your-patients/page/0/2 . Published April 18, 2019. Accessed April 28, 2019.
