New sunscreen monograph proposed by FDA

Posted: Thursday, June 27, 2019

If you are planning on spending time in the summer sun, you might want to pay attention to the new suggested regulations for sunscreens. Earlier this year, the Food and Drug Administration (FDA) proposed a rule that would update regulation requirements for most sunscreen products sold in the United States. The proposal focuses on ensuring that sunscreens are being correctly designated as safe and effective and that two all-natural sun-blocking ingredients – zinc oxide and titanium dioxide – are added to the list of actives that are safe and effective.

The FDA also proposed that the maximum sun protection factor (SPF) level increase in order to offer the best skin protection. Sunscreens that have an SPF of 15 or higher are required to have broad-spectrum protection. The FDA states that labels need to be clearer for consumers, identifying information such as active ingredients on the packing to make sunscreens more like other OTC drugs. It’s also suggested that these labels include a notification of a skin-cancer and skin-aging alert for products that haven’t been proven to prevent skin cancer.

The FDA’s goal is to update over-the-counter (OTC), nonprescription sunscreens that don’t already have FDA approval with the latest scientific research to ensure access to the most effective methods of skin protection. This announcement is important since FDA guidelines for sunscreens haven’t been updated in several years.

How can you ensure you’re getting the best protection?

Choose mineral sunscreens that contain zinc oxide or titanium dioxide, especially sunscreen lotions made with non-nanoparticles.
Look for broad-spectrum products with an SPF of 15 or higher, so you gain protection from both UVA and UVB rays
Protect sensitive and overlooked areas like the ears, lips, eyelids, and edges around clothing.
Apply sunscreen about a half hour before sun exposure.

Here at Raining Rose, we believe in making high-quality products that put you and your customer’s needs first, which is why we’ve created a line of Broad Spectrum mineral sunscreen products that contain non-nanoparticle zinc oxide as the active ingredient.

Stay informed about the FDA’s OTC sunscreen proposal here: https://www.fda.gov/news-events/press-announcements/fda-advances-new-proposed-regulation-make-sure-sunscreens-are-safe-and-effective