Major changes are shaking the US sunscreen industry

Sunscreen products are regulated in the US under the FDA as nonprescription, over-the-counter (OTC) products. Surprisingly enough, regulations have not been updated since 1999, some of the ingredients approved by the FDA are considered “old-school” and have been questioned through the years for their safety and their impact on the environment.

In February 2019, the FDA announced a new proposed rule, bringing major changes to US sunscreen manufacturers and global companies exporting sunscreens into the US. In the new proposed rule commonly used sunscreen actives are being questioned for their safety, it also refers to new requirements for the sun protection factor (SPF) value, broad-spectrum protection and products labeling.

Active sunscreen ingredients

Physical active ingredients like zinc oxide and titanium dioxide are approved for use in sunscreen, however, the most common active ingredients used in the sunscreen market today are chemical ones.Two chemical active ingredients: para-aminobenzoic acid (PABA) and trolamine salicylate are not approved by the FDA for safety issues, but in fact, those are not generally used in sunscreens in the US.

In addition, twelve active chemical ingredients are being questioned, as it is suggested that there is not enough safety data on those ingredients. The FDA is requesting sunscreen manufacturers to provide additional data on those ingredients to evaluate their safety.

The 12 ingredients that are being investigated are: cinoxate, dioxybenzone, ensulizole, homosalate, meradimate, octinoxate, octisalate, octocrylene, padimate O, sulisobenzone, oxybenzone (benzophenone-3), and avobenzone. Out of these ingredients the most questioned are oxybenzone and octinoxate.

From an environmental standpoint, Hawaii, Key West and U.S Virgin Islands recently banned the use of oxybenzone and octinoxate in sunscreen products due to studies that reveal that they might be toxic to coral reefs.

Sun Protection Factor (SPF) and Broad Spectrum

In the new proposed rule, the FDA says that there is not enough data regarding the effectiveness of sunscreens with SPF values greater than 60. The outcome is that claims of higher than 60 SPF can be misleading and transmit the wrong message regarding their sun protection capabilities. Moreover, all sunscreen products with SPF 15 and up, will need to provide a broad-spectrum protection against UVA and UVB rays.


Another rule change is concerning the product labelling. The FDA says that the list of active ingredients will need to be listed clearly on the front of the package to allow the consumers to better decide on the products they are purchasing.

So, what’s next?

Sunscreen formulators will need to re-evaluate the use of ingredients such as oxybenzone and octinoxate in their sunscreen formulations. This can also bring new opportunities for sunscreen formulators. New and greener ingredients can be included in the formulation and might better resonate with today’s consumer trends.

Written by Mrs.Tali Cohen, Marketing Manager

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