IMPACT OF SUNSCREEN REGULATIONS ON SUNCARE DEVELOPMENT 229 Nevertheless, the FDA released the conditions for compliance of sunscreens with the Final Rule of December 2012 as follows: (i) It must have an SPF of at least 15. (ii) It must be a broad spectrum with a critical wavelength of at least 370 nm. (iii) It must comply with a modifi ed Principal Display Panel-Drug Facts. It allowed companies to claim that “sunscreens reduce the risk of skin cancer and early skin aging when used as directed.” In my opinion, the claim should not be addressing skin cancer and skin aging but instead that “sunscreen reduces or eliminates (or protects from) the harmful solar radiation.” Period! In their “Proposed Final” that was issued on February 26, 2019 (5), only two fi lters (zinc oxide and titanium dioxide) were classifi ed as GRASE category I fi lters. Two other fi lters (PABA and trolamine salicylate) became category II ingredients (i.e., cannot be used anymore), and the remaining 12 ingredients (avobenzone, oxybenzone, octinoxate, octo- crylene, octisalate, homosalate, meradimate, ensulizole, cinoxate, padimate O, dioxyben- zone, and sulisobenzone) were classifi ed as category III ingredients (i.e., require further extensive testing). The FDA specifi ed that at a minimum two tests were required, namely, the MUsT test and the DART test, before any of those category III ingredients can be reclassifi ed as GRASE category I fi lters. In the FDA’s “Proposed Final” of February 26, 2019, other changes were also proposed: (i) Powders, wipes, towelettes, body washes, and shampoos were disallowed if they can contain UV fi lters with sunscreen claims. (ii) Spray sunscreens will require further safety testing. (iii) The maximum SPF allowed will now be SPF 60+. The marketing of SPF values up to 80 may be allowed but would require an NDA. (iv) The UVA and Broad Spectrum labeling now needs to satisfy not only the critical wavelength test but also a new standard according to the formula below: UVAI/UV ≥ 0.7 ( v) Insect repellent/sunscreen combination products would now be classifi ed as category II (i.e., not allowed). Many petitions were sent to the FDA requesting reversal of this proposal. In May 2019, the FDA released the fi rst of two MUsT tests on sunscreens in the Journal of the American Medical Association (JAMA) revealing that four UV fi lters (avobenzone, oxybenzone, octocrylene, and ecamsule) failed the test because of skin penetration far exceeding the proposed safety levels of 0.5 mg/mL (6). In January 2020, the FDA released its second MUsT study also in JAMA (7), which revealed that six UV fi lters failed the test, bringing the total UV fi lters that failed the test to seven (avobenzone, oxybenzone, octocrylene, octinoxate, octisalate, homosalate, and ecamsule) when both the May 2019 and the January 2020 reports were completed. The Personal Care Product Council set up a work group to lobby the FDA to consider new data on eight of the remaining 12 category II fi lters (avobenzone, oxybenzone, octi- noxate, octisalate, homosalate, ecamsule, octocrylene, and meradimate). No decision by the FDA on this proposal was reached to date. The backdrop of all those developments date back to Hawaii’s 2018 bill in their state legislature (sponsored by State Senator Mike Gabbard) that banned both oxybenzone and

JOURNAL OF COSMETIC SCIENCE 230 octinoxate by January 2021 because of their perceived impact on coral reefs (8). This was followed by many countries banning both UV fi lters including the island of Palau and the U.S. Virgin Islands, as well as similar proposals for Key West, Florida, and the State of California. This debate has caught the attention of Congress which is currently legislat- ing the new Over-The-Counter Reform Act. The legislation is expected to pass in early 2020* (See Footnote). The fi scal year 2019 Appropriations Bill currently has language directing the Environmental Protection Agency to coordinate a study with the National academy of Science to investigate the safety of all sunscreen ingredients and their impact on coral reefs and the environment. They were also tasked to evaluate the impact of banning those sunscreen ingredients on public health. The debate goes on! Let me summarize the impact of all the regulations passed, proposed, and in development on the approval of safe and effective sunscreens in the United States. With Hawaii cur- rently proposing a ban on all sunscreens that contain any UV fi lter, other than zinc oxide and titanium dioxide (9), chemists may have no choice but to develop all new sunscreen products using only these two inorganic fi lters, zinc and titanium oxides. This, of course, is an impractical and intolerable proposition. For one thing, the supply industry of those two raw materials is certainly not ready for such a huge demand. Major shortages or delays in product release will understandably occur. Will the consumer, who is used to low- priced mass marketed products, be willing to pay much more for products with similar protection? Will the consumer who is used to elegantly designed products tolerate aes- thetically unappealing sunscreen products with zinc and titanium oxides? Will the consumer—who is used to SPF 60, 70, and even 100—accept SPF ratings of 35 or a maxi- mum of 50? Will the consumer accept not having access to the convenient spray sunscreens that will now be diffi cult to formulate with these two inorganic fi lters? Are we providing the consumer with the most effective broad-spectrum sunscreen products to combat the epidemic rise of skin cancers lately with only those two ingredients? The questions are numerous, and the obvious answer is that it would be impractical, if not impossible, to create an innovative and effective industry with just those two mineral sunscreens. So, what is the solution? Obviously, part of the answer lies in the need for better-designed UV fi lters. We could start out with approving a few of the pending TEA European ingredients. Many of them have been used safely for years worldwide and are designed according to the Dalton 500 principle to reduce skin permeation. Molecules that have MW greater than 500 are gen- erally much less permeable to the skin. This could be tested, and, perhaps, the IVPT, the MUsT test, and the DART test would be a requirement before their approval by the FDA. An evaluation of what constitutes an unsafe level of permeation causing diseases should be conducted. A more realistic safety level of a value different from 0.5 ng/ml may be more appropriate. Do I agree with the FDA’s reluctance to issue a fi nal monograph especially because the usage of sunscreens today is massive? To a certain extent they are currently on the right track in critically evaluating all sunscreen ingredients, but, in my opinion, they are a tad too late. Better late than sorry? True, but their reluctance to approve safe and effective European TEA ingredients, and to instead relegate all the 12 category I ingredients that have been used since 1978, as non-usable, non-GRASE, without alternatives, casts a ma- jor shadow on their use for current skin cancer prevention and protection. How can a nonscientifi c average consumer use those products while the FDA is reporting that they