Industry Debate: US FDA vs. Sunscreens

By: Cosmetics & Toiletries LinkedIn Members

Posted: June 7, 2011

page 3 of 3

Answer 8: This all reminds me of the early 1980s when I worked at Givaudan in Clifton, New Jersey. We had a "revolutionary" UVA sun filter called, appropriately enough, Parsol 1789 (INCI: Avobenzone). At that time, I believe it was the only product absorbing in the UVA spectrum but we could not sell it, as it was not approved by the FDA...or, we could sell it but clients could not make any claims! I think that Lauder used it in a new line called Lauder SUN, but they had to pull it off the market since Parsol 1789 was not on the FDA Monograph. When it was finally approved many years later, the patent had expired and Givaudan no longer sold because Hoffmann-La Roche had taken over the marketing of the company’s sunscreens. The bottom line is: the consumer could not benefit from the ingredient’s UVA protective abilities because the FDA was so slow to move. I am not a chemist, so maybe products like titanium dioxide did provide broad-spectrum protection, but it was all very frustrating. Now I think DSM has purchased the sunscreen business. Who can keep up with all these changes!?

Answer 9: The monograph delay is indeed reminiscent of the 1980s with avobenzone (Parsol 1789)—very much so. In a previous post, I obliquely mentioned two other sunscreen actives that were developed by L'Oréal that, to this day, are not included in the relevant FDA monograph. The L'Oréal actives—i.e., terephthalylidenedicamphor sulfonic acid (Mexoryl SX) and drometrizole trisiloxane (Mexoryl XL in combination with the SX active) represent an advance beyond avobenzone, just as avobenzone was an advance beyond methyl anthranilate and sun blockers like titanium dioxide. L'Oréal, like its counterpart Givaudan with its avobenzone, was watching its patents twist in the wind even while American consumers were being denied the benefit of better UVA protection. In the end, L'Oréal partially overcame the monograph obstacle by filing a new drug application (NDA) for La Roche-Posay Anthelios, but unfortunately, the version of Anthelios now available in the United States only contains the water soluble Mexoryl SX. The non-USA version of the product has the full Mexoryl XL, which includes the synergistic, oil-soluble UVA blocking silicone drometrizole trisiloxane. I've been using the "full" version of Anthelios for a few years, but until the FDA monograph includes L'Oréal's innovative compounds, few Americans will have the better sun protection enjoyed in much of the rest of the world.

To add to this discussion, please join the Cosmetics & Toiletries LinkedIn Group.