PCPC targeted eight of the 12 UV filters proposed to be Category III by the FDA: avobenzone, oxybenzone, octinoxate, octocrylene, homosalate, octisalate, ensulizole
* UVB absorbers: para-aminobenzoic acid (PABA), cinoxate, ensulizole
, homosalate, octocrylene, octinoxate, octisalate, padimate O, trolamine salicylate
But for 12 other active ingredients (cinoxate, dioxybenzone, ensulizole
, homosalate, meradimate, octinoxate, octisalate, octocrylene, padimate O, sulisobenzone, oxybenzone, and avobenzone), there are insufficient data to make a "generally recognized as safe and effective" determination; thus, more data have been requested from the manufacturers.
Under the regulation, companies would also be able to combine avobenzone with either zinc oxide or ensulizole
, which Dr.
I presume the remaining items, namely cinoxate, dioxybenzone, sulisobenzone, padimate O, meradimate, ensulizole
, homosalate, octisalate, octinoxate and octocrylene would be rendered useless or unapproved if no company in our industry has the will, the courage, the time and the money to go through with the proposed extensive testing for approval as GRASE UV filters.
The ingredients requiring additional investigation are avobenzone, cinoxate, dioxybenzone, ensulizole
, homosalate, meradimate, octinoxate, octisalate, octocrylene, oxybenzone padimate O, and sulisobenzone.
"However, if FDA could be persuaded to increase the maximum avobenzone concentration to 5%, and allow it in combination with ensulizole
, titanium dioxide and zinc oxide, this would open up new formulation opportunities," he insisted.
This leaves only 10 ingredients that could be formulated in today's US sunscreen formulations--namely octocrylene, homosalate, octinoxate, octisalate and ensulizole
for UVB protection and avobenzone, oxybenzone, titanium dioxide and zinc oxide for UVA protection.
* The following combinations with avobenzone are still not allowed: ZnO, TiO2, ensulizole
, meradimate, PABA and padimate-O.
* Meradimate and ensulizole
(restrictions when used with avobenzone);
No decision was made on the combination of avobenzone with zinc oxide, titanium dioxide, ensulizole
, meradimate, PABA and padimate O.