PCPC targeted eight of the 12 UV filters proposed to be Category III by the FDA: avobenzone, oxybenzone, octinoxate, octocrylene, homosalate, octisalate, ensulizole and meradimate
. In June, the Public Access to SunScreen (PASS) Coalition submitted a petition to FDA entitled "Sunscreen Drug Products for Over-the-Counter Human Use." (6) PASS supports the use of sunscreens as a key part of a comprehensive sun protection plan and advocates that Americans have access to safe and effective sunscreens.
* UVA absorbers: avobenzone, ecamsule (Mexoryl SX), meradimate
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.
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.
Table II: More Recently Approved Ultraviolet Filters (The Final Rule 2011) UV Absorbers/Reflectors % Aminobenzoic acid (X) Avobenzone (A) Cinoxate (X) Dioxybenzone (X) Homosalate (B) Meradimate
(A)(X) Mexoryl SX (*) (A)(WS) Octocrylene (B) Octinoxate (H) Octisalate (B) Oxybenzone (A)(H) Padimate O (X) Phyenylbenzimidazole (WS)(X) sulfonic acid Sulisobenzone (X) Titanium dioxide (A) Trolamine salicylate (X) Zinc oxide (A) Note: UVA Filter (A), UVB Filter (B), Water Soluble (WS), Hawaii Ban (H), Rarely used (X) Approved in specific L'Oreal formulations only.
For years, industry experts have bemoaned the fact that while the US Food and Drug Administration has approved 17 category I ingredients, one is exclusive to L'Oreal (ecamsule) and six (PABA, padimate-O, cinoxate, meradimate
, sulisobenzone and trolamine salicylate) are rarely used in formulas for a variety of reasons.
The following six ingredients (PABA, padimate-O, cinoxate, meradimate
, sulisobenzone and trolamine salicylate) are rarely used in today's formulations for reasons discussed earlier.
* The following combinations with avobenzone are still not allowed: ZnO, TiO2, ensulizole, meradimate
, PABA and padimate-O.
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.
It also features UVA/UVB protection with octinoxate, meradimate
, octisalate, oxybenzone and avobenzone.