Three additional items have been added since, namely, avobenzone (1-3%), ecamsule (up to 10%), and zinc oxide (2-25%) Table II: TEA Ingredients Ingredient TEA Date Docket Amiloxate
8/14/2002 FDA-2003-N-0196 Enzacamene 8/21/2002 FDA-2003-N-0196 Octyl Triazone 8/21/2002 FDA-2003-N-0196 Bemotrizinol 4/11/2005 FDA-2005-N-0453 Bisoctrizole 4/11/2005 FDA-2005-N-0453 Isocotrizinol 9/16/2005 FDA-2006-N-0314 Ecamsule 9/18/2007 FDA-2008-N-0474 Drometrizole Trisiloxane 1/21/2009 FDA-2003-N-0196
But with the passage of The Sunscreen Innovation Act in January, formulators may eventually have as many as eight new ingredients to work with, including amiloxate
, bemotrizinol, bisoctrizol, drometrizole trisiloxane, ecamsule, enzacamene, isocotrizinol and octly triazone--just don't expect these ingredients to show up on product labels anytime soon.
It began with the submission to the FDA of three ingredients (amiloxate, enzacamene and octly triazone) followed by the submission in 2005 of three additional ingredients (bemotrizinol, bisoctrizol and isocotrizinol), and finally, two L'Oreal ingredients (ecamsule in 2007 and drometrizole trisiloxane in 2009) were submitted to the FDA for approval for use in the USA under the TEA guidelines (See Table I).
Belatedly, the FDA's first public action on all of those eight TEA applications came in March of this year, when the Administration announced that it found the data submitted by Symrise (for amiloxate) and 3V-Sigma (for diethyl hexyl butamidotriazone or isocotrizinol) insufficient to affirm the safety of those two sunscreen active ingredients.
These five ingredients are amiloxate
, enzacamene, octyl triazone, bemotrizinol and bisoctrizol.
TABLE 1.: EUROPEAN INGREDIENTS UNDER FDA REVIEW Ingredient TEA Date Docket Amiloxate
8/14/2002 FDA-2003-N-0196 Enzacamene 8/21/2002 FDA-2003-N-0196 Octyl Triazone 8/21/2002 FDA-2003-N-0196 Bemotrizinol 4/11/2005 FDA-2005-N-0453 Bisoctrizole 4/11/2005 FDA-2005-N-0453 Isocotrizinol 9/16/2005 FDA-2006-O-0314 Ecamsule 9/18/2007 FDA-2008-N-0474 Drometrizole Trisiloxane 1/21/2009 FDA-2003-N-0196 As can be seen from the table above, three of those ingredients date back to 2002.
Amiloxate from Symrise, Enzacamene from EMD and Octyl triazone from BASF were submitted August 2002 and they were the first to receive a notice of eligibility (7/11/2003, 68FR41386).
They are: Amiloxate, Enzacamene, Octyl triazone, two Tinosorbs, Uvasorb and Ecamsule.
The sunscreen, isoamyl p-methoxycinnamate (USAN: amiloxate
USP), new to the U.S., has an excellent safety and efficacy profile, executives said.