* UVB absorbers: para-aminobenzoic acid (PABA), cinoxate, ensulizole, homosalate, octocrylene, octinoxate, octisalate, padimate O, trolamine
Two others, trolamine
salicylate and para-aminobenzoic acid, were banned and relegated to Category II (non-GRASE items) and the remaining Category I filters were classified as Category III filters requiring extensive safety data before being reapproved.
As for ingredients themselves, the proposal calls for zinc oxide and titanium dioxide to be considered generally recognized as safe and effective for use in sunscreens, but for PABA and Trolamine
salicylate to be found not to be so.
However, two other ingredients PABA and trolamine
salicylate--are not GRASE for use in sunscreens because of safety issues, Theresa Michele, MD, director of the Division of Nonprescription Drug Products Division of Nonprescription Drug Products in the FDA's Center for Drug Evaluation and Research.
Two of the ingredients, PABA and trolamine
salicylate, would not be considered GRASE because of safety concerns, the FDA said, adding that for the other 12 ingredients, there is currently not enough data to determine whether they are GRASE.
Montbarbon, "Phase III randomized trial of Calendula Officinalis compared with trolamine
for the prevention of acute dermatitis during irradiation for breast cancer," Journal ofClinical Oncology, vol.
Pommier R Gomez F Sunyach MP et al.Phase III randomized trial of Calendula officinalis compared with trolamine
for the prevention of acute dermatitis during irradiation for breast cancer.
polypeptide oleate, otherwise known as Cerumenex, is an over-the-counter product that comes with many warnings and side effects.
: Five studies looked at the use of topical trolamine
, but none found an advantage for trolamine
over the control treatment.
(17) evaluated the efficacy of trolamine
salicylate PH and ultrasound therapy on delayed onset muscle soreness.