Evaluation of sunscreen safety by in vitro skin permeation studies: effects of vehicle composition.

For sunscreens to be safe and effective, the lowest possible UV-filter percutaneous absorption should be achieved. In this paper, we evaluated in vitro release and permeation through human skin of two UV-filters, octyl methoxycinnammate (OMC) and butyl methoxydibenzoyl methane (BMBM) from six commercial O/W emulsions and we estimated their margin of safety (MoS). OMC and BMBM in vitro release and skin permeation were investigated in Franz-type diffusion cells and permeation data were used to calculate MoS. OMC in vitro skin permeation depended on both its concentration and vehicle composition while BMBM skin permeation depended on its release from the vehicle. MoS values were well beyond the lowest limit accepted for safe products. Although sunscreen skin permeation may depend on many factors, the commercial products investigated are safe under normal "in use" conditions.