title: Photoprotective efficacy and photostability of fifteen sunscreen products having the same label SPF subjected to natural sunlight.
abstract: The first objective of this study is to show how different can be photoprotection by sunscreens with an identical SPF given on the packaging, when subjected to sunlight radiation. The second objective is to highlight the need for global harmonization of photostability testing and UVA protection labelling. Fifteen products with various combinations of UV filters marketed in Europe were assessed based on transmission measurements of 0.75 mg cm⁻² layer covered onto polymethylmethacrylate plate roughness 2 μm. Two absolute UV spectroscopic indices (in vitro SPF, UVA-PF), four well-known relative UVA indices: the UVA-PF/SPF ratio and critical wavelength by European Commission (EC); UVA/UVB ratio by Boots Star Rating system; UVA1/UV ratio by FDA Proposed Ruling and one new relative indices the Spectral Uniformity Index (SUI) by Diffey, were compared before and after sunlight exposure with dose about 42 SEDs. The UVA-PF values before exposure proved a high degree of variation among samples. After exposure only five sunscreens observed UVA protection standard by EC and the same products showed compliance with the first UVA rating by Boots system (three stars). According to the UVA1/UV ratio, except for one product, all sunscreens manifested certain UVA protection level (low, medium or high). In compliance with criteria of new rating proposed by Diffey, exactly all fifteen sunscreens gave some UVA rating exhibited as SUI (low, medium or high). These results mean that the different UVA protection indices can exhibit various data and be confusing for consumer. Photostability of each product was assessed with three indices: the area under curve (Auc) Index for the total UV range, and UVB, UVA, UVA2, UVA1 range separately; the residual effectiveness of in vitro SPF and UVA-PF. All fifteen sunscreens were photostable in the UVB region. Seven products exhibited photoinstability in the total UV range (290-400 nm); all of them contained a combination of the ethylhexyl methoxycinnamate (EHMC) and butyl methoxydibenzoylmethane (BMBM) together with other UV filters. Eight products lacked their stability in the UVA1 range (340-400 nm) thus confirmed that photodegradation of some current sunscreens is primarily problem of this region. The most photoinstability showed sunscreens S1 (EHMC, BMBM and phenylbenzimidazole sulphonic acid) and S6 (EHMC, BMBM, phenylbenzimidazole sulphonic acid and ethylhexyl triazone); Auc-UVA1 Index was 0.15 only. Excellent UVA1 photostability showed sunscreen S8 (EHMC, EHT and methylene bis-benzotriazolyl tetramethylbutylphenol); Auc-UVA1 Index was of 1.00. Three sunscreens showed very good UVA1 photostability (Auc-UVA1 Index ranged from 0.98 to 0.93). The fact that these products applied only in the layer of 0.75 mg cm⁻² were photostable under the sunlight dose, which corresponds to layer of 2 mg cm⁻², is proof of their quality. Comparison of the residual effectiveness of in vitro SPF and UVA-PF values with the Auc-Index showed that methods give a similar ranking of the sunscreens' photostability.
authors.affiliation: Laboratory of Cosmetology, Department of Food Science, Faculty of Chemical and Food Technology, Slovak University of Technology, Radlinského 9, SK-81237 Bratislava, Slovak Republic. jarmila.hojerova@stuba.sk
authors.forename: J
authors.initials: J
authors.lastname: Hojerová
authors.forename: A
authors.initials: A
authors.lastname: Medovcíková
authors.forename: M
authors.initials: M
authors.lastname: Mikula
mesh_terms: D004307:Dose-Response Relationship, Radiation; D004348:Drug Labeling; D004355:Drug Stability; D004655:Emulsions; D005060:Europe; D008962:Models, Theoretical; D010777:Photochemistry; D019904:Polymethyl Methacrylate / Q000737:chemistry / Q000528:radiation effects; D013053:Spectrophotometry; D013472:Sunlight; D013473:Sunscreening Agents / Q000737:chemistry / Q000145:classification / Q000592:standards; D013678:Technology, Pharmaceutical / Q000295:instrumentation / Q000379:methods*; D013997:Time Factors; D014466:Ultraviolet Rays
chemical_list: D004655:Emulsions; D013473:Sunscreening Agents; D019904:Polymethyl Methacrylate