title: Chances and limits of an improved method to assess water resistance of cosmetic sunscreen products in vitro on polymethylmethacrylate plates.
abstract: While sun protection factor (SPF) and UVA protection are the most important determinants of a cosmetic sunscreen product, water resistance is the third important feature. The Colipa in vivo method is the internationally accepted standard method to assess water resistance. It is time-consuming and expensive. A screening method to quickly predict water resistance properties on low cost therefore is a specific request of product developers. Several in vitro screening methods are published but the predictive power of all these methods is limited. In this paper, we describe an adaptation of the in vitro UVA protection method of Colipa for a water resistance screening. Although the method is quick and most parts are standardized and approved by Colipa, the results were not in advantage of other published screening methods. Taking into account, the scatter of the results, seven of 16 sunscreen products that were developed as water resistant formulations could be unambiguously estimated to be water resistant by the in vivo water resistance screening method on five subjects while nine failed. In 10 of these 16 results, the in vitro SPF-based method was in accordance with in vivo findings, whereas in six cases, the method was not predicting correctly. Based on these results, the authors recommend to use the in vitro screening methods to pre-select from candidates which cannot all be tested in vivo. The pre-selected products can be screened in the Colipa in vivo water resistance method with a reduced number of volunteers (usually 5) to predict water resistance. In case, the water resistance estimated in such an in vivo screening is found at about 65% or higher the study can be deemed successful and completed with further subjects to fulfil the Colipa requirements.
authors.affiliation: proDERM Institute for Applied Dermatological Research GmbH, 22869, Schenefeld, Germany. sbielfeldt@proderm.de
authors.forename: S
authors.initials: S
authors.lastname: Bielfeldt
authors.forename: C
authors.initials: C
authors.lastname: Röck
authors.forename: K-P
authors.initials: KP
authors.lastname: Wilhelm
mesh_terms: D003358:Cosmetics; D006801:Humans; D066298:In Vitro Techniques; D019904:Polymethyl Methacrylate / Q000737:chemistry*; D013473:Sunscreening Agents; D014867:Water / Q000737:chemistry*
chemical_list: D003358:Cosmetics; D013473:Sunscreening Agents; D014867:Water; D019904:Polymethyl Methacrylate