OBJECTIVE

1. INTRODUCTION Are European Sunscreen Products Superior? A Market Evaluation The Procter & Gamble Company, Sharon Woods Technical Center, Cincinnati, OH 45069. J F. Nash*, Ph.D. and Paul R. Tanner, B.S. CONCLUSIONS RESULTS OBJECTIVE We previously presented results of an evaluation of the US sunscreen market (Nash et al. 2004). The present study continues this work, comparing US sunscreen products to those marketed in Europe (EU). It is thought by some that EU sunscreen products provide superior protection because of the greater number of approved UVA filters in EU. The objective of this study was to evaluate sunscreen products marketed in EU and to confirm or refute the view that because of the greater availability of UVA filters in EU, such products are superior in efficacy to comparable products sold in the US. More products in EU use long wavelength (UVA) filters and, as such provide “broadspectrum” protection as defined by AAD or EC labeling criteria. However, while EU sunscreen manufacturers do have a greater selection of UVA filters, in reality they use at least one or more of three UVA actives also approved in the US to provide the UVA protection. Thus, while the EU market is superior to the US market with respect to protecting against long wavelengths of solar UV, this does not appear to be driven by the differences in regulation or the availability/choice of UVA filters, but by US manufacturers’ formulation decisions. The apparent superiority is partially offset by the absence of an SPF rating on upwards of 10% of products sold in EU that claim protection against sun damage. Sunscreens are considered cosmetics in the EU and are not subject to the regulatory requirements of similar products sold in the US. Comparison of UVA Protection in US and EU Sunscreen Products Using AAD or European Commission Recommendations 3 1 METHODS Absorbance Measurements:The UV absorbance of the product film was measured using a LabSphere UV-1000S UV Transmittance Analyzer (Labsphere Inc., NH). Reference absorbance measurements were performed on a glycerin-treated PMMA plate. UV absorbance of the product film was measured at 6 different sites on the substrate. For each product, 3 indepen-dent replicate plates were prepared and evaluated. The measurement per-formed on the product sample was corrected for the glycerin-treated reference and the resulting absorbance curve used to calculate efficacy. Calculation of Data: The critical wavelength (CW) was calculated according to Diffey et al. (2000). For in vitro Persistent Pigment Darkening (PPD), the method of Wendel et al. (2003) was used. Products: EU sunscreen products (N=123) in different forms, e.g., lotions, creams, etc., and uses, recreational (N=92) and daily (N=31), were purchased. Evaluations of these products consisted of: (i.) assessing label claims, e.g., Sun Protection Factor, UVA protection, etc., (ii.) label content/concentration of UV filters, and (iii.) evaluation of in vitro UV efficacy based on thin film substrate spectrophotometric measures of product absorbance/ transmittance curves. Substrate and Product Application: PMMA plates were used. Product, 0.75 mg/cm2, was applied uniformly to the roughened side of the PMMA plate with a pre-saturated finger cot. The product film was then allowed to dry under ambient conditions (22  2 C) for 15 min. A higher percentage of products sold in Europe are SPF 4 to SPF 14 (21%) vs. 10% of the US market. 2 Summary of Results Fig 1. Not all EU products have an SPF label (e.g., facial products). There is a greater percentage of SPF 15 to 29 products in US compared to EU. Fig 2. 97% of EU sunscreen products contain at least one UVA filter. The majority of products contain avobenzone (82%) and/or TiO2 (67%). Overall, 88% of EU sunscreens contain at least 1 of 3 UVA actives approved by FDA for use in the US, i.e., avobenzone, TiO2 or ZnO. Fig 3. Over 80% of the EU products surveyed provide broad-spectrum UVB/UVA protection using criteria of the AAD, namely Critical Wavelength ≥ 370 nm and in-vivo PPD of 4, or EC recommendation (in vitro PPD/label SPF > 0.33), consistent with greater use of UVA actives. REFERENCES Diffey BL, Tanner PR, Matts PJ, Nash JF. (2000). In vitro assessment of the broad-spectrum ultraviolet protection of sunscreen products. J Am Acad Dermatol.43: 1024-35. Lim, HW, Naylor M, Honigsmann H, Gilchrest BA, Cooper K, Morison W, Deleo VA, Scherschun L (2000) HLAmerican Academy of Dermatology Consensus Conference on UVA protection of sunscreens: summary and recommendations. Washington, DC, Feb 4, 2000. J Am Acad Dermatol. 44: 505-508 Nash JF, Tanner PR, Grosick TL, Zimnawoda M, Ryan M. (2004). Sunscreen Market Analysis: The Evolution and Use of UVA-1 Actives. J Am Acad Dermatol.50: 34. Wendel V, Klette E, Wittern KP, Gers-Barlag, H. (2003). The influence of pre-irradiation on the predictability of in vivo UVA protection with a new in vitro method. Photodermatol. Photoimmunol. Photomed.19: 93-97. In addition to avobenzone, titanium dioxide (TiO2) and zinc oxide (ZnO), there are other UVA filters used in EU including Tinsorb S™, Tinsorb M™, Mexoryl XL™, and Mexoryl SX™. Correspondance: nash.jf@pg.com