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Choosing an expected sun protection factor value.

Sun protection factor, SPF, is a measure of the efficacy of a topical sunscreen product; the higher the SPF, the greater the blockage of ultraviolet-induced erythema. While there are several methods to determine SPF, the Food and Drug Administration (FDA) methods are unique. The FDA methods define the label SPF value as the largest whole integer after subtracting an "A" value from the mean SPF. The A value, composed of the product of the upper 5% point of the t-distribution and the standard deviation (SD), divided by √(n), where n equals the number of subjects, has a significant impact on the label SPF value. Two examples explore this impact. Development of strategies to mitigate the impact of A using expected SPF values are explored using historical clinical trial data. A more enlightened choice of expected SPF values is shown to lead to higher label SPF values.