Parameters International 2006 Australia 1998 FDA 1999 FDA 2011 Calculations and results Number of test subjects Minimum of 10, Maximum of 25 Minimum of 10, Maximum undefi ned At least 20 valid Maximum of 25 At least 10 valid no maximum Up to fi ve subjects can be excluded Up to three subjects can be excluded Statistical criterion 95% confi dence interval should fall within ± of mean SPF SEM 7% of mean SPF for valid result No No Table I Continued DISPARATE SPF TESTING METHODOLOGIES 301
JOURNAL OF COSMETIC SCIENCE 302 Table II Mean SPF Values For Formulations 1–59 by Method International FDA-FM Aus/NZ 1 16.5 ± 1.9 (n = 10) 18.0 ± 2.4 (n = 21) 17.3 ± 2.8 (n = 10) 2 24.3 ± 4.4 (n = 10) 22.3 ± 1.9 (n = 20) 21.7 ± 3.3 (n = 10) 3 18.0 ± 2.5 (n = 10) 17.3 ± 1.3 (n = 20) 18.4 ± 2.7 (n = 10) 4 18.2 ± 2.1 (n = 10) 17.3 ± 1.3 (n = 20) 19.6 ± 1.3 (n = 10) 5 16.1 ± 1.8 (n = 10) 16.0 ± 1.5 (n = 20) 16.1 ± 1.8 (n = 10) 6 17.7 ± 4.6 (n = 10) 18.2 ± 1.8 (n = 20) 17.6 ± 3.7 (n = 10) 7 17.3 ± 2.4 (n = 10) 16.8 ± 2.4 (n = 20) 18.3 ± 1.2 (n = 10) 8 17.6 ± 1.8 (n = 10) 16.0 ± 1.4 (n = 20) 16.9 ± 2.5 (n = 10) 9 15.7 ± 3.1 (n = 15) 16.4 ±.7 (n = 20) 17.2 ± 1.9 (n = 10) 10 26.4 ± 3.7 (n = 10) 22.7 ± 1.5 (n = 20) 25.3 ± 3.8 (n = 10) 11 10.3 ± 1.3 (n = 10) 8.7 ± 0.9 (n = 20) 9.9 ± 1.25 (n = 10) 12 17.6 ± 1.8 (n = 10) 15.7 ± 1.4 (n = 25) 18.1 ± 2.6 (n = 10) 13 9.8 ± 2.1 (n = 10) 8.4 ± 0.7 (n = 20) 9.7 ± 1.9 (n = 10) 14 10.5 ± 10.5 (n = 10) 8.6 ± 0.9 (n = 20) 9.0 ± 1.3 (n = 10) 15 18.0 ± 2.6 (n = 10) 17.6 ± 1.8 (n = 20) 16.6 ± 2.4 (n = 10) 16 17.2 ± 1.9 (n = 10) 17.5 ± 0.9 (n =20) 21.7 ± 3.1 (n = 10) 17 18.9 ± 2.8 (n = 10) 17.0 ± 1.0 (n = 20) 18.2 ± 3.3 (n = 10) 18 16.7 ± 1.7 (n = 20) 19.1 ± 4.0 (n = 10) 19 27.6 ± 1.6 (n = 20) 27.4 ± 2.0 (n = 10) 20 15.9 ± 1.8 (n = 20) 16.2 ± 2.4 (n = 10) 21 16.5 ± 1.6 (n = 20) 16.6 ± 2.4 (n = 10) 22 15.9 ± 2.3 (n = 20) 17.6 ± 1.8 (n = 10) 23 16.3 ± 1.8 (n = 20) 17.2 ± 1.9 (n = 10) 24 16.9 ± 2.0 (n = 20) 18.4 ± 2.3 (n = 10) 25 17.3 ± 1.9 (n = 20) 18.2 ± 3.3 (n = 10) 26 15.9 ± 0.8 (n = 20) 16.5 ± 1.9 (n = 10) 27 23.4 ± 2.2 (n = 20) 22.2 ± 3.2 (n = 10) 28 23.1 ± 1.7 (n = 20) 22.2 ± 2.4 (n = 10) 29 16.9 ± 2.0 (n = 10) 16.7 ± 1.6 (n = 20) 30 18.2 ± 3.6 (n = 10) 16.8 ± 1.9 (n = 20) 31 17.4 ± 3.2 (n = 10) 16.6 ± 1.8 (n = 20) 32 17.0 ± 3.2 (n = 10) 16.8 ± 1.8 (n = 20) 33 17.4 ± 3.2 (n = 10) 16.9 ± 1.9 (n = 20) 34 19.0 ± 3.4 (n = 10) 16.8 ± 2.1 (n = 20) 35 18.0 ± 1.6 (n = 10) 17.0 ± 2.2 (n = 20) 36 16.5 ± 1.9 (n = 10) 16.7 ± 2.4 (n = 20) 37 30.5 ± 3.8 (n = 10) 31.0 ± 3.3 (n = 20) 38 33.9 ± 2.6 (n = 10) 33.3 ± 2.2 (n = 20) 39 34.4 ± 3.1 (n = 10) 32.6 ± 2.2 (n = 20) 40 33.6 ± 2.7 (n = 10) 33.6 ± 2.0 (n = 20)
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