Testing high SPF sunscreens: a demonstration of the accuracy and reproducibility of the results of testing high SPF formulations by two methods and at different testing sites.
OBJECTIVE
The goals of this study were (i) to demonstrate that existing and widely used sun protection factor (SPF) test methodologies can produce accurate and reproducible results for high SPF formulations and (ii) to provide data on the number of test-subjects needed, the variability of the data, and the appropriate exposure increments needed for testing high SPF formulations.


METHODS
Three high SPF formulations were tested, according to the Food and Drug Administration's (FDA) 1993 tentative final monograph (TFM) 'very water resistant' test method and/or the 1978 proposed monograph 'waterproof' test method, within one laboratory. A fourth high SPF formulation was tested at four independent SPF testing laboratories, using the 1978 waterproof SPF test method. All laboratories utilized xenon arc solar simulators.


RESULTS
The data illustrate that the testing conducted within one laboratory, following either the 1978 proposed or the 1993 TFM SPF test method, was able to reproducibly determine the SPFs of the formulations tested, using either the statistical analysis method in the proposed monograph or the statistical method described in the TFM. When one formulation was tested at four different laboratories, the anticipated variation in the data owing to the equipment and other operational differences was minimized through the use of the statistical method described in the 1993 monograph.


CONCLUSIONS
The data illustrate that either the 1978 proposed monograph SPF test method or the 1993 TFM SPF test method can provide accurate and reproducible results for high SPF formulations. Further, these results can be achieved with panels of 20-25 subjects with an acceptable level of variability. Utilization of the statistical controls from the 1993 sunscreen monograph can help to minimize lab-to-lab variability for well-formulated products.
Agin
Patricia Poh
PP
Research & Development, Schering-Plough Health Care Products, Inc, 3030 Jackson Avenue, PO Box 377, Memphis TN 38151,USA. patty.agin@spcorp.com
Edmonds
Susan H
SH
D004341:Drug Evaluation / Q000379:methods; D006801:Humans; D007753:Laboratories / Q000592:standards; D011835:Radiation Protection; D015203:Reproducibility of Results; D013471:Sunburn / Q000517:prevention & control; D013473:Sunscreening Agents / Q000737:chemistry*; D014867:Water
D013473:Sunscreening Agents; D014867:Water