ABSTRACT
Background of FDA Sunscreen Guidelines 770
Sun Protection Factor Determination (64 FR 27666) 770
Light Source: Solar Simulators 770
Standard Sunscreen 770
Testing Procedure 771
Selection of Panel Subjects 771
Informed Consent 771
Skin Test Sites 771
Application of Test Materials 772
Evaluation of Response 772
Determination of the MED for Unprotected Skin 772
Rejection of Test Data 772
Determination of the SPF Value 773
Determination of Individual Subject SPF Values 773
Determination of the Test Product’s SPF Value and Product
Category Designation 773
Determination of a Water Resistant or Very Water Resistant
Product 774
Test Modifications 775
US vs. the International SPF Testing Method 775
References 778
BACKGROUND OF FDA SUNSCREEN GUIDELINES
The US Food and Drug Administration (FDA) published the “Final” Monograph
(1) for sunscreen drug products for over-the-counter human use on May 21, 1999
(64 FR 27666). This Monograph outlined the testing requirements for deter-
mining a sun protection factor (SPF) for product labeling. On December 31,
2001 (66 FR 67485) (2) FDA issued a partial stay to 21 CFR Part 352, including
Subpart D-Testing Procedures, the part of the Monograph that outlines the
testing requirements for establishment of an SPF value.