chapter  38
10 Pages

US FDA Protocol for Determining Sun Protection Factor

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.