[Code of Federal Regulations]
[Title 21, Volume 5]
[Revised as of April 1, 2001]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR352.71]

[Page 281]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                           SERVICES--Continued
 
PART 352--SUNSCREEN DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE--Table of Contents
 
                      Subpart D--Testing Procedures
 
Sec. 352.71  Light source (solar simulator).

    A solar simulator used for determining the SPF of a sunscreen drug 
product should be filtered so that it provides a continuous emission 
spectrum from 290 to 400 nanometers similar to sunlight at sea level 
from the sun at a zenith angle of 10 deg. it has less than 1 percent of 
its total energy output contributed by nonsolar wavelengths shorter than 
290 nanometers; and it has not more than 5 percent of its total energy 
output contributed by wavelengths longer than 400 nanometers. In 
addition, a solar simulator should have no significant time-related 
fluctuations in radiation emissions after an appropriate warmup time, 
and it should have good beam uniformity (within 10 percent) in the 
exposure plane. To ensure that the solar simulator delivers the 
appropriate spectrum of UV radiation, it must be measured periodically 
with an accurately-calibrated spectroradiometer system or equivalent 
instrument.