[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: 21CFR352.3]

[Page 276]
 
                        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 A--General Provisions
 
Sec. 352.3  Definitions.

    As used in this part:
    (a) Minimal erythema dose (MED). The quantity of erythema-effective 
energy (expressed as Joules per square meter) required to produce the 
first perceptible, redness reaction with clearly defined borders.
    (b) Product category designation (PCD). A labeling designation for 
sunscreen drug products to aid in selecting the type of product best 
suited to an individual's complexion (pigmentation) and desired response 
to ultraviolet (UV) radiation.
    (1) Minimal sun protection product. A sunscreen product that 
provides a sun protection factor (SPF) value of 2 to under 12.
    (2) Moderate sun protection product. A sunscreen product that 
provides an SPF value of 12 to under 30.
    (3) High sun protection product. A sunscreen product that provides 
an SPF value of 30 or above.
    (c) Sunscreen active ingredient. An active ingredient listed in 
Sec. 352.10 that absorbs, reflects, or scatters radiation in the UV 
range at wavelengths from 290 to 400 nanometers.
    (d) Sun protection factor (SPF) value. The UV energy required to 
produce an MED on protected skin divided by the UV energy required to 
produce an MED on unprotected skin, which may also be defined by the 
following ratio: SPF value = MED (protected skin (PS))/MED (unprotected 
skin (US)), where MED (PS) is the minimal erythema dose for protected 
skin after application of 2 milligrams per square centimeter of the 
final formulation of the sunscreen product, and MED (US) is the minimal 
erythema dose for unprotected skin, i.e., skin to which no sunscreen 
product has been applied. In effect, the SPF value is the reciprocal of 
the effective transmission of the product viewed as a UV radiation 
filter.