[Code of Federal Regulations]
[Title 21, Volume 7]
[Revised as of April 1, 2008]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR700.35]

[Page 142-143]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 700_GENERAL--Table of Contents
 
          Subpart B_Requirements for Specific Cosmetic Products
 
Sec. 700.35  Cosmetics containing sunscreen ingredients.

    (a) A product that includes the term ``sunscreen'' in its labeling 
or in any other way represents or suggests that it is intended to 
prevent, cure, treat, or mitigate disease or to affect a structure or 
function of the body comes within the definition of a drug in section 
201(g)(1) of the act. Sunscreen active ingredients affect the structure 
or function of the body by absorbing, reflecting, or scattering the 
harmful, burning rays of the sun, thereby altering the normal 
physiological response to solar radiation. These ingredients also help 
to prevent diseases such as sunburn and may reduce the chance of 
premature skin aging, skin cancer, and other harmful effects due to the 
sun when used in conjunction with limiting sun exposure and wearing 
protective clothing. When consumers see the term ``sunscreen'' or 
similar sun protection terminology in the labeling of a product, they 
expect the product to protect them in some way from the harmful effects 
of the sun, irrespective of other labeling statements. Consequently, the 
use of the term ``sunscreen'' or similar sun protection terminology in a 
product's labeling generally causes the product to be subject to 
regulation as a drug. However, sunscreen ingredients may also be used in 
some products for nontherapeutic, nonphysiologic uses (e.g., as a color 
additive or to protect the color of the product). To avoid consumer 
misunderstanding, if a cosmetic product contains a sunscreen ingredient 
and uses the term ``sunscreen'' or similar sun protection terminology

[[Page 143]]

anywhere in its labeling, the term must be qualified by describing the 
cosmetic benefit provided by the sunscreen ingredient.
    (b) The qualifying information required under paragraph (a) of this 
section shall appear prominently and conspicuously at least once in the 
labeling in conjunction with the term ``sunscreen'' or other similar sun 
protection terminology used in the labeling. For example: ``Contains a 
sunscreen--to protect product color.''

[64 FR 27693, May 21, 1999]