[Code of Federal Regulations]
[Title 21, Volume 5]
[Revised as of April 1, 2004]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR352.60]

[Page 295-297]
 
                        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 
[STAYED INDEFINITELY]--Table of Contents
 
                           Subpart C_Labeling
 
Sec. 352.60  Labeling of permitted combinations of active ingredients.

    Statements of identity, indications, warnings, and directions for 
use, respectively, applicable to each ingredient in the product may be 
combined to eliminate duplicative words or phrases so that the resulting 
information is clear and understandable.
    (a) Statement of identity. For a combination drug product that has 
an established name, the labeling of the

[[Page 296]]

product states the established name of the combination drug product, 
followed by the statement of identity for each ingredient in the 
combination, as established in the statement of identity sections of the 
applicable OTC drug monographs. For a combination drug product that does 
not have an established name, the labeling of the product states the 
statement of identity for each ingredient in the combination, as 
established in the statement of identity sections of the applicable OTC 
drug monographs.
    (b) Indications. The labeling of the product states, under the 
heading ``Uses,'' the indication(s) for each ingredient in the 
combination as established in the indications sections of the applicable 
OTC drug monographs, unless otherwise stated in this paragraph. Other 
truthful and nonmisleading statements, describing only the indications 
for use that have been established in the applicable OTC drug monographs 
or listed in this paragraph (b), may also be used, as provided by Sec. 
330.1(c)(2) of this chapter, subject to the provisions of section 502 of 
the Federal Food, Drug, and Cosmetic Act (the act) relating to 
misbranding and the prohibition in section 301(d) of the act against the 
introduction or delivery for introduction into interstate commerce of 
unapproved new drugs in violation of section 505(a) of the act.
    (1) In addition, the labeling of the product may contain any of the 
``other allowable statements'' that are identified in the applicable 
monographs.
    (2) For permitted combinations containing a sunscreen and a skin 
protectant identified in Sec. 352.20(b).
    (c) Warnings. The labeling of the product states, under the heading 
``Warnings,'' the warning(s) for each ingredient in the combination, as 
established in the warnings section of the applicable OTC drug 
monographs. For permitted combinations containing a sunscreen and a skin 
protectant identified in Sec. 352.20(b).
    (d) Directions. The labeling of the product states, under the 
heading ``Directions,'' directions that conform to the directions 
established for each ingredient in the directions sections of the 
applicable OTC drug monographs, unless otherwise stated in this 
paragraph. When the time intervals or age limitations for administration 
of the individual ingredients differ, the directions for the combination 
product may not contain any dosage that exceeds those established for 
any individual ingredient in the applicable OTC drug monograph(s), and 
may not provide for use by any age group lower than the highest minimum 
age limit established for any individual ingredient. For permitted 
combinations containing a sunscreen and a skin protectant identified in 
Sec. 352.20(b).

    Effective Date Note: At 68 FR 33380, June 4, 2003, Sec. 352.60 was 
amended by revising paragraphs (b)(2), (c), and (d), effective June 4, 
2004. For the convenience of the user, the revised text is set forth as 
follows:

Sec. 352.60  Labeling of permitted combinations of active ingredients.

                                * * * * *

    (b) * * *
    (2) For permitted combinations containing a sunscreen and a skin 
protectant identified in Sec. 352.20(b), any or all of the applicable 
indications for sunscreens in Sec. 352.52(b) and the indication for 
skin protectants in Sec. 347.50(b)(2)(i) of this chapter should be 
used. For products marketed as a lip protectant, the indication in Sec. 
352.52(f)(1)(ii) should be used.
    (c) Warnings. The labeling of the product states, under the heading 
``Warnings,'' the warning(s) for each ingredient in the combination, as 
established in the warnings section of the applicable OTC drug 
monographs, except that the warning for skin protectants in Sec. 
347.50(c)(3) of this chapter is not required for permitted combinations 
containing a sunscreen and a skin protectant identified in Sec. 
352.20(b). For products marketed as a lip protectant or lipstick, Sec. 
352.52(f)(1)(iii), (f)(1)(iv) (except ``Keep out of eyes,'' which may be 
omitted), and (f)(1)(vi) apply.
    (d) Directions. The labeling of the product states, under the 
heading ``directions,'' directions that conform to the directions 
established for each ingredient in the directions sections of the 
applicable OTC drug monographs, unless otherwise stated in this 
paragraph. When the time intervals or age limitations for administration 
of the individual ingredients differ, the directions for the combination 
product may not contain any dosage that exceeds those established for 
any individual ingredient in the applicable OTC drug monograph(s), and 
may not provide for use by any age group lower than the highest minimum 
age limit established for any individual ingredient. For permitted 
combinations containing a sunscreen and a

[[Page 297]]

skin protectant identified in Sec. 352.20(b), the directions for 
sunscreens in Sec. 352.52(d) should be used. For products marketed as a 
lip protectant or lipstick, Sec. 352.52(d)(4) applies.