[Code of Federal Regulations]
[Title 21, Volume 5]
[Revised as of April 1, 2008]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR347.20]

[Page 275-276]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF 
 
PART 347_SKIN PROTECTANT DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN
USE--Table of Contents
 
                      Subpart B_Active Ingredients
 
Sec. 347.20  Permitted combinations of active ingredients.

    (a) Combinations of skin protectant active ingredients. (1) Any two 
or more of the ingredients identified in Sec. 347.10(a), (d), (e), (i), 
(k), (l), (m), and (r) may be combined provided the combination is 
labeled according to Sec. 347.50(b)(1) and provided each ingredient in 
the combination is within the concentration specified in Sec. 347.10.
    (2) Any two or more of the ingredients identified in Sec. 
347.10(a), (d), (e), (g), (h), (i), (k), (l), (m), and (r) may be 
combined provided the combination is labeled according to Sec. 
347.50(b)(2) and provided each ingredient in the combination is within 
the concentration specified in Sec. 347.10.
    (3) Any two or more of the ingredients identified in Sec. 
347.10(b), (c), (j), (s), (t), and (u) may be combined provided the 
combination is labeled according to Sec. 347.50(b)(3) and provided each 
ingredient in the combination is within the concentration specified in 
Sec. 347.10.

[[Page 276]]

    (4) The ingredients identified in Sec. 347.10(f) and (l) may be 
combined provided the combination is labeled according to Sec. 
347.50(b)(7) and provided each ingredient in the combination is within 
the concentration specified in Sec. 347.10.
    (b) Combinations of skin protectant and external analgesic active 
ingredients. Any one (two when required to be in combination) or more of 
the active ingredients identified in Sec. 347.10(a), (d), (e), (i), 
(k), (l), (m), and (r) may be combined with any of the following 
generally recognized as safe and effective external analgesic active 
ingredients: Single amine and ``caine''-type local anesthetics, alcohols 
and ketones, antihistamines, or any permitted combination of these 
ingredients, but not with hydrocortisone, provided the product is 
labeled according to Sec. 347.60(b)(l).
    (c) Combinations of skin protectant and first aid antiseptic active 
ingredients. Any one (two when required to be in combination) or more of 
the active ingredients identified in Sec. 347.10(a), (d), (e), (i), 
(k), (l), (m), and (r) may be combined with any generally recognized as 
safe and effective single first aid antiseptic active ingredient, or any 
permitted combination of these ingredients, provided the product is 
labeled according to Sec. 347.60(b)(2).
    (d) Combinations of skin protectant and sunscreen active 
ingredients. Any one (two when required to be in combination) or more of 
the skin protectant active ingredients identified in Sec. 347.10(a), 
(d), (e), (g), (h), (i), (k), (l), (m), and (r) may be combined with any 
generally recognized as safe and effective single sunscreen active 
ingredient, or any permitted combination of these ingredients, provided 
the product meets the conditions in Sec. 352.20(b) of this chapter and 
is labeled according to Sec. Sec. 347.60(b)(3) and 352.60(b) of this 
chapter.

    Effective Date Note: At 68 FR 33377, June 4, 2003, in Sec. 347.20 
paragraph (d) was stayed until further notice, effective June 4, 2004.