[Code of Federal Regulations]
[Title 21, Volume 5]
[Revised as of April 1, 2007]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR347.10]

[Page 275]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 347_SKIN PROTECTANT DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE--Table 
 
                      Subpart B_Active Ingredients
 
Sec.  347.10  Skin protectant active ingredients.

    Source: 68 FR 33377, June 4, 2003, unless otherwise noted.


    The active ingredients of the product consist of any of the 
following, within the concentration specified for each ingredient:
    (a) Allantoin, 0.5 to 2 percent.
    (b) Aluminum hydroxide gel, 0.15 to 5 percent.
    (c) Calamine, 1 to 25 percent.
    (d) Cocoa butter, 50 to 100 percent.
    (e) Cod liver oil, 5 to 13.56 percent, in accordance with Sec.  
347.20(a)(1) or (a)(2), provided the product is labeled so that the 
quantity used in a 24-hour period does not exceed 10,000 U.S.P. Units 
vitamin A and 400 U.S.P. Units cholecalciferol.
    (f) Colloidal oatmeal, 0.007 percent minimum; 0.003 percent minimum 
in combination with mineral oil in accordance with Sec.  347.20(a)(4).
    (g) Dimethicone, 1 to 30 percent.
    (h) Glycerin, 20 to 45 percent.
    (i) Hard fat, 50 to 100 percent.
    (j) Kaolin, 4 to 20 percent.
    (k) Lanolin, 12.5 to 50 percent.
    (l) Mineral oil, 50 to 100 percent; 30 to 35 percent in combination 
with colloidal oatmeal in accordance with Sec.  347.20(a)(4).
    (m) Petrolatum, 30 to 100 percent.
    (n) [Reserved]
    (o) Sodium bicarbonate.
    (p) [Reserved]
    (q) Topical starch, 10 to 98 percent.
    (r) White petrolatum, 30 to 100 percent.
    (s) Zinc acetate, 0.1 to 2 percent.
    (t) Zinc carbonate, 0.2 to 2 percent.
    (u) Zinc oxide, 1 to 25 percent.