Code of Federal Regulations

  Title 21, Volume 7, Parts 600 to 799

  Revised as of April 1, 1996

 From the U.S. Government Printing Office via GPO Access

  CITE: 21CFR701

 

  Page 180-192

 

         TITLE 21--FOOD AND DRUGS

 

 CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES--(Continued)

 

 PART 701--COSMETIC LABELING

 

          Subpart B--Package Form

 

 701.10  Principal display panel.

 701.11  Identity labeling.

 701.12  Name and place of business of manufacturer, packer, or

           distributor.

 701.13  Declaration of net quantity of contents.

 

     Authority: Secs. 201, 502, 601, 602, 603, 701, 704 of the Federal

 Food, Drug, and Cosmetic Act (21 U.S.C. 321, 352, 361, 362, 363, 371,

 374); secs. 5, 6 of the Fair Packaging and Labeling Act (15 U.S.C. 1454,

 1455).

 

     Source: 39 FR 10056, Mar. 15, 1974, unless otherwise noted.

 

          Subpart B--Package Form

 

 Sec. 701.10   Principal display panel.

 

     The term principal display panel as it applies to cosmetics in

 package form and as used in this part, means the part of a label that is

 most likely to be displayed, presented, shown, or examined under

 customary conditions of display for retail sale. The principal display

 panel shall be large enough to accommodate all the mandatory label

 information required to be placed thereon by this part with clarity and

 conspicuousness and without obscuring designs, vignettes, or crowding.

 Where packages bear alternate principal display panels, information

 required to be placed on the principal display panel shall be duplicated

 on each principal display panel. For the purpose of obtaining uniform

 type size in declaring the quantity of contents of all packages of

 substantially the same size, the term ``area of the principal display

 panel''

 

   Page 188

 

 means the area of the side or surface that bears the principal display

 panel, which area shall be:

     (a) In the case of a rectangular package where one entire side

 properly can be considered to be the principal display panel side, the

 product of the height times the width of that side;

     (b) In the case of a cylindrical or nearly cylindrical container, 40

 percent of the product of the height of the container times the

 circumference; and

     (c) In the case of any other shape of container, 40 percent of the

 total surface of the container: Provided, however, That where such

 container presents an obvious ``principal display panel'' such as the

 top of a triangular or circular package, the area shall consist of the

 entire top surface.

 

 In determining the area of the principal display panel, exclude tops,

 bottoms, flanges at the tops and bottoms of cans, and shoulders and

 necks of bottles or jars. In the case of cylindrical or nearly

 cylindrical containers, information required by this part to appear on

 the principal display panel shall appear within that 40 percent of the

 circumference which is most likely to be displayed, presented, shown, or

 examined under customary conditions of display for retail sale.

 

 Sec. 701.11   Identity labeling.

 

     (a) The principal display panel of a cosmetic in package form shall

 bear as one of its principal features a statement of the identity of the

 commodity.

     (b) Such statement of identity shall be in terms of:

     (1) The common or usual name of the cosmetic; or

     (2) An appropriately descriptive name or, when the nature of the

 cosmetic is obvious, a fanciful name understood by the public to

 identify such cosmetic; or

     (3) An appropriate illustration or vignette representing the

 intended cosmetic use.

     (c) The statement of identity shall be presented in bold type on the

 principal display panel, shall be in a size reasonably related to the

 most prominent printed matter on such panel, and shall be in lines

 generally parallel to the base on which the package rests as it is

 designed to be displayed.

 

 Sec. 701.12   Name and place of business of manufacturer, packer, or

           distributor.

 

     (a) The label of a cosmetic in package form shall specify

 conspicuously the name and place of business of the manufacturer,

 packer, or distributor.

     (b) The requirement for declaration of the name of the manufacturer,

 packer, or distributor shall be deemed to be satisfied in the case of a

 corporation only by the actual corporate name, which may be preceded or

 followed by the name of the particular division of the corporation.

 Abbreviations for ``Company,'' ``Incorporated,'' etc., may be used and

 ``The'' may be omitted. In the case of an individual, partnership, or

 association, the name under which the business is conducted shall be

 used.

     (c) Where the cosmetic is not manufactured by the person whose name

 appears on the label, the name shall be qualified by a phrase that

 reveals the connection such person has with such cosmetic; such as,

 ``Manufactured for --------------'', ``Distributed by ----------------

 '', or any other wording that expresses the facts.

     (d) The statement of the place of business shall include the street

 address, city, State, and ZIP Code; however, the street address may be

 omitted if it is shown in a current city directory or telephone

 directory. The requirement for inclusion of the ZIP Code shall apply

 only to consumer commodity labels developed or revised after the

 effective date of this section. In the case of nonconsumer packages, the

 ZIP Code shall appear either on the label or the labeling (including the

 invoice).

     (e) If a person manufactures, packs, or distributes a cosmetic at a

 place other than his principal place of business, the label may state

 the principal place of business in lieu of the actual place where such

 cosmetic was manufactured or packed or is to be distributed, unless such

 statement would be misleading.

 

 Sec. 701.13   Declaration of net quantity of contents.

 

     (a) The label of a cosmetic in package form shall bear a declaration

 of the net quantity of contents. This shall be expressed in terms of

 weight, measure,

 

   Page 189

 

 numerical count, or a combination of numerical count and weight or

 measure. The statement shall be in terms of fluid measure if the

 cosmetic is liquid or in terms of weight if the cosmetic is solid,

 semisolid, or viscous, or a mixture of solid and liquid. If there is a

 firmly established, general consumer usage and trade custom of declaring

 the net quantity of a cosmetic by numerical count, linear measure, or

 measure of area, such respective term may be used. If there is a firmly

 established, general consumer usage and trade custom of declaring the

 contents of a liquid cosmetic by weight, or a solid, semisolid, or

 viscous cosmetic by fluid measure, it may be used. Whenever the

 Commissioner determines for a specific packaged cosmetic that an

 existing practice of declaring net quantity of contents by weight,

 measure, numerical count, or a combination of these does not facilitate

 value comparisons by consumers, he shall by regulation designate the

 appropriate term or terms to be used for such cosmetic.

     (b) Statements of weight shall be in terms of avoirdupois pound and

 ounce. Statements of fluid measure shall be in terms of the U.S. gallon

 of 231 cubic inches and quart, pint, and fluid-ounce subdivisions

 thereof and shall express the volume at 68 deg. F. (20 deg. C.).

     (c) When the declaration of quantity of contents by numerical count,

 linear measure, or measure of area does not give accurate information as

 to the quantity of cosmetic in the package, it shall be augmented by

 such statement of weight, measure, or size of the individual units or

 the total weight or measure of the cosmetic as will give such

 information.

     (d) The declaration may contain common or decimal fractions. A

 common fraction shall be in terms of halves, quarters, eighths,

 sixteenths, or thirty-seconds; except that if there exists a firmly

 established, general consumer usage and trade custom of employing

 different common fractions in the net quantity declaration of a

 particular commodity they may be employed. A common fraction shall be

 reduced to its lowest terms; a decimal fraction shall not be carried out

 to more than two places. A statement that includes small fractions of an

 ounce shall be deemed to permit smaller variations than one which does

 not include such fractions.

     (e) The declaration shall be located on the principal display panel

 of the label; with respect to packages bearing alternate principal

 display panels, it shall be duplicated on each principal display panel:

 Provided, That:

     (1) The principal display panel of a cosmetic marketed in a

 ``boudoir-type'' container including decorative cosmetic containers of

 the ``cartridge,'' ``pill box,'' ``compact,'' or ``pencil'' variety, and

 those with a capacity of one-fourth ounce or less, may be considered to

 be a tear-away tag or tape affixed to the decorative container and

 bearing the mandatory label information as required by this part, but

 the type size of the net quantity of contents statement shall be

 governed by the dimensions of the decorative container; and

     (2) The principal display panel of a cosmetic marketed on a display

 card to which the immediate container is affixed may be considered to be

 the display panel of the card, and the type size of the net quantity of

 content statement is governed by the dimensions of the display card.

     (f) The declaration shall appear as a distinct item on the principal

 display panel, shall be separated (by at least a space equal to the

 height of the lettering used in the declaration) from other printed

 label information appearing above or below the declaration and (by at

 least a space equal to twice the width of the letter ``N'' of the style

 of type used in the quantity of contents statement) from other printed

 label information appearing to the left or right of the declaration. It

 shall not include any term qualifying a unit of weight, measure, or

 count (such as ``giant pint'' and ``full quart'') that tends to

 exaggerate the amount of the cosmetic in the container. It shall be

 placed on the principal display panel within the bottom 30 percent of

 the area of the label panel in line generally parallel to the base on

 which the package rests as it is designed to be displayed: Provided,

 That:

     (1) On packages having a principal display panel of 5 square inches

 or less, the requirement for placement within the bottom 30 percent of

 the area of the

 

   Page 190

 

 label panel shall not apply when the declaration of net quantity of

 contents meets the other requirements of this part; and

     (2) In the case of a cosmetic that is marketed with both outer and

 inner retail containers bearing the mandatory label information required

 by this part, and the inner container is not intended to be sold

 separately, the net quantity of contents placement requirement of this

 section applicable to such inner containers is waived.

     (g) The declaration shall accurately reveal the quantity of cosmetic

 in the package exclusive of wrappers and other material packed

 therewith: Provided, That:

     (1) In the case of cosmetics packed in containers designed to

 deliver the cosmetic under pressure, the declaration shall state the net

 quantity of the contents that will be expelled when the instructions for

 use as shown on the container are followed. The propellant is included

 in the net quantity declaration; and

     (2) In the case of a package which contains the integral components

 making up a complete kit, and which is designed to deliver the

 components in the manner of an application (for example, a home

 permanent wave kit), the declaration may state the net quantity of the

 contents in nondeceptive terms of the number of applications available

 in the kit when the instructions for use as shown on the container are

 followed.

     (h) The declaration shall appear in conspicuous and easily legible

 boldface print or type in distinct contrast (by typography, layout,

 color, embossing, or molding) to other matter on the package; except

 that a declaration of net quantity blown, embossed, or molded on a glass

 or plastic surface is permissible when all label information is so

 formed on the surface. Requirements of conspicuousness and legibility

 shall include the specifications that:

     (1) The ratio of height to width (of the letter) shall not exceed a

 differential of 3 units to 1 unit (no more than 3 times as high as it is

 wide).

     (2) Letter heights pertain to upper case or capital letters. When

 upper and lower case or all lower case letters are used, it is the lower

 case letter ``o'' or its equivalent that shall meet the minimum

 standards.

     (3) When fractions are used, each component numeral shall meet one-

 half the minimum height standards.

     (i) The declaration shall be in letters and numerals in a type size

 established in relationship to the area of the principal display panel

 of the package and shall be uniform for all packages of substantially

 the same size by complying with the following type specifications:

     (1) Not less than one-sixteenth inch in height on packages the

 principal display panel of which has an area of 5 square inches or less.

     (2) Not less than one-eighth inch in height on packages the

 principal display panel of which has an area of more than 5 but not more

 than 25 square inches.

     (3) Not less than three-sixteenths inch in height on packages the

 principal display panel of which has an area of more than 25 but not

 more than 100 square inches.

     (4) Not less than one-fourth inch in height on packages the

 principal display panel of which has an area of more than 100 square

 inches, except not less than one-half inch in height if the area is more

 than 400 square inches.

 

 Where the declaration is blown, embossed, or molded on a glass or

 plastic surface rather than by printing, typing, or coloring, the

 lettering sizes specified in paragraphs (i)(1) through (4) of this

 section shall be increased by one-sixteenth of an inch.

     (j) On packages containing less than 4 pounds or 1 gallon and

 labeled in terms of weight or fluid measure:

     (1) The declaration shall be expressed both in ounces, with

 identification by weight or by liquid measure and, if applicable (1

 pound or 1 pint or more), followed in parentheses by a declaration in

 pounds for weight units, with any remainder in terms of ounces or common

 or decimal fractions of the pound (as set forth in paragraphs (m)(1) and

 (2) of this section), or in the case of liquid measure, in the largest

 whole units (quarts, quarts and pints, or pints, as appropriate) with

 any remainder in terms of fluid ounces or common or decimal fractions of

 the pint or quart (as set forth in paragraphs (m)(3) and

 

   Page 191

 

 (4) of this section). Net weight or fluid measure of less than 1 ounce

 shall be expressed in common or decimal fractions of the respective

 ounce and not in drams.

     (2) The declaration may appear in more than one line. The term ``net

 weight'' shall be used when stating the net quantity of contents in

 terms of weight. Use of the terms ``net'' or ``net contents'' in terms

 of fluid measure or numerical count is optional. It is sufficient to

 distinguish avoirdupois ounce from fluid ounce through association of

 terms; for example, ``Net wt. 6 oz.'' or ``6 oz. net wt.'' and ``Net

 contents 6 fl. oz.'' or ``6 fl. oz.''

     (k) On packages containing 4 pounds or 1 gallon or more and labeled

 in terms of weight or fluid measure, the declaration shall be expressed

 in pounds for weight units with any remainder in terms of ounces or

 common or decimal fractions of the pound; in the case of fluid measure,

 it shall be expressed in the largest whole unit (gallons, followed by

 common or decimal fractions of a gallon or by the next smaller whole

 unit or units (quarts or quarts and pints)) with any remainder in terms

 of fluid ounces or common or decimal fractions of the pint or quart (as

 set forth in paragraph (m)(5) of this section).

     (l)  Reserved

     (m) Examples: (1) A declaration of 1\1/2\ pounds weight shall be

 expressed as ``Net wt. 24 oz. (1 lb. 8 oz.)'', ``Net wt. 24 oz. (1\1/2\

 lb.)'', or ``Net wt. 24 oz. (1.5 lb.)''.

     (2) A declaration of three-fourths pound avoirdupois weight shall be

 expressed as ``Net wt. 12 oz.''

     (3) A declaration of 1 quart liquid measure shall be expressed as

 ``Net contents 32 fl. oz. (1 qt.)''.

     (4) A declaration of 1\3/4\ quarts liquid measure shall be expressed

 as ``Net contents 56 fl. oz. (1 qt. 1\1/2\ pt.)'' or ``Net contents 56

 fl. oz. (1 qt. 1 pt. 8 oz.)'' but not in terms of quart and ounce such

 as ``Net content 56 fl. oz. (1 qt. 24 oz.)''.

     (5) A declaration of 2\1/2\ gallons liquid measure shall be

 expressed in the alternative as ``Net contents 2 gal. 2 qt.'' and not as

 ``2 gal. 4 pt.''

     (n) For quantities, the following abbreviations and none other may

 be employed (periods and plural forms are optional):

 

 weight wt.           gallon gal.

 square sq.           quart qt.

 fluid fl.            pint pt.

 yard yd.             ounce oz.

 feet or foot ft.     pound lb.

 inch in.

 

     (o) On packages labeled in terms of linear measure, the declaration

 shall be expressed both in terms of inches and, if applicable (1 foot or

 more), the largest whole units (yards, yards and feet, feet). The

 declaration in terms of the largest whole units shall be in parentheses

 following the declaration in terms of inches and any remainder shall be

 in terms of inches or common or decimal fractions of the foot or yard.

 Examples are ``86 inches (2 yd. 1 ft. 2 inches)'', ``90 inches (2\1/2\

 yd.)'', ``30 inches (2.5 ft.)'', etc.

     (p) On packages labeled in terms of area measure, the declaration

 shall be expressed in terms of square inches and, if applicable (1

 square foot or more), the largest whole square unit (square yards,

 square yards and square feet, square feet). The declaration in terms of

 the largest whole units shall be in parentheses following the

 declaration in terms of square inches and any remainder shall be in

 terms of square inches or common or decimal fractions of the square foot

 or square yard; for example, ``158 sq. inches (1 sq. ft. 14 sq.

 inches)'', etc.

     (q) Nothing in this section shall prohibit supplemental statements

 at locations other than the principal display panel(s) describing in

 nondeceptive terms the net quantity of contents, provided that such

 supplemental statements of net quantity of contents shall not include

 any term qualifying a unit of weight, measure, or count that tends to

 exaggerate the amount of the cosmetic contained in the package; for

 example, ``giant pint'' and ``full quart.'' Dual or combination

 declarations of net quantity of contents as provided for in paragraphs

 (a), (c), and (j) of this section (for example, a combination of net

 weight plus numerical count) are not regarded as supplemental net

 quantity statements and shall be located on the principal display panel.

     (r) A separate statement of the net quantity of contents in terms of

 the

 

   Page 192

 

 metric system is not regarded as a supplemental statement and an

 accurate statement of the net quantity of contents in terms of the

 metric system of weight or measure may also appear on the principal

 display panel or on other panels.

     (s) The declaration of net quantity of contents shall express an

 accurate statement of the quantity of contents of the package.

 Reasonable variations caused by loss or gain of moisture during the

 course of good distribution practice or by unavoidable deviations in

 good manufacturing practice will be recognized. Variations from stated

 quantity of contents shall not be unreasonably large.