FDA facts sheet #3
Text copied directly from the FDA web site http://vm.cfsan.fda.gov/~lrd/cfr701b.html#701_11
[Code of Federal Regulations]
[Title 21, Volume 7, Parts 600 to 799]
[Revised as of April 1, 1999]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR701.1]
[Page 134-139]
TITLE 21--FOOD AND DRUGS
DEPARTMENT OF HEALTH AND HUMAN SERVICES--(Continued)
PART 701--COSMETIC LABELING--Table of Contents
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'' 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
[[Page 135]]
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, 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.
[[Page 136]]
(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 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
[[Page 137]]
(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 (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
[[Page 138]]
(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.
square sq.
fluid fl.
yard yd.
feet or foot ft.
inch in.
gallon gal.
quart qt.
pint pt.
ounce oz.
pound lb.
(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 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.
[[Page 139]]
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