Ill. Admin. Code tit. 77 § 720.60

Current through Register Vol. 48, No. 45, November 8, 2024

Section 720.60 - Cosmetics

a) Cosmetic: Labeling; Misbranding.

Among representations in labeling of a cosmetic which render such cosmetic misbranded is a false or misleading representation with respect to another cosmetic or a food, drug or device.

b) The labeling of a cosmetic which contains two or more ingredients may be misleading by reason (among other reasons) of the designation of such cosmetic in such labeling by a name which includes or suggests the name of one or more but not all such ingredients, even though the names of all such ingredients are stated elsewhere in the labeling.

c) Cosmetic: Labeling; Required Statements; Exemption.

If a cosmetic is not manufactured by the person whose name appears on the label, the name shall be qualified by a phrase which reveals the connection such person has with such cosmetic such as "Manufactured for and Packed by ________," "Distributed by __________" or other similar phrase which expresses the facts.

d) The statement of the place of business shall include the street address if any, of such place, unless such street address is shown in a current city directory or telephone directory.

e) Where 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 each package of such cosmetic was manufactured or packed or is to be distributed, if such statement is not misleading in any particular.

f) The requirement that the label shall contain the name and place of business of the manufacturer, packer or distributor shall not be considered to relieve any cosmetic from the requirement that its label shall not be misleading in any particular.

g)

1) The statement of the quantity of the contents shall reveal the quantity of cosmetic in the package, exclusive of wrappers and other material packed with such cosmetic.

2) The statement shall be expressed in the terms of weight, measure, numerical count, or a combination of numerical count and weight or measure, which are generally used by consumers to express quantity of such cosmetic and which give accurate information as to the quantity thereof. But if no general consumer usage in expressing accurate information as to the quantity of such cosmetic exists, the statement shall be in terms of liquid measure if the cosmetic is liquid, or in terms of weight if the cosmetic is solid, semisolid or viscous, or in such terms of numerical count, or numerical count and weight or measure, as will give accurate information as to the quantity of the cosmetic in the package.

h)

1) A statement of weight shall be in terms of the avoirdupois pound and ounce. A statement if liquid measure shall be in terms of the United States gallon of 231 cubic inches and quart, pint and fluid ounce subdivisions thereof, and shall express the volume at 68° Fahrenheit (20° Centigrade). However, in the case of an export shipment, the statement may be in terms of a system of weight or measure in common use in the country to which such shipment is exported.

2) A statement of weight or measure in the terms specified in subsection (h)(1) above may be supplemented by a statement in terms of the metric system of weight or measure.

3) Unless an unqualified statement of numerical count gives accurate information as to the quantity of cosmetic in the package, it shall be supplemented by such statement of weight, measure or size of the individual units of the cosmetic as will give such information.

i) Statement shall contain only such fractions as are generally used in expressing the quantity of the cosmetic. A common fraction shall be reduced to its lowest terms; a decimal fraction shall not be carried out to more than two places.

j)

1) If the quantity of cosmetic in the package equals or exceeds the smallest unit of weight or measure which is specified in subsection (h) above, and which is applicable to such cosmetic under the provisions of subsection (g)(2) above, the statement shall express the number of the largest of such units contained in the package (for example, the statement on the label of a package which contains one pint of cosmetic shall be "1 pint," not "16 fluid ounces"), unless the statement is made in accordance with the provisions of subsection (j)(2) below. Where such number is a whole number and a fraction, there may be substituted for the fraction its equivalent in smaller units, if any smaller is specified in subsection (h) above (for example, 13/4 quarts may be expressed as "1 quart 11/2 pints" or "1 quart 1 pint 8 fluid ounces," 11/4 pounds may be expressed as "1 pound 4 ounces"). The stated number of any unit which is smaller than the largest unit (specified in subsection (h) above) contained in the package shall not equal or exceed the number of such smaller units in the next larger unit so specified (for example, instead of "1 quart 16 fluid ounces" the statement shall be "11/2 quarts" or "1 quart 1 pint": instead of "24 ounces" the statement shall be "11/2 pounds" or "1 pound 8 ounces").

2) In the case of a cosmetic with respect to which there exists an established custom of stating the quantity of the contents as a fraction of a unit, which unit is larger than the quantity of the contents as a fraction of a unit, which unit is larger than the quantity contained in the package, or as units smaller than the largest unit contained therein, the statement may be made in accordance with such custom if it is informative to consumers.

k) The statement shall express the minimum quantity, or the average quantity, of the contents of the package. If the statement is not so qualified as to show definitely that the quantity expressed is the minimum quantity, the statement shall be considered to express the average quantity.

l) Where the statement expresses the minimum quantity, no variation below the stated minimum shall be permitted except variations below the stated weight or measure caused by ordinary and customary exposure, after the cosmetic is introduced into commerce, to conditions which normally occur in good distribution practice and which unavoidably result in decreased weight or measure. Variations above the stated minimum shall not be unreasonably large.

m) Where the statement does not express the minimum quantity:

1) Variations from the stated weight or measure shall be permitted when caused by ordinary and customary exposure, after the cosmetic is introduced into commerce, to conditions which normally occur in good distribution practice and which unavoidably result in change of weight or measure.

2) Variations from the stated weight, measure or numerical count shall be permitted when caused by unavoidable deviations in weighing, measuring or counting individual packages which occur in good packing practice. But under this subsection (m)(2) variations shall not be permitted to such extent that the average of the quantities in the packages comprising a shipment or other delivery of the cosmetic is below the quantity stated, and no unreasonable shortage in any package shall be permitted, even though overages in other packages in the same shipment or delivery compensate for such shortage.

n) The extent of variations from the stated quantity of the contents permissible under subsections (l) and (m) above in the case of each shipment or other delivery shall be determined by the facts in such case.

o) A cosmetic shall be exempt from compliance with the requirements of clause (2) of Section 19(b) of the Act if the quantity of the contents of the package, as expressed in terms applicable to such cosmetic under the provisions of subsection (g)(2) above, is less than one-fourth ounce avoirdupois, or less than one-eighth fluid ounce, or (in case the units of the cosmetic can be easily counted without opening the package) less than six units.

p) Cosmetic: Labeling Requirements; Form of Stating.

A word, statement or other information required by or under authority of the Act to appear on the label may lack that prominence and conspicuousness required by Section 19(c) of the Act by reason (among other reasons) of:

1) The failure of such word, statement or information to appear on the part or panel of the label which is presented or displayed under customary conditions of purchase;

2) The failure of such word, statement or information to appear on two or more parts or panels of the label, each of which has sufficient space therefor, and each of which is so designed as to render it likely to be, under customary conditions of purchase, the part of panel displayed;

3) The failure of the label to extend over the area of the container or package available for such extension, so as to provide sufficient label space for the prominent placing of such word, statement or information;

4) Insufficiency of label space (for the prominent placing of such word, statement or information) resulting from the use of label space for any word, statement, design or device which is not required by or under authority of the Act to appear on the label;

5) Insufficiency of label space (for the prominent placing of such word, statement or information) resulting from the use of label space to give materially greater conspicuousness to any other word, statement or information, or to any design or device;

6) Smallness or style of type in which such word, statement or information appears, insufficient background contrast, obscuring designs or vignettes, or crowding with other written, printed or graphic matter.

q)

1) All words, statements and other information required by or under authority of the Act to appear on the label or labeling shall appear thereon in the English language.

2) If the label contains any representation in a foreign language, all words, statement and other information required by or under authority of the Act to appear on the label shall appear thereon in the foreign language.

3) If the labeling contains any representation in a foreign language, all words, statements and other information required by or under authority of the Act to appear on the label or labeling shall appear on the labeling in the foreign language.

r) Cosmetic: Labeling Requirements; Exemptions.

Except as provided by subsections (s) and (t) below, a shipment or other delivery of a cosmetic which is, in accordance with the practice of the trade, to be processed, labeled or repacked in substantial quantity at an establishment other than that where originally processed or packed, shall be exempt, during the time of introduction into and movement in commerce and the time of holding in such establishment, from compliance with the labeling requirements of Sections 18(a) and 19(b) of the Act if:

1) The person who introduced such shipment or delivery into commerce is the operator of the establishment where such cosmetic is to be processed, labeled or repacked; or

2) In case such person is not such operator, such shipment or delivery is made to such establishment under a written agreement, signed by and containing the post office addresses of such person and such operator, and containing such specifications for the processing, labeling or repacking, as the case may be, of such cosmetic in such establishment as will insure, if such specifications are followed, that such cosmetic will not be adulterated or misbranded within the meaning of the Act upon completion of such processing, labeling or repacking. Such person and such operator shall each keep a copy of such agreement until two years after the final shipment or delivery of such cosmetic from such establishment, and shall make such copies available for inspection at any reasonable hour to any officer or employee of the Illinois Department of Public Health who requests them.

s) An exemption of a shipment or other delivery of a cosmetic under subsection (r)(1) above shall, at the beginning of the act of removing such shipment or delivery, or any part, from such establishment, become void ab initio if the cosmetic comprising such shipment, delivery, or part, is adulterated or misbranded within the meaning of the act when so removed.

t) An exemption of a shipment or other delivery of a cosmetic under subsection (r)(2) above shall become void ab initio with respect to the person who introduced such shipment or delivery into interstate commerce upon refusal by such person to make available for inspection a copy of the agreement, as required by such clause.

u) An exemption of a shipment or other delivery of a cosmetic under subsection (r)(2) above shall expire:

1) At the beginning of the act of removing such shipment or delivery, or any part, from such establishment if the cosmetic comprising such shipment, delivery, or part, is adulterated or misbranded within the meaning of the act when so removed; or

2) Upon refusal by the operator of the establishment where such cosmetic is to be processed, labeled or repacked, to make available for inspection a copy of the agreement, as required by such clause.

Ill. Admin. Code tit. 77, § 720.60