This electronic document was downloaded from the GPO web site, August 2002, and is provided for information purposes only. The Code of Federal Regulations, Title 21, is updated each year in early summer. The most current version of the regulations may be found at the GPO web site or from the current printed version.

 [Code of Federal Regulations]
 [Title 21, Volume 1]
 [Revised as of April 1, 2002]
 From the U.S. Government Printing Office via GPO Access
 [CITE: 21CFR73.2995]
 
 [Page 382-383]
 
                         TITLE 21--FOOD AND DRUGS
 
 CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
                                 SERVICES
 
 PART 73--LISTING OF COLOR ADDITIVES EXEMPT FROM CERTIFICATION--Table of Contents
 
                           Subpart C--Cosmetics
 
 Sec. 73.2995  Luminescent zinc sulfide.
 
     (a) Identity. The color additive luminescent zinc sulfide is zinc
 sulfide containing a copper activator. Following excitation by daylight
 or a suitable artificial light, luminescent zinc sulfide produces a
 yellow-green phosphorescence with a maximum at 530 nanometers.
     (b) Specifications. Luminescent zinc sulfide shall conform to the
 following specifications and shall be free from impurities other than
 those named to the extent that such impurities may be avoided by good
 manufacturing practice:
 
 Zinc sulfide, not less than 99.8 percent.
 Copper, 100<INF>#</INF>5 parts per million.
 Lead, not more than 20 parts per million.
 Arsenic, not more than 3 parts per million.
 Mercury, not more than 1 part per million.
 Cadmium, not more than 15 parts per million.
 
     (c) Uses and restrictions. The color additive luminescent zinc
 sulfide may be safely used for coloring externally applied facial makeup
 preparations and nail polish included under Sec. 720.4(c)(7)(ix) and
 (c)(8)(v) of this chapter, respectively, to the following restrictions:
     (1) The amount of luminescent zinc sulfide in facial makeup
 preparations shall not exceed 10 percent by weight of the final product.
     (2) Facial makeup preparations containing luminescent zinc sulfide
 are intended for use only on limited, infrequent occasions, e.g.,
 Halloween, and not for regular or daily use.
     (d) Labeling requirements. (1) The label of the color additive and
 any mixtures prepared therefrom shall bear expiration dates for the
 sealed and open container (established through generally accepted
 stability testing methods), other information required by Sec. 70.25 of
 this chapter, and adequate directions to prepare a final product
 complying with the limitations prescribed in paragraph (c) of this
 section.
     (2) The label of a facial makeup preparation containing the color
 additive
 
 [[Page 383]]
 
 shall bear, in addition to other information required by the law, the
 following statement conspicuously displayed:
     Do not use in the area of the eye.
     (e) Exemption from certification. Certification of this color
 additive is not necessary for the protection of the public health, and
 therefore batches thereof are exempt from the certification requirements
 of section 721(c) of the act.
 
 [65 FR 48377, Aug. 8, 2000; 65 FR 75158, Dec. 1, 2000]


Color Additive Regulations
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