[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2007]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR73.2995]
[Page 379]
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
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, 1005 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 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]
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