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2010-09-24
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Sunscreen Drug Products for Over-the-Counter Human Use; Amendment to the Tentative Final Monograph; Enforcement Policy
Proposed Rules
D09002ee1bdfee2fe
D09002ee1bdfee398
United States
Department of Health and Human Services
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org
United States Government Agency or Subagency
United States
Food and Drug Administration
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org
United States Government Agency or Subagency
The Food and Drug Administration (FDA) is issuing a notice of proposed rulemaking that amends the tentative final monograph (proposed rule) for over-the-counter (OTC) sunscreen drug products. This amendment would establish conditions under which products containing zinc oxide as a sunscreen active ingredient are generally recognized as safe and effective and not misbranded at concentrations of up to 25 percent alone and 2 to 25 percent in combination with any proposed Category I sunscreen active ingredient except avobenzone. OTC marketing of such drug products is being permitted pending establishment under the OTC drug review of a final monograph covering sunscreen drug products. This proposal is part of the ongoing review of OTC drug products conducted by FDA.
63 FR 56584
https://www.govinfo.gov/app/details/FR-1998-10-22/98-28274
98-28274
fr22oc98-30
RIN 0910-AA01
4160-01-F
Docket No. 78N-0038
https://www.govinfo.gov/app/details/FR-1998-10-22/98-28274
https://www.govinfo.gov/content/pkg/FR-1998-10-22/html/98-28274.htm
https://www.govinfo.gov/content/pkg/FR-1998-10-22/pdf/98-28274.pdf
6 p.
56584
56589
63 FR 56584
Code of Federal Regulations
Title 21 Part 352
21 CFR Part 352
Regulation Identification Number 0910-AA01
RIN 0910-AA01
Sunscreen Drug Products for Over-the-Counter Human Use; Amendment to the Tentative Final Monograph; Enforcement Policy; Federal Register Vol. 63, Issue
PRORULE
98-28274
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
1999-01-20
Docket No. 78N-0038
4160-01-F
98-28274
Notice of proposed rulemaking.
The Food and Drug Administration (FDA) is issuing a notice of proposed rulemaking that amends the tentative final monograph (proposed rule) for over-the-counter (OTC) sunscreen drug products. This amendment would establish conditions under which products containing zinc oxide as a sunscreen active ingredient are generally recognized as safe and effective and not misbranded at concentrations of up to 25 percent alone and 2 to 25 percent in combination with any proposed Category I sunscreen active ingredient except avobenzone. OTC marketing of such drug products is being permitted pending establishment under the OTC drug review of a final monograph covering sunscreen drug products. This proposal is part of the ongoing review of OTC drug products conducted by FDA.
Submit written comments by January 20, 1999; written comments on the agency's economic impact determination by January 20, 1999. FDA is proposing that any final rule based on this proposal become effective 12 months after its date of publication in the Federal Register.
Donald Dobbs, Center for Drug Evaluation and Research (HFD-560), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-2222.
Federal Register
Vol. 63, no. 204
Office of the Federal Register, National Archives and Records Administration
1998-10-22
continuing
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256 p.
Table of Contents:
AE 2.7:
GS 4.107:
AE 2.106:
KF70.A2
https://www.govinfo.gov/app/details/FR-1998-10-22
P0b002ee180a6ade3
0097-6326
0042-1219
0364-1406
769-004-00000-9
000582072
f:fr22oc98
https://www.govinfo.gov/app/details/FR-1998-10-22
https://www.govinfo.gov/content/pkg/FR-1998-10-22/pdf/FR-1998-10-22.pdf
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56780
DGPO
2010-09-24
2023-05-06
FR-1998-10-22
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FR
FR-1998-10-22
63
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