C1-2011-14766. Labeling and Effectiveness Testing; Sunscreen Drug Products for Over-the-Counter Human Use
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Start Preamble
Correction
In rule document 2011-14766 appearing on pages 35620-35665 in the issue of Friday, June 17, 2011, make the following correction:
End Preamble[Corrected]In § 201.327, on page 35661, in the third column, § 201.327(i)(1)(ii)(A)(2) and (3) should read as follows:
(2) Vi (λ) = 100.094* (298 -λ) (298 < λ ≤ 328 nm)
(3) Vi (λ) = 100.015* (140 -λ) (328 < λ ≤ 400 nm)
[FR Doc. C1-2011-14766 Filed 7-1-11; 8:45 am]
BILLING CODE 1505-01-D
Document Information
- Comments Received:
- 0 Comments
- Published:
- 07/05/2011
- Department:
- Food and Drug Administration
- Entry Type:
- Rule
- Document Number:
- C1-2011-14766
- Pages:
- 38975-38975 (1 pages)
- Docket Numbers:
- Docket No. FDA-1978-N-0018
- RINs:
- 0910-AF43: Sunscreen Drug Products For Over-The-Counter-Human Use; Final Monograph
- RIN Links:
- https://www.federalregister.gov/regulations/0910-AF43/sunscreen-drug-products-for-over-the-counter-human-use-final-monograph-
- PDF File:
- c1-2011-14766.pdf
- Supporting Documents:
- » Request for Extension from Personal Care Products Council and Consumer Healthcare Products Association
- » Reference 210 - Yiin_2015_Assessment of Dermal Absorption of DEET-Containing Insect Repellent and Oxybenzone-Containing Sunscreen
- » Reference 190 - EPA_Using Insect Repellents Safely and Effectively
- » Reference 185 - Kong_2015_Assessment of Consumer Knowledge of New Sunscreen Labels
- » Reference 180 - TGA_2016_Australian regulatory guidelines for sunscreens
- » Reference 179 - Fourtanier_2008_Sunscreens containing the BS UVA absorber prevent cutaneous detrimental effects of UV exposure
- » Reference 169 - Damian_2011_An action spectrum for UV radiation-induced immunosuppression in humans
- » Reference 154 - Liu_2018_Particle Size Distribution Analysis of OTC Aerosol or Powder Drug Products with Potential for Inhalation Exposure
- » Reference 153 - Liu_2017_Particle Size Distribution Analysis of OTC Drug Products with Unintended Inhalation Exposure to Consumers
- » Reference 152 - Brown_2013_Thoracic and Respirable Particle Definitions for Human Health Risk Assessment