C1-2011-14766. Labeling and Effectiveness Testing; Sunscreen Drug Products for Over-the-Counter Human Use  

  • 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:

    [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)

    End Preamble

    [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