Pink Sheet is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By


J&J, trade group press FDA on sunscreen monograph

This article was originally published in The Tan Sheet

Executive Summary

The Personal Care Products Council requests a meeting with FDA to discuss the sunscreen ingredient monograph proposed in 2007. In a Nov. 3 1letter to Principal Deputy Commissioner Josh Sharfstein, the council urges the agency "to finalize the sunscreen regulations in a way that allows for labeling that educates and helps consumers protect themselves from the dangers of sun exposure." A council spokeswoman said the trade group has not heard back from FDA. Johnson & Johnson and its subsidiary Neutrogena sent a subsequent 2letter Nov. 5 voicing the company's concerns about the monograph's proposal to cap sunscreen label claims at SPF 50, unless adequate supporting data are submitted (3"The Tan Sheet" Aug. 27, 2007). "Any proposed cap on SPF labeling is not necessary and will significantly contribute to reduced innovation and likely reduced communication spends within our industry," J&J says

You may also be interested in...

Comments on sunscreen ingredients' environmental impact

FDA requests comments on the potential environmental impact of sunscreen ingredients and other substances the agency may add to OTC monographs. In a 1notice prepared for the Feb. 22 Federal Register, the Center for Drug Evaluation and Research says environmental regulations require it to estimate the substances' expected introductory concentration in the aquatic environment. The notice lists ingredients not currently approved for use including: amiloxate, bemotrizinol, bisoctrizole, diethylhexyl butamido triazone, enzacamene and octyl triazone for sunscreen; climbazole, piroctone olamine and sodium shale oil sulfonate for dandruff; laxative ingredient sodium picosulfate; and triclosan for acne treatment. The notice also lists ingredients currently marketed in the U.S. through new drug applications as possible OTC monograph additions, ecamsule for sunscreen and triclosan for oral care. The sunscreen ingredients would be part of the first final monograph published for the indication. A final monograph emerged in 1999, but its publication was consistently stayed due to industry pressure, which continued since FDA issued a draft rule in August 2007 (2"The Tan Sheet" Nov. 30, 2009, In Brief). CDER will accept environmental impact comments concerning these ingredients for three months

Sunscreen Proposed Rule May Create UVA Protection Marketing Opportunity

FDA's proposed rule amending its final monograph on sunscreens to include UVA ray protection standards could create new marketing opportunities for manufacturers (see chart: "1Selected Proposed Changes To OTC Sunscreen Monograph")

Pandemic Response In US Consumer Health Market: OTC Pain Relief And Cough/Cold Purchases

Pain relief product sales grew 27% and upper respiratory sales 35% for the week ended 7 March as consumers respond to COVID-19, according to Nielsen data noted in a Jefferies report on consumer health purchasing trends. Private label market share is up slightly, while OTC purchases continue primarily in conventional stores.





Ask The Analyst

Please Note: You can also Click below Link for Ask the Analyst
Ask The Analyst

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts