HBW Insight is part of Pharma Intelligence UK Limited

This site is operated by Pharma Intelligence UK Limited, a company registered in England and Wales with company number 13787459 whose registered office is 5 Howick Place, London SW1P 1WG. The Pharma Intelligence group is owned by Caerus Topco S.à r.l. and all copyright resides with the group.

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


FDA’s ‘Exploratory’ MUsT Won't Affect OTC Sunscreen Rulemaking Schedule

This article was originally published in The Rose Sheet

Executive Summary

FDA’s plans for a maximal usage study to better understand sunscreen ingredient absorption should not hold up delivery of a final OTC sunscreen monograph by the end of 2019, the agency says. There are questions among industry stakeholders as to how FDA’s research relates to MUsTs currently requested from TEA sponsors seeking GRASE approvals.

You may also be interested in...

FDA MUsT Shows Sunscreen Ingredient Absorption ‘Not Just A Theoretical Concern’

In FDA’s maximal usage trial published May 6 in JAMA, oxybenzone, octocrylene, avobenzone and ecamsule all absorbed into subjects’ bloodstreams at levels that raise systemic safety questions. The active ingredients are among 12 that FDA identified in a February proposed rule as currently lacking data to support continued GRASE status.

CHPA Consulting With OTC Antiseptic Advocates As Sunscreen GRASE Push Begins

Following FDA’s proposed sunscreen rule in February, the Consumer Healthcare Products Association has opened a line of communication with the American Cleaning Institute to gain insight into the GRASE data delivery process that kicked off for consumer antiseptic products in September 2016.

Systemic Exposure Data A MUsT For OTC Monograph Sunscreens, Other Topical Drugs In FDA Draft Guidance

Challenges posed by FDA-advised maximal usage trials have been the bane of OTC sunscreen and antimicrobial drug ingredient sponsors recently, but a draft guidance from the agency signals that those trials will be expected generally from companies looking to add topical ingredients to OTC drug monographs. CDER details its expectations for studies of ingredients’ absorption potential to inform systemic exposure and overall safety and efficacy conclusions.

Related Content


Latest Headlines
See All



Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

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