january, 2020

29jan4:00 PM8:00 PMAn Update on the FDA New Proposed Sunscreen Regulation: The Testing Protocol and the Impact on Industry and the Consumer


Event Details

Speakers from the FDA will explain what the safety concerns are for sunscreen formulations, the testing that will be required by the FDA to determine sunscreen products are “Generally Regarded as Safe and Effective” for human use.  Other speakers will discuss the impact the new regulations will have on testing labs, industry and a blogger will present the impact on the consumer.


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Preliminary Agenda

4:00-4:10 PM     Welcome and Introduction

4:10-4:35 PM     Dr. Raney

4:35-5:00 PM     Dr. Bashaw

5:00- 5:25 PM    Dr. Stinchcomb

5:25-5:50 PM     Dr. Yi

5:50-6:20 PM     Break/Cocktail Hour

6:20- 6:45PM     Dr. Caswell

6:45- 7:05 PM    Dr. Kowcz

7:05- 8:00 PM    Dinner

7:15 – 8:00 PM   Dinner speakers: Mr. Berkland and Ms. Espinoza


Dr. E. Dennis Bashaw, Pharm.D
Presentation Title:  A History of Dermal Absorption Assessment at the FDA


Although it has a long history in the occupational safety arena, the dermal absorption of topically applied substances has been a relative late-comer to pharmaceutics and drug evaluation.  This was primarily due to the limitations in analytical methods that were only overcome in the mid-1990s. Since that the time US Food and Drug Administration (FDA) has been requiring of all NDA applications the submission of in vivo absorption data under the “maximal” conditions of use as used in the clinical trials program and anticipated in labeling.  Since its establishment as a requirement the FDA has evaluated over 50 Maximal Usage Trials or MUsT, the results of which informed both the pharmacology and toxicology evaluation and labeling.

This presentation will present a history of the assessment of dermal absorption, the underpinnings of the Maximal Usage Trial, a discussion of the recent experience of the FDA in the assessment of OTC sunscreens, and the incorporation of the MUsT methodology into the ongoing Sunscreen Monograph evaluation.



Senior Science Advisor to the Office of Clinical Pharmacology

Division of Clinical Pharmacology-3

US Food and Drug Administration.

Dr. Bashaw received his BS in Pharmacy and Doctor of Pharmacy from the University of Kentucky in 1986.  Upon completion of a residency at the National Institutes of Health-Clinical Center, Dr. Bashaw accepted a commission in the United States Public Health Service as a reviewer in the then Division of Biopharmaceutics.  In his 32 yrs at the FDA he has been a primary reviewer, team leader, deputy division director and division director across a number of therapeutic areas including, but not limited to neuropharmacology, surgical drugs, anti-inflammatory, over-the-counter, and pulmonary drugs in addition to his current responsibilities.

He was appointed the Director of the Division of Clinical Pharmacology-3 (DCP-3) in March 2006.  As the Director of DCP-3, Dr. Bashaw oversaw the work of 26 PhDs. and PharmDs supporting the review of drugs in the reproductive-urologic, gastrointestinal and dermatologic areas.  He held that position until Dec 2017 when he retired from the US Public Health Service with 30yrs of service.  While a Commissioned Officer at the FDA, Dr. Bashaw received over 30 awards for performance and/or scientific merit, including the Public Health Service Meritorious Service Medal which was given for scientific excellence.  This is the second highest award a PHS Officer can receive.

In May 2018 Dr. Bashaw returned to the FDA as the Senior Science Advisor to the Office of Clinical Pharmacology.  In this position he primarily over sees the activities related to the assessment of dermal absorption with regards to antiseptics and sunscreens, in addition he is the Office representative on a number of cross Office working groups including nanotechnology and orphan diseases.  He is a highly regarded and internationally recognized expert in these areas and has published widely and has represented the FDA internationally as an invited speaker.


Dr. Sejeong Yi

Presentation Title

In Vitro Skin Permeation Test (IVPT) Coupled with Maximal Use Trial (MUsT) to Assess Dermal Absorption of Topical OTC Products


Any unwanted systemic exposure to topical products potentially have safety concerns. To address dermal absorption of active ingredients, the FDA has required maximal use trials (MUsT) as a part of safety evaluation for some topical OTC products such as sunscreens and topical antiseptics that are chronically used. As there are potential formulation effects on dermal absorption of an active ingredient, the in vitro skin permeation test (IVPT) should be used to inform formulation selection for a MUsT program and to address formulation effects of OTC products on dermal absorption. However, many in vitro skin permeation studies have produced results with high variability and low reproducibility. In order for the IVPT to be used for the OTC regulatory purpose, the IVPT needs to be adequately validated considering some important elements of the IVPT.



Dr. Sojeong Yi is a clinical pharmacology reviewer responsible for OTC topical antiseptics and sunscreens as well as gastroenterology drug products in the Office of Clinical Pharmacology, FDA. Since she joined FDA in 2016, she has actively been involving in publishing proposed rules and final rules of topical antiseptic monographs and providing regulatory and scientific guidance on MUsT programs of OTC topical antiseptics. Prior to joining FDA, she worked as a research fellow in Clinical Pharmacology Unit of Seoul National University Hospital. She earned a PhD and MS degree in Clinical Pharmacology in Seoul National University and B.S. degree in Pharmacy in Ewha Women’s University in South Korea.


Dr. Audra Stinchcomb

Presentation Title: Environmental Harmonization in Multi-Application Sunscreen Use: In Vitro Permeation Testing to Healthy Volunteers


Exposure to heat has resulted in increased oxybenzone flux and cumulative skin permeation from some sunscreen products tested in vitro. Based on these results, we designed healthy human volunteer studies in order to evaluate the rate and extent of oxybenzone absorption in vivo with 8 h of heat application, as compared to baseline skin temperature conditions. The human pharmacokinetic studies were done using a streamlined mini-maximal usage trial (MUsT) design, a miniMUsT.  We hypothesize that with frequent sunscreen reapplication and high summer temperatures and humidities, adults and children may be unintentionally exposed to higher concentrations of systemic oxybenzone (and other UV filters).   The miniMUsT design allows marketed products and novel sunscreen formulations to be compared in a crossover fashion, prior to implementation of the required MUsT design.  Our goal is to establish an in vitro/in vivo correlation for oxybenzone absorption. Optimized in vitro studies may help to decrease the number of clinical trials required for UV filter product testing.


Dr. Stinchcomb is Professor of Pharmaceutical Sciences, School of Pharmacy, University of Maryland, Baltimore.  She is also currently the Chief Scientific Officer and Co-Founder of F6 Pharma Inc., a palliative care product company.  She received her Bachelor’s in Pharmacy from the University of Colorado, and a PhD in Pharmaceutics from the University of Michigan.  She completed a postdoctoral fellowship at UCSF.  She was a Professor at the University of Kentucky from 2001-11, and joined the faculty at UMB in November 2011.  She is a Fellow of the American Association of Pharmaceutical Scientists.  Dr. Stinchcomb’s research interests span across many disciplines, including pharmaceutics, drug delivery, medicinal chemistry, neuroscience, dermatology, bioengineering, regulatory science, and translational research models.

Dr. Mike Caswell

Title: Old and New Methodologies for SPF testing and Data Validity of Each


Three older SPF test methodologies, Food & Drug Administration Final Monograph, Australia/New Zealand, and COLIPA International, have coalesced into two methodologies, Food & Drug Administration Final Rule and ISO 24444.  Data will be presented that indicates that the three older methods gave essentially identical SPF values.  Additional data will be presented indicating that the two newer methods also give essentially identical SPF values.  Using the additional data, interlaboratory variation will be explored.  Lastly, reading and understanding data validity of an SPF test will be reviewed.


Dr. Mike Caswell earned his Ph.D. in biochemistry at the University of North Carolina – Chapel Hill and studied physical organic chemistry at Yale University.  After beginning his industrial career at Unilever, he conducted research at Schering-Plough, Body Drench, C.B. Fleet, and three start-up drug companies.  Dr. Mike is a Certified Clinical Research Coordinator and a Certified Clinical Research Associate by the Association of Clinical Research Professionals.  Currently he is a Principal Investigator at Consumer Product Testing Company, Inc., where he manages the clinical operations.


Dr. Alexandra Kowcz

Presentation Title:

Current Status of the FDA Final Sunscreen Monograph and Status of the Industry in Response


Alexandra Kowcz is the Chief Scientist for the Personal Care Products Council. Most recently, she served as Vice President of US Research & Development at Beiersdorf, Inc. (manufacturer of Nivea, Eucerin and Aquaphor consumer brands).  Her various responsibilities include the management of US product development, medical and scientific affairs, clinical testing, product safety testing, analytical testing, microbiology, regulatory, claims substantiation, chemical processing and new technology research.

She has held a number of R&D positions of increasing responsibility at Procter & Gamble, Bristol Myers International, Richardson-Vicks, Clairol, Inc., Centerchem, Rhone-Poulenc Rorer and Bristol-Myers. Additionally, she is the author and co-author of numerous patents, publications, chapters, and scientific poster presentations. Alexandra has presented at many national and international meetings on technical subjects dealing with formulation chemistry, skin research, competitive intelligence, technological innovation, claims development and chemical processing.

She holds degrees in Biology and Chemistry from Fairfield University and completed her graduate studies at the University of Connecticut. She is an active member of the SCC (Society of Cosmetic Chemists) and the AAD (American Academy of Dermatology).


Mr. Gabriel Berkland

Presentation Title

An analysis of the impact the FDA final monograph may have on the sunscreen industry.



The FDA’s much-anticipated final monograph stands to shake up the $2.1B sun care industry in the United States. An estimated 93% of active ingredients in sunscreens currently used in the USA are at risk of being banned due to health concerns. How would a full or partial ban of organic ingredients impact the suppliers, firms, and consumers in the sun care industry? What do consumers ultimately care about when making a sunscreen purchase, and how would the FDA’s decision impact their purchasing decisions? How can suppliers, firms, and consumers be prepared for upcoming changes?


Gabriel works in marketing for EMD Performance Materials, focusing on cosmetics applications. His varied background includes studies in management science (B.S.), accounting, and business (MBA). He started his career in B2C sales, and now is in a business reliant on B2B sales. This holistic perspective allows Gabriel to analyze the sunscreen industry from multiple viewpoints.


Ms.Trina Espinoza

Presentation Title:

How Do Blogs/Vlogs Play A Role in Beauty and what can the industry learn about consumer perception of sunscreen products?


 People are looking to the internet for answers regarding beauty and personal care products.  Social media enables one to speak directly to the consumer in a unique way that is informal and establishes a personal connection.  Consumers have questions on a variety of subjects and consumer products.  In my experience roughly half of these questions are related to sun care.  A scientific paper is published, and the press may write an article with a brief attention-getting headline.  The headline may be sensationalized or oversimplified to attract the attention of readers.  It is not uncommon for readers to read the headline without reading the article, or to misinterpret the information contained in the article.  In this way, inaccurate information spreads to the general population.  This presentation will address such concerns and give examples of common misconceptions consumers have regarding the safety and use of sunscreen products. 


Trina Espinoza is a science communicator and the founder of the cosmetic science channel, Ms. Beautyphile. She has spent the last four years sharing the underlying science behind beauty products through a network of social media platforms (FB, YT, Instagram, Twitter: @msbeautyphile). She was featured in Mashable as “6 YouTube channels making learning about science fun”, has been nominated for a regional Emmy, and has made guest appearances on American Chemical Society’s Reactions series. She is currently a Science Advisor to the National Hispanic Heritage Foundation, live streams for In-Cosmetics global, and writes about science for the Seeker digital media network.


Dr. Sam Raney

Presentation Title: A Generic Perspective on the Us of In Vitro Assessment Methods


Dr. Sam Raney is a thought leader in topical and transdermal drug products, with over 25 years of experience producing numerous research manuscripts, review articles, book chapters and patents in pharmaceutical product development. Dr. Raney has been a researcher and adjunct professor within academia, a principal or sub investigator on over 400 pharmaceutical product studies, has held senior management roles in industry, serves as an expert panel member in the U.S. Pharmacopeia., and is the Lead for Topical and Transdermal Drug Products in the FDA Office of Generic Drugs. Dr. Raney holds a Bachelors in Molecular Biophysics & Biochemistry from Yale University, and a Ph.D. in Biochemistry & Molecular Biology from the University of British Columbia in Canada.



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