HBW Insight 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


FDA Wiping Market Of Verboten Sunscreen Formats Following 2016 Warnings

This article was originally published in The Rose Sheet

Executive Summary

Consumer access to SPF-infused wipes is shrinking following FDA warning letters last year to companies that have since discontinued cited products, which the agency says are unapproved drugs ineligible for OTC sunscreen drug review. It remains to be seen how the maker of KLENSKIN Shower-On sunscreen products will respond, with its entire business model hanging in the balance.

You may also be interested in...

Diamond Wipes’ FDA Headaches Suggest Cosmetic Recall Hangover

Following an FDA warning letter in 2016 for an unapproved sunscreen drug product, Diamond Wipes now must answer agency concerns regarding “poor-quality water” used in its manufacturing operations. Both warnings stemmed from inspections in the wake of a 2014 product recall for mold contamination.

FDA Scorches Sunscreen Wipe Marketers With October Warning Letters

Inspections conducted over the past year may have contributed to a wider FDA crackdown on unapproved sunscreen drug products – specifically those in dosage forms deemed ineligible under OTC drug review for inclusion in the sunscreen monograph – with five marketers targeted so far this month with warning letters.

FDA Drafts Guidance On Safety-Data Musts For GRASE Sunscreen Actives

Time and extent applicants seeking GRASE status for UV filters should provide FDA with the kind of clinical safety data used to support approval of chronic-use cutaneous drug products, and nonclinical testing should focus on potential long-term adverse effects, according to newly released draft guidance required from the agency under the Sunscreen Innovation Act. FDA is particularly interested in receiving comments about final formulation safety testing it anticipates requiring under specified monograph conditions.





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