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 Drafts Guidance On Safety-Data Musts For GRASE Sunscreen Actives

This article was originally published in The Rose Sheet

Executive Summary

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drug products, and nonclinical testing should focus on potential long-term adverse effects, according to newly released draft guidance required from the agency under the Sunscreen Innovation Act.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.

You may also be interested in...

FDA Wiping Market Of Verboten Sunscreen Formats Following 2016 Warnings

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.

Manufacturers Argue FDA Sunscreen Reviews Keep Outside Science In Shadow

FDA officials and the Public Access to Sunscreen Coalition will meet Nov. 1 in effort to find common ground between FDA and outside scientists on standards for testing requirements of new sunscreens under one of four draft guidances the agency is scheduled to finalize by the end of the year.

PCPC Continues Efforts To Set Record Straight On Sunscreens

Recent “alarmist reports” and studies regarding the state of the US sunscreen market and the merits of UV-protective products available to consumers are sending a potentially confusing message, which could discourage sunscreen use at a time of epidemic skin-cancer rates, the Personal Care Products Council suggests. The group hosted a webinar July 11 to clarify sunscreen regulations and promote daily use.

Related Content




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