Follow us twitter facebook
Edition: Global
Click here to subscribe toour free weekly newsletter click here
Industry buzz

FDA delays deadline for new sunscreens labels

The U.S. Food and Drug Administration (FDA) has extended the compliance dates for the Final Rule for Over-the-Counter (OTC) Sunscreen Drug Products [1]. In practice, operators will enjoy a six months delay for relabeling their products.

The extension follows requests from the Personal Care Products Council (PCPC) and the Consumer Healthcare Products Association (CHPA). The two trade associations described the process for testing and relabeling products, and expressed concerns regarding a potential shortage of sunscreens on the market.

Both the dates for large and small volume manufacturers have been extended. The new deadlines are:

  • December 17, 2012 (from original date June 18, 2012) for OTC sunscreen products with annual sales of US$25,000 or more,
  • December 17, 2013 (instead of June 17, 2013) for OTC sunscreen products with annual sales of less than US$25,000

We had concerns about a possible shortage of sunscreens on the market. Thus, in the hopes that FDA would allow for an additional 6 months for implementation, we worked hard to educate the Agency on the operational timeline for bringing the industry into compliance with the final rule,” said Farah Ahmed, Chair of the PCPC’s Sunscreen Task Force.

Full text of the new rule “Labeling and Effectiveness Testing; Sunscreen Drug Products for Over-the- Counter Human Use; Delay of Compliance Dates” (21 CFR Parts 201 and 310) are available on line or may be downloaded here below:



Vincent Gallon


[1] Federal Register of June 17, 2011 (76 FR 35620)

© 2012 - Premium Beauty News -
latest news

A new trade show dedicated to clean beauty in London

Dubbed Clean Beauty in London the new trade show intends to gather experts, scientists, suppliers, brands, influencers and journalists under one roof “to build the future of clean beauty.” Taking place on October 12 & 13, 2020 at The Brewery, located at 52 Chiswell Street at the heart of London, the event aims to encourage (...)

read more
job opportunities
Experts’ views
India emerges as the next beauty giant

Asia Cosme Lab
India emerges as the next beauty giant

Thanks to a growing young population (first youth population in the world) and the emergence of a vast middle class, as well as a higher Internet connection from both urban and rural areas, India is set to emerge as the next beauty giant after China. Asia Cosme Lab took a deep dive in the fascinating Indian market, where both (...)

read more


We use cookies to give you a better browsing experience. By continuing your visit to this site, you accept the use of cookies. Read more and set cookies