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Section: Regulations > SPF/Sun

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FDA Moves to Improve Quality, Safety and Efficacy of Sunscreens

The U.S. Food and Drug Administration announced recent activities that are part of its ongoing implementation of new authorities for certain over-the-counter drugs including sunscreens.

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Key West Joins Hawaii in the Ban of Octinoxate and Oxybenzone

The Florida Keys will no longer allow the use of sunscreens containing oxybenzone and octinoxate. Does this mean California is next?

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[podcast] Consequences of Hawaii's Sunscreen Ban

In this podcast, renowned cosmetic regulatory expert David Steinberg walks us through Hawaii's recent sunscreen law, the "junk science" backing it (as he refers to it) and its broader implications.

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DSM Seeks FDA Sunscreen Monograph Approval of Bemotrizinol

DSM believes it is important for consumers in the USA to benefit from the efficacy and aesthetics that modern filters such as BEMT can provide. As such, the company is pushing for Monograph status.

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PCPC Sounds Off on US FDA's Sunscreen Proposals

Industry organizations worry that consumers may be deterred from using sunscreens—causing unintended negative health effects—due to the U.S. Food and Drug Administration's recent sunscreen proposals.

The study authors argue that the materials are potential carcinogens and could behave as estrogen disruptors.

UPDATE: Report Targets Benzophenone and Octocrylene in Sunscreens

The research mentioned in the Bloomberg report has since elicited a detailed rebuttal from an author at the University Hospital of Zurich.

BASF Micronized UV Filter Added to Annex VI of EU Cosmetics Regulation

BASF's Tinosorb A2B (INCI: Tris-biphenyl Triazine) has been added to Annex VI (the positive list) of the EU Cosmetics Regulation (EC) No. 1223/2009.

'[Sunscreen] developers will be able to innovate more efficiently while maintaining high standards of quality and safety for consumers.'

[update] How ISO's Endorsement of Two Test Methods Will Enlighten Sunscreen Development

After 10 years, sunscreen developers are nearing the finish line for more ethical, cost efficient, reliable and faster testing thanks to ISO's endorsement of two standards. The final vote was in September 2024. Here, two experts explain what this means.

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Sunscreen Data Requests, Misperceptions and the Public Health Crisis

"The FDA is not saying 40% of sunscreens (or whatever) do not meet its rules for safety and effectiveness—not to the extent the EWG is suggesting." But the FDA also is muddying the waters, according to PASS Coalition adviser Michael Werner.

Sunscreen Innovation Act Passes House and Moves to President

New U.S. sunscreen actives are potentially within reach, as the The Sunscreen Innovation Act (S. 2141) by passed the U.S. House of Representatives and will be sent to President Barack Obama for his signature and enactment into law.

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FDA's Sunscreen Guidance Focuses on Safety and Effectiveness Data

The guidance also sheds light on the FDA’s requests for safety and effectiveness data on eight active sunscreen ingredients that are already under evaluation, including the data on human absorption.

Sunscreen Innovation Act Passes House and Moves to Senate

New sunscreen actives may finally be on their way in the United States, as the Sunscreen Innovation Act (H.R.4250) passed the House of Representatives on July 28, 2014. The bill now goes to the Senate with the cosmetics industry eager to have it pushed through.

P. oceana seagrass is endemic to the international coasts of the Mediterranean in tourism hotspots exposed to sunscreens.

Seagrass Rhizomes Accumulate UV Filters and Parabens, Study Finds

A recent study published in Marine Pollution Bulletin found that rhizomes of the seagrass Posidonia oceana off the international coasts of the Mediterranean have accumulated UV filters and the preservative methylparaben.

Initially designated as drugs in the U.S., sunscreens have been stifled under regulations and bureaucracy. This article reviews how it came to this, where current regulations stand and proposes a few “pipe dream” solutions.

Sunscreens and Pipe Dreams for their Regulation in the US

Initially designated as drugs in the U.S., sunscreens have been stifled under regulations and bureaucracy. This article reviews how it came to this, where current regulations stand and proposes a few “pipe dream” solutions.

PASS Coalition Supports Move to Speed Approval of New UV Filters, Looks to Canada

In March 2014, the PASS Coalition published its support of a proposed Act to potentially speed the FDA's approval of new UV filters. In a related blog post, PASS followers congratulated those involved, and urged Canadian regulators to do the same.

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Could the US Virgin Islands Be Next to Ban Octinoxate and Oxybenzone?

A bill banning the sale, importation and distribution of certain sunscreen ingredients in personal care is making its way through the U.S. Virgin Islands' legislature.

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[podcast] Sunscreen Innovation Act Update: MUsT Test and Penetration Potential

"What’s changed with respect to sunscreen evaluation is ... the test model they are using now is designed for drugs ...and has never been applied previously for the sunscreens," Epstein reports.

New U.S. UV Filters and the Cosmetic Outlook in Canada for Sunscreens

Skin cancer is the most common cancer today, but only recently has industry pressure and political leadership compelled changes in the North American regulatory paradigm of sunscreen products. The passage of the Sunscreen Innovation Act in the United States and the suggestion to regulate sunscreens as cosmetics in Canada would give regulators the tools to reboot a stalled approval system.

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