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Type: News

Section: Regulations > Regional

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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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FDA Reviews Sunscreen Active

The Food and Drug Administration(FDA) has requested safety and efficacy data for the sunscreen active ingredient diethylhexyl butamido triazone in concentrations...

FDA Responds to EWG Sunscreen List

The FDA responded to EWG's report on sunscreens that claimed the FDA fails to set meaningful sunscreen standards.

FDA Proposes New Sunscreen Rules

FDA Proposes New Sunscreen Rules

The FDA has proposed a new regulation for the formulating, testing and labeling of OTC sunscreens with ultraviolet UVA and UVB protection.

FDA Releases a Final Sunscreen Rule

After nearly a four-year wait for an action on sunscreens, the US Food and Drug Administration (FDA) has issued a Final Sunscreen Rule, which addresses the testing and labeling of OTC sunscreen products.

US FDA Pushes Sunscreen Reform on Three Fronts

The U.S. Food and Drug Administration has announced three new efforts to advance its framework for sun protection products including Maximal Usage Trials (MUsT)—just ahead of summer vacation and in line with #DontFryDay.

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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.

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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.

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Could the FDA Sunscreen Monograph See a New Addition?

It's been decades since the FDA's OTC Sunscreen Monograph welcomed a new addition; back then, it was avobenzone. Now, another could be joining the ranks.

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FDA Extends Comment Period for Proposed Sunscreen Rule

Extension to run through Dec. 26, 2007; agency seeks to balance industry concerns and the interests of public health to ensure that sunscreen products properly inform consumers of the level of protection.

EWG Sunscreen Ratings Stir Controversy; CTFA Backs FDA

The Environmental Working Group (EWG) has stirred up the sun care industry with its recent survey and ranking of 780+ sunscreens.

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Benzene in Sunscreens Prompts FDA Citizen Petition, PCPC Responds

Benzene has been detected in several brands and batches of sunscreens above the 2 ppm threshold, Valisure LLC reported, though most likely as a contaminant, another source noted. The firm has petitioned the FDA to act; the PCPC is carefully reviewing these findings.

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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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PCPC, CHPA Respond to FDA’s Latest Findings on Sunscreen Absorption

In response to part two of the FDA’s sunscreen ingredient maximal usage trial, published in January 2020 in JAMA, the (PCPC) and (CHPA) released a statement reassuring consumers of product safety.

Sunscreen Innovation Act Introduced into Congress to Amend FDA's TEA Program

On Mar. 13, 2014, U.S. Senator Jack Reed (D-RI) and U.S. Congressman Ed Whitfield (R-KY) introduced the bipartisan, bicameral Sunscreen Innovation Act (S. 2141 and H.R. 4250, respectively), which has been supported by the Public Access to SunScreen (PASS) Coalition.

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FDA Pushes Higher Limits, New Labeling and More Data for Sunscreens

Broad spectrum sunscreens are critical for preventing skin cancer and UV damage, yet many of their essential requirements have not been updated in years. This was the driver for new sunscreen regulatory rules proposed by the FDA.

FDA Publishes Opinion on Two Sunscreen TEAs and Is Urged for More Action by PASS

The end of February was busy for the U.S. Food and Drug Administration (FDA), which published two letters on the Time and Extent Applications (TEAs) for diethylhexyl butamido triazone (Uvasorb HEB) and amiloxate (Neo Heliopan E 1000), finding insufficient scientific evidence to claim either as generally recognized as safe and effective (GRASE) and denying their addition to the OTC Sunscreen Monograph.

Sunscreen Innovation Act Passes: What Does it Mean?

The Public Access to SunScreens (PASS) Coalition applauded the U.S. Senate's passage of the Sunscreen Innovation Act (S. 2141). While the Act aims to streamline the approval process for new sunscreen actives, will it? Industry expert David Steinberg gives his take.

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