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Section: Regulations > SPF/Sun

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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.

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.

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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...

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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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[podcast] Why the FDA Disallows Europe’s Sunscreens

Between limited UV filter options and bans on organic sunscreens, the U.S. sunscreen market is wrought with strife. So why not just add Europe's UV filters to expand the U.S. portfolio? As David Steinberg explains in this podcast, it's not that easy. Listen now.

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.

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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.

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Croda Backs Proposed Updates to FDA Sunscreen Regulations

The proposed update would reclassify TiO2 (titanium dioxide) and ZnO (zinc oxide) as GRASE (Generally Recognized as Safe and Effective) category I. Previously, none of the 16 active ingredients currently on the market were considered GRASE.

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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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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.

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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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.

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.

FDA Rule for Broad-spectrum Labeling: Key Substrate Findings

UVA protection is part of the mandatory testing for claiming broad-spectrum sun protection. A worldwide standardization is in development with the ISO TC217, expected for UVA testing 2012. The FDA has issued a final rule following Colipa’s proposed UVA in vitro method. While this rule establishes UVA labeling and testing, inconsistencies remain. This study compares the critical wavelength in roughness and application before and after two levels of UV doses.

FDA Rule for Broad-spectrum Labeling: Key Substrate Findings

UVA protection is part of the mandatory testing for claiming broad-spectrum sun protection. A worldwide standardization is in development with the ISO TC217, expected for UVA testing 2012. The FDA has issued a final rule following Colipa’s proposed UVA in vitro method. While this rule establishes UVA labeling and testing, inconsistencies remain. This study compares the critical wavelength in roughness and application before and after two levels of UV doses.

Lawsuit Filed Against Sunscreen Manufacturers

A consumer lawsuit filed March 30, 2006, accuses sunscreen makers of exposing millions of people to cancer and other dangers.

Changes to US Sunscreen Regulations

The newest regulations and comments on sunscreens from the US Food and Drug Administration (FDA) were officially published in the Federal Register on June 17, 2011, and will go into effect June 17, 2012.

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