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Section: Regulations

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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.

Eighteen studies identified complications such as rash, irritation, immune system disorders, stratum corneum DNA damage and hormonal disruption.

Literature Review Connects Sunscreen Absorption with Potential Adverse Effects

A literature review published in Dermatology Research suggests the potential adverse effects, i.e., irritation, rashes, hormone disruption, etc., of sunscreen ingredients absorbed into human skin and present in human plasma and urine.

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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...

Industry Debate: US FDA vs. Sunscreens

During last month’s NYSCC Suppliers' Day, several attendees expressed frustration regarding the delay of the US Food and Drug Administration’s Final Sunscreen Monograph. Cosmetics & Toiletries asked its LinkedIn members to comment. Here’s what the market had to say.

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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[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.

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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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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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Why the FDA's 'Sunscreens in the Bloodstream' Study is Flawed

A recent study published in the Journal of the American Medical Association tested the potential systemic absorption of certain sunscreens. Results identified their presence in subjects' bloodstreams; however, as industry expert David Steinberg explains, the study is misleading and fails to consider crucial variables.

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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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