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Section: Cosmetic Ingredients > Actives

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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.

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.

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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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[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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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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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.

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.

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.

FDA Issues New Guidances on Nanotechnology

The US Food and Drug Administration has issued two new draft guidances on the use of nanotechnology by the cosmetics and foods industries.

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U.S. FDA Hand Sanitizer Solutions Explained

The U.S. Food and Drug Administration has liberalized the compounding of alcohol-based hand sanitizers such that any registered compounder can create these products as long as they follow the published formulas and guidelines. This article clears up the math on what these guidelines allow.

FDA and SDA Address Triclosan Concern

The FDA updated its Web site on Apr. 8, 2010, with its most recent information on triclosan. According to the FDA, triclosan provides a benefit to a number of personal care products, and it does not have sufficient safety evidence to recommend changing consumer use of products that contain triclosan. However, the FDA also did not have evidence that triclosan provided any additional benefit when added to antibacterial soaps and body washes.

FDA Issues Final Guidance on Nanomaterials

On June 26, 2014, The U.S. Food and Drug Administration (FDA) issued Final Guidance for Industry: Safety of Nanomaterials in Cosmetics, a final guidance document addressing the use of nanotechnology in cosmetics.

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VIDEO: 2 Questions on the FDA's Triclosan Ruling

The FDA's ruling on triclosan raises two questions, which David C. Steinberg describe in this fourth video in our series. However, he concedes that fighting the ruling is like "doubling down on an already-lost bet."

FDA Clears Isoprenylcysteine Analog for Rosacea Treatment

A isoprenylcysteine (IPC) analog manufactured by biopharmaceutical company Signum Dermalogix Inc. (Dermalogix) has been approved by the U.S. Food and Drug Administration (FDA) for the treatment of rosacea.

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Antibacterial Soap? You Can Skip It, Says FDA

The FDA is issuing a final rule under which OTC consumer antiseptic wash products containing the majority of the antibacterial active ingredients—including triclosan and triclocarban—will no longer be able to be marketed.

FDA Releases Draft Guidance Toward Nanotech Regulation

The US Food and Drug Administration (FDA) has released a draft guidance outlining its view on how to identify whether regulated products contain nanomaterials or apply such technologies.

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