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Section: Regulations > SPF/Sun

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.

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 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.

Sunscreen Regulations: Why 'Final' is Not the Right Word

Over the past 25 years, no category of “cosmetics” has seen change like sunscreens. This discussion reviews how current regulations have come to be, and looks to where they are headed.

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.

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.

PASS Responds to CDC Public Comments Request on Skin Cancer Prevention

In its comments, PASS requests the CDC to "urge the FDA to clear the 10-year backlog in new sunscreen applications and create a predictable, transparent and timely review process for pre-market approval of new sunscreen ingredients."

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.

Harmonizing Cosmetics Standards: ISO

The importance of harmonization continues to grow. Past and present standard-setting work by ISO, such as in microbiology and sun protection, is laying the foundation for future bridges across regulatory gaps.

PCPC Responds to CDC's Request for Skin Cancer Comments

The Personal Care Products Council's (PCPC) Farah Ahmed submitted comments to the Centers for Disease Control and Prevention (CDC) in response to the CDC’s request for information about reducing exposure to UV radiation in order to reduce skin cancer rates.

PASS Responds to CDC Public Comments Request on Skin Cancer Prevention

In its comments, PASS requests the CDC to "urge the FDA to clear the 10-year backlog in new sunscreen applications and create a predictable, transparent and timely review process for pre-market approval of new sunscreen ingredients."

Regulatory Review—Titanium Dioxide

This column will discuss titanium dioxide (TiO2). TiO2 is the most frequently used ingredient in cosmetics after water (aqua), fragrance (parfum), methylparaben, propylparaben, glycerin and propylene glycol, according to the U.S. Food and Drug Administration’s (FDA) Voluntary Cosmetic Registration Program.

Coalition Established to Improve Regulatory Pathway for US Sun Care

The Public Access to Sunscreens Coalition launches with the mission to work collaboratively with the FDA and other entities to facilitate availability of improved UV ingredients; sun care products in the U.S. market.

Science Exposed—What Should the Minimum Recommended SPF Be to Avoid Sunburn?

“Science Exposed” is a new column aimed at digging into industry controversies to strip them down to the scientific facts. Here, sun protection expert Brian Diffey, PhD DSc, critiques the current SPF test method.

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.

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 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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