FDA approves first new sunscreen ingredient in over 25 years
The U.S. FDA has approved bemotrizinol (BEMT), the first new sunscreen active ingredient since 1999. BEMT, used in Europe and Asia for over 20 years, provides broad-spectrum UVA/UVB protection with low skin absorption. The approval follows years of regulatory delays due to the FDA’s classification of sunscreen as a drug. Products may take over a year to reach consumers. The move addresses criticism that U.S. sunscreens lag behind international standards and is seen as a significant public health step.
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FDA Approves Bemotrizinol, First New Sunscreen Ingredient in Over 20 Years
The US Food and Drug Administration has approved bemotrizinol (BEMT) for use in sunscreens, marking the first new sunscreen chemical approved in over two decades. BEMT, already used in European and Asian sunscreens for decades, offers broad-spectrum protection against both UVA and UVB rays without leaving white streaks typical of mineral sunscreens. It is more stable in sunlight and has low absorption into the body, addressing concerns about chemical sunscreen safety. The approval followed a streamlined process authorized by Congress in 2020, bypassing the FDA's previously bureaucratic system. Consumer advocacy groups noted that American sunscreens have historically provided far less UVA protection than labeled, and this approval is expected to improve consumer protection. The article also notes a growing anti-sunscreen movement amid distrust of medical establishments and desire for natural alternatives.
TheWeek feedFDA Approves First New Sunscreen Ingredient in Over Two Decades
The U.S. Food and Drug Administration has approved bemotrizinol (BEMT) for use in sunscreens, marking the first new sunscreen active ingredient approved in over 20 years. BEMT, already used in European and Asian sunscreens for decades, offers broad-spectrum protection against both UVA and UVB rays without leaving white streaks common with mineral sunscreens. The ingredient is more stable than existing options, does not break down in sunlight, and has low absorption into the body, addressing safety concerns raised in 2019 about chemical sunscreen ingredients. The approval came through a streamlined process authorized by Congress in 2020 as part of the Make America Healthy Again agenda. Consumer advocates note that many U.S. sunscreens have provided significantly lower UVA protection than labeled SPF values suggest, making this approval a significant step for public health.
TheWeek feedFDA Approves First New Sunscreen Ingredient in Over Two Decades
The U.S. Food and Drug Administration has approved bemotrizinol (BEMT) for use in sunscreens, marking the first new sunscreen active ingredient approved in over 20 years. BEMT, already used in European and Asian sunscreens for decades, offers broad-spectrum protection against both UVA and UVB rays without leaving white streaks or a greasy feel. The ingredient is considered safe for adults and children aged six months and older, with low skin absorption and high stability in sunlight. The approval follows a streamlined process authorized by Congress in 2020, bypassing previous bureaucratic delays. The move addresses long-standing concerns that U.S. sunscreens provided inadequate UVA protection despite high SPF labels. The article also notes a growing anti-sunscreen movement fueled by distrust of medical establishments and concerns over chemical absorption, though BEMT's low absorption profile may mitigate some of those worries.
TheWeek feedFDA Approves First New Sunscreen Ingredient in Over 25 Years
The U.S. Food and Drug Administration (FDA) has approved bemotrizinol (BEMT) as a new active sunscreen ingredient, the first such approval since 1999. BEMT, which provides broad-spectrum UVA and UVB protection with low skin absorption, has been used in the European Union since 2000 and is approved in Australia, Canada, and several Asian countries. The approval follows years of regulatory delays, as the U.S. classifies sunscreen ingredients as over-the-counter drugs, unlike the EU's cosmetic classification. Congress passed the Sunscreen Innovation Act in 2014 and included provisions in the 2020 CARES Act to expedite approvals, but BEMT is the first ingredient approved under the new process. The article notes bipartisan support for reform, including from Rep. Alexandria Ocasio-Cortez and Sen. Mike Lee, and discusses ongoing efforts to allow non-animal testing. While emphasizing the importance of safety testing, the piece argues for alternative approval pathways, such as international drug reciprocity.
Reason.comFDA Approves First New Sunscreen Ingredient in Over 25 Years
The U.S. Food and Drug Administration (FDA) has approved bemotrizinol (BEMT), a new sunscreen active ingredient, for use in sunscreens by adults and children aged six months and older. This marks the first addition to the FDA's permitted sunscreen ingredient list since 1999. BEMT, which provides broad-spectrum protection against UVA and UVB rays with low skin absorption, has been used in the European Union since 2000 and is approved in Australia, Canada, and several Asian countries. The approval follows years of regulatory delays attributed to the FDA's classification of sunscreen ingredients as over-the-counter drugs, unlike the EU's cosmetic classification. Congressional efforts, including the 2014 Sunscreen Innovation Act and a 2020 CARES Act provision, sought to expedite the process. The ingredient will be sold exclusively by DSM under the name Parsol Shield starting August 9, 2026, with other manufacturers allowed after 18 months. The article notes bipartisan support for regulatory reform, including from Rep. Alexandria Ocasio-Cortez and Sen. Mike Lee, and discusses ongoing safety considerations based on a 2020 FDA study on skin absorption.
Reason.comFDA Approves First New Sunscreen Ingredient in Over 25 Years
The U.S. Food and Drug Administration (FDA) has approved bemotrizinol (BEMT), a new sunscreen active ingredient, for use in sunscreens by adults and children aged 6 months and older. This marks the first addition to the FDA's permitted sunscreen ingredient list since 1999. BEMT, which provides broad-spectrum protection against UVA and UVB rays, has been used in the European Union since 2000 and is approved in Australia, Canada, and several Asian countries. The approval follows years of regulatory delays, which critics attribute to the FDA's classification of sunscreen ingredients as over-the-counter drugs rather than cosmetics, as in the EU. Congress passed the Sunscreen Innovation Act in 2014 and included provisions in the 2020 CARES Act to expedite approvals, but BEMT is the first ingredient approved under the new process. The article notes bipartisan support for further regulatory reform, including from Rep. Alexandria Ocasio-Cortez and Sen. Mike Lee, and highlights ongoing safety concerns about sunscreen absorption into the bloodstream.
Reason.comFDA approves first new sunscreen ingredient in decades, catching US up to European and Asian formulas
The US Food and Drug Administration (FDA) has approved bemotrizinol (BEMT), a chemical UV filter used in European and Asian sunscreens for over 20 years. This is the first new sunscreen ingredient approved in the US since 1999. BEMT absorbs both UVA and UVB rays and is more stable than existing US filters. The approval addresses long-standing criticism that US sunscreens lag behind international counterparts due to the FDA's classification of sunscreen as a non-prescription drug, which requires lengthy regulatory approval. US sunscreens have relied on avobenzone for UVA protection, which dermatologists describe as unstable. The new ingredient is expected to improve both protection and cosmetic feel, though consumers may wait over a year for products containing it to reach the market.
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