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Rachel V Thomas

US FDA Approves First New Sunscreen Ingredient Since the 1990s

For the first time in 20 years, the US Food and Drug Administration (FDA) has added bemotrizinol to the list of permitted sunscreen active ingredients.

Bemotrizinol is the first new active ingredient added to the over-the-counter (OTC) sunscreen monograph since the late 1990s and has been used for years in Europe and Asia.

“As promised in the Trump Administration’s MAHA Strategy Report, HHS is advancing innovation by bringing a new sunscreen ingredient to the US market for the first time in 20 years,” said HHS Secretary Robert F. Kennedy Jr.

“Bemotrizinol has been used safely in Europe for decades, and FDA’s action will increase competition and consumer confidence in sunscreen products.”

On December 11, 2025, the FDA proposed allowing the use of bemotrizinol in sunscreens. The agency finalized the action within seven months of issuing the proposed order.

Bemotrizinol is known to provide stable, long-lasting protection against both types of ultraviolet (UV) rays that can damage the skin. According to the FDA, it is also gentle enough to be used safely by young children.

Also read: <a href="https://www.healthandme.com/health-news/x-men-star-tyler-mane-reveals-super-rare-male-breast-cancer-diagnosis-article-154555991" data-type="tilCustomLink">X-Men Star Tyler Mane Reveals ‘Super-Rare’ Male Breast Cancer Diagnosis</a>

Bemotrizinol, also known as BEMT, is a chemical sunscreen filter that absorbs both UVB and UVA rays. The sun emits ultraviolet radiation, which sunscreen products are designed to block.

UVA and UVB rays affect the skin differently. UVA rays are primarily associated with tanning and skin ageing, while UVB rays are more closely linked to sunburn. UVB rays can also be partially blocked by barriers such as windows and clouds.

According to the University of Texas MD Anderson Cancer Center, about 95 per cent of the UV radiation reaching the Earth's surface is UVA, while UVB accounts for the remaining 5 per cent.

Sunscreens protect the skin either by creating a physical barrier using mineral ingredients or by using chemical filters that absorb UV radiation before it reaches the skin. Bemotrizinol belongs to the latter category. 

The addition of BEMT is being welcomed by many experts because options that are both highly effective and considered safe remain limited in the US sunscreen market, according to an annual report by the Environmental Working Group (EWG), a nonprofit health and environmental advocacy organization.

<h2>Why Is Bemotrizinol Considered Beneficial?</h2>

Read More: <a href="https://www.healthandme.com/health-wellness/confused-by-your-cholesterol-report-heres-what-ldl-and-apob-really-mean-article-154530945" data-type="tilCustomLink">Confused By Your Cholesterol Report? Here's What LDL And ApoB Really Mean</a>

Bemotrizinol offers several characteristics that make it an effective sunscreen ingredient. It provides broad-spectrum protection against both UVA and UVB radiation and can achieve higher SPF protection at lower concentrations than some other commonly used sunscreen chemicals, according to Certified Laboratories and the FDA.

The ingredient is also photostable, meaning it breaks down more slowly when exposed to sunlight, helping maintain protection for longer periods. Because it is oil-soluble, it can be easily incorporated into creams and lotions.

In addition, bemotrizinol is minimally absorbed through the skin and rarely causes irritation, which is one reason the FDA considers it safe for use in children as young as six months old.

Meanwhile, DSM Nutritional Products, a manufacturer submitted an OTC monograph order request seeking to add bemotrizinol, marketed as Parsol Shield, at concentrations of up to 6 per cent as a new active ingredient in the OTC sunscreen monograph.

“The FDA reviewed the request and proposed to amend the OTC monograph to add bemotrizinol as a sunscreen active ingredient,” the agency said in its announcement.

In December 2025, DSM had announced that, once approved, Parsol Shield would be available for use in sunscreen products in accordance with the monograph requirements.

According to the FDA, OTC monograph drugs such as sunscreens can enter the market without an approved drug application if they meet specific requirements, including permitted active ingredients, uses and dosage limits established under the monograph.

The FDA can modify an OTC monograph through an administrative order, and manufacturers can initiate the process by submitting an OTC monograph order request.

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For the first time in 20 years, the US Food and Drug Administration (FDA) has added bemotrizinol to the list of permitted sunscreen active ingredients.Bemotrizinol is the first new active ingredient added to the over-the-counter (OTC) sunscreen monograph since the late 1990s and has been used for years in Europe and Asia.“As promised in the Trump Administration’s MAHA Strategy Report, HHS is advancing innovation by bringing a new sunscreen ingredient to the US market for the first time in 20 years,” said HHS Secretary Robert F. Kennedy Jr.“Bemotrizinol has been used safely in Europe for decades, and FDA’s action will increase competition and consumer confidence in sunscreen products.”On December 11, 2025, the FDA proposed allowing the use of bemotrizinol in sunscreens. The agency finalized the action within seven months of issuing the proposed order.Bemotrizinol is known to provide stable, long-lasting protection against both types of ultraviolet (UV) rays that can damage the skin. According to the FDA, it is also gentle enough to be used safely by young children.What Is Bemotrizinol?Also read: X-Men Star Tyler Mane Reveals ‘Super-Rare’ Male Breast Cancer DiagnosisBemotrizinol, also known as BEMT, is a chemical sunscreen filter that absorbs both UVB and UVA rays. The sun emits ultraviolet radiation, which sunscreen products are designed to block. UVA and UVB rays affect the skin differently. UVA rays are primarily associated with tanning and skin ageing, while UVB rays are more closely linked to sunburn. UVB rays can also be partially blocked by barriers such as windows and clouds.According to the University of Texas MD Anderson Cancer Center, about 95 per cent of the UV radiation reaching the Earth's surface is UVA, while UVB accounts for the remaining 5 per cent.Sunscreens protect the skin either by creating a physical barrier using mineral ingredients or by using chemical filters that absorb UV radiation before it reaches the skin. Bemotrizinol belongs to the latter category. The addition of BEMT is being welcomed by many experts because options that are both highly effective and considered safe remain limited in the US sunscreen market, according to an annual report by the Environmental Working Group (EWG), a nonprofit health and environmental advocacy organization.Why Is Bemotrizinol Considered Beneficial?Read More: Confused By Your Cholesterol Report? Here's What LDL And ApoB Really MeanBemotrizinol offers several characteristics that make it an effective sunscreen ingredient. It provides broad-spectrum protection against both UVA and UVB radiation and can achieve higher SPF protection at lower concentrations than some other commonly used sunscreen chemicals, according to Certified Laboratories and the FDA.The ingredient is also photostable, meaning it breaks down more slowly when exposed to sunlight, helping maintain protection for longer periods. Because it is oil-soluble, it can be easily incorporated into creams and lotions.In addition, bemotrizinol is minimally absorbed through the skin and rarely causes irritation, which is one reason the FDA considers it safe for use in children as young as six months old.Bemotrizinol Added to OTC Meanwhile, DSM Nutritional Products, a manufacturer submitted an OTC monograph order request seeking to add bemotrizinol, marketed as Parsol Shield, at concentrations of up to 6 per cent as a new active ingredient in the OTC sunscreen monograph.“The FDA reviewed the request and proposed to amend the OTC monograph to add bemotrizinol as a sunscreen active ingredient,” the agency said in its announcement.In December 2025, DSM had announced that, once approved, Parsol Shield would be available for use in sunscreen products in accordance with the monograph requirements.According to the FDA, OTC monograph drugs such as sunscreens can enter the market without an approved drug application if they meet specific requirements, including permitted active ingredients, uses and dosage limits established under the monograph.The FDA can modify an OTC monograph through an administrative order, and manufacturers can initiate the process by submitting an OTC monograph order request.

us fda approves first new sunscreen ingredient since the 1990s

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