Is the new U.S. regulation an open door or obstacle for K-sunscreens?

A longstanding frustration for K-beauty consumers in the United States has been U.S. Food and Drug Administration (FDA) restrictions on certain ultraviolet (UV) filters, which have forced Korean sun care brands to sell U.S.-specific formulations with different ingredients than those in Korea.

But the agency’s recent regulatory shift could alter the landscape for Korean cosmetics firms and distributors such as Olive Young.

On Sunday, bemotrizinol, a UV filter used by Korean and European sunscreen makers for more than two decades, became the first new active ingredient added to the FDA’s dedicated manual since the late 1990s.

Factories south of Seoul have been preparing for this change long before the FDA issued a final administrative order in June. Cosmax, one of Korea’s two largest cosmetics manufacturers, began designing U.S.-compliant formulas with bemotrizinol late last year, and its rival Kolmar Korea said that roughly 80 percent of all sunscreen-related inquiries since the FDA’s announcement have concerned the single ingredient.

So when can Americans actually buy a Korean-made sunscreen with bemotrizinol? The answer encompasses an 18-month exclusivity clause that turns out to be hazier than it first looks, a list of unapproved companion ingredients and a regulatory system that treats sunscreen as a drug.

What changed on Aug. 9?

The FDA issued a final administrative order on June 10 to include bemotrizinol — at concentrations up to 6 percent — in its over-the-counter (OTC) sunscreen monograph, which lists the ingredients that may be sold in the United States without individual product approval. The order took effect on Sunday.

Bemotrizinol is the first new sunscreen active ingredient since the late 1990s and the first ingredient added to any of the FDA’s OTC monographs through a streamlined request procedure created by the Cares Act of 2020, according to Washington-based law firm Venable.

DSM Nutritional Products, a U.S. arm of Swiss-Dutch ingredients group DSM-Firmenich and now the sole holder of the right to market the ingredient in the United States for the next 18 months, filed the request on Sept. 23, 2024. The FDA proposed the order on Dec. 12, 2025, and finalized it about six months later.

Why does one ingredient matter this much?

For U.S. shoppers, the old rules meant that their beloved Korean sunscreen was often not the one they got. Brands shipped U.S. versions — reformulated to adhere to the FDA’s list of approved ingredients — which buyers have long complained feel heavier and leave a white cast that the originals are famous for avoiding.The friction reached retail in late May, when Olive Young opened its first in-person and online stores in the United States, barring American customers' from purchasing items on its Olive Young Global website.

Bemotrizinol is a chemical filter that absorbs both UVA and UVB rays, holds up well in sunlight and barely penetrates the skin, which is why FDA reviewers cleared it for use on children as young as 6 months. Commercially, the ingredient is part of what makes Korean sunscreens feel the way that they do: light, nongreasy and free of the chalky cast that mineral filters leave.

The stakes are not small. Korea exported $7 billion in cosmetics in the first half of the year, according to the Ministry of Food and Drug Safety’s preliminary tally, up 27.3 percent from the same period a year earlier and a record for any first half. According to data from the Korea Customs Service, basic skincare products accounted for 41.7 percent of all exports — of which sun and wrinkle care comprised 25.5 percent — through the first three quarters of 2025.

The United States took $1.45 billion of the total $7 billion, or 20.7 percent — more than any other single market — for a 41.5 percent on-year growth.

So can Korean manufacturers start selling?

In many cases, yes, and sooner than the FDA order suggests, as long as the ingredient comes from DSM.

The molecule was developed in the late 1990s by Ciba Specialty Chemicals, later acquired by BASF, and its patents expired years ago. This means that making bemotrizinol — sold by BASF as Tinosorb S, and DSM as Parsol Shield — is not the problem.

But selling it in the United States is another matter. Or so it seemed. 

Section V of the order states that, for 18 months, solely DSM Nutritional Products or its licensees, assignees and successors in interest are authorized to market drugs incorporating the ingredient.

Ask the company that holds the exclusivity, though, and the lines blur. A representative at DSM’s Korea branch confirmed by phone that manufacturers that purchase Parsol Shield and use it to make sunscreens do not need a separate license from the company to sell those products in the United States.

"dsm-firmenich has granted BASF a sublicense that permits the supply of BEMT [bemotrizinol] during the exclusivity period," said DSM in a email to the Korea JoongAngDaily. "As a result, BASF is authorized to support the U.S. market under the terms of a limited sublicense – not from FDA or only independent exclusivity right."

"Currently, dsm-firmenich and BASF, through its sublicense agreement, are the only authorized sources of BEMT for use in FDA-compliant, monograph-compliant sunscreen products in the U.S."

That matches how Korean manufacturers were moving long before the FDA’s announcement in June.

“The exclusivity means only products using DSM’s bemotrizinol can be distributed,” Cosmax told The Korea JoongAng Daily in a written response. “Since [we have] been sourcing the ingredient from DSM, we do not expect anything to change for us.” The company also said that clients have already asked it to reformulate existing OTC sunscreens with the new ingredient.

A spokesperson at a major Korean cosmetics manufacturer, who agreed to be quoted under the condition of anonymity, said that this mindset is shared across the industry: Formulate with the approved supplier’s ingredient, and the road to the U.S. OTC market is wide open.

Kolmar Korea, in a written response, said that it expects products with the ingredient to arrive in earnest in the second half of 2027, months before DSM’s exclusivity clause is scheduled to lapse.

That leaves the harder question: What about bemotrizinol made by anyone else? BASF sells the same molecule as Tinosorb S, a name familiar to the K-beauty industry.

U.S. law firm analyses published in June drew the fence tighter. Venable wrote that early U.S. products would likely come from DSM or its licensees, that other manufacturers should weigh their licensing options and that broader availability from other makers was a story for 2028.

Spencer Fane, a law firm based in Kansas City, Missouri, similarly described the FDA order as marking marketing exclusivity, or a limit on who may sell. DSM’s account of its own practice, at least for its customers, is more permissive than those analyses implied.

Will it be the same sunscreen sold in Korea?

Not exactly, and not yet.

Korean and European sun care products typically pair bemotrizinol with other modern filters, notably bisoctrizole, marketed as Tinosorb M, and drometrizole trisiloxane. Neither appears on the FDA’s list of permitted ingredients.

In other words, companies cannot simply import sunscreens that they already make for other regions, Carl D’Ruiz, who led the request submission at DSM-Firmenich, told Chemical & Engineering News (C&EN) in June.

What will cross instead are new recipes built only from permitted ingredients.

Cosmax said that it has kept unlisted filters out of its U.S.-bound OTC candidate formulas from the start and has already completed lab-scale stability tests and gathered sun protection factor, or SPF, data.

“Korean sun care products with the same skincare-like feel that first drew customers’ attention can now be supplied to the U.S. market,” said a company spokesperson.

The claim holds for texture more than for chemistry. The exact bottles on Korean shelves, with their unapproved companion filters, still cannot ship.

The manufacturer spokesperson put it plainly: One approved ingredient does not make Korean and U.S. formulas interchangeable, and any company putting bemotrizinol into a U.S.-bound product will likely need to develop it from scratch because the FDA still bars many filters that are common elsewhere.

U.S. fans of Korean sun care products have lived through something similar. Several Korean brands reformulated or pulled their sunscreens from the U.S. market last year rather than keep shipping products the FDA classifies as unapproved drugs.

Who would make the sunscreens, and when?

The manufacturers best positioned are the ones already inside the U.S. drug system, as sunscreen is a drug, not a cosmetic, in the United States — a distinction the FDA itself spells out in the order.

That means production in facilities has to meet current good manufacturing practice standards for drugs; take place at a registered manufacturing facility, with annual fees of $19,188 per facility or $12,792 for contract manufacturers in the fiscal year ending in September; adhere to the FDA Drug Fact Sheet labels; and be listed on the National Drug Code Directory.

Kolmar Korea obtained FDA OTC manufacturing certification in 2013, the first in the K-beauty industry by its account; its second U.S. plant, completed last year, is also OTC-certified. Cosmax’s Hwaseong plant in Gyeonggi and its New Jersey plant have produced OTC products since 2016.

The same rules that slow entry double as a moat. For the thousands of smaller Korean brands that rely on these manufacturers, the path to a U.S.-legal bemotrizinol sunscreen runs through a handful of certified factories. A representative at a major Korean beauty retailer said that developing a product for launch typically takes six months to a year, even as long as two.

Amorepacific, one of Korea’s largest cosmetics firms, said that the approval “will help improve the efficiency of managing our global sun care portfolio,” noting that filter rules differ across the United States, the European Union, China and Korea.

Where can I buy Korean formulas in the meantime?

Nothing about the order changed the channels that exist today. Korean-formula sunscreens still reach U.S. customers through global shopping malls and direct purchase from Korea, and those shipments remain, in the FDA’s eyes, drugs that customs can stop if it deems necessary.

Products on U.S. store shelves are a different matter. Only FDA-compliant sunscreens can legally be sold there. Retailers, for their part, are waiting on manufacturers. The retail representative said that the work sits upstream; once a formula contains only FDA-permitted ingredients, exports can move quickly.

When does the door open all the way?

The first U.S. bemotrizinol sunscreens from DSM or its licensees are expected to hit shelves this fall.

"The FDA Final Order becomes effective on Aug. 9, 2026, which is 60 calendar days after its issuance," said DSM. "The 18-month exclusivity period is tied to commercialization and begins when the first FDA drug-listed, monograph-compliant sunscreen product containing BEMT is marketed in the United States."

"In other words, Aug. 9, 2026 marks the date on which the Final Order takes effect, while the exclusivity period itself is triggered by the market launch of the first qualifying product, in accordance with the FDA's exclusivity framework."

One more variable sits in the background: A separate FDA proposal from September 2021, still pending, would tighten conditions for all sunscreens, including those with bemotrizinol, if finalized. The molecule is legal. The market that it enters is still being drawn.

BY KIM MIN-YOUNG [kim.minyoung5@joongang.co.kr]