The U.S. sunscreen regulatory landscape changed in 2026, creating new considerations for beauty brands developing products for the American market.
In June, the U.S. Food and Drug Administration added bemotrizinol (BEMT) to the OTC sunscreen monograph—the first new sunscreen active ingredient added to the U.S. monograph in decades. In September, FDA also finalized the removal of PABA and trolamine salicylate, with that change scheduled to take effect in 2027.
These developments are important, but they need to be interpreted carefully.
FDA’s 2026 actions do not mean that every existing sunscreen must be reformulated. They also do not mean that FDA introduced an entirely new sunscreen labeling and testing system in 2026.
Many requirements frequently discussed alongside the 2026 news—including SPF testing, Broad Spectrum claims, water-resistance testing and Drug Facts labeling—have already applied for years.
So, what actually changed in 2026, what has not yet changed, and what should beauty brands consider when developing sunscreen products for the U.S. market?
This guide explains the updates from a practical product-development and manufacturing perspective.
What Actually Changed in 2026?
There are two finalized FDA sunscreen developments that brands should understand: the addition of BEMT to OTC Monograph M020 and the future removal of PABA and trolamine salicylate.
Bemotrizinol Was Added to OTC Monograph M020
On June 10, 2026, FDA issued Final Administrative Order OTC000039, amending OTC Monograph M020 to add bemotrizinol as a permitted sunscreen active ingredient.
The order became effective on August 9, 2026.
Also known as BEMT, bemotrizinol may be used at concentrations of up to 6% under the conditions established in the final order. A finished sunscreen containing BEMT must provide an SPF value of at least 2 and meet the other applicable conditions of the monograph.
The order permits BEMT in the following dosage forms:
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Oil
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Lotion
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Cream
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Gel
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Butter
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Paste
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Ointment
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Stick
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Certain spray products
For sprays, the product must either contain no propellant or use a delivery system in which the propellant remains isolated from the sunscreen formulation.
This means that a qualifying pump spray or certain bag-on-valve systems may be used. However, the order does not support a conventional aerosol formulation in which the propellant is directly combined with the BEMT-containing formula. Powder dosage forms are also not included under the permitted BEMT conditions.
The final order additionally establishes conditions governing the combination of BEMT with other sunscreen active ingredients and certain skin-protectant active ingredients.
For brands, this creates a new formulation option. It does not mean that BEMT can simply be added to any existing sunscreen base without reviewing the complete active-ingredient system, dosage form, product claims and finished-product performance.
BEMT Was Added to the Monograph—Finished Products Are Not Individually FDA-Approved
The regulatory wording matters.
FDA added BEMT as a permitted sunscreen active ingredient under OTC Monograph M020. It did not separately approve every finished sunscreen containing BEMT.
Under the OTC monograph pathway, a sunscreen may be marketed without an approved new drug application when it complies with the applicable monograph conditions and other relevant requirements.
Brands and manufacturers should therefore avoid describing ordinary monograph products as:
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“FDA-approved sunscreen formulas”
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“FDA-approved sunscreen products”
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“FDA-approved BEMT formulas”
More accurate language includes:
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“Formulated for the U.S. OTC sunscreen monograph pathway”
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“Designed to comply with applicable FDA OTC sunscreen monograph requirements”
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“Contains sunscreen active ingredients permitted under OTC Monograph M020”
These statements should only be used after the specific formula, dosage form, claims, testing and labeling have been properly evaluated.
BEMT Exclusivity and Ingredient Access
The addition of BEMT to the monograph does not automatically mean that every manufacturer can immediately source and commercialize it in the same way.
Final Administrative Order OTC000039 provides an 18-month statutory exclusivity period to DSM Nutritional Products LLC and qualifying licensees, assignees or successors in interest in connection with the change authorized by the order.
For brands considering a BEMT sunscreen, this creates an important commercial question:
Can the manufacturing partner access an appropriate authorized BEMT supply during the applicable exclusivity period?
Ingredient sourcing, supplier authorization, specifications, documentation and commercial availability should therefore be reviewed at the beginning of development—not after the formula and launch plan have already been finalized.
FDA Finalized the Removal of PABA and Trolamine Salicylate
A second important development occurred in September 2026.
On September 11, 2026, FDA issued Final Administrative Order OTC000008-1, determining that sunscreen drug products containing PABA or trolamine salicylate as sunscreen active ingredients are not generally recognized as safe and effective.
The order removes these ingredients from OTC Monograph M020 and is scheduled to take effect on September 11, 2027.
FDA has stated that it is not aware of sunscreen products containing PABA or trolamine salicylate currently being marketed in the United States. For most current beauty brands, the order is therefore unlikely to trigger an immediate reformulation project.
Nevertheless, companies reviewing older formulas, legacy portfolios or future product concepts should confirm that these ingredients are not included in new U.S. development programs.
What Has Not Been Finalized as a New 2026 Requirement?
FDA issued a broader proposed sunscreen order in 2021 addressing active ingredients, labeling, dosage forms, maximum SPF values, final-formulation testing, recordkeeping and other matters.
Not all of those proposals became final requirements in 2026.
FDA has stated that it is continuing to address remaining provisions, including labeling, dosage forms and maximum SPF levels, through future orders as appropriate.
Brands should therefore distinguish among:
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Requirements currently in effect
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Final orders with a future effective date
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Proposed requirements that have not yet been finalized
A proposal may be relevant to future product planning, but it should not be presented as an already-effective requirement.
Most importantly, FDA did not introduce a completely new sunscreen labeling or effectiveness-testing system in 2026.
Existing FDA Requirements Brands Still Need to Manage
Separate from the 2026 ingredient updates, existing U.S. sunscreen requirements continue to apply.
In the United States, sunscreens are regulated as drugs because their intended uses include preventing sunburn and, for qualifying Broad Spectrum SPF products, helping reduce certain risks associated with sun exposure.
Developing a U.S. sunscreen is therefore not the same as developing an ordinary cosmetic moisturizer with UV filters added.
Active Ingredients and Dosage Forms
A product developed under the FDA OTC Sunscreen Monograph M020 pathway must use permitted active ingredients at appropriate concentrations and in permitted combinations and dosage forms.
A product-specific review should consider:
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Every sunscreen active ingredient
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The concentration of each active ingredient
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The proposed combination of actives
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The intended dosage form
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Applicable product claims
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The conditions of OTC Monograph M020
For a BEMT product, this review must also account for the ingredient-specific conditions established by Final Administrative Order OTC000039.
SPF, Broad Spectrum and Water-Resistance Testing
The labeled SPF value must be supported by the applicable FDA effectiveness testing requirements.
A product intended to use the “Broad Spectrum” claim must meet the corresponding broad-spectrum test requirements. Broad-spectrum testing is linked to use of that claim; it is not a new test introduced for every sunscreen in 2026.
If a product will make a water-resistance claim, the claim must be supported by the applicable testing. Permitted statements specify either 40 or 80 minutes of water resistance based on the test results.
Terms such as “waterproof,” “sweatproof” and “sunblock” should not be used as substitutes for permitted sunscreen labeling language.
Blackbird works with qualified third-party laboratories to help brands coordinate applicable finished-product testing, including SPF, Broad Spectrum and water-resistance testing. Testing requirements are considered during formulation development so that the intended claims, submitted samples and commercial formula remain aligned.
Because changes to the active-ingredient system, base formula or manufacturing process may affect product performance, testing should be planned before the final formula, packaging and launch timeline are confirmed.
Drug Facts and Product Labeling
Sunscreen labeling must accurately communicate the product’s active ingredients, SPF, claims, directions, warnings and other required OTC drug information.
Depending on the product, brands may need to address:
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Active-ingredient declarations
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Drug Facts content and formatting
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SPF presentation
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Broad Spectrum statements
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Water-resistance duration
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Required warnings
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Directions for use
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Principal-display-panel claims
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Consistency between product claims and supporting tests
Labeling should be reviewed before commercial packaging is printed. Waiting until the end of development can result in avoidable artwork revisions, packaging delays or unsupported claims.
Manufacturing and Product Compliance
Regulatory claim testing is only one part of sunscreen development.
Brands and manufacturers must also consider whether the finished product can be produced consistently and whether the formulation remains suitable in its intended packaging throughout its expected shelf life.
Relevant development and manufacturing work may include:
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Ingredient and supplier qualification
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Formula optimization
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Finished-product stability
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Packaging compatibility
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Product specifications
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Quality-control methods
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Pilot production and scale-up
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Batch documentation
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Change control
Changes to an ingredient, supplier, concentration, manufacturing process, packaging component or product claim may affect whether existing tests and documentation remain applicable.
For brands entering the U.S. sunscreen market, these requirements need to be translated into a product-specific development plan. Blackbird can assist with the OTC sunscreen preparation process by helping brands evaluate the intended monograph pathway, review active ingredients and dosage forms, coordinate formulation and third-party testing, prepare applicable labeling information, and organize relevant manufacturing documentation.
This work supports development under the applicable FDA OTC sunscreen framework. It should not be described as obtaining FDA approval for an individual monograph sunscreen product.
What the 2026 Updates Mean for Brands and Manufacturers
The practical impact of the 2026 FDA actions depends on the product and the brand’s development strategy.
Existing Sunscreen Products
The addition of BEMT does not make existing compliant sunscreen products noncompliant and does not, by itself, require reformulation.
For an existing product, brands should instead confirm whether its active ingredients, claims, testing, labeling and manufacturing documentation remain aligned with the requirements that currently apply.
A reformulation should have a clear regulatory, performance or commercial objective—not occur simply because a new active ingredient became available.
New BEMT Sunscreen Products
For brands developing a new sunscreen, BEMT may create additional formulation possibilities. However, its inclusion should be based on a meaningful product-development reason.
Before choosing BEMT, brands and manufacturers should evaluate:
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The intended protection profile
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The complete active-ingredient system
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Formula architecture and compatibility
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Product format and packaging
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Ingredient sourcing and authorization
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Target SPF and claims
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Finished-product testing
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Manufacturing feasibility
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Commercial positioning
The expected performance of a finished sunscreen cannot be inferred only from the individual UV filters it contains. SPF, Broad Spectrum protection and water resistance must ultimately be supported by the finished formulation.
Products Containing PABA or Trolamine Salicylate
Any brand using or considering PABA or trolamine salicylate should assess the September 11, 2027 effective date.
An affected company may need to plan for reformulation, testing, labeling changes, inventory management and manufacturing transition. Brands not using these ingredients do not need to reformulate simply because the order was issued.
A Practical Development Process for U.S. Sunscreen Products
A U.S. sunscreen project should connect regulatory preparation with formulation, testing, labeling and manufacturing.
A practical development process typically includes:
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Define the product and regulatory pathway: Confirm the intended market, dosage form, target SPF, product claims and applicable OTC monograph pathway.
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Review the active-ingredient system: Evaluate each active ingredient, concentration, combination and dosage-form condition.
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Confirm ingredient sourcing: Review raw-material availability and supplier documentation. For BEMT projects, applicable exclusivity and supply authorization should be considered early.
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Develop the finished formulation: Evaluate formula compatibility, stability, sensory performance, packaging and manufacturing feasibility.
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Establish the testing plan: Identify the SPF, Broad Spectrum, water-resistance and other product-specific evaluations needed to support the intended claims.
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Prepare labeling and OTC documentation: Review Drug Facts content, active-ingredient declarations, directions, warnings and claim language, together with other applicable OTC preparation requirements.
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Complete scale-up and production preparation: Confirm the commercial formula, product specifications, manufacturing procedures, quality controls and change-management requirements.
Managing these steps as one connected program can help reduce late formulation changes, repeated testing, packaging revisions and avoidable launch delays.
Brands can also explore Blackbird’s current sunscreen product collection when comparing possible formats, textures and product directions.
Developing a Sunscreen for the U.S. Market?
The 2026 FDA actions create new possibilities for sunscreen development, particularly through the addition of BEMT. However, selecting an active ingredient is only one part of building a market-ready sunscreen.
Brands must connect the ingredient strategy with applicable OTC requirements, finished-product testing, labeling and commercial manufacturing.
Blackbird Skincare helps beauty brands translate these requirements into practical sunscreen development and production plans, including OTC preparation and coordination with qualified third-party testing laboratories.
This article is provided for general informational purposes and does not constitute legal or regulatory advice. Applicable requirements should be evaluated for each specific formulation, product claim, distribution plan and effective date.
FAQs
Do the 2026 FDA sunscreen updates require brands to reformulate existing products?
Not necessarily. Reformulation depends on the current formula, ingredients, product claims, and future market plans. Brands should review their existing sunscreen products to determine whether adjustments are needed.
What should brands prepare before launching sunscreen products in the U.S.?
Brands should evaluate ingredients, testing requirements, product claims, labeling, and manufacturing capabilities early in the development process to avoid delays and unnecessary revisions.
How long does it take to develop a sunscreen product?
The timeline depends on formula development, testing, packaging, and production requirements. Early planning with an experienced sunscreen manufacturer can help improve development efficiency.
Can brands create customized sunscreen formulas?
Yes. Brands can work with manufacturers to develop sunscreen formulas based on their target market, product positioning, texture preferences, and performance requirements.
Why choose an experienced sunscreen manufacturer?
An experienced manufacturer can support formula development, testing coordination, compliance preparation, and scalable production to help brands bring sunscreen products to market.
Written by Tiana Bian
Published 2026-07-22
