Last Updated: June 22, 2026

CLINICAL TRIALS PROFILE FOR AVOBENZONE; ECAMSULE; OCTOCRYLENE


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All Clinical Trials for AVOBENZONE; ECAMSULE; OCTOCRYLENE

Trial ID Title Status Sponsor Phase Start Date Summary
NCT03582215 ↗ Assessment of the Human Systemic Absorption of Sunscreen Ingredients Completed Spaulding Clinical Research LLC Phase 1 2018-07-18 This study is designed to assess the systemic exposure and pharmacokinetics of sunscreen active ingredients (avobenzone, oxybenzone, ecamsule, octocrylene homosalate, octisalate and octinoxate) when sunscreen product is applied under maximal use conditions. Part 1 is an open-label, randomized, 4-arm study in 24 healthy adult subjects with the primary objective to explore whether the active components (avobenzone, oxybenzone, ecamsule and octocrylene) of 4 sunscreen products (1 sunscreen product in each arm) are absorbed into the systemic circulation when a sunscreen product is applied under maximal use conditions. One sunscreen product with the highest avobenzone exposure will be selected for the second part of the study. If there is no quantifiable exposure of avobenzone for any of the sunscreen products, the formulation with the highest oxybenzone exposure will be selected for Part 2. In addition, 3 new sunscreen products are included in Part 2. Part 2 is an open label, 4-arm study in 48 healthy adult subjects with the primary objective to assess the pharmacokinetics of the active components in the selected product from Part 1 and 3 additional products with a combination of active ingredients (avobenzone, oxybenzone, octocrylene, ecamsule homosalate, octisalate and octinoxate as applicable/contained in the different products).
NCT03582215 ↗ Assessment of the Human Systemic Absorption of Sunscreen Ingredients Completed Food and Drug Administration (FDA) Phase 1 2018-07-18 This study is designed to assess the systemic exposure and pharmacokinetics of sunscreen active ingredients (avobenzone, oxybenzone, ecamsule, octocrylene homosalate, octisalate and octinoxate) when sunscreen product is applied under maximal use conditions. Part 1 is an open-label, randomized, 4-arm study in 24 healthy adult subjects with the primary objective to explore whether the active components (avobenzone, oxybenzone, ecamsule and octocrylene) of 4 sunscreen products (1 sunscreen product in each arm) are absorbed into the systemic circulation when a sunscreen product is applied under maximal use conditions. One sunscreen product with the highest avobenzone exposure will be selected for the second part of the study. If there is no quantifiable exposure of avobenzone for any of the sunscreen products, the formulation with the highest oxybenzone exposure will be selected for Part 2. In addition, 3 new sunscreen products are included in Part 2. Part 2 is an open label, 4-arm study in 48 healthy adult subjects with the primary objective to assess the pharmacokinetics of the active components in the selected product from Part 1 and 3 additional products with a combination of active ingredients (avobenzone, oxybenzone, octocrylene, ecamsule homosalate, octisalate and octinoxate as applicable/contained in the different products).
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for AVOBENZONE; ECAMSULE; OCTOCRYLENE

Condition Name

Condition Name for AVOBENZONE; ECAMSULE; OCTOCRYLENE
Intervention Trials
Systemic Exposure to Sunscreen Ingredients 1
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Condition MeSH

Condition MeSH for AVOBENZONE; ECAMSULE; OCTOCRYLENE
Intervention Trials
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Clinical Trial Locations for AVOBENZONE; ECAMSULE; OCTOCRYLENE

Trials by Country

Trials by Country for AVOBENZONE; ECAMSULE; OCTOCRYLENE
Location Trials
United States 1
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Trials by US State

Trials by US State for AVOBENZONE; ECAMSULE; OCTOCRYLENE
Location Trials
Wisconsin 1
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Clinical Trial Progress for AVOBENZONE; ECAMSULE; OCTOCRYLENE

Clinical Trial Phase

Clinical Trial Phase for AVOBENZONE; ECAMSULE; OCTOCRYLENE
Clinical Trial Phase Trials
Phase 1 1
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Clinical Trial Status

Clinical Trial Status for AVOBENZONE; ECAMSULE; OCTOCRYLENE
Clinical Trial Phase Trials
Completed 1
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Clinical Trial Sponsors for AVOBENZONE; ECAMSULE; OCTOCRYLENE

Sponsor Name

Sponsor Name for AVOBENZONE; ECAMSULE; OCTOCRYLENE
Sponsor Trials
Food and Drug Administration (FDA) 1
Spaulding Clinical Research LLC 1
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Sponsor Type

Sponsor Type for AVOBENZONE; ECAMSULE; OCTOCRYLENE
Sponsor Trials
U.S. Fed 1
Other 1
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Clinical Trials Update, Market Analysis, and Forecast for Avobenzone, Ecamsule, and Octocrylene (UV Filters)

Last updated: June 7, 2026

The UV-filter sunscreen actives avobenzone, ecamsule (Mexoryl), and octocrylene are in late-stage life-cycle management and formulation optimization rather than a single cohesive “new-drug” pipeline. Near-term growth is driven by broad sunscreen penetration, chemical-stability and photoprotection improvements, regulatory labeling requirements, and product line expansion (SPF boosts, water resistance, and body-specific formats). Pricing pressure and competitive intensity remain the key headwinds.

What follows is the highest-level clinical and commercial view of the three UV filters as actives, with emphasis on trial directions (stability, photoprotection, safety, and consumer acceptability) and market projections for sunscreen formulations that use these ingredients.


What clinical trials are ongoing for avobenzone, ecamsule, and octocrylene?

Short answer: Clinical activity for these UV filters is dominated by formulation-level studies (photostability, SPF/PA performance, in-use tolerability, and consumer performance endpoints), plus periodic safety re-checks tied to regulatory maintenance and product labeling.

Are these UV filters being tested for new indications?

No. The clinical trial pattern for avobenzone, ecamsule, and octocrylene is consistent with sunscreen and photoprotection performance, not systemic indications. The “pipeline” is largely reformulation and product evolution.

What kinds of studies are typical for these actives?

Across UV filter portfolios, clinical endpoints usually include:

  • In vivo SPF and UVA protection performance (including UVA-PF or PA metrics depending on jurisdiction)
  • Photostability under standardized light exposure (UVB, UVA, or both)
  • Skin tolerability and irritation/sensitization assessments
  • Water resistance after immersion and after repeated exposure
  • Investigator-assessed and subject-reported outcomes (e.g., redness, dryness, stinging)
  • Residual residue testing and sensory attributes (spreadability, film feel, cosmetic acceptability), especially for “no-whit” or “non-greasy” claims

Where does avobenzone clinical activity cluster?

Avobenzone’s clinical and regulatory focus typically emphasizes stabilization. In vivo work often tests:

  • combinations that reduce avobenzone photodegradation
  • polymeric matrices and emulsion systems that maintain UVA performance
  • vehicle changes that reduce irritation and improve wear comfort

Where does ecamsule clinical activity cluster?

Ecamsule is commonly optimized for:

  • stable UVA protection with improved cosmetic profile
  • film-former and particle dispersion approaches to reduce whitening and improve spread
  • water resistance and wear under real-world conditions

Where does octocrylene clinical activity cluster?

Octocrylene’s trial work focuses on:

  • photostabilization in combination sunscreens
  • tolerability and minimal stinging claims
  • compatibility with other filters in multi-filter systems

Actionable implication: If your R&D, licensing, or diligence depends on “clinical-stage risk,” the dominant risk is product-formulation reproducibility and regulatory conformity, not lack of biological activity.


What is the current regulatory status of avobenzone, ecamsule, and octocrylene in the US and EU?

United States (FDA)

Avobenzone, octocrylene, and ecamsule are used in approved sunscreen drug products in the US. The US regulatory landscape is shaped by FDA’s sunscreen monograph updates and ongoing formal framework development, with manufacturers maintaining compliance through:

  • approved active ingredient usage and labeling
  • stability, safety, and effectiveness data consistent with the drug approval record for each specific product

European Union

In the EU, these actives are used under the EU sunscreen regulatory framework (Cosmetic-to-Drug classification is separate from EU sunscreen compliance rules). Key focus areas include:

  • authorized concentration ranges per filter
  • photostability evidence and safety assessments
  • environmental and safety discussions impacting individual actives and formulations

How does reformulation affect regulatory status?

Regulators evaluate the specific finished product. Even if the active is approved/authorized, changes to:

  • vehicle,
  • concentration,
  • film-former system,
  • particle engineering (for ecamsule),
  • combination filter ratios, can trigger new data packages, bridging studies, or regulatory submissions.

What are the market drivers for avobenzone, ecamsule, and octocrylene sunscreens?

Demand drivers

  • Higher sunscreen usage tied to skin cancer awareness and dermatologist recommendations
  • Expansion of “daily use” formats (facial, body, spray, stick, and tinted products)
  • Premiumization (better feel, less whitening, better UVA protection)
  • Increased uptake in emerging markets with UV index and urban lifestyle exposure

Supply and formulation drivers

  • Improved photostability to protect UVA performance over wear time
  • Water resistance and sweat-resistant claims
  • “No sting” and “sensitive skin” positioning using multi-filter stabilization systems

Commercial positioning by active

  • Avobenzone: core UVA protection driver; frequently used in combination for stabilization and extended wear
  • Ecamsule (Tinosorb-type UV absorber category in practice, but chemically distinct): often chosen when cosmetic acceptability and UVA coverage are key differentiators
  • Octocrylene: common co-filter for photostability and broad-spectrum building

How big is the sunscreen market that relies on avobenzone, ecamsule, and octocrylene?

Short answer: These actives participate in a large, mature global sunscreen market measured in billions of dollars across OTC drug and cosmetic channels, with most growth tied to sun care category expansion and premium product share.

Because “active-only” market share for UV filters is not reported consistently across manufacturers and jurisdictions, the practical approach is to model market growth at the finished-product level and then allocate by formulation prevalence.

Market modeling approach used in projection

  • Start with global sun care market growth rates by region
  • Allocate penetration of chemical UV filters and multi-filter systems
  • Assign relative usage likelihood: avobenzone for UVA-heavy claims; octocrylene as stabilizer in many conventional formulas; ecamsule where cosmetic and UVA performance drive premiumization
  • Apply share shifts based on stability, regulatory environment, and consumer sensory trends

Actionable implication: Forecast confidence is highest at the “sunscreen formulation” level. Active-level forecasts are strongest when tied to known formulation prevalence within major brand supply chains.


When does market exclusivity end for avobenzone, ecamsule, and octocrylene?

Short answer: As UV filters, these actives face limited “exclusive drug” lifetimes compared with small-molecule therapeutics. Market exclusivity is typically dominated by:

  • finished product brand life-cycle management
  • formulation-specific patents (stabilization matrices, combinations, and processing)
  • regulatory exclusivity tied to product-specific approvals rather than the active itself

What tends to extend commercial exclusivity in UV filters?

  • Patented photostabilization systems (especially for avobenzone-based products)
  • Particle engineering and dispersion systems (ecamsule-driven cosmetic performance)
  • Fixed multi-filter ratios and specific manufacturing methods
  • Proprietary film-formers and emulsifier systems that improve skin feel and reduce irritation

What patent landscape covers avobenzone, ecamsule, and octocrylene in sunscreen formulations?

Short answer: The enforceable estate is mainly formulation patents, delivery-system patents, and method-of-use claims around photoprotection performance. Active-ingredient patents, where they exist, are older and usually outside of most near-term exclusivity windows.

Typical patent categories in this space

  • Photostable sunscreen compositions (stabilized UVA systems)
  • Fixed combinations of UV filters with specified concentration ranges
  • Emulsion or polymer matrix improvements for stability and cosmetic feel
  • Manufacturing methods controlling particle size distribution and dispersion (relevant for ecamsule-style particulate concepts)
  • Use claims for broad-spectrum photoprotection with defined performance metrics

What does this mean for market-entry timing?

Generic entry risk is less about “can the active be copied” and more about:

  • performance equivalence
  • regulatory pathway feasibility for new formulations
  • infringement risk around proprietary stabilized systems and product-specific claims

Actionable implication: If you are evaluating IP clearance, treat the “active” as a starting point and focus diligence on stabilized combination formulations and delivery systems rather than the UV filter molecules alone.


What does the competitive landscape look like for sunscreen actives using avobenzone, ecamsule, and octocrylene?

Competitor buckets

  1. Multinationals with large sun care portfolios and patented stabilization platforms
  2. Specialty formulation houses supplying turnkey actives and systems
  3. Regional brands competing on price but still requiring stable, broad-spectrum performance
  4. “Dermocosmetic” and premium skin care brands optimizing cosmetic elegance, including whitening-free claims

Where competitive pressure is highest

  • Mainstream SPF 30-50 daily use products
  • Mass-market price tiers during promo cycles
  • Regions with price-sensitive demand where performance differentiation is harder to defend

Where differentiation is strongest

  • Premium UVA performance and “photostability over wear” claims
  • Sensitive skin and minimal sting positioning
  • Tinted and “makeup-like” sunscreen formats with improved feel

Market forecast: clinical and commercial outlook for avobenzone, ecamsule, and octocrylene (2026-2032)

Short answer: Expect steady category growth with mid-single-digit CAGR in many regions, driven by sunscreen adoption and product premiumization. Growth allocation will favor multi-filter systems that maintain UVA performance and consumer acceptance. The highest incremental gains come from improved photostability and sensory upgrades.

Projection table (scenario-based, formulation-level)

Metric Base case (steady growth) Upside (premiumization + penetration) Downside (regulatory or pricing squeeze)
Global sun care market Mid-single-digit CAGR High-single-digit CAGR Low-single-digit CAGR
Share of stabilized multi-filter products Increasing Strong increasing Flat-to-slightly down
Relative role of avobenzone Remains core UVA component Gains with better stabilization Mild downshift if reformulation constraints
Relative role of octocrylene Co-filter persists Gains with broad-spectrum systems Mild downshift if safety/labeling changes propagate
Relative role of ecamsule Gains in premium “cosmetic elegance” segment Larger premium share gain Limited gain if price pressure increases

Time-phased view

  • Near term (2026-2027): more incremental formulation launches, stability upgrades, and line extensions
  • Mid term (2028-2030): higher intensity premiumization, tinted and wear-optimized products, and regulatory label fine-tuning
  • Long term (2031-2032): consolidation of suppliers and shift toward scalable stabilization platforms that protect UVA performance

Actionable implication: For investment and licensing, the best risk-adjusted opportunities typically sit in manufacturing-ready stabilization technologies and repeatable photoprotection performance claims, not in new clinical indications.


What generic entry risks exist for sunscreen products using these actives?

Key entry barriers

  • Patent estates on stabilized combination formulations and delivery systems
  • Regulatory and labeling compliance for specific finished products
  • Need for bioequivalence-like performance evidence (in vivo SPF/UVA protection and tolerability data)

Likelihood by category

  • Simple reformulations that swap actives without changing performance can face formulation IP risk if they map onto claimed systems.
  • Performance-matched multi-filter systems are more likely to trigger infringement analysis around combination ratios and stabilization steps.
  • Cosmetic-elegance particulate systems can raise additional scrutiny due to dispersion and manufacturing method claims.

How does avobenzone compare with ecamsule and octocrylene in product differentiation?

Summary comparison

Attribute Avobenzone Ecamsule Octocrylene
Role Core UVA absorber UVA-focused aesthetic premium option Co-filter, often photostabilizing
Common product use Broad-spectrum UVA-centric formulas Premium facial and “no-whit” positioning Broad-spectrum stabilization and wear
Differentiation lever Stabilized photoprotection Cosmetic elegance and dispersion Compatibility and stability in combos
Main development risk Maintaining UVA stability over wear Particle dispersion, whitening reduction, stability Tolerability and stable broad-spectrum balance

Key Takeaways

  • Clinical activity for avobenzone, ecamsule, and octocrylene is formulation-centric, focused on photostability, UVA/UVB performance, and tolerability rather than new therapeutic indications.
  • Market growth is driven by sunscreen adoption and premiumization toward better wear, UVA protection stability, and improved sensory profiles.
  • Commercial exclusivity is mainly protected by formulation patents and delivery-system IP around stabilized multi-filter compositions, not by active-ingredient exclusivity.
  • Forecast upside concentrates in photostable, consumer-acceptable multi-filter products; downside concentrates in pricing pressure and any regional tightening of sunscreen regulatory constraints.

FAQs

  1. Which sunscreen actives are most associated with UVA protection: avobenzone, ecamsule, or octocrylene?
  2. How do photostability requirements affect formulation choices for avobenzone-based sunscreens?
  3. What are the most common clinical endpoints used to support SPF and UVA claims for these UV filters?
  4. What type of patents most often block generic or “copycat” sunscreen reformulations?
  5. How does consumer demand for non-whitening facial sunscreens shift the mix toward ecamsule?

References

No sources cited.

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