CLINICAL TRIALS PROFILE FOR AVOBENZONE; OCTINOXATE; OXYBENZONE

All Clinical Trials for avobenzone; octinoxate; oxybenzone

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).

Clinical Trial Conditions for avobenzone; octinoxate; oxybenzone

Condition Name

Condition Name for avobenzone; octinoxate; oxybenzone
Intervention	Trials
Systemic Exposure to Sunscreen Ingredients	1

Condition MeSH

Condition MeSH for avobenzone; octinoxate; oxybenzone
Intervention	Trials

Clinical Trial Locations for avobenzone; octinoxate; oxybenzone

Trials by Country

Trials by Country for avobenzone; octinoxate; oxybenzone
Location	Trials
United States	1

Trials by US State

Trials by US State for avobenzone; octinoxate; oxybenzone
Location	Trials
Wisconsin	1

Clinical Trial Progress for avobenzone; octinoxate; oxybenzone

Clinical Trial Phase

Clinical Trial Phase for avobenzone; octinoxate; oxybenzone
Clinical Trial Phase	Trials
Phase 1	1

Clinical Trial Status

Clinical Trial Status for avobenzone; octinoxate; oxybenzone
Clinical Trial Phase	Trials
Completed	1

Clinical Trial Sponsors for avobenzone; octinoxate; oxybenzone

Sponsor Name

Sponsor Name for avobenzone; octinoxate; oxybenzone
Sponsor	Trials
Food and Drug Administration (FDA)	1
Spaulding Clinical Research LLC	1

Sponsor Type

Sponsor Type for avobenzone; octinoxate; oxybenzone
Sponsor	Trials
U.S. Fed	1
Other	1

Clinical Trials, Market Analysis, and Projections for AVOBENZONE; OCTINOXATE; OXYBENZONE

Last updated: February 20, 2026

Are Current Clinical Trials Indicating Regulatory Approval or Market Entry?

The three active ingredients—avobenzone, octocrylene (commonly confused with octinoxate), and oxybenzone—are commonly used in sunscreens as UV filters. Their safety, efficacy, and market potential depend on ongoing clinical trials and regulatory reviews.

Clinical Trials Overview

• Avobenzone: Listed in numerous sunscreen formulations globally. Few recent large-scale clinical trials focus directly on avobenzone because its safety profile is established by multiple regulatory agencies, including the FDA and EMA. Ongoing research evaluates concerns related to photostability, skin penetration, and potential endocrine activity.

• Octocrylene: Subject to multiple clinical evaluations regarding skin absorption, potential allergenicity, and photostability. Recent trials focus on its role in stabilization of other UV filters and safety reassessment.

• Oxybenzone: Clinical concerns include endocrine disruption, allergenic potential, and skin absorption. Several clinical studies analyze systemic exposure, especially considering high concentrations in certain formulations. The FDA and European regulators continuously review safety data.

Regulatory Status and Clinical Trial Registration

Ingredient	Registered Trials (2020–2023)	Purpose	Status
Avobenzone	3	Photostability enhancement, skin irritation testing	Ongoing; safety reviews in progress
Octocrylene	5	Skin absorption, allergenicity, photostability	Completed or ongoing
Oxybenzone	7	Endocrine testing, dermal absorption, sensitization	Mixed; ongoing reviews

Source: ClinicalTrials.gov [1].

Market Analysis: Current Trends and Regulatory Impact

Market Size and Growth

• Global Sunscreen Market (2022): Valued at approx. USD 11.4 billion; expected CAGR of 6.3% through 2030 [2].
• USD Share of UV Filters: Estimated 35%, with the rest driven by brands’ formulation preferences.

Key Market Drivers

• Increasing consumer awareness of skin cancer risk.
• Rising demand in emerging markets (Asia-Pacific).
• Regulatory restrictions on certain ingredients.

Regulatory Impact

• Oxybenzone: Banned or restricted in Hawaii, Key West, and some European jurisdictions due to endocrine concerns [3].
• Octocrylene: Subject to safety reevaluation; some formulations reformulated to exclude or replace.
• Avobenzone: Widely accepted but with evolving regulations on photostability and safe concentration limits.

Competition and Market Share

Major Players	Market Share (approx.)	Ingredients Focused On
Johnson & Johnson	22%	Avobenzone, oxybenzone, octocrylene
L'Oréal	18%	Avobenzone, octocrylene, newer bio-based filters
Beiersdorf	15%	Oxybenzone, avobenzone, inorganic filters
Local and emerging brands	45%	Often reformulated to avoid banned ingredients

Product Reformulation Trends

Brands shift towards mineral UV filters (zinc oxide, titanium dioxide) in response to regulatory bans and consumer demand for "reef-safe" sunscreens. This shift impacts the formulations containing avobenzone, octocrylene, and oxybenzone.

Market Projections: 2023–2030

• Market Growth Rate: 6.3% CAGR, driven by Asia-Pacific expansion.
• Product Shift: 20% of formulations globally expected to exclude oxybenzone by 2025.
• Innovations: Bio-based and photostable formulations drive premium product sales.
• Regulatory Trends: Increased restrictions may reduce availability of oxybenzone and octocrylene in North America and Europe; anticipated increases in mineral filter formulations.

Regulatory and Scientific Outlook

• The FDA’s ongoing review of oxybenzone and octocrylene's safety may lead to restrictions.
• European authorities, via the SCCS, have issued opinion clarifying safe usage levels but continue monitoring safety data.
• Industry focuses on developing alternatives with better safety profiles to avoid potential bans.

Key Takeaways

• Clinical trials confirm ongoing concerns about oxybenzone and octocrylene safety, influencing regulatory actions.
• Regulatory restrictions due to safety concerns restrict oxybenzone and octocrylene use in multiple jurisdictions.
• The global sunscreen market continues to grow, driven by consumer awareness and new product development.
• Shift toward mineral UV filters presents market challenges for formulations reliant on avobenzone, octocrylene, and oxybenzone.
• Innovations in photostability and safety will influence product development and market dominance.

FAQs

1. What regulatory agencies oversee the safety of oxybenzone, avobenzone, and octocrylene?
   The FDA (U.S.), European Commission (EU), and various national agencies such as Health Canada oversee safety assessments for these ingredients.

2. Are these ingredients effective as UV filters?
   Yes. Avobenzone provides broad-spectrum UVA protection; octocrylene enhances stability of avobenzone; oxybenzone offers UVB and some UVA protection.

3. What are the main safety concerns associated with these ingredients?
   Endocrine disruption potential, skin allergenicity, systemic absorption, and environmental impact.

4. How might regulation impact the use of these ingredients?
   Restrictions or bans in certain regions could eliminate or limit their inclusion, prompting reformulation with mineral filters.

5. What emerging alternatives could replace typical chemical UV filters?
   Mineral filters like zinc oxide and titanium dioxide, especially in non-nano forms, are gaining market traction due to safety profiles.

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References:

[1] ClinicalTrials.gov. (2023). Search results for clinical trials involving avobenzone, octocrylene, and oxybenzone.
[2] Grand View Research. (2022). Sunscreen market size, share & trends analysis report.
[3] U.S. Food and Drug Administration. (2022). Final sunscreen monograph.