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Ecamsule (Mexoryl SX)

Also known as: Ecamsule, Mexoryl SX, Terephthalylidene dicamphor sulfonic acid

A UVA filter with a U.S. product-specific approval history, not a blanket approval of every international sunscreen using the name.

Gouache painting of a plain tube and cream smear on sandstone
Editorial illustration

Ecamsule, also called Mexoryl SX, is a UVA sunscreen filter. FDA reviewed a specific U.S. combination cream containing 2% ecamsule with avobenzone and octocrylene. That product-specific approval is not blanket authorization for every imported ecamsule sunscreen, and this one filter's presence does not establish the finished product's SPF or broad-spectrum performance.1, 2

  • Ecamsule is the filter associated with Mexoryl SX.1
  • The FDA medical review concerns a cream with 2% ecamsule, 2% avobenzone and 10% octocrylene.1
  • An NDA is product-specific, unlike a general monograph ingredient listing.1, 2

What is Ecamsule (Mexoryl SX)?

Sunscreen approval can follow a monograph pathway or a product-specific drug application. Ecamsule's U.S. history illustrates why those pathways should be distinguished. International products using similar trade names can contain different filters or combinations; a shared marketing family is not one chemical identity.1

Where it comes from

Natural sources

  • Not a botanical sunscreen or a dietary nutrient.

How it's made

Manufactured organic UV filter; not identical to other filters using the Mexoryl trade-name family.

What it does in products

  • UVA filtering as part of a sunscreen system

Benefits

UVA contribution within an evaluated sunscreen

moderate evidence

Ecamsule contributes to the filtering system in the specified combination product evaluated by FDA.1

The FDA application evaluates the complete cream, including companion filters. It does not assign a standalone SPF to ecamsule or establish the same performance for every international product.

Evidence scope and limitations

Ecamsule/Mexoryl SX and U.S. NDA 021502's specified combination cream; contextual comparison with the sunscreen monograph.

  • The application is a historical product-specific source, not confirmation of current retail availability.
  • No efficacy or authorization is inferred for another Mexoryl filter or imported formula.

Evidence last checked: 2026-10-01

Side effects & safety

Irritation or individual sunscreen intolerance (varies)Safety observations for the reviewed combination product do not isolate every reaction to ecamsule or cover all formulations.

Safety considerations

  • Companion filters and the vehicle are part of the evaluated sunscreen, not interchangeable optional ingredients.
  • Not for: Follow the finished product's Drug Facts and warnings; do not mix a raw UV filter into a cosmetic and assume sunscreen protection.
1

Amounts studied & product use

These figures describe research or common product use, not a personal dose or treatment recommendation.

In skincare studies and products

The cited FDA medical review evaluates 2% ecamsule in a cream also containing 2% avobenzone and 10% octocrylene. That is a product-specific regulatory example, not a universal concentration ceiling, DIY recipe or standalone SPF calculation.

1

Regulatory status

  • The cited U.S. approval history is NDA 021502 for a specified combination cream, not unrestricted monograph clearance of any ecamsule product.
  • INCI name on cosmetic labels: Terephthalylidene Dicamphor Sulfonic Acid.
1, 2, 3

Mexoryl is a trade-name family, not a substitution rule

This guide concerns ecamsule/Mexoryl SX. A different suffix or a different filter name should not inherit the same identity or FDA application.

A label's filter list also cannot replace the finished product's tested SPF, broad-spectrum statement and use directions. Protection is delivered by the sunscreen as formulated and applied, not by a trade name in isolation.

1, 2, 3

Frequently asked questions

Is every ecamsule sunscreen FDA-approved?

No. The cited approval concerns a specified U.S. combination product. Its application cannot establish the regulatory status of every imported or reformulated sunscreen.1

Does 2% ecamsule tell me the SPF?

No. A filter concentration cannot by itself establish the tested protection of the finished formula or its broad-spectrum claim.1, 2

The bottom line

Keep ecamsule's identity, the approved combination and the finished product's testing separate. Product-specific approval is not universal authorization.

References

  1. Anthelios SX: FDA medical review of avobenzone, ecamsule and octocrylene cream. U.S. Food and Drug Administration (2006) · government guidance · NDA 021502
  2. OTC Monograph M020: Sunscreen Drug Products for OTC Human Use. U.S. Food and Drug Administration (2026) · government guidance · M020; interpret with subsequent final orders
  3. Questions and Answers: FDA's regulatory actions on over-the-counter sunscreen. U.S. Food and Drug Administration (2026) · government guidance · Final Order OTC000008-1; September 10, 2026

Revision history

  1. Initial AI-assisted evidence compilation with source-linked claims, formulation distinctions and explicit research limitations; not independent medical review.