Ingredient Directory
Low ConcernVegan

Drometrizole Trisiloxane

Mexoryl XL

Safety Notes

Broad-spectrum filter covering UVB + UVA-I and II; photostable; silicone carrier; developed by L'Oréal (Mexoryl XL); EU approved; US approved under FDA NDA (time-limited); limited global regulatory approval; good safety profile

Function & Common Use

Function

UV Filter (UVA-I + UVB)

Category

UV Filter

Common In

Premium broad-spectrum sunscreens

Origin

Synthetic (silicone-linked)

Concentration Limits

India (CDSCO)

Subject to India regulatory assessment

EU Cosmetics Reg.

15% (EU Annex VI)

US FDA (21 CFR)

No specific 21 CFR cosmetic limit identified in source checked; EU limit reference: 15% (EU Annex VI)

Korea (MFDS)

No specific MFDS limit identified in source checked; verify if ingredient is used in a Korean functional cosmetic category

Pregnancy: No specific restriction identified in source checked; standard cosmetic use

Frequently Asked Questions

Is Drometrizole Trisiloxane safe to use in skincare?

Drometrizole Trisiloxane has a Low concern rating from The Clean Sheet. Broad-spectrum filter covering UVB + UVA-I and II; photostable; silicone carrier; developed by L'Oréal (Mexoryl XL); EU approved; US approved under FDA NDA (time-limited); limited global regulatory approval; good safety profile

Is Drometrizole Trisiloxane allowed in India?

Drometrizole Trisiloxane is currently classified as "Not specifically listed" under Indian cosmetics regulations. The maximum permitted concentration is Subject to India regulatory assessment.

What is Drometrizole Trisiloxane used for in cosmetics?

Drometrizole Trisiloxane functions as: UV Filter (UVA-I + UVB). It is commonly found in: Premium broad-spectrum sunscreens.

TCS Assessment
Low Concern
Data Confidence
Medium
Based on peer-reviewed safety data, regulatory status, and expert review by The Clean Sheet panel.

Regulatory Status

India (CDSCO)
Not specifically listed
EU
Permitted
US FDA
Permitted
Korea (MFDS)
Permitted
Australia (TGA)
Regulated as a primary sunscreen active under TGA ARTG requirements when SPF claims are made; cosmetic use (non-SPF) subject to standard cosmetic framework
Canada (NHPID)
UV filter; may require Health Canada NPN registration if drug (sunscreen) claims are made; cosmetic use subject to Canada Consumer Product Safety Act

EU Annex: Annex VI

Identifiers

CAS155633-54-8
ECN/A

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