Is Drometrizole Trisiloxane safe in cosmetics?
Drometrizole Trisiloxane has a safety rating of "GOOD" in our database. EU status: permitted. US status: prohibited.
Drometrizole Trisiloxane
Also known as: Phenol, 2-(2H-benzotriazol-2-yl)-4-methyl-6-[2-methyl-3-[1,3,3,3-tetramethyl-1-[(trimethylsilyl)oxy]-1-disiloxanyl]propyl]-, Phenol, 2-(2H-benzotriazol-2-yl)-4-methyl-6-[2-methyl-3-[1,3,3,3-tetramethyl-1-[(trimethylsilyl)oxy]disiloxanyl]propyl]-, 2-(2H-Benzotriazol-2-yl)-4-methyl-6-[2-methyl-3-[1,3,3,3-tetramethyl-1-[(trimethylsilyl)oxy]-1-disiloxanyl]propyl]phenol, 2-(2H-Benzotriazol-2-yl)-4-methyl-6-[2-methyl-3-[1,3,3,3-tetramethyl-1-[(trimethylsilyl)oxy]disiloxanyl]propyl]phenol, OR 10154 (+1 more)
INCI: DROMETRIZOLE TRISILOXANE
Drometrizole Trisiloxane (CAS 155633-54-8) is a cosmetic active ingredient functioning as Oil-soluble broad-spectrum UV filter; dual absorption peaks at ~303 nm (UVB). EU Regulation 1223/2009 status: permitted, max Approved under EU Cosmetics Regulation Annex VI; concentration limits apply. Industrial safety data is also available in the chemical safety database.
View industrial chemical safety profile for CAS 155633-54-8 →
Auto-generated CPSR Part A draft with source citations
Function
Oil-soluble broad-spectrum UV filter; dual absorption peaks at ~303 nm (UVB) and ~344 nm (UVA2); provides oil-phase UVA coverage; synergistic with ecamsule (Mexoryl SX) to deliver full-spectrum UVA1+UVA2 protection in the L'Oréal Mexoryl system
Safety Rating
GOOD
Regulatory Status
EU EU Status
permitted
EU Max Conc.
Approved under EU Cosmetics Regulation Annex VI; concentration limits apply
US US Status
prohibited
US Notes
Not approved in the US under the FDA OTC sunscreen monograph. Available only in products outside US jurisdiction. The L'Oréal Mexoryl system (Mexoryl SX + Mexoryl XL combination) is proprietary; US sunscreens with ecamsule must proceed via L'Oréal's NDA pathway, and drometrizole trisiloxane has no independent FDA approval pathway.
For full compliance data across multiple jurisdictions, use the Substance Compliance tool.
Safety Data
Margin of Safety, dermal absorption, and sensitization profile summaries for Drometrizole Trisiloxane.
Calculate MoS for your specific formulation with the MoS Calculator.
Sensitization Profile
Contact sensitization data for Drometrizole Trisiloxane based on clinical patch test studies and IFRA standards.
Sensitization Rate
low
Allergen Class
other
EU Allergen Listed
no
Patch Test Positive Rate
0.1%
Cross-reactivity Group
none
Reaction Type
contact-dermatitis
Source: SCCS
Endocrine Disruptor Evidence (Expanded)
Cross-referenced EDC classifications, mechanism data, and dose-response evidence from EDLists, SIN List, and cosmetic-specific detail sources.
Cosmetic-Specific Mechanism
Category: UV filter
Receptor targets: ERα (limited)
LOEC: 10 µM
EU status: allowed (max 15%)
weak modulator
ECHA REACH Registration
European Chemicals Agency REACH dossier and Substances of Very High Concern listing.
Registration Type
Full
Tonnage Band
No longer valid
Substance Type
SUBSTANCE
SVHC Candidate
No
EU CosIng Annex Listing
European Commission CosIng database Annex references per Regulation (EC) No 1223/2009.
Annex VI — Permitted UV Filters
Max: 15%
Expanded Jurisdictional Detail
Additional regulatory detail beyond the 7-jurisdiction summary: Saudi SFDA, Korea MFDS, ASEAN ACD, Japan/Korea, Brazil/India, and cross-jurisdictional restriction entries.
KR Korea MFDS Annex 2 (Restricted)
Category: UV Filter. Max: 15%.
SA Saudi SFDA (VI - UV Filters)
Max: 0.15.
JPKR Japan/Korea Cosmetics
Japan (Restricted): max Wash-away: 15% | Leave-on: 15% | Mucosa: Prohibited
Korea (Restricted): max 15%
BRIN Brazil/India Cosmetics
India: Permitted UV Filter · max 0.15
Additional Jurisdictional Restrictions (4)
| Jurisdiction | Status | Max % | Product Type |
|---|---|---|---|
| JP | restricted | Wash-away: 15% | Leave-on: 15% | Mucosa: Prohibited | Wash-away: 15% | Leave-on: 15% | Mucosa: Prohibited |
| CN | permitted_uv_filter | 15 | All cosmetics |
| IN | permitted_uv_filter | 15.0 | sunscreen and other cosmetic products |
| BR | permitted_uv_filter | 15 | Sunscreen products; EU max 15% |
Additional Ingredient Properties
5 property records from structured ingredient metadata.
allergen_detail
{"eu_allergen_listed": "no", "allergen_class": "other", "patch_test_frequency_pct": "0.1", "sensitization_rate": "low", "common_reaction_type": "contact-dermatitis", "ifra_restricted": "no", "source": "SCCS"}
anti_pollution
{"cas_number": "155633-54-8", "ingredient_class": "blue_light_filter", "primary_mechanism": "film_forming_barrier", "pollution_types_targeted": "blue_light_HEV/UV_A/UV_B", "IR_A_protection": "no", "visible_light_protection": "no", "digital_screen_protection_claim": "no", "PAH_neutralization": "no", "ozone_protection": "no", "mitochondrial_protection": "no", "Nrf2_activation": "no", "AhR_pathway_mo…
baby_pediatric
{"cas_number": "155633-54-8", "ingredient_class": "sunscreen_baby", "pediatric_safety_rating": "acceptable", "minimum_age_months": "12", "neonatal_safe": "no", "premature_infant_safe": "insufficient_data", "skin_barrier_maturity_consideration": "Mexoryl XL - EU", "transepidermal_absorption_risk_pediatric": "low", "systemic_exposure_concern_pediatric": "low", "dose_per_kg_body_weight_concern": "Sun…
ecotoxicity
{"biodegradable": "no", "biodegradation_days": "365+", "bioaccumulative": "yes", "aquatic_toxicity_level": "moderate", "coral_reef_safe": "unknown", "marine_toxicity": "moderate toxicity", "freshwater_toxicity": "silicone persistence", "endocrine_disruptor": "suspected", "persistent_organic_pollutant": "yes", "microplastic": "no", "nano_particle": "no", "hawaii_banned": "no", "eu_restricted_enviro…
sunscreen_uv
{"cas_number": "155633-54-8", "uv_filter_type": "organic_broad_spectrum", "chemical_class": "other", "absorption_spectrum_nm_range": "290-380", "peak_absorption_wavelength_nm": "345", "molar_extinction_coefficient": "38500", "critical_wavelength_nm": "370", "UVA_PF": "15-22", "SPF_contribution_per_percent": "7.8", "photostability_rating": "photostable", "photodegradation_half_life_hours": ">18", "…
Function Categories & List Membership
Cosmetic/Chemical Function Categories
UV stabilizer
Regulatory List Membership (2)
EU Regulated in Personal Care
EU CosIng Cosmetics Ingredient Database
Expert Verdict
Expert safety assessment and concern-level summary for Drometrizole Trisiloxane.
Regulatory Flags
uv-filter
uva-uvb
dual-peak
oil-soluble
photostable
eu-approved
not-fda-approved
mexoryl-xl
loreal-proprietary
mexoryl-system
trisiloxane-backbone
uva2-primary
uvb-secondary
eu_cosing_listed
Known Synonyms
Phenol, 2-(2H-benzotriazol-2-yl)-4-methyl-6-[2-methyl-3-[1,3,3,3-tetramethyl-1-[(trimethylsilyl)oxy]-1-disiloxanyl]propyl]-
Phenol, 2-(2H-benzotriazol-2-yl)-4-methyl-6-[2-methyl-3-[1,3,3,3-tetramethyl-1-[(trimethylsilyl)oxy]disiloxanyl]propyl]-
2-(2H-Benzotriazol-2-yl)-4-methyl-6-[2-methyl-3-[1,3,3,3-tetramethyl-1-[(trimethylsilyl)oxy]-1-disiloxanyl]propyl]phenol
2-(2H-Benzotriazol-2-yl)-4-methyl-6-[2-methyl-3-[1,3,3,3-tetramethyl-1-[(trimethylsilyl)oxy]disiloxanyl]propyl]phenol
OR 10154
EC 422-940-4
Chemical Function
UV stabilizer
Regulatory Lists
Canada; pharmaceutical
Europe; Personal care
Australian Status
AICIS status: listed_with_terms
Specific information requirements: Obligations to provide information apply. You must tell us within 28 days if the circumstances of your importation or manufacture (introduction) are different to those in our assessment.
Frequently Asked Questions
Is Drometrizole Trisiloxane allowed in the EU?
Drometrizole Trisiloxane EU regulatory status: permitted. Maximum allowed concentration: Approved under EU Cosmetics Regulation Annex VI; concentration limits apply. This is based on EU Regulation 1223/2009 and its amendments.
What does Drometrizole Trisiloxane do in cosmetics?
Drometrizole Trisiloxane functions as: Oil-soluble broad-spectrum UV filter; dual absorption peaks at ~303 nm (UVB) and ~344 nm (UVA2); provides oil-phase UVA coverage; synergistic with ecamsule (Mexoryl SX) to deliver full-spectrum UVA1+UVA2 protection in the L'Oréal Mexoryl system. It is classified as a Active Ingredient in our database. CAS number: 155633-54-8.
Compliance Tools
Check Drometrizole Trisiloxane compliance across multiple jurisdictions:
Ingredient Decoder
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82 Allergen Checker
Check for EU declarable fragrance allergens
Substance Compliance
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MoS Calculator
Calculate Margin of Safety using SCCS methodology
Heavy Metal Limits
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