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Chemistry

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Also known as: 155633-54-8, Silatrizole, Mexoryl xl, Drometrizole trisiloxane [inci], Drometrizole trisiloxane [who-dd], 2-(benzotriazol-2-yl)-4-methyl-6-[2-methyl-3-[methyl-bis(trimethylsilyloxy)silyl]propyl]phenol
Molecular Formula
C24H39N3O3Si3
Molecular Weight
501.8  g/mol
InChI Key
HUVYTMDMDZRHBN-UHFFFAOYSA-N
FDA UNII
HC22845I1X

Silatrizole
Drometrizole trisiloxane is a photostable UVA and UVB light filter. The compound is a lipophilic benzotriazole derivative marketed as Meroxyl XL by L'Oreal, although sunscreens with drometrizole trisiloxane are currently only approved for use in the EU, Canada, Australia, and Japan, among other countries. Despite being used elsewhere in the world with relatively few reports of adverse reactions, the FDA continues to cite that the existing scientific record is not sufficient to establish the compound as being generally recognized as safe and effective for over-the-counter sunscreen use.
1 2D Structure

Silatrizole

2 Identification
2.1 Computed Descriptors
2.1.1 IUPAC Name
2-(benzotriazol-2-yl)-4-methyl-6-[2-methyl-3-[methyl-bis(trimethylsilyloxy)silyl]propyl]phenol
2.1.2 InChI
InChI=1S/C24H39N3O3Si3/c1-18-14-20(15-19(2)17-33(9,29-31(3,4)5)30-32(6,7)8)24(28)23(16-18)27-25-21-12-10-11-13-22(21)26-27/h10-14,16,19,28H,15,17H2,1-9H3
2.1.3 InChI Key
HUVYTMDMDZRHBN-UHFFFAOYSA-N
2.1.4 Canonical SMILES
CC1=CC(=C(C(=C1)N2N=C3C=CC=CC3=N2)O)CC(C)C[Si](C)(O[Si](C)(C)C)O[Si](C)(C)C
2.2 Other Identifiers
2.2.1 UNII
HC22845I1X
2.3 Synonyms
2.3.1 MeSH Synonyms

1. Mexoryl Xl

2. Silatrizole

2.3.2 Depositor-Supplied Synonyms

1. 155633-54-8

2. Silatrizole

3. Mexoryl Xl

4. Drometrizole Trisiloxane [inci]

5. Drometrizole Trisiloxane [who-dd]

6. 2-(benzotriazol-2-yl)-4-methyl-6-[2-methyl-3-[methyl-bis(trimethylsilyloxy)silyl]propyl]phenol

7. Or 10154

8. Or-10154

9. Hc22845i1x

10. Phenol, 2-(2h-benzotriazol-2-yl)-4-methyl-6-(2-methyl-3-(1,3,3,3-tetramethyl-1-((trimethylsilyl)oxy)-1-disiloxanyl)propyl)-

11. Phenol, 2-(2h-benzotriazol-2-yl)-4-methyl-6-(2-methyl-3-(1,3,3,3-tetramethyl-1-((trimethylsilyl)oxy)disiloxanyl)propyl)-

12. 2-(2h-benzo[d][1,2,3]triazol-2-yl)-6-(3-(1,1,1,3,5,5,5-heptamethyltrisiloxan-3-yl)-2-methylpropyl)-4-methylphenol

13. Phenol, 2-(2h-benzotriazol-2-yl)-4-methyl-6-[2-methyl-3-[1,3,3,3-tetramethyl-1-[(trimethylsilyl)oxy]-1-disiloxanyl]propyl]-

14. Unii-hc22845i1x

15. Mexoryl Xl;silatrizole

16. Schembl15380

17. Amy224

18. Dtxsid40431753

19. Act12435

20. Bcp28866

21. Db11585

22. Drometrizole Trisiloxane [usp-rs]

23. Ncgc00532508-01

24. Db-091411

25. Drometrizole Trisiloxane, Analytical Standard

26. Q5308268

27. Drometrizole Trisiloxane, United States Pharmacopeia (usp) Reference Standard

28. 2-(2h-benzotriazol-2-yl)-4-methyl-6-(2-methyl-3-(1,3,3,3-tetramethyl-1-(trimethylsilyloxy)-disiloxanyl)propyl)phenol

29. 320341-73-9

2.4 Create Date
2006-10-25
3 Chemical and Physical Properties
Molecular Weight 501.8 g/mol
Molecular Formula C24H39N3O3Si3
Hydrogen Bond Donor Count1
Hydrogen Bond Acceptor Count5
Rotatable Bond Count9
Exact Mass501.22992172 g/mol
Monoisotopic Mass501.22992172 g/mol
Topological Polar Surface Area69.4 Ų
Heavy Atom Count33
Formal Charge0
Complexity613
Isotope Atom Count0
Defined Atom Stereocenter Count0
Undefined Atom Stereocenter Count1
Defined Bond Stereocenter Count0
Undefined Bond Stereocenter Count0
Covalently Bonded Unit Count1
4 Drug and Medication Information
4.1 Drug Indication

Drometrizole trisiloxane is used as an active ingredient in various sunscreens for the indication of protecting the skin by absorbing the damaging UV radiation of sunlight.


5 Pharmacology and Biochemistry
5.1 Pharmacology

As an active ingredient in sunscreen products, drometrizole trisiloxane is applied directly onto human skin where it acts as a chemical sunscreen layer between skin and sunlight that also directly absorbs the UV sunlight radiation. Since drometrizole trisiloxane is also considered to have little to no absorption through the skin, little systemic exposure and pharmacokinetics are expected and users can freely wash off and re-apply the compound as necessary.


5.2 Absorption, Distribution and Excretion

Absorption

Drometrizole trisiloxane is reported as having little to no absorption through the skin. At this time, however, studies demonstrate that the components of most commonly used sunscreens are likely absorbed into the skin at least to some extent - although penetration to deeper tissues and the cutaneous circulation remains limited. Despite the extensive use of sunscreen products around the world, there have been few reports of adverse effects related to their use.


Route of Elimination

Drometrizole trisiloxane is reported as having little to no absorption through the skin. The systemic presence of the compound is consequently expected to be minimal.


Volume of Distribution

Drometrizole trisiloxane is reported as having little to no absorption through the skin. The systemic presence of the compound is consequently expected to be minimal.


Clearance

Drometrizole trisiloxane is reported as having little to no absorption through the skin. The systemic presence of the compound is consequently expected to be minimal.


5.3 Metabolism/Metabolites

Drometrizole trisiloxane is reported as having little to no absorption through the skin. The systemic presence of the compound is consequently expected to be minimal.


5.4 Biological Half-Life

Drometrizole trisiloxane is reported as having little to no absorption through the skin. The systemic presence of the compound is consequently expected to be minimal.


5.5 Mechanism of Action

Ultraviolet radiation is the invisible energy component to sunlight and consists of three wavelength ranges: (a) UVA is long-range UV radiation between 320-400nm. Although not as energetic as UVB, UVA can penetrate deep into the dermis. UVA can cause immediate tanning, premature skin aging, and can also play a role in the formation of some skin cancers. Approximately 95% of UVA from the sun passes through Earth's ozone layer. (b) UVB is short-wavelength UV radiation between 280-320nm. It is capable of penetrating the outer protective layer of the skin and is responsible for delayed tanning, sunburns, and most skin cancers. A large amount of UVB is absorbed by the ozone layer, however, as only 5% reaches the Earth's surface. (c) UVC is comprised of wavelengths between 100-280nm and is very energetic. It is very dangerous to all forms of life, even when the exposure is short. However, UVC radiation is generally filtered out by the ozone layer and never reaches the Earth. Ultimately, the shorter the wavelength, the more harmful the UV radiation - although shorter wavelength UV radiation is less able to penetrate the skin. Subsequently, drometrizole trisiloxane is a broad spectrum lipophilic benzotriazole derivative chemical sunscreen that is capable of absorbing UVA and UVB radiation. It is also photostable, meaning that it will not degrade in the presence of sunlight, unlike other UV filters like the widely used UVA absorber avobenzone. When combined with the UV blocker ecamsule, it has been shown that the two UV blockers elicit a synergistic effect involving an enhanced protective action for the skin against UVA and UVB radiation. Additionally, drometrizole trisiloxane is usually combined with other active sunscreen agents like titanium dioxide, avobenzone, and others to ensure the combined product covers or protects against as broad a spectrum of UV radiation as possible, considering drometrizole trisiloxane does not absorb against the entire range of UV radiation. And finally, at the molecular level, it is believed that the general structure of various UV blockers like drometrizole trisiloxane as aromatic molecules conjugated with carbonyl groups is capable of absorbing high energy ultraviolet rays and then consequently releasing that energy as less harmful, lower energy rays.


FDF Dossiers

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DROMETRIZOLE TRISILOXANE

Brand Name : SPF 60 ANTHELIOS XL LOTION

Dosage Form : LOTION

Dosage Strength : 2.5%/W/W

Packaging : 100ML

Approval Date :

Application Number : 2402157

Regulatory Info : NON-PRESCRIPTION DRUGS

Registration Country : Canada

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DROMETRIZOLE TRISILOXANE

Brand Name : OMBRELLE CREAM SPF 60

Dosage Form : CREAM

Dosage Strength : 3%

Packaging : 75ML

Approval Date :

Application Number : 2280353

Regulatory Info : NON-PRESCRIPTION DRUGS

Registration Country : Canada

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DROMETRIZOLE TRISILOXANE

Brand Name : SPF 45 SPORT CLEAR CONTINUOUS SPRAY

Dosage Form : AEROSOL

Dosage Strength : 1%

Packaging : 140ML

Approval Date :

Application Number : 2374196

Regulatory Info : NON-PRESCRIPTION DRUGS

Registration Country : Canada

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DROMETRIZOLE TRISILOXANE

Brand Name : SPORT CLEAR SPRAY SUNSCREEN

Dosage Form : AEROSOL

Dosage Strength : 2%/W/W

Packaging :

Approval Date :

Application Number : 2374218

Regulatory Info : NON-PRESCRIPTION DRUGS

Registration Country : Canada

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DROMETRIZOLE TRISILOXANE

Brand Name : FPS 30 SOIN COMPLET

Dosage Form : LOTION

Dosage Strength : 2.5%/W/W

Packaging : 240ML

Approval Date :

Application Number : 2410044

Regulatory Info : NON-PRESCRIPTION DRUGS

Registration Country : Canada

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DROMETRIZOLE TRISILOXANE

Brand Name : FPS 60 SOIN COMPLET

Dosage Form : LOTION

Dosage Strength : 2.5%/W/W

Packaging : 240ML

Approval Date :

Application Number : 2410060

Regulatory Info : NON-PRESCRIPTION DRUGS

Registration Country : Canada

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DROMETRIZOLE TRISILOXANE

Brand Name : SPF 30 SPORT ENDURANCE

Dosage Form : LOTION

Dosage Strength : 0.5%/W/W

Packaging : 231ML

Approval Date :

Application Number : 2447770

Regulatory Info : NON-PRESCRIPTION DRUGS

Registration Country : Canada

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DROMETRIZOLE TRISILOXANE

Brand Name : SPF 60 SPORT ENDURANCE

Dosage Form : LOTION

Dosage Strength : 0.5%/W/W

Packaging : 231ML

Approval Date :

Application Number : 2447843

Regulatory Info : NON-PRESCRIPTION DRUGS

Registration Country : Canada

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DROMETRIZOLE TRISILOXANE

Brand Name : ULTRA LIGHT ADVANCED CONTINUOUS SPRAY LOTION

Dosage Form : LOTION

Dosage Strength : 0.5%/W/W

Packaging :

Approval Date :

Application Number : 2448718

Regulatory Info : NON-PRESCRIPTION DRUGS

Registration Country : Canada

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DROMETRIZOLE TRISILOXANE

Brand Name : BARE SKIN FEEL UV LOTION

Dosage Form : LOTION

Dosage Strength : 2.5%/W/W

Packaging : 150ML

Approval Date :

Application Number : 2401916

Regulatory Info : NON-PRESCRIPTION DRUGS

Registration Country : Canada

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Canada

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DROMETRIZOLE TRISILOXANE

Brand Name : FPS 30 SOIN COMPLET

Dosage Form : LOTION

Dosage Strength : 2.5%/W/W

Packaging : 240ML

Approval Date :

Application Number : 2410044

Regulatory Info : NON-PRESCRIPTION DRUGS

Registration Country : Canada

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DROMETRIZOLE TRISILOXANE

Brand Name : SPF 60 SPORT ENDURANCE

Dosage Form : LOTION

Dosage Strength : 0.5%/W/W

Packaging : 231ML

Approval Date :

Application Number : 2447843

Regulatory Info : NON-PRESCRIPTION DRUGS

Registration Country : Canada

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DROMETRIZOLE TRISILOXANE

Brand Name : COMPLETE* DRY TOUCH SUNSCREEN/ÉCRAN SOLAIRE

Dosage Form : LOTION

Dosage Strength : 0.5%/W/W

Packaging :

Approval Date :

Application Number : 2461048

Regulatory Info : NON-PRESCRIPTION DRUGS

Registration Country : Canada

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DROMETRIZOLE TRISILOXANE

Brand Name : SPF 50+ KIDS (80 MINUTES) WATER RESISTANT

Dosage Form : SPRAY

Dosage Strength : 0.5%/W/W

Packaging : 122G

Approval Date :

Application Number : 2464322

Regulatory Info : NON-PRESCRIPTION DRUGS

Registration Country : Canada

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DROMETRIZOLE TRISILOXANE

Brand Name : COMPLETE SENSITIVE ADVANCED [80 MINUTES] WATER/SWEAT RESISTANT LOTION SPF 60

Dosage Form : LOTION

Dosage Strength : 0.5%/W/W

Packaging : 200ML

Approval Date :

Application Number : 2465884

Regulatory Info : NON-PRESCRIPTION DRUGS

Registration Country : Canada

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DROMETRIZOLE TRISILOXANE

Brand Name : FACE ANTI-SHINE CREAM

Dosage Form : CREAM

Dosage Strength : 0.5%/W/W

Packaging :

Approval Date :

Application Number : 2489589

Regulatory Info : NON-PRESCRIPTION DRUGS

Registration Country : Canada

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DROMETRIZOLE TRISILOXANE

Brand Name : SENSITIVE EXPERT+ FACE

Dosage Form : CREAM

Dosage Strength : 0.5%/W/W

Packaging :

Approval Date :

Application Number : 2507439

Regulatory Info : NON-PRESCRIPTION DRUGS

Registration Country : Canada

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DROMETRIZOLE TRISILOXANE

Brand Name : ULTRA LIGHT ADVANCED LOTION

Dosage Form : LOTION

Dosage Strength : 7%/W/W

Packaging :

Approval Date :

Application Number : 2509237

Regulatory Info : NON-PRESCRIPTION DRUGS

Registration Country : Canada

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DROMETRIZOLE TRISILOXANE

Brand Name : BARE SKIN FEEL UV LOTION

Dosage Form : LOTION

Dosage Strength : 2.5%/W/W

Packaging : 150ML

Approval Date :

Application Number : 2401916

Regulatory Info : NON-PRESCRIPTION DRUGS

Registration Country : Canada

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DROMETRIZOLE TRISILOXANE

Brand Name : ANTI-SHINE DRY TOUCH UV LOTION

Dosage Form : LOTION

Dosage Strength : 0.5%/W/W

Packaging : 50ML

Approval Date :

Application Number : 2466406

Regulatory Info : NON-PRESCRIPTION DRUGS

Registration Country : Canada

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ABOUT THIS PAGE

Looking for 320341-73-9 / Silatrizole API manufacturers, exporters & distributors?

Silatrizole manufacturers, exporters & distributors 1

32

PharmaCompass offers a list of Silatrizole API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, and more, enabling you to easily find the right Silatrizole manufacturer or Silatrizole supplier for your needs.

Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Silatrizole manufacturer or Silatrizole supplier.

API | Excipient name

Silatrizole

Synonyms

155633-54-8, Mexoryl xl, Drometrizole trisiloxane [inci], Drometrizole trisiloxane [who-dd], 2-(benzotriazol-2-yl)-4-methyl-6-[2-methyl-3-[methyl-bis(trimethylsilyloxy)silyl]propyl]phenol, Or 10154

Cas Number

320341-73-9

Unique Ingredient Identifier (UNII)

HC22845I1X

About Silatrizole

Drometrizole trisiloxane is a photostable UVA and UVB light filter. The compound is a lipophilic benzotriazole derivative marketed as Meroxyl XL by L'Oreal, although sunscreens with drometrizole trisiloxane are currently only approved for use in the EU, Canada, Australia, and Japan, among other countries. Despite being used elsewhere in the world with relatively few reports of adverse reactions, the FDA continues to cite that the existing scientific record is not sufficient to establish the compound as being generally recognized as safe and effective for over-the-counter sunscreen use.

Drometrizole trisiloxane [INCI] Manufacturers

A Drometrizole trisiloxane [INCI] manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Drometrizole trisiloxane [INCI], including repackagers and relabelers. The FDA regulates Drometrizole trisiloxane [INCI] manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Drometrizole trisiloxane [INCI] API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.

Drometrizole trisiloxane [INCI] Suppliers

A Drometrizole trisiloxane [INCI] supplier is an individual or a company that provides Drometrizole trisiloxane [INCI] active pharmaceutical ingredient (API) or Drometrizole trisiloxane [INCI] finished formulations upon request. The Drometrizole trisiloxane [INCI] suppliers may include Drometrizole trisiloxane [INCI] API manufacturers, exporters, distributors and traders.

Drometrizole trisiloxane [INCI] GMP

Drometrizole trisiloxane [INCI] Active pharmaceutical ingredient (API) is produced in GMP-certified manufacturing facility.

GMP stands for Good Manufacturing Practices, which is a system used in the pharmaceutical industry to make sure that goods are regularly produced and monitored in accordance with quality standards. The FDA’s current Good Manufacturing Practices requirements are referred to as cGMP or current GMP which indicates that the company follows the most recent GMP specifications. The World Health Organization (WHO) has its own set of GMP guidelines, called the WHO GMP. Different countries can also set their own guidelines for GMP like China (Chinese GMP) or the EU (EU GMP).

PharmaCompass offers a list of Drometrizole trisiloxane [INCI] GMP manufacturers, exporters & distributors, which can be sorted by USDMF, JDMF, KDMF, CEP (COS), WC, and more, enabling you to easily find the right Drometrizole trisiloxane [INCI] GMP manufacturer or Drometrizole trisiloxane [INCI] GMP API supplier for your needs.

Drometrizole trisiloxane [INCI] CoA

A Drometrizole trisiloxane [INCI] CoA (Certificate of Analysis) is a formal document that attests to Drometrizole trisiloxane [INCI]'s compliance with Drometrizole trisiloxane [INCI] specifications and serves as a tool for batch-level quality control.

Drometrizole trisiloxane [INCI] CoA mostly includes findings from lab analyses of a specific batch. For each Drometrizole trisiloxane [INCI] CoA document that a company creates, the USFDA specifies specific requirements, such as supplier information, material identification, transportation data, evidence of conformity and signature data.

Drometrizole trisiloxane [INCI] may be tested according to a variety of international standards, such as European Pharmacopoeia (Drometrizole trisiloxane [INCI] EP), Drometrizole trisiloxane [INCI] JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Drometrizole trisiloxane [INCI] USP).

Inform the supplier about your product requirements, specifying if you need a product with particular monograph like EP (Ph. Eur.), USP, JP, BP, or any other quality. In addition, clarify whether you need hydrochloride (HCl), anhydricum, base, micronisatum or a specific level of purity. To find reputable suppliers, utilize the filters and select those certified by GMP, FDA, or any other certification as per your requirement.
For your convenience, we have listed synonyms and CAS numbers to help you find the best supplier. The use of synonyms and CAS numbers can be helpful in identifying potential suppliers, but it is crucial to note that they might not always indicate the exact same product. It is important to confirm the product details with the supplier before making a purchase to ensure that it meets your requirements.
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