Overview
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 .
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 .
Associated Conditions
- Sunburn
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|
No clinical trials found
No clinical trials found for this drug
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| L'Oreal USA Products Inc | 49967-083 | TOPICAL | 5 mg in 1 mL | 12/31/2023 | |
| L'Oreal USA Products Inc | 49967-704 | TOPICAL | 5 mg in 1 mL | 12/31/2023 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
| No EMA approvals found for this drug. | |||
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No HSA approvals found for this drug. | |||||
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| No NMPA approvals found for this drug. | |||||
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| No PPB approvals found for this drug. | |||||
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| LA ROCHE-POSAY LABORATOIRE DERMATOLOGIQUE ANTHELIOS DRY TOUCH GEL CREME TINTED SPF50+ | 297587 | Medicine | A | 12/15/2017 | |
| LA ROCHE-POSAY LABORATOIRE DERMATOLOGIQUE ANTHELIOS XL DRY TOUCH GEL-CREAM SPF50+ | 308621 | Medicine | A | 8/24/2018 | |
| LA ROCHE-POSAY LABORATOIRE DERMATOLOGIQUE ANTHELIOS XL WET SKIN KIDS GEL CREAM SPF50+ | 300899 | Medicine | A | 3/16/2018 | |
| La Roche-Posay Laboratoire Dermatologique Anthelios XL Ultra-Light Spray SPF50+ | 300600 | Medicine | A | 3/9/2018 | |
| LA ROCHE POSAY LABORATOIRE DERMATOLOGIQUE ANTHELIOS KA+ SUNSCREEN SPF50+ | 404334 | Medicine | A | 2/3/2023 | |
| ANTHELIOS UVMUNE 400 ULTRA INVISIBLE FLUID | 495107 | Medicine | A | 6/30/2025 | |
| ANTHELIOS UVMUNE 400 KIDS INVISIBLE SPRAY | 495706 | Medicine | A | 7/1/2025 | |
| ANTHELIOS UVMUNE 400 KIDS INVISIBLE FLUID | 495707 | Medicine | A | 7/1/2025 | |
| LA ROCHE POSAY LABORATOIRE DERMATOLOGIQUE ANTHELIOS ULTRA TINTED BB CREAM SPF50+ | 307005 | Medicine | A | 7/13/2018 | |
| LA ROCHE-POSAY LABORATOIRE DERMATOLOGIQUE ANTHELIOS DRY TOUCH GEL CREME SPF50+ | 297590 | Medicine | A | 12/15/2017 |
Health Canada Drug Approvals
Approved Product | Company | DIN | Dosage Form | Strength | Market Date |
|---|---|---|---|---|---|
| ROSALIAC UV LEGERE | laboratoires la roche-posay canada | 02330792 | Cream - Topical | 1.0 % / W/W | 6/16/2010 |
| BLUE THERAPY MULTI-DEFENDER DRY SKIN | biotherm canada | 02461579 | Cream - Topical | 1.5 % / W/W | N/A |
| SHEER LOTION SPF 45 BARE SKIN FEEL | vichy canada | 02401924 | Lotion - Topical | 2.5 % / W/W | 4/8/2013 |
| FPS 60 CRÈME UV HYDRATANTE | vichy canada | 02280388 | Cream - Topical | 3.00 % / W/W | 4/20/2007 |
| FPS 30 LAIT SOLAIRE | biotherm canada | 02378485 | Cream - Topical | 1.0 % / W/W | 3/26/2012 |
| FPS 60 LOTION UV ULTRA-LÉGÈRE | vichy canada | 02518031 | Lotion - Topical | 7 % / W/W | 4/13/2022 |
| FACE ANTI-SHINE CREAM | ombrelle canada | 02489589 | Cream - Topical | 0.5 % / W/W | 2/19/2020 |
| ULTRA-FLUID BODY MILK SUN PROTECTION SPF 30 | biotherm canada | 02296829 | Lotion - Topical | 0.75 % | 4/1/2008 |
| ULTRA FLUIDE VISAGE | laboratoires la roche-posay canada | 02490021 | Lotion - Topical | 7 % / W/W | 4/15/2020 |
| UV+AGE DAILY | vichy canada | 02526239 | Lotion - Topical | 7 % / W/W | 1/24/2024 |
CIMA AEMPS Drug Approvals
Approved Product | Company | Registration Number | Pharmaceutical Form | Prescription Type | Status |
|---|---|---|---|---|---|
| No CIMA AEMPS (Spain) approvals found for this drug. | |||||
Philippines FDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Philippines FDA approvals found for this drug. | |||||
Saudi SFDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Saudi SFDA approvals found for this drug. | |||||
Malaysia NPRA Drug Approvals
Approved Product | Company | Registration Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Malaysia NPRA approvals found for this drug. | |||||
UK EMC Drug Information
Medicine Name | MA Holder | MA Number | Pharmaceutical Form | Active Ingredient | Authorization Date |
|---|---|---|---|---|---|
| No UK EMC drug information found for this drug. | |||||
Help Us Improve
Your feedback helps us provide better drug information and insights.