Overview
Ensulizole, also known as 2-phenylbenzimidazole-5-sulfonic acid, is a water-soluble sunscreen agent that absorbs strongly at UV-B wavelengths. It is commonly found in cosmetic products and sunscreen formulas in combination with other UV filter compounds due to its minimal protection against UV-A wavelengths. Due to its water solubility, ensulizole is commonly used in products formulated to feel light and less oily . It was demonstrated by studies that ensulizole treatment provided protection against cyclobutane pyrimidine dimers and photosensitized the formation of oxidized guanine bases after UV-A or UV-B exposure . According to the FDA, the maximal approved concentration of ensulizole is 148 mM although concentrations ranging between 74 and 148mM can be found in commercial sunscreen products .
Indication
Indicated to be used as an UV-B-absorbing molecule in sunscreen formulations.
Associated Conditions
No associated conditions information available.
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 |
|---|---|---|---|---|---|
| AHAVA Dead Sea Laboratories Ltd | 60289-286 | TOPICAL | 0.5 g in 50 mL | 7/28/2025 |
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 |
|---|---|---|---|---|---|
| BHC Skin Care Facial Sunscreen SPF 50+ | 271593 | Medicine | A | 2/29/2016 | |
| Protection Plus Daily SPF50+ Broad Spectrum Cream | 226086 | Medicine | A | 7/22/2014 | |
| Clearskincare Sunscreen SPF30 | 371951 | Medicine | A | 8/2/2021 | |
| HYDRA UV PROTECT SPF 50+ | 411213 | Medicine | A | 6/26/2023 | |
| Face SPF 50+ Very High Protection UVA UVB Everyday Lotion Tinted - Hydrating | 481365 | Medicine | A | 3/3/2025 | |
| Ultra UV Protective Daily Moisturiser SPF 50 Mattifying | 343242 | Medicine | A | 9/10/2020 | |
| FAVE FLUID SPF50+ | 401273 | Medicine | A | 12/19/2022 | |
| SIMKA INVISIBLE FACIAL FLUID UVA + UVB BROAD SPECTRUM SPF 50 | 433392 | Medicine | A | 1/10/2024 | |
| To Save Face SPF 30 Facial Sunscreen | 432870 | Medicine | A | 1/8/2024 | |
| Photoderm Suncare Serum SPF50+ | 477153 | Medicine | A | 1/30/2025 |
Health Canada Drug Approvals
Approved Product | Company | DIN | Dosage Form | Strength | Market Date |
|---|---|---|---|---|---|
| OIL OF OLAY DAILY UV PROTECTANT MOIST CRM | procter & gamble inc | 01947400 | Cream - Topical | 1 % | 12/31/1992 |
| OLAY PROFESSIONAL PRO-X AGE PROTECTION LOTION WITH SPF 30 | procter & gamble inc | 02310414 | Lotion - Topical | 2 % / W/W | 2/5/2009 |
| MARCELLE HYDRA-C 24 H + SPF 15 FPS MOISTURIZING CREAM CRÈME HYDRATANTE DRY SKIN PEAUX SÈCHES | groupe marcelle inc | 02434768 | Cream - Topical | 2.0 % / W/W | 11/3/2015 |
| OLAY DEFINITY REFINING LOTION WITH UV PROTECTION | procter & gamble inc | 02270587 | Lotion - Topical | 1 % | 7/27/2006 |
| OLAY AGE DEFYING ANTI-WRINKLE - DAILY SPF 15 LOTION | procter & gamble inc | 02260328 | Suspension - Topical | 1 % | 2/9/2006 |
| MESOESTETIC SUN PROTECTION SPF 30 | tylstin medical | 02318911 | Cream - Topical | 2 % | 7/13/2009 |
| OIL OF OLAY PROTECTIVE MOISTURE LOTION | procter & gamble inc | 02231786 | Lotion - Topical | 1 % | 3/27/1998 |
| 15 SPF FPS PREMIUM SUNSCREEN | empack spraytech inc | 02264250 | Lotion - Topical | 2 % / W/W | 5/4/2005 |
| FPS 60 LOTION UV ULTRA-LÉGÈRE | vichy canada | 02518031 | Lotion - Topical | 0.5 % / W/W | 4/13/2022 |
| CC SUNSCREEN | the avon company canada limited | 02474581 | Cream - Topical | 3.5 % / W/W | 5/13/2019 |
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. | |||||
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