{"id":"bemotrizinol","rwe":[{"pmid":"41887574","year":"2026","title":"Breaking the Sunscreen Bottleneck: Regulatory Reform and Clinical Impact.","finding":"","journal":"Journal of the American Academy of Dermatology","studyType":"Clinical Study"},{"pmid":"41726609","year":"2026","title":"In Silico Perspective on Avobenzone, Octisalate, Octocrylene, Homosalate, and Bemotrizinol as Organic UV Filters Using DFT, TD-DFT, and Molecular Dynamics.","finding":"","journal":"ACS omega","studyType":"Clinical Study"},{"pmid":"41730063","year":"2006","title":"Sunscreens.","finding":"","journal":"","studyType":"Clinical Study"},{"pmid":"40931463","year":"2026","title":"New alternatives in photoprotection: Preparation and evaluation of lamellar silicate derivatives and their use as sunscreens.","finding":"","journal":"International journal of cosmetic science","studyType":"Clinical Study"},{"pmid":"40778531","year":"2025","title":"Modernizing U.S. Sunscreen Regulations: How Newer Filters Can Improve Public Health.","finding":"","journal":"Photodermatology, photoimmunology & photomedicine","studyType":"Clinical Study"}],"_fda":{"id":"2ab47dd5-c8aa-0224-e063-6394a90acee4","set_id":"2ab49052-085f-024e-e063-6394a90a81b8","openfda":{"nui":["N0000178375","N0000175788"],"unii":["K72T3FS567","G63QQF2NOX","PWZ1720CBH","9YQ9DI1W42","V06SV4M95S","25X51I8RD4","4Y5P7MUD51","4X49Y0596W","5A68WGF6WM"],"route":["TOPICAL"],"spl_id":["2ab47dd5-c8aa-0224-e063-6394a90acee4"],"brand_name":["Dr.Jucre Rebirth Sun Protection"],"spl_set_id":["2ab49052-085f-024e-e063-6394a90a81b8"],"package_ndc":["83071-150-01","83071-150-02"],"product_ndc":["83071-150"],"generic_name":["OCTINOXATE, HOMOSALATE, OCTISALATE, AVOBENZONE, ENSULIZOLE, OCTOCRYLENE, BEMOTRIZINOL, NIACINAMIDE, ADENOSINE"],"product_type":["HUMAN OTC DRUG"],"substance_name":["ADENOSINE","AVOBENZONE","BEMOTRIZINOL","ENSULIZOLE","HOMOSALATE","NIACINAMIDE","OCTINOXATE","OCTISALATE","OCTOCRYLENE"],"pharm_class_epc":["Adenosine Receptor Agonist [EPC]"],"pharm_class_moa":["Adenosine Receptor Agonists [MoA]"],"manufacturer_name":["NATURECELL CO., LTD."],"is_original_packager":[true]},"purpose":["PURPOSE Sunscreen Sunscreen Sunscreen Sunscreen Sunscreen Sunscreen Sunscreen Skin Brightening Anti wrinkle"],"version":"1","warnings":["WARNINGS For external use only. Avoid contact with eyes. Discontinue use if signs of irritation or rashes appear. Replace the cap after use. Refrain from using it on wounded areas. Keep out of reach of children."],"questions":["Questions ■ www.ibiostar.com ■ Tel (424)227-9568"],"effective_time":"20250102","active_ingredient":["ACTIVE INGREDIENTS Ethylhexyl Methoxycinnamate 7.30% Homosalate 6.00% Ethylhexyl Salicylate 4.50% Butyl Methoxydibenzoylmethane 4.00% Phenylbenzimidazole Sulfonic Acid 3.50% Octocrylene 2.00% Bis-Ethylhexyloxyphenol Methoxyphenyl Triazine 1.50% Niacinamide 2.0% Adenosine 0.04%"],"inactive_ingredient":["INACTIVE INGREDIENTS Water, Butylene Glycol, Dimethicone, Dipropylene Glycol, Hydrogenated Poly(C6-14 Olefin), Neopentyl Glycol Diheptanoate, Cyclopentasiloxane, Methyl Methacrylate Crosspolymer, Aminomethyl Propanol, Cyclohexasiloxane, Caprylyl Methicone, Human Adipose Derived Stem Cell Conditioned Media, Potassium Cetyl Phosphate, Triceteareth-4 Phosphate, Glycol Stearate, Cetearyl Alcohol, Glyceryl Stearate, PEG-100 Stearate, Silica, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, PEG-2 Stearate, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Phenoxyethanol, Glyceryl Caprylate, Santalum Album (Sandalwood) Oil, Caprylyl Glycol, Xanthan Gum, Polysorbate 60, Sorbitan Isostearate, Disodium EDTA, Hydroxypropyl Cyclodextrin, Plankton Extract, Thioctic Acid, 1,2-Hexanediol, Tremella Fuciformis (Mushroom) Extract, Potassium Hydroxide"],"indications_and_usage":["Uses ■ Helps prevent sun burn ■ Helps brighten skin tone ■ Helps improve wrinkle problem"],"other_safety_information":["Other Information ■ Do not store this product in an inappropriate place such as high or low temperatures or under direct sun light."],"dosage_and_administration":["Directions ■ Apply an appropriate amount evenly on the skin. ■ Apply liberally and uniformly to all exposed areas 15-20 minutes before sun exposure. Reapply often (every 2 hours) and after swimming, excessive perspiration and washing to ensure maximum sun protection."],"spl_product_data_elements":["Dr.Jucre Rebirth Sun Protection OCTINOXATE, HOMOSALATE, OCTISALATE, AVOBENZONE, ENSULIZOLE, OCTOCRYLENE, BEMOTRIZINOL, NIACINAMIDE, ADENOSINE WATER BUTYLENE GLYCOL DIMETHICONE OCTINOXATE OCTINOXATE HOMOSALATE HOMOSALATE OCTISALATE OCTISALATE AVOBENZONE AVOBENZONE ENSULIZOLE ENSULIZOLE OCTOCRYLENE OCTOCRYLENE BEMOTRIZINOL BEMOTRIZINOL NIACINAMIDE NIACINAMIDE ADENOSINE ADENOSINE"],"keep_out_of_reach_of_children":["KEEP OUT OF REACH OF CHILDREN Keep out of the reach of children."],"package_label_principal_display_panel":["Carton Image"]},"tags":[{"label":"bemotrizinol","category":"class"},{"label":"Small Molecule","category":"modality"},{"label":"Topical","category":"route"},{"label":"Cream","category":"form"},{"label":"Active","category":"status"},{"label":"Sunscreen agent","category":"indication"}],"phase":"marketed","safety":{"boxedWarnings":[]},"trials":[],"aliases":[],"patents":[],"pricing":[],"_sources":{"trials":{"url":"https://clinicaltrials.gov/search?intr=BEMOTRIZINOL","method":"api_direct","source":"ClinicalTrials.gov","rawText":"","confidence":1,"sourceType":"ctgov","retrievedAt":"2026-04-19T23:45:09.097992+00:00"},"regulatory.ca":{"url":"","method":"api_direct","source":"Health Canada DPD","rawText":"","confidence":1,"sourceType":"health_canada_dpd","retrievedAt":"2026-04-19T23:45:15.530432+00:00"},"publicationCount":{"url":"https://pubmed.ncbi.nlm.nih.gov/?term=BEMOTRIZINOL","method":"api_direct","source":"PubMed/NCBI","rawText":"","confidence":1,"sourceType":"pubmed","retrievedAt":"2026-04-19T23:45:15.853211+00:00"},"mechanism.drugClass":{"url":"https://api.fda.gov/drug/label.json","method":"deterministic","source":"FDA Label (EPC)","rawText":"","confidence":1,"sourceType":"fda_label","retrievedAt":"2026-04-19T23:45:07.821175+00:00"},"administration.route":{"url":"","method":"deterministic","source":"FDA Label","rawText":"","confidence":1,"sourceType":"fda_label","retrievedAt":"2026-04-19T23:45:07.821215+00:00"},"safety.boxedWarnings":{"url":"","method":"deterministic","source":"FDA Label (no boxed warning)","rawText":"","confidence":1,"sourceType":"fda_label","retrievedAt":"2026-04-19T23:45:07.821220+00:00"},"crossReferences.chemblId":{"url":"https://www.ebi.ac.uk/chembl/compound_report_card/CHEMBL2104956/","method":"api_direct","source":"ChEMBL (EMBL-EBI)","rawText":"","confidence":1,"sourceType":"chembl","retrievedAt":"2026-04-19T23:45:16.583973+00:00"}},"allNames":"tinosorb s","offLabel":[],"synonyms":["bemotrizinol","Tinosorb S"],"timeline":[],"aiSummary":"Tinosorb S, also known as bemotrizinol, is a small molecule sunscreen agent developed by a pharmaceutical company. It is used to protect the skin from the sun's ultraviolet (UV) rays. As a patented product, its commercial status is not yet generic. Key safety considerations include its potential to cause skin irritation and allergic reactions. Tinosorb S is used to prevent sunburn and reduce the risk of skin cancer.","brandName":"Tinosorb S","ecosystem":[{"indication":"Sunscreen agent","otherDrugs":[{"name":"ensulizole","slug":"ensulizole","company":""},{"name":"sulisobenzone","slug":"sulisobenzone","company":""}],"globalPrevalence":null}],"mechanism":{"modality":"Small Molecule","drugClass":"Adenosine Receptor Agonist [EPC]","explanation":"","oneSentence":"","technicalDetail":"Tinosorb S, a bemotrizinol derivative, acts as a UV-A and UV-B absorber, with a peak absorption wavelength of around 360 nm, providing broad-spectrum protection against UVA and UVB radiation."},"commercial":{},"references":[{"id":1,"url":"https://drugcentral.org/drugcard/3014","fields":["approvals","synonyms","ATC","PK","indications","contraindications","DDIs","targets","patents","FAERS"],"source":"DrugCentral"},{"id":2,"url":"https://clinicaltrials.gov/search?intr=BEMOTRIZINOL","fields":["trials"],"source":"ClinicalTrials.gov"},{"id":3,"url":"https://pubmed.ncbi.nlm.nih.gov/?term=BEMOTRIZINOL","fields":["publications"],"source":"PubMed/NCBI"}],"_enrichedAt":"2026-03-30T08:50:17.955889","_validation":{"fieldsValidated":0,"lastValidatedAt":"2026-04-19T23:45:18.631115+00:00","fieldsConflicting":1,"overallConfidence":0.8},"biosimilars":[],"competitors":[],"genericName":"bemotrizinol","indications":{"approved":[{"name":"Sunscreen agent","source":"DrugCentral","snomedId":49663007,"regulator":"FDA","eligibility":"all ages, no specific eligibility criteria mentioned"}],"offLabel":[],"pipeline":[]},"drugCategory":"active","labelChanges":[],"relatedDrugs":[],"trialDetails":[{"nctId":"NCT05277376","phase":"PHASE3","title":"Pharmacokinetic (PK) Evaluation of Bemotrizinol (6%) in a Sunscreen Maximum Usage Trial","status":"COMPLETED","sponsor":"dsm-firmenich Switzerland AG","startDate":"2022-03-15","conditions":["Pharmacokinetics","Absorption; Chemicals"],"enrollment":162,"completionDate":"2022-10-28"},{"nctId":"NCT05260359","phase":"PHASE2","title":"Dermal Irritation, Sensitization and Cumulative Irritation Potential of 6% Bemotrizinol","status":"COMPLETED","sponsor":"dsm-firmenich Switzerland AG","startDate":"2022-02-23","conditions":["Sunburn"],"enrollment":224,"completionDate":"2022-04-08"},{"nctId":"NCT05254925","phase":"PHASE2","title":"Phototoxicity Potential of 6% Bemotrizinol","status":"COMPLETED","sponsor":"dsm-firmenich Switzerland AG","startDate":"2022-02-28","conditions":["Phototoxic Response"],"enrollment":34,"completionDate":"2022-04-03"},{"nctId":"NCT05254912","phase":"PHASE2","title":"Photoallergic Potential of 6% Bemotrizinol","status":"COMPLETED","sponsor":"dsm-firmenich Switzerland AG","startDate":"2022-03-07","conditions":["Photoallergic Response"],"enrollment":50,"completionDate":"2022-04-22"},{"nctId":"NCT04355286","phase":"PHASE1","title":"Bemotrizinol UV Filter Part 1 Clinical PK Evaluation in Topical MUsT Study","status":"COMPLETED","sponsor":"dsm-firmenich Switzerland AG","startDate":"2020-11-03","conditions":["Absorption; Chemicals","Sunscreening Agents"],"enrollment":14,"completionDate":"2020-11-17"},{"nctId":"NCT01695356","phase":"PHASE4","title":"Ultraviolet and UV-Visible Light Photoprotection for the Treatment of Melasma","status":"COMPLETED","sponsor":"Universidad Autonoma de San Luis Potosí","startDate":"2012-09","conditions":["Melasma"],"enrollment":68,"completionDate":"2013-11"},{"nctId":"NCT00530387","phase":"NA","title":"Multi-Centre European Photopatch Test Study","status":"COMPLETED","sponsor":"NHS Tayside","startDate":"2008-07","conditions":["Dermatitis, Photocontact"],"enrollment":1000,"completionDate":"2011-07"}],"genericFilers":[],"latestUpdates":[],"manufacturing":[],"administration":{"route":"Topical","formulation":"Cream","formulations":[{"form":"CREAM","route":"TOPICAL","productName":"Anubis Barcelona Protective Line"},{"form":"CREAM","route":"TOPICAL","productName":"AnubisMed"},{"form":"CREAM","route":"TOPICAL","productName":"Homme Aqua Sun Block SPF50 Plus PA 2Plus"},{"form":"CREAM","route":"TOPICAL","productName":"SPA SKILHA HELIOPROT AB SPF 40"},{"form":"CREAM","route":"TOPICAL","productName":"CELGEN MILD SUN"},{"form":"CREAM","route":"TOPICAL","productName":"Codenature Viami Tone Up Shield Cream"},{"form":"CREAM","route":"TOPICAL","productName":"ELROEL Pang Pang Big Sun Cushion S7"},{"form":"CREAM","route":"TOPICAL","productName":"ELROEL Pang Pang Mini Sun Cushion S7"},{"form":"CREAM","route":"TOPICAL","productName":"LAPOTHICELL Sunscreen"},{"form":"CREAM","route":"TOPICAL","productName":"OHUI SUN SCIENCE Perfect Sunblock Blue EX plus"},{"form":"CREAM","route":"TOPICAL","productName":"OHUI SUNSCIENCE LUMINOUS WHITENING SUNBLOCK"},{"form":"CREAM","route":"TOPICAL","productName":"OHUI Sun Science intensive sunblock cake EX"},{"form":"CREAM","route":"TOPICAL","productName":"Ph.Hubby 1g Sun Cream Intensive Protection"},{"form":"CREAM","route":"TOPICAL","productName":"Ph.Hubby Beige BB Tone Up Sun"},{"form":"CREAM","route":"TOPICAL","productName":"Ph.Hubby Pink BB Tone Up Sun"}]},"crossReferences":{"NDDF":"015431","UNII":"PWZ1720CBH","CHEBI":"CHEBI:135857","INN_ID":"8585","RXNORM":"1306115","UMLSCUI":"C2698346","chemblId":"CHEMBL2104956","ChEMBL_ID":"CHEMBL2104956","KEGG_DRUG":"D03227","DRUGBANK_ID":"DB11206","PUBCHEM_CID":"135487856","MESH_SUPPLEMENTAL_RECORD_UI":"C439083"},"formularyStatus":[],"_enricherVersion":"v2","developmentCodes":[],"ownershipHistory":[],"publicationCount":24,"therapeuticAreas":["Oncology"],"biosimilarFilings":[],"recentPublications":[{"date":"2026 Mar 24","pmid":"41887574","title":"Breaking the Sunscreen Bottleneck: Regulatory Reform and Clinical Impact.","journal":"Journal of the American Academy of Dermatology"},{"date":"2026 Feb 17","pmid":"41726609","title":"In Silico Perspective on Avobenzone, Octisalate, Octocrylene, Homosalate, and Bemotrizinol as Organic UV Filters Using DFT, TD-DFT, and Molecular Dynamics.","journal":"ACS omega"},{"date":"2006","pmid":"41730063","title":"Sunscreens.","journal":""},{"date":"2026 Feb","pmid":"40931463","title":"New alternatives in photoprotection: Preparation and evaluation of lamellar silicate derivatives and their use as sunscreens.","journal":"International journal of cosmetic science"},{"date":"2025 Sep","pmid":"40778531","title":"Modernizing U.S. Sunscreen Regulations: How Newer Filters Can Improve Public Health.","journal":"Photodermatology, photoimmunology & photomedicine"}],"companionDiagnostics":[],"genericManufacturerList":[],"status":"active","companyName":"","companyId":"","modality":"Small molecule","firstApprovalDate":"","enrichmentLevel":3,"visitCount":0,"regulatoryByCountry":[{"country_code":"CA","regulator":"Health Canada","status":"approved","approval_date":null,"mah":"","brand_name_local":"","application_number":""},{"country_code":"US","regulator":"FDA","status":"approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null}],"trialStats":{"total":0,"withResults":0},"validation":{"fieldsValidated":0,"lastValidatedAt":"2026-04-19T23:45:18.631115+00:00","fieldsConflicting":1,"overallConfidence":0.8},"verificationStatus":"partial","dataCompleteness":{"mechanism":false,"indications":true,"safety":false,"trials":true,"score":2}}