{"id":"avobenzone","rwe":[],"tags":[{"label":"avobenzone","category":"class"},{"label":"Small Molecule","category":"modality"},{"label":"Tyrosinase","category":"target"},{"label":"TYR","category":"gene"},{"label":"Topical","category":"route"},{"label":"Aerosol","category":"form"},{"label":"Active","category":"status"},{"label":"Bayer Healthcare Llc","category":"company"},{"label":"Approved 1990s","category":"decade"},{"label":"Cosmetics","category":"pharmacology"},{"label":"Dermatologic Agents","category":"pharmacology"},{"label":"Protective Agents","category":"pharmacology"},{"label":"Radiation-Protective Agents","category":"pharmacology"},{"label":"Sunscreening Agents","category":"pharmacology"}],"phase":"marketed","safety":{"safetySignals":[{"llr":795.966,"date":"","count":264,"signal":"Macular degeneration","source":"DrugCentral FAERS","actionTaken":"Reported 264 times (LLR=796)"},{"llr":279.084,"date":"","count":140,"signal":"Therapy interrupted","source":"DrugCentral FAERS","actionTaken":"Reported 140 times (LLR=279)"},{"llr":240.591,"date":"","count":94,"signal":"Chronic sinusitis","source":"DrugCentral FAERS","actionTaken":"Reported 94 times (LLR=241)"},{"llr":217.677,"date":"","count":98,"signal":"Paraesthesia oral","source":"DrugCentral FAERS","actionTaken":"Reported 98 times (LLR=218)"},{"llr":208.379,"date":"","count":98,"signal":"Procedural pain","source":"DrugCentral FAERS","actionTaken":"Reported 98 times (LLR=208)"},{"llr":161.781,"date":"","count":100,"signal":"Therapy cessation","source":"DrugCentral FAERS","actionTaken":"Reported 100 times (LLR=162)"},{"llr":150.299,"date":"","count":382,"signal":"Death","source":"DrugCentral FAERS","actionTaken":"Reported 382 times (LLR=150)"},{"llr":124.567,"date":"","count":39,"signal":"Vaginal flatulence","source":"DrugCentral FAERS","actionTaken":"Reported 39 times (LLR=125)"},{"llr":116.471,"date":"","count":33,"signal":"Body tinea","source":"DrugCentral FAERS","actionTaken":"Reported 33 times (LLR=116)"},{"llr":105.197,"date":"","count":42,"signal":"Female genital tract fistula","source":"DrugCentral FAERS","actionTaken":"Reported 42 times (LLR=105)"},{"llr":94.727,"date":"","count":44,"signal":"Radiculopathy","source":"DrugCentral FAERS","actionTaken":"Reported 44 times (LLR=95)"},{"llr":94.418,"date":"","count":40,"signal":"Proctitis","source":"DrugCentral FAERS","actionTaken":"Reported 40 times (LLR=94)"},{"llr":92.198,"date":"","count":33,"signal":"Infection susceptibility increased","source":"DrugCentral FAERS","actionTaken":"Reported 33 times (LLR=92)"},{"llr":89.68,"date":"","count":33,"signal":"Inhibitory drug interaction","source":"DrugCentral FAERS","actionTaken":"Reported 33 times (LLR=90)"},{"llr":87.758,"date":"","count":39,"signal":"Vaginal discharge","source":"DrugCentral FAERS","actionTaken":"Reported 39 times (LLR=88)"}],"commonSideEffects":[{"effect":"Nausea","drugRate":"≥20%","severity":"common"},{"effect":"Vomiting","drugRate":"≥20%","severity":"common"},{"effect":"Diarrhea","drugRate":"≥20%","severity":"common"},{"effect":"Abdominal pain","drugRate":"≥20%","severity":"common"},{"effect":"Fatigue","drugRate":"≥20%","severity":"common"},{"effect":"Headache","drugRate":"≥20%","severity":"common"},{"effect":"Dizziness","drugRate":"≥20%","severity":"common"},{"effect":"Insomnia","drugRate":"≥20%","severity":"common"},{"effect":"Anxiety","drugRate":"≥20%","severity":"common"},{"effect":"Depression","drugRate":"≥20%","severity":"common"},{"effect":"Suicidal ideation","drugRate":"≥20%","severity":"serious"},{"effect":"Suicidal behavior","drugRate":"≥20%","severity":"serious"},{"effect":"Suicide","drugRate":"≥20%","severity":"serious"},{"effect":"Hypersensitivity reactions","drugRate":"≥10%","severity":"serious"},{"effect":"Hypersensitivity","drugRate":"≥10%","severity":"serious"},{"effect":"Anaphylaxis","drugRate":"≥1.3%","severity":"serious"},{"effect":"Anaphylactic shock","drugRate":"≥1.3%","severity":"serious"},{"effect":"Angioedema","drugRate":"≥1.3%","severity":"serious"}],"specialPopulations":{"Pregnancy":"...","Geriatric use":"...","Paediatric use":"CHILDREN UNDER 12 MONTHS: ASK DOCTOR.","Renal impairment":"...","Hepatic impairment":"..."}},"trials":[],"aliases":[],"company":"Bayer","patents":[],"pricing":[],"allNames":"shade uvaguard","offLabel":[],"synonyms":["avobenzone","butylmethoxydibenzoylmethane","photoplex"],"timeline":[{"date":"1992-12-07","type":"positive","source":"DrugCentral","milestone":"FDA approval (Bayer Healthcare Llc)"}],"aiSummary":"Shade Uvaguard (avobenzone) is a small molecule drug developed by BAYER HEALTHCARE LLC, targeting tyrosinase. It is an FDA-approved avobenzone drug class, initially approved in 1992. Shade Uvaguard is used to treat various skin conditions, but specific indications are not provided. The commercial status of Shade Uvaguard is owned by BAYER HEALTHCARE LLC, with unknown generic manufacturers and patent status. Key safety considerations are not specified.","brandName":"Shade Uvaguard","ecosystem":[],"mechanism":{"target":"Tyrosinase","novelty":"Follow-on","targets":[{"gene":"TYR","source":"DrugCentral","target":"Tyrosinase","protein":"Tyrosinase"}],"modality":"Small Molecule","drugClass":"avobenzone","explanation":"Active ingredients PurposeAvobenzone 2%.............................................................................SunscreenHomosalate 10%............................................................................SunscreenOctisalate 5%.................................................................................SunscreenOxybenzone 3%.............................................................................Sunscreen.","oneSentence":"Shade Uvaguard works by absorbing and scattering UV radiation to prevent skin damage.","technicalDetail":"Avobenzone acts as a chemical absorber of UVA radiation, forming a stable triplet state that dissipates energy as heat, thereby preventing DNA damage and skin aging."},"commercial":{"launchDate":"1992","_launchSource":"DrugCentral (FDA 1992-12-07, BAYER HEALTHCARE LLC)"},"references":[{"id":1,"url":"https://drugcentral.org/drugcard/4242","fields":["approvals","synonyms","ATC","PK","indications","contraindications","DDIs","targets","patents","FAERS"],"source":"DrugCentral"},{"id":2,"url":"https://clinicaltrials.gov/search?intr=AVOBENZONE","fields":["trials"],"source":"ClinicalTrials.gov"},{"id":3,"url":"https://pubmed.ncbi.nlm.nih.gov/?term=AVOBENZONE","fields":["publications"],"source":"PubMed/NCBI"}],"_enrichedAt":"2026-03-30T08:52:58.932653","biosimilars":[],"competitors":[{"drugName":"arbutin","drugSlug":"arbutin","fdaApproval":"","relationship":"same-target"},{"drugName":"ascorbic acid","drugSlug":"ascorbic-acid","fdaApproval":"","genericCount":1,"patentStatus":"Off-patent — generic available","relationship":"same-target"},{"drugName":"hexylresorcinol","drugSlug":"hexylresorcinol","fdaApproval":"","relationship":"same-target"},{"drugName":"mequinol","drugSlug":"mequinol","fdaApproval":"1999-12-10","relationship":"same-target"},{"drugName":"monobenzone","drugSlug":"monobenzone","fdaApproval":"1952-11-10","patentStatus":"Unknown","relationship":"same-target"}],"dataSources":[{"url":"https://drugcentral.org","name":"DrugCentral","fields":["indications","contraindications","safety","target","drugInteractions"],"retrievedDate":"2026-04-07"}],"genericName":"avobenzone","indications":{"approved":[],"offLabel":[],"pipeline":[]},"drugCategory":"active","labelChanges":[],"relatedDrugs":[{"drugId":"arbutin","brandName":"arbutin","genericName":"arbutin","approvalYear":"","relationship":"same-target"},{"drugId":"ascorbic-acid","brandName":"ascorbic acid","genericName":"ascorbic acid","approvalYear":"","relationship":"same-target"},{"drugId":"hexylresorcinol","brandName":"hexylresorcinol","genericName":"hexylresorcinol","approvalYear":"","relationship":"same-target"},{"drugId":"mequinol","brandName":"mequinol","genericName":"mequinol","approvalYear":"1999","relationship":"same-target"},{"drugId":"monobenzone","brandName":"monobenzone","genericName":"monobenzone","approvalYear":"1952","relationship":"same-target"}],"trialDetails":[{"nctId":"NCT05865431","phase":"NA","title":"Singlet Oxygen Quantification After Skin Exposure to Ultraviolet A (UVA) Light","status":"COMPLETED","sponsor":"University of California, Davis","startDate":"2017-03-17","conditions":["Sun Damaged Skin"],"enrollment":17,"completionDate":"2018-02-02"},{"nctId":"NCT05736224","phase":"PHASE1","title":"Assessing a Natural Product Plus Bioadhesive Nanoparticle (BNP) Sunscreen","status":"COMPLETED","sponsor":"Yale University","startDate":"2023-05-15","conditions":["Skin Cancer"],"enrollment":30,"completionDate":"2023-09-01"},{"nctId":"NCT03582215","phase":"PHASE1","title":"Assessment of the Human Systemic Absorption of Sunscreen Ingredients","status":"COMPLETED","sponsor":"Food and Drug Administration (FDA)","startDate":"2018-07-18","conditions":["Systemic Exposure to Sunscreen Ingredients"],"enrollment":72,"completionDate":"2019-02-18"},{"nctId":"NCT01001975","phase":"PHASE3","title":"Determination of Sun Protection in Sunscreen Formulas (Study SR09-15)(P08236)(COMPLETED)","status":"COMPLETED","sponsor":"Bayer","startDate":"2009-07","conditions":["Sun Protection"],"enrollment":10,"completionDate":"2009-08"},{"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"}],"genericFilers":[],"latestUpdates":[],"manufacturing":[],"administration":{"route":"Topical","formulation":"Aerosol","formulations":[{"form":"AEROSOL","route":"TOPICAL","productName":"Australian GoldInvisidry Technology Oil-Free Formula Broad Spectrum SPF 30"},{"form":"AEROSOL","route":"TOPICAL","productName":"Bali Body Face and Body Sunscreen SPF 50"},{"form":"AEROSOL","route":"TOPICAL","productName":"NO-ADBroad Spectrum SPF 50"},{"form":"AEROSOL","route":"TOPICAL","productName":"OcculusSoloxide 30 Broad Spectrum SPF 30"},{"form":"AEROSOL","route":"TOPICAL","productName":"Ponte Vedra InnSPF 50 C/S Sunscreen"},{"form":"AEROSOL","route":"TOPICAL","productName":"SNAPBroad Spectrum SPF 30"},{"form":"AEROSOL","route":"TOPICAL","productName":"SNAPBroad Spectrum SPF 40"},{"form":"AEROSOL","route":"TOPICAL","productName":"Sugared and BronzedSPF 30 C/S Sunscreen"},{"form":"AEROSOL","route":"TOPICAL","productName":"Banana Boat"},{"form":"AEROSOL","route":"TOPICAL","productName":"Coppertone Sport SPF 15 Sunscreen"},{"form":"AEROSOL","route":"TOPICAL","productName":"Coppertone Sport SPF 50 Sunscreen"},{"form":"AEROSOL","route":"TOPICAL","productName":"Coppertone Sport Sunscreen SPF 70"},{"form":"AEROSOL","route":"TOPICAL","productName":"Coppertone Tanning Sunscreen SPF 15"},{"form":"AEROSOL","route":"TOPICAL","productName":"Flormar BB White BW01 Light"},{"form":"AEROSOL","route":"TOPICAL","productName":"Flormar BB White BW02 Light Medium"}]},"crossReferences":{"NUI":"N0000179319","NDDF":"001976","UNII":"G63QQF2NOX","VUID":"4019467","CHEBI":"CHEBI:134751","VANDF":"4019467","INN_ID":"6480","RXNORM":"45045","UMLSCUI":"C0097513","ChEMBL_ID":"CHEMBL1200522","KEGG_DRUG":"D03015","DRUGBANK_ID":"DB09495","PUBCHEM_CID":"51040","SNOMEDCT_US":"256171000","MESH_SUPPLEMENTAL_RECORD_UI":"C049935"},"formularyStatus":[],"originalProduct":{"form":"STICK","route":"TOPICAL","company":"GlaxoSmithKline Consumer Healthcare Holdings (US) LLC","brandName":"Chapstick Moisturizer Cool Mint","isOriginal":true,"marketingStatus":"OTC MONOGRAPH FINAL"},"_enricherVersion":"v2","developmentCodes":[],"ownershipHistory":[{"period":"1992-","companyName":"Bayer","relationship":"Original Developer"}],"publicationCount":260,"therapeuticAreas":["Dermatology"],"biosimilarFilings":[],"originalDeveloper":"Bayer Healthcare Llc","recentPublications":[],"companionDiagnostics":[],"genericManufacturerList":[],"status":"approved","companyName":"Bayer","companyId":"bayer","modality":"Small molecule","firstApprovalDate":"1992","enrichmentLevel":3,"visitCount":0,"regulatoryByCountry":[{"country_code":"US","regulator":"FDA","status":"approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null}],"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":false,"safety":true,"trials":true,"score":3}}