{"id":"oxybenzone","rwe":[],"_fda":{"id":"085b50a9-68d7-d6e6-e063-6394a90a09be","set_id":"0039ca4d-2a0c-4b19-a029-1c080fc292ce","openfda":{"unii":["4Y5P7MUD51","95OOS7VE0Y"],"route":["TOPICAL"],"spl_id":["085b50a9-68d7-d6e6-e063-6394a90a09be"],"brand_name":["Artistry Youth Xtend Lifting Smoothing Foundation Shade Chiffon L2C1"],"spl_set_id":["0039ca4d-2a0c-4b19-a029-1c080fc292ce"],"package_ndc":["50390-239-00"],"product_ndc":["50390-239"],"generic_name":["OCTINOXATE, OXYBENZONE"],"product_type":["HUMAN OTC DRUG"],"substance_name":["OCTINOXATE","OXYBENZONE"],"manufacturer_name":["Amway Corp"],"application_number":["M020"],"is_original_packager":[true]},"purpose":["Purpose Sunscreen"],"version":"2","stop_use":["Stop use and ask a doctor if rash occurs"],"warnings":["Warnings For external use only Do not use on broken or damaged skin When using this product keep out of eyes. Rinse with water to remove. Stop use and ask a doctor if rash occurs Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away."],"do_not_use":["Do not use on broken or damaged skin"],"when_using":["When using this product keep out of eyes. Rinse with water to remove."],"effective_time":"20231023","active_ingredient":["Active Ingredients Octinoxate 7.5% (W/W / P/P) Oxybenzone 0.5% (W/W P/P) Purpose Sunscreen"],"inactive_ingredient":["Inactive ingredients WATER/AQUA/EAU, CYCLOPENTASILOXANE, METHYL TRIMETHICONE, BUTYLENE GLYCOL, GLYCERIN, LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE, TALC, DIMETHICONE, TRIMETHYLOLPROPANE TRICAPRYLATE/TRICAPRATE, POLYGLYCERYL-6 POLYRICINOLEATE, HDI/ TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER, DIMETHICONE/PEG-10/15 CROSSPOLYMER, DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER, PHENOXYETHANOL, SODIUM CHLORIDE, SODIUM CITRATE, POLYGLYCERYL- 3 POLYDIMETHYLSILOXYETHYL DIMETHICONE, TRIETHOXYCAPRYLYLSILANE, ALUMINA, SORBITAN LAURATE, ALUMINUM HYDROXIDE, STEARIC ACID, METHYLPARABEN, SODIUM HYALURONATE, PROPYLPARABEN, FRAGRANCE/ PARFUM, HYDROXYETHYLCELLULOSE, ACETYL DIPEPTIDE-1 CETYL ESTER, ETHYLPARABEN, SILICA, IODOPROPYNYL BUTYLCARBAMATE, LECITHIN, CHLORELLA VULGARIS EXTRACT, GLYCINE SOJA (SOYBEAN) OIL, CERAMIDE-3, LIMNANTHES ALBA (MEADOWFOAM) SEED OIL, BETA-SITOSTEROL, PERILLA OCYMOIDES SEED OIL, SALVIA HISPANICA SEED OIL, OENOTHERA BIENNIS (EVENING PRIMROSE) OIL, TETRAHEXYLDECYL ASCORBATE. MAY CONTAIN/PEUT CONTEINIR: TITANIUM DIOXIDE, IRON OXIDES, BISMUTH OXYCHLORIDE"],"indications_and_usage":["Uses Helps prevent sunburn"],"spl_unclassified_section":["Drug Facts","Other Information Protect this product from excessive heat and direct sun"],"dosage_and_administration":["Directions For suncreen use Apply liberally 15 minutes before sun exposure Use a water resistant sunscreen if swimming or sweating or washing Reapply at least every 2 hours Spending time in the sun increases your risk of skin cancer and early skin aging. Sun Protection Measures. To decrease this risk, regularly use a sunscreen with a broad spectrum SPF of 15 or higher and other sun protection measures including: limit time in the sun, especially from 10 a.m. – 2 p.m. wear long-sleeve shirts, pants, hats, and sunglasses Children under 6 months: ask a doctor"],"spl_product_data_elements":["Artistry Youth Xtend Lifting Smoothing Foundation Shade Chiffon L2C1 OCTINOXATE, OXYBENZONE CHLORELLA VULGARIS SOYBEAN OIL CERAMIDE NP MEADOWFOAM SEED OIL .BETA.-SITOSTEROL PERILLA FRUTESCENS SEED OIL CHIA SEED OIL EVENING PRIMROSE OIL TETRAHEXYLDECYL ASCORBATE WATER CYCLOMETHICONE 5 METHYL TRIMETHICONE BUTYLENE GLYCOL GLYCERIN LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE TALC DIMETHICONE TRIMETHYLOLPROPANE TRICAPRYLATE/TRICAPRATE POLYGLYCERYL-6 POLYRICINOLEATE HEXAMETHYLENE DIISOCYANATE/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER DIMETHICONE/PEG-10/15 CROSSPOLYMER PHENOXYETHANOL SODIUM CHLORIDE SODIUM CITRATE TRIETHOXYCAPRYLYLSILANE ALUMINUM OXIDE SORBITAN MONOLAURATE ALUMINUM HYDROXIDE STEARIC ACID METHYLPARABEN HYALURONATE SODIUM PROPYLPARABEN HYDROXYETHYL CELLULOSE, UNSPECIFIED ACETYL TYROSYLARGININE CETYL ESTER ETHYLPARABEN SILICON DIOXIDE IODOPROPYNYL BUTYLCARBAMATE OCTINOXATE OCTINOXATE OXYBENZONE OXYBENZONE"],"keep_out_of_reach_of_children":["Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away."],"package_label_principal_display_panel":["Package Labeling: Label4 Shade13"]},"tags":[],"safety":{"boxedWarnings":[],"safetySignals":[{"date":"","signal":"RASH","source":"FDA FAERS","actionTaken":"40 reports"},{"date":"","signal":"SKIN CANCER","source":"FDA FAERS","actionTaken":"38 reports"},{"date":"","signal":"SUNBURN","source":"FDA FAERS","actionTaken":"38 reports"},{"date":"","signal":"DRUG INEFFECTIVE","source":"FDA FAERS","actionTaken":"37 reports"},{"date":"","signal":"PRURITUS","source":"FDA FAERS","actionTaken":"33 reports"},{"date":"","signal":"PAIN","source":"FDA FAERS","actionTaken":"26 reports"},{"date":"","signal":"ERYTHEMA","source":"FDA FAERS","actionTaken":"24 reports"},{"date":"","signal":"FATIGUE","source":"FDA FAERS","actionTaken":"24 reports"},{"date":"","signal":"DYSPNOEA","source":"FDA FAERS","actionTaken":"23 reports"},{"date":"","signal":"HEADACHE","source":"FDA FAERS","actionTaken":"23 reports"}],"commonSideEffects":[]},"trials":[],"_chembl":{"chemblId":"CHEMBL1625","moleculeType":"Small molecule","molecularWeight":"228.25"},"aliases":[],"patents":[],"pricing":[],"_fixedAt":"2026-03-30T16:14:56.738607","_sources":{"trials":{"url":"https://clinicaltrials.gov/search?intr=OXYBENZONE","method":"api_direct","source":"ClinicalTrials.gov","rawText":"","confidence":1,"sourceType":"ctgov","retrievedAt":"2026-04-20T02:37:33.374152+00:00"},"regulatory.ca":{"url":"","method":"api_direct","source":"Health Canada DPD","rawText":"","confidence":1,"sourceType":"health_canada_dpd","retrievedAt":"2026-04-20T02:37:45.560858+00:00"},"publicationCount":{"url":"https://pubmed.ncbi.nlm.nih.gov/?term=OXYBENZONE","method":"api_direct","source":"PubMed/NCBI","rawText":"","confidence":1,"sourceType":"pubmed","retrievedAt":"2026-04-20T02:37:46.518391+00:00"},"administration.route":{"url":"","method":"deterministic","source":"FDA Label","rawText":"","confidence":1,"sourceType":"fda_label","retrievedAt":"2026-04-20T02:37:31.138635+00:00"},"safety.boxedWarnings":{"url":"","method":"deterministic","source":"FDA Label (no boxed warning)","rawText":"","confidence":1,"sourceType":"fda_label","retrievedAt":"2026-04-20T02:37:31.138672+00:00"},"safety.safetySignals":{"url":"https://api.fda.gov/drug/event.json","method":"api_direct","source":"FDA FAERS","rawText":"","confidence":1,"sourceType":"fda_faers","retrievedAt":"2026-04-20T02:37:47.991660+00:00"},"crossReferences.chemblId":{"url":"https://www.ebi.ac.uk/chembl/compound_report_card/CHEMBL1625/","method":"api_direct","source":"ChEMBL (EMBL-EBI)","rawText":"","confidence":1,"sourceType":"chembl","retrievedAt":"2026-04-20T02:37:46.980917+00:00"},"regulatory.fda_application":{"url":"","method":"deterministic","source":"FDA Label","rawText":"M020","confidence":1,"sourceType":"fda_label","retrievedAt":"2026-04-20T02:37:31.138678+00:00"}},"allNames":"shade uvaguard","offLabel":[],"timeline":[],"_dailymed":{"setId":"c504463a-28bf-4161-875f-ef73520931c5","title":"SOFTLIPS OASIS PINEAPPLE COCONUT (DIMETHICONE, OXYBENZONE, OCTINOXATE) STICK [THE MENTHOLATUM COMPANY]"},"ecosystem":[],"mechanism":{"target":"Hormone-sensitive lipase","modality":"Small Molecule"},"_scrapedAt":"2026-03-28T00:33:59.883Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"references":[],"_validation":{"fieldsValidated":0,"lastValidatedAt":"2026-04-20T02:37:50.338608+00:00","fieldsConflicting":1,"overallConfidence":0.8},"biosimilars":[],"competitors":[],"dataSources":[{"url":"https://drugcentral.org","name":"DrugCentral","fields":["indications","contraindications","safety","target","drugInteractions"],"retrievedDate":"2026-04-07"}],"indications":{"approved":[],"offLabel":[],"pipeline":[]},"_fixedFields":["sideEffects","modality→Small Molecule"],"labelChanges":[],"relatedDrugs":[],"trialDetails":[{"nctId":"NCT06450951","phase":"NA","title":"A Personalized Biomonitoring and Report-back Intervention to Reduce Exposure to Endocrine Disrupting Chemicals","status":"ACTIVE_NOT_RECRUITING","sponsor":"Million Marker Wellness, Inc.","startDate":"2024-05-23","conditions":"Environmental Exposure","enrollment":600},{"nctId":"NCT05124899","phase":"NA","title":"Clinical Study to Evaluate the 80-Minute Water Resistant Sun Protection Factor (SPF) of Sunscreen Products","status":"COMPLETED","sponsor":"HALEON","startDate":"2021-11-16","conditions":"Sunscreening Agents","enrollment":15},{"nctId":"NCT05109104","phase":"NA","title":"Clinical Study to Evaluate the Sun Protection Factor (SPF) of Three Sunscreen Products","status":"COMPLETED","sponsor":"HALEON","startDate":"2021-11-08","conditions":"Sunscreening Agents","enrollment":13},{"nctId":"NCT05085327","phase":"NA","title":"Clinical Study to Evaluate the Sun Protection Factor (SPF) of Sunscreen Products","status":"COMPLETED","sponsor":"HALEON","startDate":"2021-10-19","conditions":"Sunscreening Agents","enrollment":11},{"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},{"nctId":"NCT02668536","phase":"PHASE1","title":"A Sunscreen Based on Bioadhesive Nanoparticles","status":"COMPLETED","sponsor":"Yale University","startDate":"2017-07-17","conditions":"Melanoma, UV Ray Skin Damage","enrollment":13},{"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},{"nctId":"NCT00530387","phase":"NA","title":"Multi-Centre European Photopatch Test Study","status":"COMPLETED","sponsor":"NHS Tayside","startDate":"2008-07","conditions":"Dermatitis, Photocontact","enrollment":1000}],"_emaApprovals":[],"_faersSignals":[],"genericFilers":[],"latestUpdates":[],"manufacturing":[],"administration":{"route":"Topical"},"crossReferences":{"chemblId":"CHEMBL1625"},"formularyStatus":[],"_approvalHistory":[],"developmentCodes":[],"ownershipHistory":[],"publicationCount":465,"therapeuticAreas":["Other"],"biosimilarFilings":[],"companionDiagnostics":[],"genericManufacturerList":[],"phase":"marketed","status":"approved","brandName":"Shade Uvaguard","genericName":"OXYBENZONE","companyName":"Bayer Healthcare Llc","companyId":"","modality":"Small molecule","firstApprovalDate":"1992","aiSummary":"","enrichmentLevel":3,"visitCount":1,"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":"2026-04-20T02:37:50.338608+00:00","fieldsConflicting":1,"overallConfidence":0.8},"verificationStatus":"enriching","dataCompleteness":{"mechanism":false,"indications":false,"safety":false,"trials":true,"score":1}}