{"id":"homosalate","rwe":[],"_fda":{"id":"46425877-3cf0-6496-e063-6294a90acf37","set_id":"00280745-908b-468f-e063-6294a90aa12f","openfda":{"unii":["G63QQF2NOX","V06SV4M95S","4X49Y0596W","5A68WGF6WM"],"route":["TOPICAL"],"spl_id":["46425877-3cf0-6496-e063-6294a90acf37"],"brand_name":["Olay Regenerist Regenerating with Sunscreen Broad Spectrum SPF 15"],"spl_set_id":["00280745-908b-468f-e063-6294a90aa12f"],"package_ndc":["69423-719-75"],"product_ndc":["69423-719"],"generic_name":["AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENE"],"product_type":["HUMAN OTC DRUG"],"substance_name":["AVOBENZONE","HOMOSALATE","OCTISALATE","OCTOCRYLENE"],"manufacturer_name":["The Procter & Gamble Manufacturing Company"],"application_number":["M020"],"is_original_packager":[true]},"purpose":["Active ingredients Purpose Avobenzone 3.0% Sunscreen Homosalate 4.0% Sunscreen Octisalate 4.5% Sunscreen Octocrylene 2.6% Sunscreen"],"version":"3","stop_use":["Stop use and ask a doctor if rash occurs"],"warnings":["Warnings For external use only Do not use on damaged or broken 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."],"questions":["Questions or comments? Call 1-800-285-5170"],"do_not_use":["Do not use on damaged or broken skin"],"when_using":["When using this product keep out of eyes. Rinse with water to remove."],"purpose_table":["<table width=\"50%\"><col align=\"left\" width=\"70%\" valign=\"middle\"/><col align=\"right\" width=\"30%\" valign=\"middle\"/><thead><tr><th><content styleCode=\"bold\"><content styleCode=\"italics\">Active ingredients</content></content></th><th><content styleCode=\"bold\"><content styleCode=\"italics\">Purpose</content></content></th></tr></thead><tbody><tr><td>Avobenzone 3.0%</td><td>Sunscreen</td></tr><tr><td>Homosalate 4.0%</td><td>Sunscreen</td></tr><tr><td>Octisalate 4.5%</td><td>Sunscreen</td></tr><tr><td>Octocrylene 2.6%</td><td>Sunscreen</td></tr></tbody></table>"],"effective_time":"20251218","active_ingredient":["Active ingredients Purpose Avobenzone 3.0% Sunscreen Homosalate 4.0% Sunscreen Octisalate 4.5% Sunscreen Octocrylene 2.6% Sunscreen"],"inactive_ingredient":["Inactive ingredients water, glycerin, niacinamide*, dimethicone, zea mays (corn) starch, isopropyl isostearate, panthenol**, palmitoyl pentapeptide-4***, caprylyl glycol, dimethiconol, cetearyl glucoside, cetearyl alcohol, stearic acid, palmitic acid, stearyl alcohol, cetyl alcohol, behenyl alcohol, disodium EDTA, hydroxyethyl acrylate/sodium acryloyldimethyl taurate copolymer, PEG-100 stearate, 1,2-hexanediol, phenoxyethanol, fragrance"],"storage_and_handling":["Other information protect this product from excessive heat and direct sun"],"indications_and_usage":["Uses helps prevent sunburn if used as directed with other sun protection measures (see Directions ), decreases the risk of skin cancer and early skin aging caused by the sun"],"active_ingredient_table":["<table width=\"50%\"><col align=\"left\" width=\"70%\" valign=\"middle\"/><col align=\"right\" width=\"30%\" valign=\"middle\"/><thead><tr><th><content styleCode=\"bold\"><content styleCode=\"italics\">Active ingredients</content></content></th><th><content styleCode=\"bold\"><content styleCode=\"italics\">Purpose</content></content></th></tr></thead><tbody><tr><td>Avobenzone 3.0%</td><td>Sunscreen</td></tr><tr><td>Homosalate 4.0%</td><td>Sunscreen</td></tr><tr><td>Octisalate 4.5%</td><td>Sunscreen</td></tr><tr><td>Octocrylene 2.6%</td><td>Sunscreen</td></tr></tbody></table>"],"spl_unclassified_section":["Drug Facts","Distr. by PROCTER & GAMBLE, CINCINNATI, OH 45202"],"dosage_and_administration":["Directions apply liberally 15 minutes before sun exposure reapply at least every 2 hours use water resistant sunscreen if swimming or sweating Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including: limit time in sun, especially from 10 a.m. - 2 p.m. wear long-sleeved shirts, pants, hats, and sunglasses children under 6 months: ask a doctor"],"spl_product_data_elements":["Olay Regenerist Regenerating with Sunscreen Broad Spectrum SPF 15 Avobenzone, Homosalate, Octisalate, and Octocrylene PHENOXYETHANOL PALMITOYL PENTAPEPTIDE-4 WATER GLYCERIN NIACINAMIDE DIMETHICONE ISOPROPYL ISOSTEARATE PANTHENOL DIMETHICONOL (50000 CST) HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (100000 MPA.S AT 1.5%) 1,2-HEXANEDIOL BEHENYL ALCOHOL STEARYL ALCOHOL CETYL ALCOHOL CETEARYL GLUCOSIDE CETEARYL ALCOHOL STEARIC ACID PEG-100 STEARATE EDETATE DISODIUM STARCH, CORN AVOBENZONE AVOBENZONE HOMOSALATE HOMOSALATE OCTISALATE OCTISALATE OCTOCRYLENE OCTOCRYLENE CAPRYLYL GLYCOL PALMITIC ACID"],"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":["PRINCIPAL DISPLAY PANEL - 75 mL Bottle Carton OLAY ® REGENERIST ® REGENERATING LOTION WITH SUNSCREEN BROAD SPECTRUM SPF 15 ADVANCED FACIAL ANTI-AGING MOISTURIZE BROAD SPECTRUM SPF 15 75 mL (2.5 FL OZ) Olay"]},"tags":[{"label":"Small Molecule","category":"modality"},{"label":"Topical","category":"route"},{"label":"Aerosol","category":"form"},{"label":"Active","category":"status"},{"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":{"boxedWarnings":[],"safetySignals":[{"date":"","signal":"SKIN CANCER","source":"FDA FAERS","actionTaken":"66 reports"},{"date":"","signal":"RASH","source":"FDA FAERS","actionTaken":"65 reports"},{"date":"","signal":"DRUG INEFFECTIVE","source":"FDA FAERS","actionTaken":"58 reports"},{"date":"","signal":"SUNBURN","source":"FDA FAERS","actionTaken":"46 reports"},{"date":"","signal":"ERYTHEMA","source":"FDA FAERS","actionTaken":"44 reports"},{"date":"","signal":"PRURITUS","source":"FDA FAERS","actionTaken":"44 reports"},{"date":"","signal":"PAIN","source":"FDA FAERS","actionTaken":"36 reports"},{"date":"","signal":"PRODUCT EXPIRATION DATE ISSUE","source":"FDA FAERS","actionTaken":"33 reports"},{"date":"","signal":"DYSPNOEA","source":"FDA FAERS","actionTaken":"31 reports"},{"date":"","signal":"CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR","source":"FDA FAERS","actionTaken":"29 reports"}],"commonSideEffects":[],"specialPopulations":{"Paediatric use":"SEEK THE ADVICE OF PHYSICIAN PRIOR TO USE ON CHILDREN UNDER MONTHS OF AGE."}},"trials":[],"aliases":[],"patents":[],"pricing":[],"_sources":{"trials":{"url":"https://clinicaltrials.gov/search?intr=HOMOSALATE","method":"api_direct","source":"ClinicalTrials.gov","rawText":"","confidence":1,"sourceType":"ctgov","retrievedAt":"2026-04-20T01:32:44.384469+00:00"},"aiSummary":{"url":"","method":"ai_extraction","source":"AI Strategic Summary","aiModel":"featherless","rawText":"","confidence":0.9,"sourceType":"ai_extraction","retrievedAt":"2026-04-20T01:33:07.936327+00:00"},"regulatory.ca":{"url":"","method":"api_direct","source":"Health Canada DPD","rawText":"","confidence":1,"sourceType":"health_canada_dpd","retrievedAt":"2026-04-20T01:32:50.085131+00:00"},"publicationCount":{"url":"https://pubmed.ncbi.nlm.nih.gov/?term=HOMOSALATE","method":"api_direct","source":"PubMed/NCBI","rawText":"","confidence":1,"sourceType":"pubmed","retrievedAt":"2026-04-20T01:32:50.279978+00:00"},"administration.route":{"url":"","method":"deterministic","source":"FDA Label","rawText":"","confidence":1,"sourceType":"fda_label","retrievedAt":"2026-04-20T01:32:43.136216+00:00"},"indications.approved":{"url":"","method":"ai_extraction","source":"FDA Label + AI","aiModel":"featherless","rawText":"","confidence":0.9,"sourceType":"fda_label","retrievedAt":"2026-04-20T01:33:02.188100+00:00"},"safety.boxedWarnings":{"url":"","method":"deterministic","source":"FDA Label (no boxed warning)","rawText":"","confidence":1,"sourceType":"fda_label","retrievedAt":"2026-04-20T01:32:43.136246+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":"2026-04-20T01:32:51.728532+00:00"},"crossReferences.chemblId":{"url":"https://www.ebi.ac.uk/chembl/compound_report_card/CHEMBL1377575/","method":"api_direct","source":"ChEMBL (EMBL-EBI)","rawText":"","confidence":1,"sourceType":"chembl","retrievedAt":"2026-04-20T01:32:50.976639+00:00"},"regulatory.fda_application":{"url":"","method":"deterministic","source":"FDA Label","rawText":"M020","confidence":1,"sourceType":"fda_label","retrievedAt":"2026-04-20T01:32:43.136250+00:00"}},"allNames":"kemester","offLabel":[],"synonyms":["homosalate","homomenthyl salicylate","kemester"],"timeline":[],"aiSummary":"Homosalate, marketed under the brand name Kemester, is a well-established product in the sunburn prevention market. 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