{"active_ingredient":["Active Ingredients Homosalate 7.3% Octisalate 5.0% Zinc Oxide 6.5%"],"adverse_reactions":["You may report an adverse reaction to: cosnova USA Inc 55 5th Ave. New York, NY 10003, USA."],"do_not_use":["Do not use on damaged or broken skin."],"dosage_and_administration":["Directions Apply liberally 15 minutes before sun exposure. Use a water resistant sunscreen if swimming or sweating. Reapply at least every 2 hours."],"effective_time":"20240507","id":"17e483c5-6e48-9a50-e063-6394a90aa604","inactive_ingredient":["Inactive ingredients RICINUS COMMUNIS (CASTOR) SEED OIL, EUPHORBIA CERIFERA CERA (EUPHORBIA CERIFERA (CANDELILLA) WAX, BIS-DIGLYCERYL POLYACYLADIPATE-1, BUTYROSPERMUM PARKII (SHEA) BUTTER, RUBUS IDAEUS (RASPBERRY) SEED OIL, SYNTHETIC WAX, CAPRYLIC/CAPRIC TRIGLYCERIDE, C13-15 ALKANE, CETYL ALCOHOL, COPERNICIA CERIFERA CERA (COPERNICIA CERIFERA (CARNAUBA) WAX), MICA, SILICA, PARFUM (FRAGRANCE), HELIANTHUS ANNUUS (SUNFLOWER) SEED OIL, POLYHYDROXYSTEARIC ACID, CAPRYLYL GLYCOL, HEXYLENE GLYCOL, HAEMATOCOCCUS PLUVIALIS EXTRACT, PHENOXYETHANOL, CI 15850 (RED 7), CI 77492 (IRON OXIDES)."],"indications_and_usage":["Uses Helps prevent sunburn."],"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."],"openfda":{"application_number":["M020"],"brand_name":["Essence Pout Protector SPF 20 Lip Balm"],"generic_name":["HOMOSALATE, OCTISALATE, ZINC OXIDE"],"is_original_packager":[true],"manufacturer_name":["cosnova GmbH"],"package_ndc":["84270-001-01"],"product_ndc":["84270-001"],"product_type":["HUMAN OTC DRUG"],"route":["TOPICAL"],"spl_id":["17e483c5-6e48-9a50-e063-6394a90aa604"],"spl_set_id":["17e483c5-6e47-9a50-e063-6394a90aa604"],"substance_name":["ZINC OXIDE","HOMOSALATE","OCTISALATE"],"unii":["SOI2LOH54Z","V06SV4M95S","4X49Y0596W"]},"other_safety_information":["Other information Protect this product from excessive heat and direct sun."],"package_label_principal_display_panel":["Product Packaging 1"],"purpose":["Purpose Sunscreen"],"set_id":"17e483c5-6e47-9a50-e063-6394a90aa604","spl_product_data_elements":["Essence Pout Protector SPF 20 Lip Balm Homosalate, Octisalate, Zinc Oxide D&C RED NO. 7 FERRIC OXIDE YELLOW SHEA BUTTER HAEMATOCOCCUS PLUVIALIS CETYL ALCOHOL SILICON DIOXIDE CAPRYLYL GLYCOL CANDELILLA WAX HEXYLENE GLYCOL ZINC OXIDE ZINC OXIDE HOMOSALATE HOMOSALATE OCTISALATE OCTISALATE RASPBERRY SEED OIL SYNTHETIC WAX (1200 MW) CASTOR OIL BIS-DIGLYCERYL POLYACYLADIPATE-1 CARNAUBA WAX MICA SUNFLOWER OIL POLYHYDROXYSTEARIC ACID (2300 MW) PHENOXYETHANOL MEDIUM-CHAIN TRIGLYCERIDES C13-15 ALKANE"],"spl_unclassified_section":["Drug Facts"],"stop_use":["Stop use and ask a doctor if rash occurs."],"version":"1","warnings":["Warnings Skin Cancer/Skin Aging Alert: Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to help prevent sunburn, not skin cancer or early skin aging. 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."],"when_using":["When using this product keep out of eyes. Rinse with water to remove."]}