{"active_ingredient":["Active ingredient Titanium Dioxide 16.1%"],"do_not_use":["Do not use on damaged or broken skin"],"dosage_and_administration":["Directions shake well before use apply liberally 15 minutes before sun exposure reapply: at least every 2 hours use a water resistant sunscreen if swimming or sweating children under 6 months of age: Ask a doctor 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 Broad Spectrum SPF value 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-sleeved shirts, pants, hats, and sunglasses."],"effective_time":"20260605","id":"4f07f500-b84f-4ca6-8b8a-63e7a273eef5","inactive_ingredient":["Inactive ingredients Water, Propylene Glycol Dicaprylate/Dicaprate, Dimethicone, C15-19 Alkane, Dicaprylyl Carbonate, Silica, Dibutyl Adipate, Alcohol Denat., PEG-30 Dipolyhydroxystearate, Polyglyceryl-2 Dipolyhydroxystearate, Iron Oxides, Caprylic/Capric Triglyceride, Butyloctyl Salicylate, Magnesium Sulfate, VP/Eicosene Copolymer, 1,2-Hexanediol, Caprylyl Glycol, Panthenol, Fragrance, Disteardimonium Hectorite, Tocopheryl Acetate, Dimethicone/Vinyl Dimethicone Crosspolymer, Propylene Carbonate, PEG-10 Dimethicone, Triethoxycaprylylsilane, Lecithin, Plankton Extract, Hydroxyacetophenone, Phenethyl Alcohol, Tocopherol"],"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"],"keep_out_of_reach_of_children":["Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away."],"openfda":{"application_number":["M020"],"brand_name":["Eryfotona Actinica Tinted"],"generic_name":["TITANIUM DIOXIDE"],"is_original_packager":[true],"manufacturer_name":["ISDIN Corp."],"package_ndc":["69494-020-01","69494-020-02","69494-020-04","69494-020-03"],"product_ndc":["69494-020"],"product_type":["HUMAN OTC DRUG"],"route":["TOPICAL"],"spl_id":["4f07f500-b84f-4ca6-8b8a-63e7a273eef5"],"spl_set_id":["97357703-0e93-4216-bd1b-a9b202781959"],"substance_name":["TITANIUM DIOXIDE"],"unii":["15FIX9V2JP"]},"package_label_principal_display_panel":["PRINCIPAL DISPLAY PANEL - 100 mL Bottle Carton ISDIN Eryfotona Actinica ® Tinted Lightweight Emulsion Sunscreen BROAD SPECTRUM SPF 50 Designed for Actinic Damage 100% MINERAL UV FILTER* AND DNA REPAIRSOMES ® 3.4 FL OZ (100 mL) PRINCIPAL DISPLAY PANEL - 100 mL Bottle Carton"],"purpose":["Purpose Sunscreen"],"questions":["Questions or comments? Call (862) 242-8129 Monday – Friday (9 a.m. to 5 p.m. EST) or visit www.isdin.com"],"set_id":"97357703-0e93-4216-bd1b-a9b202781959","spl_product_data_elements":["Eryfotona Actinica Tinted Titanium Dioxide Titanium Dioxide Titanium Dioxide Soybean Lecithin Disteardimonium Hectorite Dibutyl Adipate Propylene Glycol Dicaprylate/Dicaprate C15-19 Alkane Panthenol Water Polyglyceryl-2 Dipolyhydroxystearate PEG-10 DIMETHICONE (600 CST) SILICON DIOXIDE MEDIUM-CHAIN TRIGLYCERIDES Dimethicone VINYLPYRROLIDONE/EICOSENE COPOLYMER .ALPHA.-TOCOPHEROL ACETATE Butyloctyl Salicylate MAGNESIUM SULFATE, UNSPECIFIED FORM Caprylyl Glycol 1,2-Hexanediol Tocopherol Alcohol DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) Propylene Carbonate PHENYLETHYL ALCOHOL Ferric Oxide Red FERROSOFERRIC OXIDE Ferric Oxide Yellow Hydroxyacetophenone Dicaprylyl Carbonate PEG-30 DIPOLYHYDROXYSTEARATE (4000 MW) Triethoxycaprylylsilane ANACYSTIS NIDULANS"],"spl_unclassified_section":["Drug Facts"],"stop_use":["Stop use and ask doctor if rash occurs"],"storage_and_handling":["Other information protect the product in this container from excessive heat and direct sun."],"version":"1","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 doctor if rash occurs Keep out of reach of children. If 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."]}