{"active_ingredient":["Active Ingredients Homosalate 10.0% Sunscreen Octisalate 5.0% Zinc Oxide 16.5% Sunscreen"],"dosage_and_administration":["Directions Apply liberally 15 minutes before sun exposure. Reapply after 80 minutes of swimming or sweating, immediately after towel drying and at least every 2 hours. 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 of 15 or higher and other sun protection measures including: limit time in the sun, especially from 10 am to 2 pm. Wear long-sleeve shirts, pants, hats, and sunglasses. Children under 6 months: ask a physician."],"effective_time":"20231114","id":"6a3535ae-574f-48d8-bfc0-5b38f54c93ee","inactive_ingredient":["Inactive Ingredients C15-19 Alkane, Calcium gluconate, citric acid, dimethicone, disodium EDTA, disteardimonium hectorite, ethylhexylglycerin, gluconolactone, Gossypium hirsutum (cotton) extract, glycerin, glyceryl behenate, hydrogenated polyisobutene, lecithin, octyldodecyl neopentanoate, phenoxyethanol, polyglyercyl-2 isostearate, polyglyceryl-6 polyricinoleate, polyhydroxystearic acid, polysilicone-11, pullulan, saccharide isomerate, sclerotium gum, silica, sodium benzoate, sodium chloride, sodium citrate, sodium hydroxide, sodium olivate, tocopherol, tocopheryl acetate, triethoxycaprylysilane, xanthan gum, water"],"indications_and_usage":["Uses Helps prevent sunburn. If used as directed with other sun protection measure (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 KEEP OUT OF REACH OF CHILDREN"],"openfda":{"application_number":["M020"],"brand_name":["Private Label SPF 50 80 min Water Resistant"],"generic_name":["HOMOSALATE, OCTISALATE, ZINC OXIDE SUNSCREEN"],"is_original_packager":[true],"manufacturer_name":["Swiss-American CDMO, LLC"],"package_ndc":["60232-0035-1"],"product_ndc":["60232-0035"],"product_type":["HUMAN OTC DRUG"],"route":["TOPICAL"],"spl_id":["6a3535ae-574f-48d8-bfc0-5b38f54c93ee"],"spl_set_id":["8849fa88-24c8-410d-b16e-60da38288f98"],"substance_name":["HOMOSALATE","OCTISALATE","ZINC OXIDE"],"unii":["V06SV4M95S","4X49Y0596W","SOI2LOH54Z"]},"other_safety_information":["Other safety information Protect this product from excessive heat and direct sun."],"package_label_principal_display_panel":["Labeling B-PL035 Artwork"],"purpose":["Uses Helps prevent sunburn. If used as directed with other sun protection measure (See Directions), decreases the risk of skin cancer and early skin aging caused by the sun."],"questions":["Questions? Call toll free 1-866-416-2366"],"set_id":"8849fa88-24c8-410d-b16e-60da38288f98","spl_product_data_elements":["Private Label SPF 50 80 min Water Resistant homosalate, octisalate, zinc oxide sunscreen HOMOSALATE HOMOSALATE OCTISALATE OCTISALATE ZINC OXIDE ZINC CATION WATER SODIUM HYDROXIDE EDETATE DISODIUM GLYCERIN SODIUM CHLORIDE PHENOXYETHANOL ETHYLHEXYLGLYCERIN OCTYLDODECYL NEOPENTANOATE C15-19 ALKANE POLYHYDROXYSTEARIC ACID (2300 MW) TRIETHOXYCAPRYLYLSILANE SORBITAN OLIVATE DIMETHICONE TOCOPHEROL DISTEARDIMONIUM HECTORITE POLYGLYCERYL-2 ISOSTEARATE POLYGLYCERYL-6 POLYRICINOLEATE GLUCONOLACTONE SODIUM BENZOATE CALCIUM GLUCONATE SACCHARIDE ISOMERATE CITRIC ACID MONOHYDRATE SODIUM CITRATE HYDROGENATED POLYBUTENE (1300 MW) GOSSYPIUM HIRSUTUM LEAF GLYCERYL MONOBEHENATE .ALPHA.-TOCOPHEROL ACETATE XANTHAN GUM LECITHIN, SOYBEAN PULLULAN BETASIZOFIRAN SILICON DIOXIDE DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE)"],"version":"4","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 physician if rash occurs. If product is swallowed get medical help or contact a Poison Control Center right away."]}