{
"meta": {
"disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.",
"terms": "https://open.fda.gov/terms/",
"license": "https://open.fda.gov/license/",
"last_updated": "2026-10-30",
"results": {
"skip": 0,
"limit": 1,
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}
},
"results": [
{
"spl_product_data_elements": [
"SHISEIDO ULTIMATE SUN PROTECTOR octisalate, homosalate, octocrylene, and avobenzone OCTISALATE OCTISALATE HOMOSALATE HOMOSALATE OCTOCRYLENE OCTOCRYLENE AVOBENZONE AVOBENZONE WATER DIISOPROPYL SEBACATE TALC METHYL METHACRYLATE/GLYCOL DIMETHACRYLATE CROSSPOLYMER DIMETHICONE PEG/PPG-9/2 DIMETHYL ETHER LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE TRIETHYLHEXANOIN GLYCERIN DEXTRIN PALMITATE (CORN; 20000 MW) SUCROSE TETRASTEARATE TRIACETATE ISODODECANE TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) SILICON DIOXIDE SODIUM CHLORIDE PEG/PPG-14/7 DIMETHYL ETHER SAXIFRAGA STOLONIFERA LEAF GREEN TEA LEAF SOPHORA FLAVESCENS ROOT PPG-17 DISTEARDIMONIUM HECTORITE CALCIUM STEARATE ISOSTEARIC ACID PALMITIC ACID EDETATE TRISODIUM ALCOHOL SILICA DIMETHYL SILYLATE VINYL DIMETHICONE/METHICONE SILSESQUIOXANE CROSSPOLYMER POLYETHYLENE GLYCOL 300 BUTYLATED HYDROXYTOLUENE .ALPHA.-TOCOPHEROL BUTYLENE GLYCOL STEARIC ACID SODIUM METABISULFITE SYZYGIUM JAMBOS LEAF METHYLPARABEN FERRIC OXIDE RED FERRIC OXIDE YELLOW FERROSOFERRIC OXIDE"
],
"spl_unclassified_section": [
"Drug Facts"
],
"active_ingredient": [
"Active ingredients Purpose Octisalate 5.0% Sunscreen Avobenzone 2.3% Sunscreen Homosalate 10.0% Sunscreen Octocrylene 5.0% Sunscreen"
],
"active_ingredient_table": [
"| Active ingredients | Purpose |
|---|
| Octisalate 5.0% | Sunscreen |
| Avobenzone 2.3% | Sunscreen |
| Homosalate 10.0% | Sunscreen |
| Octocrylene 5.0% | Sunscreen |
"
],
"purpose": [
"Active ingredients Purpose Octisalate 5.0% Sunscreen Avobenzone 2.3% Sunscreen Homosalate 10.0% Sunscreen Octocrylene 5.0% Sunscreen"
],
"purpose_table": [
"| Active ingredients | Purpose |
|---|
| Octisalate 5.0% | Sunscreen |
| Avobenzone 2.3% | Sunscreen |
| Homosalate 10.0% | Sunscreen |
| Octocrylene 5.0% | Sunscreen |
"
],
"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"
],
"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. Flammable: Do not use near heat, flame, or while smoking."
],
"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."
],
"stop_use": [
"Stop use and ask a doctor if rash occurs."
],
"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. Flammable: Do not use near heat, flame, or while smoking."
],
"dosage_and_administration": [
"Directions For sunscreen use: apply liberally 15 minutes before sun exposure reapply: after 80 minutes of swimming or sweating immediately after towel drying at least every two 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 a.m. – 2 p.m. wear long-sleeve shirts, pants, hats, and sunglasses children under 6 months: Ask a doctor"
],
"inactive_ingredient": [
"Inactive Ingredients :WATER▪DIISOPROPYL SEBACATE▪TALC▪METHYL METHACRYLATE CROSSPOLYMER▪DIMETHICONE▪PEG/PPG-9/2 DIMETHYL ETHER▪SD ALCOHOL 40-B▪LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE▪TRIETHYLHEXANOIN▪GLYCERIN▪DEXTRIN PALMITATE▪SUCROSE TETRASTEARATE TRIACETATE▪ISODODECANE▪PPG-3 DIPIVALATE▪TRIMETHYLSILOXYSILICATE▪SILICA▪SODIUM CHLORIDE▪PEG/PPG-14/7 DIMETHYL ETHER▪SAXIFRAGA SARMENTOSA EXTRACT▪CAMELLIA SINENSIS LEAF EXTRACT▪SOPHORA ANGUSTIFOLIA ROOT EXTRACT▪PPG-17▪DISTEARDIMONIUM HECTORITE▪CALCIUM STEARATE▪ISOSTEARIC ACID▪PALMITIC ACID▪TRISODIUM EDTA▪ALCOHOL▪SILICA DIMETHYL SILYLATE▪VINYL DIMETHICONE/METHICONE SILSESQUIOXANE CROSSPOLYMER▪PEG-6▪BHT▪TOCOPHEROL▪BUTYLENE GLYCOL▪STEARIC ACID▪SODIUM METABISULFITE▪SYZYGIUM JAMBOS LEAF EXTRACT▪POLYSILICONE-2▪METHYLPARABEN▪FRAGRANCE▪IRON OXIDES▪"
],
"storage_and_handling": [
"Other information Protect this product in this container from excessive heat and direct sun."
],
"questions": [
"Questions or comments? Call toll free 1-800-906-7503"
],
"package_label_principal_display_panel": [
"PRINCIPAL DISPLAY PANEL - 150 mL Bottle Label SHISEIDO GINZA TOKYO Ultimate Sun Protector Lotion 50+ SynchroShield WetForce x HeatForce Turns Invisible BROAD SPECTRUM SPF 50+ For Face/Body WATER RESISTANT (80 MINUTES) SUNSCREEN 150mL 5 FL. OZ. Principal Display Panel - 150 mL Bottle Label"
],
"set_id": "7a98171f-bf21-40d4-bc78-883aa0b0c438",
"id": "e6522904-8d36-4733-bc3e-7eae181fc7a8",
"effective_time": "20250320",
"version": "5",
"openfda": {
"application_number": [
"M020"
],
"brand_name": [
"SHISEIDO ULTIMATE SUN PROTECTOR"
],
"generic_name": [
"OCTISALATE, HOMOSALATE, OCTOCRYLENE, AND AVOBENZONE"
],
"manufacturer_name": [
"SHISEIDO AMERICAS CORPORATION"
],
"product_ndc": [
"58411-481"
],
"product_type": [
"HUMAN OTC DRUG"
],
"route": [
"TOPICAL"
],
"substance_name": [
"OCTISALATE",
"HOMOSALATE",
"OCTOCRYLENE",
"AVOBENZONE"
],
"spl_id": [
"e6522904-8d36-4733-bc3e-7eae181fc7a8"
],
"spl_set_id": [
"7a98171f-bf21-40d4-bc78-883aa0b0c438"
],
"package_ndc": [
"58411-481-10",
"58411-481-11",
"58411-481-12"
],
"is_original_packager": [
true
],
"unii": [
"4X49Y0596W",
"V06SV4M95S",
"5A68WGF6WM",
"G63QQF2NOX"
]
}
}
]
}