{
"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": "2026-10-28",
"results": {
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}
},
"results": [
{
"spl_product_data_elements": [
"SHISEIDO ULTIMATE SUN PROTECTOR AVOBENZONE, HOMOSALATE, OCTISALATE, and OCTOCRYLENE AVOBENZONE AVOBENZONE HOMOSALATE HOMOSALATE OCTISALATE OCTISALATE OCTOCRYLENE OCTOCRYLENE WATER DIISOPROPYL SEBACATE TALC TRIETHYLHEXANOIN DIMETHICONE PEG/PPG-9/2 DIMETHYL ETHER ALCOHOL LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE GLYCERIN DEXTRIN PALMITATE (CORN; 20000 MW) ISODODECANE SUCROSE TETRASTEARATE TRIACETATE TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) SILICON DIOXIDE DISTEARDIMONIUM HECTORITE HYDROGENATED POLYISOBUTENE (1300 MW) PPG-17 PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE CALCIUM STEARATE PHENOXYETHANOL ISOSTEARIC ACID PALMITIC ACID EDETATE TRISODIUM POLYETHYLENE GLYCOL 300 SILICA DIMETHYL SILYLATE SODIUM CHLORIDE BUTYLATED HYDROXYTOLUENE .ALPHA.-TOCOPHEROL GLYCYRRHIZINATE DIPOTASSIUM BUTYLENE GLYCOL PEG/PPG-14/7 DIMETHYL ETHER POLYGLYCERYL-6 POLYRICINOLEATE SODIUM METABISULFITE STEARIC ACID SAXIFRAGA STOLONIFERA LEAF GREEN TEA LEAF SYZYGIUM JAMBOS LEAF FD&C YELLOW NO. 5 D&C RED NO. 33 SOPHORA FLAVESCENS ROOT"
],
"spl_unclassified_section": [
"Drug Facts"
],
"active_ingredient": [
"Active ingredients Purpose AVOBENZONE 2.3% Sunscreen HOMOSALATE 10.0% Sunscreen OCTISALATE 5.0% Sunscreen OCTOCRYLENE 5.0% Sunscreen"
],
"active_ingredient_table": [
"| Active ingredients | Purpose |
|---|
| AVOBENZONE 2.3% | Sunscreen |
| HOMOSALATE 10.0% | Sunscreen |
| OCTISALATE 5.0% | Sunscreen |
| OCTOCRYLENE 5.0% | Sunscreen |
"
],
"purpose": [
"Active ingredients Purpose AVOBENZONE 2.3% Sunscreen HOMOSALATE 10.0% Sunscreen OCTISALATE 5.0% Sunscreen OCTOCRYLENE 5.0% Sunscreen"
],
"purpose_table": [
"| Active ingredients | Purpose |
|---|
| AVOBENZONE 2.3% | Sunscreen |
| HOMOSALATE 10.0% | Sunscreen |
| OCTISALATE 5.0% | 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."
],
"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 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 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･TRIETHYLHEXANOIN･DIMETHICONE･PEG/PPG-9/2 DIMETHYL ETHER･ALCOHOL DENAT.･LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE･GLYCERIN･DEXTRIN PALMITATE･SUCROSE TETRASTEARATE TRIACETATE･ISODODECANE･PPG-3 DIPIVALATE･TRIMETHYLSILOXYSILICATE･SILICA･DISTEARDIMONIUM HECTORITE･HYDROGENATED POLYISOBUTENE･SODIUM CHLORIDE･DIPOTASSIUM GLYCYRRHIZATE･AMINOETHANESULFINIC ACID･PEG/PPG-14/7 DIMETHYL ETHER･SAXIFRAGA SARMENTOSA EXTRACT･CAMELLIA SINENSIS LEAF EXTRACT･EUCHEUMA SERRA/GRATELOUPIA SPARSA/SACCHARINA ANGUSTATA/ULVA LINZA/UNDARIA PINNATIFIDA EXTRACT･SOPHORA ANGUSTIFOLIA ROOT EXTRACT･SACCHARINA ANGUSTATA/UNDARIA PINNATIFIDA EXTRACT･PPG-17･PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE･CALCIUM STEARATE･ISOSTEARIC ACID･PALMITIC ACID･TRISODIUM EDTA･ALCOHOL･SILICA DIMETHYL SILYLATE･PEG-6･BHT･TOCOPHEROL･BUTYLENE GLYCOL･STEARIC ACID･SODIUM METABISULFITE･POLYGLYCERYL-6 POLYRICINOLEATE･BIS-BUTYLDIMETHICONE POLYGLYCERYL-3･SYZYGIUM JAMBOS LEAF EXTRACT･PHENOXYETHANOL･FRAGRANCE･RED 33･YELLOW 5･"
],
"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 Container Carton SHISEIDO GINZA TOKYO Ultimate Sun Protector Lotion SPF 60+ Invisible and breathable protection veil strengthened by heat and water. BROAD SPECTRUM SPF 60+ WATER RESISTANT (80 MINUTES) SUNSCREEN 150mL 5 FL. OZ. PRINCIPAL DISPLAY PANEL - 150 mL Container Carton"
],
"set_id": "00ec7d9c-8550-45ce-8d0a-ef2caf84f98d",
"id": "88f71022-7e27-4e69-96e9-89880cb20aaf",
"effective_time": "20250321",
"version": "4",
"openfda": {
"application_number": [
"M020"
],
"brand_name": [
"SHISEIDO ULTIMATE SUN PROTECTOR"
],
"generic_name": [
"AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENE"
],
"manufacturer_name": [
"SHISEIDO AMERICAS CORPORATION"
],
"product_ndc": [
"58411-888"
],
"product_type": [
"HUMAN OTC DRUG"
],
"route": [
"TOPICAL"
],
"substance_name": [
"AVOBENZONE",
"HOMOSALATE",
"OCTISALATE",
"OCTOCRYLENE"
],
"spl_id": [
"88f71022-7e27-4e69-96e9-89880cb20aaf"
],
"spl_set_id": [
"00ec7d9c-8550-45ce-8d0a-ef2caf84f98d"
],
"package_ndc": [
"58411-888-40",
"58411-888-41",
"58411-888-42"
],
"is_original_packager": [
true
],
"unii": [
"G63QQF2NOX",
"V06SV4M95S",
"4X49Y0596W",
"5A68WGF6WM"
]
}
}
]
}