Indications and 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
SHISEIDO ULTIMATE SUN PROTECTION
- Manufacturer
- SHISEIDO AMERICAS CORPORATION | SHISEIDO AMERICA INC.
- Effective date
- 2020-06-19
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 4
- Source
- legacy-cache
- Hydrated at
- 2026-08-01 23:25:04
Label at a glance#
ProductSHISEIDO ULTIMATE SUN PROTECTION
Active ingredientOCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDE
Label structure9 sections
Dosage and administration
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: lim...
Storage and handling
protect this product in this container from excessive heat and direct sun. avoid contact with clothing and other textiles-may stain.
Contacts and useful links#
Label contents#
Full prescribing information#
SPL UNCLASSIFIED SECTION
Drug Facts
OTC - ACTIVE INGREDIENT SECTION
OTC - PURPOSE SECTION
| Active ingredients | Purpose |
|---|---|
| OCTINOXATE 7.4% | Sunscreen |
| OCTOCRYLENE 3.0% | Sunscreen |
| TITANIUM DIOXIDE 1.4% | Sunscreen |
| ZINC OXIDE 16.4% | Sunscreen |
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
For external use only
OTC - DO NOT USE SECTION
Do not use on damaged or broken skin
OTC - WHEN USING SECTION
When using this product keep out of eyes. Rinse with water to remove.
OTC - STOP USE SECTION
Stop use and ask a doctor if rash occurs
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.
SPL UNCLASSIFIED SECTION
Flammable. Do not use near heat, or while smoking.
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 Ingredients
WATER•DIMETHICONE•SD ALCOHOL 40-B•ISOHEXADECANE•BUTYLENE GLYCOL•ISOPROPYL MYRISTATE•METHYL METHACRYLATE CROSSPOLYMER•LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE•XYLITOL•GLYCERIN•POLYBUTYLENE GLYCOL/PPG-9/1 COPOLYMER•ISODODECANE•TRIMETHYLSILOXYSILICATE•DISTEARDIMONIUM HECTORITE•PEG-6•DEXTRIN PALMITATE•PEG-32•PEG/PPG-14/7 DIMETHYL ETHER•SAXIFRAGA SARMENTOSA EXTRACT•SCUTELLARIA BAICALENSIS ROOT EXTRACT•ONONIS SPINOSA ROOT EXTRACT•ECTOIN•SOPHORA ANGUSTIFOLIA ROOT EXTRACT•SILICA•HYDROGEN DIMETHICONE•CARBOXYDECYL TRISILOXANE•ALUMINUM HYDROXIDE•STEARIC ACID•TRISODIUM EDTA•POLYMETHYLSILSESQUIOXANE•TALC•ALCOHOL•BHT•SYZYGIUM JAMBOS LEAF EXTRACT•TOCOPHEROL•PHENOXYETHANOL•FRAGRANCE•
Other information
- protect this product in this container from excessive heat and direct sun.
- avoid contact with clothing and other textiles-may stain.
Questions or comments?
Call toll free 1-800-906-7503
PRINCIPAL DISPLAY PANEL - 50 mL Tube Carton
SHISEIDO
GINZA TOKYO
Ultimate
Sun Protection Cream
50+
WetForce
BROAD SPECTRUM
SPF 50+
For Face
WATER RESISTANT
(80 MINUTES)
SUNSCREEN
50mL NET WT. 2 OZ.
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| OCTINOXATE | ACTIVE INGREDIENT | 4Y5P7MUD51 | 1 | |
| OCTOCRYLENE | ACTIVE INGREDIENT | 5A68WGF6WM | 1 | |
| TITANIUM DIOXIDE | ACTIVE INGREDIENT | 15FIX9V2JP | 1 | |
| ZINC OXIDE | ACTIVE INGREDIENT | SOI2LOH54Z | 1 | |
| OCTINOXATE | ACTIVE MOIETY | 4Y5P7MUD51 | 1 | |
| OCTOCRYLENE | ACTIVE MOIETY | 5A68WGF6WM | 1 | |
| TITANIUM DIOXIDE | ACTIVE MOIETY | 15FIX9V2JP | 1 | |
| ZINC OXIDE | ACTIVE MOIETY | SOI2LOH54Z | 1 | |
| .ALPHA.-TOCOPHEROL | INACTIVE INGREDIENT | H4N855PNZ1 | 1 | |
| ALCOHOL | INACTIVE INGREDIENT | 3K9958V90M | 1 | |
| ALUMINUM HYDROXIDE | INACTIVE INGREDIENT | 5QB0T2IUN0 | 1 | |
| BUTYLATED HYDROXYTOLUENE | INACTIVE INGREDIENT | 1P9D0Z171K | 1 | |
| BUTYLENE GLYCOL | INACTIVE INGREDIENT | 3XUS85K0RA | 1 | |
| DIMETHICONE | INACTIVE INGREDIENT | 92RU3N3Y1O | 1 | |
| DISTEARDIMONIUM HECTORITE | INACTIVE INGREDIENT | X687XDK09L | 1 | |
| ECTOINE | INACTIVE INGREDIENT | 7GXZ3858RY | 1 | |
| EDETATE TRISODIUM | INACTIVE INGREDIENT | 420IP921MB | 1 | |
| GLYCERIN | INACTIVE INGREDIENT | PDC6A3C0OX | 1 | |
| ISODODECANE | INACTIVE INGREDIENT | A8289P68Y2 | 1 | |
| ISOHEXADECANE | INACTIVE INGREDIENT | 918X1OUF1E | 1 | |
| ISOPROPYL MYRISTATE | INACTIVE INGREDIENT | 0RE8K4LNJS | 1 | |
| LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE | INACTIVE INGREDIENT | 25G622K2RA | 1 | |
| ONONIS SPINOSA ROOT | INACTIVE INGREDIENT | FD2FMC53M1 | 1 | |
| PEG/PPG-14/7 DIMETHYL ETHER | INACTIVE INGREDIENT | 6DNW9T7YT2 | 1 | |
| PHENOXYETHANOL | INACTIVE INGREDIENT | HIE492ZZ3T | 1 | |
| POLYETHYLENE GLYCOL 1500 | INACTIVE INGREDIENT | 1212Z7S33A | 1 | |
| POLYETHYLENE GLYCOL 300 | INACTIVE INGREDIENT | 5655G9Y8AQ | 1 | |
| POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) | INACTIVE INGREDIENT | 59Z907ZB69 | 1 | |
| SAXIFRAGA STOLONIFERA LEAF | INACTIVE INGREDIENT | O3TMV4903H | 1 | |
| SCUTELLARIA BAICALENSIS ROOT | INACTIVE INGREDIENT | 7J95K7ID2S | 1 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | 1 | |
| SOPHORA FLAVESCENS ROOT | INACTIVE INGREDIENT | IYR6K8KQ5K | 1 | |
| STEARIC ACID | INACTIVE INGREDIENT | 4ELV7Z65AP | 1 | |
| SYZYGIUM JAMBOS LEAF | INACTIVE INGREDIENT | 407Z4W5LFF | 1 | |
| TALC | INACTIVE INGREDIENT | 7SEV7J4R1U | 1 | |
| TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) | INACTIVE INGREDIENT | 5041RX63GN | 1 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | 1 | |
| XYLITOL | INACTIVE INGREDIENT | VCQ006KQ1E | 1 |
Products#
Every source-derived product name is available through these pages.
- SHISEIDO ULTIMATE SUN PROTECTION
- OCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDE, and ZINC OXIDE
- WATER
- DIMETHICONE
- ISOHEXADECANE
- BUTYLENE GLYCOL
- ISOPROPYL MYRISTATE
- LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE
- XYLITOL
- GLYCERIN
- ISODODECANE
- TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8)
- DISTEARDIMONIUM HECTORITE
- POLYETHYLENE GLYCOL 300
- POLYETHYLENE GLYCOL 1600
- PEG/PPG-14/7 DIMETHYL ETHER
- SAXIFRAGA STOLONIFERA LEAF
- SCUTELLARIA BAICALENSIS ROOT
- ONONIS SPINOSA ROOT
- ECTOINE
- SOPHORA FLAVESCENS ROOT
- SILICON DIOXIDE
- ALUMINUM HYDROXIDE
- STEARIC ACID
- EDETATE TRISODIUM
- POLYMETHYLSILSESQUIOXANE (4.5 MICRONS)
- TALC
- ALCOHOL
- BUTYLATED HYDROXYTOLUENE
- SYZYGIUM JAMBOS LEAF
- .ALPHA.-TOCOPHEROL
- PHENOXYETHANOL
- OCTINOXATE
- OCTOCRYLENE
- TITANIUM DIOXIDE
- ZINC OXIDE
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 58411-254 | 58411-254-60, 58411-254-61, 58411-254-62, 58411-254-80 |
Ingredients#
Every source-derived ingredient row is available through these pages.
Source Document#
Inactive ingredient matches#
Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.
| DailyMed ingredient | IID ingredient | UNII | Dosage form / route | Potency | Maximum daily exposure | Match |
|---|---|---|---|---|---|---|
| ALCOHOL | ALCOHOL | 3K9958V90M | INJECTION / INTRAVENOUS | 92 %w/v | ||
| TALC | TALC | 7SEV7J4R1U | TABLET, FOR SUSPENSION / ORAL | 24 mg | ||
| PHENOXYETHANOL | PHENOXYETHANOL | HIE492ZZ3T | GEL / TOPICAL | 14 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | CAPSULE / RESPIRATORY (INHALATION) | NA | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | INJECTION / INTRADERMAL | 1.6 %w/v | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | SUSPENSION / ORAL | 400 mg | ||
| .ALPHA.-TOCOPHEROL | .ALPHA.-TOCOPHEROL | H4N855PNZ1 | TABLET / ORAL | 2 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | LOTION / TOPICAL | 3990 mg | ||
| TALC | TALC | 7SEV7J4R1U | CAPSULE, COATED / ORAL | 87 mg | ||
| BUTYLATED HYDROXYTOLUENE | BUTYLATED HYDROXYTOLUENE | 1P9D0Z171K | TABLET / SUBLINGUAL | 0.13 mg | ||
| BUTYLATED HYDROXYTOLUENE | BUTYLATED HYDROXYTOLUENE | 1P9D0Z171K | CREAM / TOPICAL | 6 mg | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | LIQUID / INTRAMUSCULAR | 400 mg | ||
| ISOPROPYL MYRISTATE | ISOPROPYL MYRISTATE | 0RE8K4LNJS | LOTION / TOPICAL | 50 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | SOLUTION/ DROPS / AURICULAR (OTIC) | 25 mg | ||
| TALC | TALC | 7SEV7J4R1U | TABLET / SUBLINGUAL | 32.4 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | SOLUTION / ORAL | 32400 mg | ||
| TALC | TALC | 7SEV7J4R1U | CAPSULE, COATED PELLETS / ORAL | 14 mg | ||
| TALC | TALC | 7SEV7J4R1U | POWDER, FOR SUSPENSION / ORAL | 735 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | SOLUTION / OPHTHALMIC | 6 %w/v | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | SOAP / TOPICAL | 0.76 %w/w | ||
| .ALPHA.-TOCOPHEROL | .ALPHA.-TOCOPHEROL | H4N855PNZ1 | TABLET, FILM COATED / ORAL | 246 mg | ||
| POLYETHYLENE GLYCOL 300 | POLYETHYLENE GLYCOL 300 | 5655G9Y8AQ | TABLET / ORAL | 1 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | CONCENTRATE / ORAL | 1800 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | PASTE / DENTAL | 20 %w/w | ||
| POLYETHYLENE GLYCOL 300 | POLYETHYLENE GLYCOL 300 | 5655G9Y8AQ | DROPS / AURICULAR (OTIC) | 97.43 %w/w | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | TABLET / ORAL | 336 mg | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | LIQUID / ORAL | 3563 mg | ||
| TALC | TALC | 7SEV7J4R1U | TABLET / BUCCAL | 15 mg | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | TABLET, EXTENDED RELEASE / ORAL | 200 mg | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | MOUTHWASH / BUCCAL | 200 mg/1ml | ||
| TALC | TALC | 7SEV7J4R1U | GRANULE, DELAYED RELEASE / ORAL | 525 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | TABLET, FILM COATED / ORAL | 1.55 mg | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | AEROSOL, FOAM / TOPICAL | 8 %w/w | ||
| PHENOXYETHANOL | PHENOXYETHANOL | HIE492ZZ3T | CREAM, AUGMENTED / TOPICAL | 10 mg | ||
| PHENOXYETHANOL | PHENOXYETHANOL | HIE492ZZ3T | AEROSOL, FOAM / TOPICAL | 72 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | CREAM / VAGINAL | 51 mg | ||
| BUTYLATED HYDROXYTOLUENE | BUTYLATED HYDROXYTOLUENE | 1P9D0Z171K | SWAB / TOPICAL | 0.5 %w/w | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | AEROSOL / TOPICAL | 3 %w/w | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | INJECTION, SOLUTION / INTRAVENOUS | 6405 mg | ||
| BUTYLATED HYDROXYTOLUENE | BUTYLATED HYDROXYTOLUENE | 1P9D0Z171K | INJECTION, POWDER, FOR SOLUTION / INTRAVENOUS | NA | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | GEL / DENTAL | 1.8 %w/w | ||
| ISOPROPYL MYRISTATE | ISOPROPYL MYRISTATE | 0RE8K4LNJS | GEL / TOPICAL | 29 mg | ||
| .ALPHA.-TOCOPHEROL | .ALPHA.-TOCOPHEROL | H4N855PNZ1 | CAPSULE / ORAL | 16 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | TABLET / PERIODONTAL | 0.53 mg | ||
| ISOPROPYL MYRISTATE | ISOPROPYL MYRISTATE | 0RE8K4LNJS | AEROSOL / TOPICAL | 9.3 %w/w | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | JELLY / VAGINAL | NA | ||
| POLYETHYLENE GLYCOL 300 | POLYETHYLENE GLYCOL 300 | 5655G9Y8AQ | INJECTION / INTRAVENOUS | 16950 mg | ||
| ALUMINUM HYDROXIDE | ALUMINUM HYDROXIDE | 5QB0T2IUN0 | OINTMENT / TOPICAL | NA | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | AEROSOL, SPRAY / TOPICAL | 561 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | TABLET / ORAL | 42 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | SOLUTION / DENTAL | 15 %w/v | ||
| TALC | TALC | 7SEV7J4R1U | TABLET, DELAYED RELEASE PARTICLES / ORAL | 56 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | TAMPON / VAGINAL | NA | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | SUSPENSION / OPHTHALMIC | 58 mg | ||
| TALC | TALC | 7SEV7J4R1U | TABLET / ORAL | 1000 mg | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | SOLUTION / NASAL | 10 mg/1ml | ||
| TALC | TALC | 7SEV7J4R1U | GUM, CHEWING / BUCCAL | NA | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | EMULSION / TOPICAL | NA | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | CAPSULE, LIQUID FILLED / ORAL | 185 mg | ||
| TALC | TALC | 7SEV7J4R1U | TABLET, ORALLY DISINTEGRATING / ORAL | 80 mg |
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| 47aa8624-2268-858c-e063-6294a90af7e8 | d3eb1ebc-7f04-4a9e-86c8-1813c544a1e2 | 2026-01-05 | Warnings | d3eb1ebc-7f04-4a9e-86c8-1813c544a1e2 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.