SHISEIDO ULTIMATE SUN PROTECTOR- octisalate, titanium dioxide, octocrylene, and zinc oxide cream 
SHISEIDO AMERICAS CORPORATION

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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SHISEIDO ULTIMATE SUN PROTECTOR CREAM

Drug Facts

Active ingredientsPurpose
Octisalate 5.0%Sunscreen
Octocrylene 7.0%Sunscreen
Titanium Dioxide 3.8%Sunscreen
Zinc Oxide 19.4%Sunscreen

Uses

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.

Directions

For sunscreen use:

Inactive Ingredients

WATER▪DIMETHICONE▪SD ALCOHOL 40-B▪ISOPROPYL MYRISTATE▪PEG/PPG-9/2 DIMETHYL ETHER▪METHYL METHACRYLATE CROSSPOLYMER▪LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE▪GLYCERIN▪ISOHEXADECANE▪POLYBUTYLENE GLYCOL/PPG-9/1 COPOLYMER▪ISODODECANE▪TRIMETHYLSILOXYSILICATE▪DISTEARDIMONIUM HECTORITE▪DEXTRIN PALMITATE▪PEG/PPG-14/7 DIMETHYL ETHER▪SAXIFRAGA SARMENTOSA EXTRACT▪SCUTELLARIA BAICALENSIS ROOT EXTRACT▪CAMELLIA SINENSIS LEAF EXTRACT▪ONONIS SPINOSA ROOT EXTRACT▪SODIUM HYALURONATE▪SOPHORA ANGUSTIFOLIA ROOT EXTRACT▪ALUMINUM HYDROXIDE▪SILICA▪HYDROGEN DIMETHICONE▪STEARIC ACID▪SORBITAN SESQUIISOSTEARATE▪CARBOXYDECYL TRISILOXANE▪TRISODIUM EDTA▪BUTYLENE GLYCOL▪ALCOHOL▪POLYMETHYLSILSESQUIOXANE▪TALC▪TOCOPHEROL▪BHT▪SODIUM METABISULFITE▪PEG-6▪SYZYGIUM JAMBOS LEAF EXTRACT▪PHENOXYETHANOL▪FRAGRANCE▪

Other information

Protect this product in this container from excessive heat and direct sun.

Questions or comments?

Call toll free 1-800-906-7503

PRINCIPAL DISPLAY PANEL - 50 mL Tube Label

SHISEIDO
GINZA TOKYO

Ultimate
Sun Protector Cream

50+

SynchroShield
WetForce × HeatForce

BROAD SPECTRUM
SPF 50+

For Face

WATER RESISTANT
(80 MINUTES)

SUNSCREEN

50mL NET WT. 2 OZ.

PRINCIPAL DISPLAY PANEL - 50 mL Tube Label
SHISEIDO ULTIMATE SUN PROTECTOR 
octisalate, titanium dioxide, octocrylene, and zinc oxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58411-480
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE3.105 g  in 50 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE2.359 g  in 50 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE4.347 g  in 50 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE12.047 g  in 50 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
PEG/PPG-9/2 DIMETHYL ETHER (UNII: LM6Q66468X)  
METHYL METHACRYLATE/GLYCOL DIMETHACRYLATE CROSSPOLYMER (UNII: 657L0NC5MT)  
LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: 25G622K2RA)  
GLYCERIN (UNII: PDC6A3C0OX)  
ISOHEXADECANE (UNII: 918X1OUF1E)  
ISODODECANE (UNII: A8289P68Y2)  
TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN)  
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
DEXTRIN PALMITATE (CORN; 20000 MW) (UNII: 89B2BSF9I3)  
PEG/PPG-14/7 DIMETHYL ETHER (UNII: 6DNW9T7YT2)  
SAXIFRAGA STOLONIFERA LEAF (UNII: O3TMV4903H)  
SCUTELLARIA BAICALENSIS ROOT (UNII: 7J95K7ID2S)  
GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
ONONIS SPINOSA ROOT (UNII: FD2FMC53M1)  
HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
SOPHORA FLAVESCENS ROOT (UNII: IYR6K8KQ5K)  
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
HYDROGEN DIMETHICONE (13 CST) (UNII: 4QGR4P2YOI)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
SORBITAN SESQUIISOSTEARATE (UNII: VU97D01BF9)  
EDETATE TRISODIUM (UNII: 420IP921MB)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
ALCOHOL (UNII: 3K9958V90M)  
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)  
TALC (UNII: 7SEV7J4R1U)  
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
SODIUM METABISULFITE (UNII: 4VON5FNS3C)  
POLYETHYLENE GLYCOL 300 (UNII: 5655G9Y8AQ)  
SYZYGIUM JAMBOS LEAF (UNII: 407Z4W5LFF)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
SODIUM POLYMETAPHOSPHATE (UNII: P1BM4ZH95L)  
.ALPHA.-CELLULOSE (UNII: I355QGZ19A)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58411-480-601 in 1 CARTON01/01/2020
150 mL in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart35201/01/2020
Labeler - SHISEIDO AMERICAS CORPORATION (193691821)
Establishment
NameAddressID/FEIBusiness Operations
SHISEIDO AMERICAS INC.782677132MANUFACTURE(58411-480) , ANALYSIS(58411-480)

Revised: 10/2019
Document Id: a7d1a327-5297-40ac-83c0-1a4d5a1fa4d4
Set id: c656792a-e1ed-478d-b501-9bdc92d16eca
Version: 1
Effective Time: 20191017
 
SHISEIDO AMERICAS CORPORATION