SHISEIDO ULTIMATE SUN PROTECTOR- octisalate, homosalate, octocrylene, and avobenzone lotion 
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 LOTION

Drug Facts

Active ingredientsPurpose
Octisalate 5.0%Sunscreen
Avobenzone 2.3%Sunscreen
Homosalate 10.0%Sunscreen
Octocrylene 5.0%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▪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▪

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 - 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
SHISEIDO ULTIMATE SUN PROTECTOR 
octisalate, homosalate, octocrylene, and avobenzone lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58411-481
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE50 mg  in 1 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE100 mg  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE50 mg  in 1 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE23 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
DIISOPROPYL SEBACATE (UNII: J8T3X564IH)  
TALC (UNII: 7SEV7J4R1U)  
METHYL METHACRYLATE/GLYCOL DIMETHACRYLATE CROSSPOLYMER (UNII: EG97988M5Q)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
PEG/PPG-9/2 DIMETHYL ETHER (UNII: LM6Q66468X)  
LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: 25G622K2RA)  
TRIETHYLHEXANOIN (UNII: 7K3W1BIU6K)  
GLYCERIN (UNII: PDC6A3C0OX)  
DEXTRIN PALMITATE (CORN; 20000 MW) (UNII: 89B2BSF9I3)  
SUCROSE TETRASTEARATE TRIACETATE (UNII: 1K7LBQ045N)  
ISODODECANE (UNII: A8289P68Y2)  
TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
PEG/PPG-14/7 DIMETHYL ETHER (UNII: 6DNW9T7YT2)  
SAXIFRAGA STOLONIFERA LEAF (UNII: O3TMV4903H)  
GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
SOPHORA FLAVESCENS ROOT (UNII: IYR6K8KQ5K)  
PPG-17 (UNII: OV0Q322E0U)  
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
CALCIUM STEARATE (UNII: 776XM7047L)  
ISOSTEARIC ACID (UNII: X33R8U0062)  
PALMITIC ACID (UNII: 2V16EO95H1)  
EDETATE TRISODIUM (UNII: 420IP921MB)  
ALCOHOL (UNII: 3K9958V90M)  
SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W)  
VINYL DIMETHICONE/METHICONE SILSESQUIOXANE CROSSPOLYMER (UNII: 9NH1UDD2RR)  
POLYETHYLENE GLYCOL 300 (UNII: 5655G9Y8AQ)  
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
SODIUM METABISULFITE (UNII: 4VON5FNS3C)  
SYZYGIUM JAMBOS LEAF (UNII: 407Z4W5LFF)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58411-481-101 in 1 CARTON01/01/2020
1150 mL in 1 BOTTLE; Type 0: Not a Combination Product
2NDC:58411-481-111 in 1 CARTON01/01/2020
250 mL in 1 BOTTLE; 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(58411-481) , ANALYSIS(58411-481)

Revised: 10/2020
Document Id: af22ecf0-cac8-4c7f-ad90-d588ac171083
Set id: 7a98171f-bf21-40d4-bc78-883aa0b0c438
Version: 2
Effective Time: 20201006
 
SHISEIDO AMERICAS CORPORATION