SHISEIDO ULTIMATE SUN PROTECTION- octinoxate, octocrylene, titanium dioxide, and zinc oxide 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 PROTECTION

Drug Facts

Active ingredientsPurpose
OCTINOXATE 7.4%Sunscreen
OCTOCRYLENE 3.0%Sunscreen
TITANIUM DIOXIDE 1.4%Sunscreen
ZINC OXIDE 16.4%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.

Directions

For sunscreen use:

Inactive Ingredients

WATER•DIMETHICONE•BUTYLENE GLYCOL•ISOPROPYL MYRISTATE•ISOHEXADECANE•SD ALCOHOL 40-B•ISODODECANE•METHYL METHACRYLATE CROSSPOLYMER•PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE•TRIMETHYLSILOXYSILICATE•POLYBUTYLENE GLYCOL/PPG-9/1 COPOLYMER•XYLITOL•GLYCERIN•METHYL GLUCETH-10•PEG/PPG-14/7 DIMETHYL ETHER•SAXIFRAGA SARMENTOSA EXTRACT•SCUTELLARIA BAICALENSIS ROOT EXTRACT•ECTOIN•SOPHORA ANGUSTIFOLIA ROOT EXTRACT•HYDROGENATED POLYDECENE•HYDROGEN DIMETHICONE•ISOSTEARIC ACID•DEXTRIN PALMITATE•ALUMINUM HYDROXIDE•STEARIC ACID•DISTEARDIMONIUM HECTORITE•SILICA•POLYMETHYLSILSESQUIOXANE•TALC•ALCOHOL•TRISODIUM EDTA•BHT•SYZYGIUM JAMBOS LEAF EXTRACT•TOCOPHEROL•FRAGRANCE•

Other information

Questions or comments?

Call toll free 1-800-906-7503

PRINCIPAL DISPLAY PANEL - 100 mL Bottle Carton

SHISEIDO

Anti-Aging Suncare

50+
WetForce

Ultimate
Sun Protection Lotion

BROAD SPECTRUM
SPF 50+

For Face/Body

WATER RESISTANT (80 MINUTES)

SUNSCREEN

100mL 3.3 FL. OZ.

Principal Display Panel - 100 mL Bottle Carton
SHISEIDO ULTIMATE SUN PROTECTION 
octinoxate, octocrylene, titanium dioxide, and zinc oxide lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58411-253
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE8406 mg  in 100 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE3408 mg  in 100 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE1590 mg  in 100 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE18630 mg  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
ISOHEXADECANE (UNII: 918X1OUF1E)  
ISODODECANE (UNII: A8289P68Y2)  
PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: TYP81E471F)  
TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN)  
XYLITOL (UNII: VCQ006KQ1E)  
GLYCERIN (UNII: PDC6A3C0OX)  
METHYL GLUCETH-10 (UNII: N0MWT4C7WH)  
PEG/PPG-14/7 DIMETHYL ETHER (UNII: 6DNW9T7YT2)  
SAXIFRAGA STOLONIFERA LEAF (UNII: O3TMV4903H)  
SCUTELLARIA BAICALENSIS ROOT (UNII: 7J95K7ID2S)  
ECTOINE (UNII: 7GXZ3858RY)  
SOPHORA FLAVESCENS ROOT (UNII: IYR6K8KQ5K)  
HYDROGENATED POLYDECENE TYPE I (UNII: U333RI6EB7)  
ISOSTEARIC ACID (UNII: X33R8U0062)  
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)  
TALC (UNII: 7SEV7J4R1U)  
ALCOHOL (UNII: 3K9958V90M)  
EDETATE TRISODIUM (UNII: 420IP921MB)  
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
SYZYGIUM JAMBOS LEAF (UNII: 407Z4W5LFF)  
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58411-253-101 in 1 CARTON02/01/2015
1100 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
2NDC:58411-253-802 mL in 1 POUCH; Type 0: Not a Combination Product02/01/201512/31/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35202/01/2015
Labeler - SHISEIDO AMERICAS CORPORATION (193691821)
Establishment
NameAddressID/FEIBusiness Operations
SHISEIDO AMERICA INC.782677132manufacture(58411-253) , analysis(58411-253)

Revised: 6/2020
Document Id: 934d88e8-7244-49f9-b0e1-419f4d2ab0d2
Set id: e39220dd-2c0f-4ac0-a787-eb66a8599485
Version: 3
Effective Time: 20200619
 
SHISEIDO AMERICAS CORPORATION