SHISEIDO ULTIMATE SUN PROTECTION- octinoxate, octocrylene, titanium dioxide, 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 PROTECTION

Drug Facts

Active ingredients Purpose
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.

Flammable. Do not use near heat, or while smoking.

Directions

For sunscreen use:

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

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.

Principal Display Panel - 50 mL Tube Carton
SHISEIDO ULTIMATE SUN PROTECTION 
octinoxate, octocrylene, titanium dioxide, and zinc oxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58411-254
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE4255 mg  in 50 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE1725 mg  in 50 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE805 mg  in 50 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE9430 mg  in 50 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
ISOHEXADECANE (UNII: 918X1OUF1E)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: 25G622K2RA)  
XYLITOL (UNII: VCQ006KQ1E)  
GLYCERIN (UNII: PDC6A3C0OX)  
ISODODECANE (UNII: A8289P68Y2)  
TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN)  
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
POLYETHYLENE GLYCOL 300 (UNII: 5655G9Y8AQ)  
POLYETHYLENE GLYCOL 1600 (UNII: 1212Z7S33A)  
PEG/PPG-14/7 DIMETHYL ETHER (UNII: 6DNW9T7YT2)  
SAXIFRAGA STOLONIFERA LEAF (UNII: O3TMV4903H)  
SCUTELLARIA BAICALENSIS ROOT (UNII: 7J95K7ID2S)  
ONONIS SPINOSA ROOT (UNII: FD2FMC53M1)  
ECTOINE (UNII: 7GXZ3858RY)  
SOPHORA FLAVESCENS ROOT (UNII: IYR6K8KQ5K)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
EDETATE TRISODIUM (UNII: 420IP921MB)  
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)  
TALC (UNII: 7SEV7J4R1U)  
ALCOHOL (UNII: 3K9958V90M)  
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
SYZYGIUM JAMBOS LEAF (UNII: 407Z4W5LFF)  
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58411-254-601 in 1 CARTON02/01/2015
150 mL in 1 TUBE; Type 0: Not a Combination Product
2NDC:58411-254-611 in 1 CARTON02/01/2015
230 mL in 1 TUBE; Type 0: Not a Combination Product
3NDC:58411-254-621 in 1 CARTON02/01/2015
315 mL in 1 TUBE; Type 0: Not a Combination Product
4NDC:58411-254-802 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(58411-254) , analysis(58411-254)

Revised: 6/2020
Document Id: b9dec41e-cdf6-4eee-ba26-c26fb415ffcc
Set id: d3eb1ebc-7f04-4a9e-86c8-1813c544a1e2
Version: 4
Effective Time: 20200619
 
SHISEIDO AMERICAS CORPORATION