SHISEIDO ULTIMATE SUN PROTECTION- avobenzone, octinoxate, octocrylene, and oxybenzone 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 LOTION

Drug Facts

Active ingredientsPurpose
AVOBENZONE 2.5%Sunscreen
OCTINOXATE 4.9%Sunscreen
OCTOCRYLENE 5.0%Sunscreen
OXYBENZONE 3.0%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.

Directions

For sunscreen use:

Inactive Ingredients

WATER∙DIMETHICONE∙SD ALCOHOL 40-B∙TALC∙METHYL METHACRYLATE CROSSPOLYMER∙ISODODECANE∙CETYL ETHYLHEXANOATE∙DIISOPROPYL SEBACATE∙TRIETHYLHEXANOIN∙LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE∙GLYCERIN∙DEXTRIN PALMITATE∙SUCROSE TETRASTEARATE TRIACETATE∙POLYBUTYLENE GLYCOL/PPG-9/1 COPOLYMER∙TRIMETHYLSILOXYSILICATE∙XYLITOL∙SILICA∙SODIUM CHLORIDE∙PEG/PPG-14/7 DIMETHYL ETHER∙SAXIFRAGA SARMENTOSA EXTRACT∙SOPHORA ANGUSTIFOLIA ROOT EXTRACT∙DISTEARDIMONIUM HECTORITE∙ISOSTEARIC ACID∙CALCIUM STEARATE∙TRISODIUM EDTA∙VINYL DIMETHICONE/METHICONE SILSESQUIOXANE CROSSPOLYMER∙ALCOHOL∙BHT∙BUTYLENE GLYCOL∙STEARIC ACID∙SODIUM METABISULFITE∙SYZYGIUM JAMBOS LEAF EXTRACT∙TOCOPHEROL∙POLYSILICONE-2∙METHYLPARABEN∙FRAGRANCE∙IRON OXIDES∙

Other information

Questions or comments?

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PRINCIPAL DISPLAY PANEL - 50 mL Bottle Carton

SHISEIDO
GINZA TOKYO

Ultimate
Sun Protection Lotion

50+

WetForce
Turns Invisible

BROAD SPECTRUM
SPF 50+

For Face/Body

WATER RESISTANT
(80 MINUTES)

SUNSCREEN

50mL 1.6 FL. OZ.

PRINCIPAL DISPLAY PANEL - 50 mL Bottle Carton
SHISEIDO ULTIMATE SUN PROTECTION 
avobenzone, octinoxate, octocrylene, and oxybenzone cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58411-359
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE1288 mg  in 50 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE2524 mg  in 50 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE2575 mg  in 50 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE1545 mg  in 50 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
TALC (UNII: 7SEV7J4R1U)  
ISODODECANE (UNII: A8289P68Y2)  
CETYL ETHYLHEXANOATE (UNII: 134647WMX4)  
DIISOPROPYL SEBACATE (UNII: J8T3X564IH)  
TRIETHYLHEXANOIN (UNII: 7K3W1BIU6K)  
LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: 25G622K2RA)  
GLYCERIN (UNII: PDC6A3C0OX)  
DEXTRIN PALMITATE (CORN; 20000 MW) (UNII: 89B2BSF9I3)  
SUCROSE TETRASTEARATE TRIACETATE (UNII: 1K7LBQ045N)  
TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN)  
XYLITOL (UNII: VCQ006KQ1E)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
PEG/PPG-14/7 DIMETHYL ETHER (UNII: 6DNW9T7YT2)  
SAXIFRAGA STOLONIFERA LEAF (UNII: O3TMV4903H)  
SOPHORA FLAVESCENS ROOT (UNII: IYR6K8KQ5K)  
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
ISOSTEARIC ACID (UNII: X33R8U0062)  
CALCIUM STEARATE (UNII: 776XM7047L)  
EDETATE TRISODIUM (UNII: 420IP921MB)  
VINYL DIMETHICONE/METHICONE SILSESQUIOXANE CROSSPOLYMER (UNII: 9NH1UDD2RR)  
ALCOHOL (UNII: 3K9958V90M)  
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
SODIUM METABISULFITE (UNII: 4VON5FNS3C)  
SYZYGIUM JAMBOS LEAF (UNII: 407Z4W5LFF)  
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  
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:58411-359-101 in 1 CARTON02/01/2018
150 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
2NDC:58411-359-111 in 1 CARTON02/01/2018
2100 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35202/01/2018
Labeler - SHISEIDO AMERICAS CORPORATION (193691821)
Establishment
NameAddressID/FEIBusiness Operations
SHISEIDO AMERICA INC.782677132manufacture(58411-359) , analysis(58411-359)

Revised: 12/2018
Document Id: 7cf2d5a4-09fc-2d2d-e053-2a91aa0a93c6
Set id: cafa7961-ed07-4e24-9bf3-16ccefbc8fd7
Version: 2
Effective Time: 20181213
 
SHISEIDO AMERICAS CORPORATION