SHISEIDO SUN PROTECTION EYE- octinoxate, octocrylene, and zinc oxide cream 
SHISEIDO AMERICA INC.

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SHISEIDO SUN PROTECTION EYE CREAM

Drug Facts

ACTIVE INGREDIENTS:Purpose
OCTINOXATE 2.9%Sunscreen
OCTOCRYLENE 3.0%Sunscreen
ZINC OXIDE 10.6%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 • ISOHEXADECANE • GLYCERIN • BUTYLENE GLYCOL • DIPROPYLENE GLYCOL • ISODODECANE • LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE • DISTEARDIMONIUM HECTORITE • POLYBUTYLENE GLYCOL/PPG-9/1 COPOLYMER • TRIMETHYLSILOXYSILICATE • XYLITOL • METHYL GLUCETH-10 • DIMETHICONE • SD ALCOHOL 40-B • PEG/PPG-14/7 DIMETHYL ETHER • ZINC MYRISTATE • TOCOPHERYL ACETATE • DIPOTASSIUM GLYCYRRHIZATE • SCUTELLARIA BAICALENSIS ROOT EXTRACT • ONONIS SPINOSA ROOT EXTRACT • ECTOIN • SOPHORA ANGUSTIFOLIA ROOT EXTRACT • HYDROGEN DIMETHICONE • ISOSTEARIC ACID • TRISODIUM EDTA • ALCOHOL • ALUMINA • TRIETHOXYCAPRYLYLSILANE • BHT • TOCOPHEROL • SYZYGIUM JAMBOS LEAF EXTRACT • PHENOXYETHANOL • FRAGRANCE • TITANIUM DIOXIDE •

Other information

Questions or comments?

Call toll free 1-800-906-7503

PRINCIPAL DISPLAY PANEL - 15mL Tube Carton

SHISEIDO

Multi-Defense
Sun Protection
System

34

Sun Protection
Eye Cream

BROAD SPECTRUM
SPF 34

SUNSCREEN

15mL NET WT. .6 OZ.

Principal Display Panel - 15mL Tube Carton
SHISEIDO SUN PROTECTION EYE 
octinoxate, octocrylene, and zinc oxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52686-335
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE479 mg  in 16.5 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE495 mg  in 16.5 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE1749 mg  in 16.5 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
ISOHEXADECANE (UNII: 918X1OUF1E)  
GLYCERIN (UNII: PDC6A3C0OX)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
DIPROPYLENE GLYCOL (UNII: E107L85C40)  
ISODODECANE (UNII: A8289P68Y2)  
TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN)  
XYLITOL (UNII: VCQ006KQ1E)  
METHYL GLUCETH-10 (UNII: N0MWT4C7WH)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
PEG/PPG-14/7 DIMETHYL ETHER (UNII: 6DNW9T7YT2)  
ZINC MYRISTATE (UNII: K09A9E2GGO)  
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)  
GLYCYRRHIZINATE DIPOTASSIUM (UNII: CA2Y0FE3FX)  
SCUTELLARIA BAICALENSIS ROOT (UNII: 7J95K7ID2S)  
ONONIS SPINOSA ROOT (UNII: FD2FMC53M1)  
ECTOINE (UNII: 7GXZ3858RY)  
SOPHORA FLAVESCENS ROOT (UNII: IYR6K8KQ5K)  
ISOSTEARIC ACID (UNII: X33R8U0062)  
EDETATE TRISODIUM (UNII: 420IP921MB)  
ALCOHOL (UNII: 3K9958V90M)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  
SYZYGIUM JAMBOS LEAF (UNII: 407Z4W5LFF)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:52686-335-601 in 1 CARTON12/01/201211/01/2015
116.5 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph drugM02012/01/2012
Labeler - SHISEIDO AMERICA INC. (782677132)
Establishment
NameAddressID/FEIBusiness Operations
SHISEIDO AMERICA INC.782677132manufacture(52686-335) , analysis(52686-335)

Revised: 12/2023
Document Id: d60b9657-e1ec-42a6-8706-7e7370d01402
Set id: 5b3cc278-efaa-4adc-a5fb-9833243d2c0d
Version: 4
Effective Time: 20231227
 
SHISEIDO AMERICA INC.