SHISEIDO SUN PROTECTION EYE- octinoxate, octocrylene, and zinc oxide cream 
SHISEIDO AMERICAS CORPORATION

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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

  • helps prevent sunburn
  • if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun

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:

  • apply liberally 15 minutes before sun exposure
  • use a water resistant sunscreen if swimming or sweating
  • reapply at least every 2 hours
  • Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a broad spectrum SPF of 15 or higher and other sun protection measures including:
    • limit time in the sun, especially from 10 a.m. – 2 p.m.
    • wear long-sleeve shirts, pants, hats, and sunglasses
  • children under 6 months: Ask a doctor

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

  • 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 - 15 mL Tube Carton

SHISEIDO
GINZA TOKYO

Sun Protection
Eye Cream

34

BROAD SPECTRUM
SPF 34

SUNSCREEN

15mL NET WT. .6 OZ.

Principal Display Panel - 15 mL Tube Carton
SHISEIDO SUN PROTECTION EYE 
octinoxate, octocrylene, and zinc oxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58411-345
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:58411-345-601 in 1 CARTON12/01/201205/01/2021
116.5 g in 1 TUBE; Type 0: Not a Combination Product
2NDC:58411-345-611 in 1 CARTON12/01/201205/01/2021
2NDC:58411-345-801.65 g in 1 POUCH; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH DRUGM02012/01/201205/01/2021
Labeler - SHISEIDO AMERICAS CORPORATION (193691821)
Establishment
NameAddressID/FEIBusiness Operations
Shiseido America Inc.782677132ANALYSIS(58411-345) , MANUFACTURE(58411-345)

Revised: 12/2024
Document Id: 731099af-889b-47a3-b19a-6b2013ca2382
Set id: e7b66f54-0898-4319-94c3-c1cd28ca041d
Version: 3
Effective Time: 20241223
 
SHISEIDO AMERICAS CORPORATION