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

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 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 Type HUMAN OTC DRUG Item Code (Source) NDC:52686-335
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 479 mg  in 16.5 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 495 mg  in 16.5 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 1749 mg  in 16.5 g
Inactive Ingredients
Ingredient Name Strength
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 Code Package Description Marketing Start Date Marketing End Date
1 NDC:52686-335-60 1 in 1 CARTON
1 16.5 g in 1 TUBE
2 NDC:52686-335-61 1 in 1 CARTON
2 NDC:52686-335-80 1.65 g in 1 POUCH
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC MONOGRAPH NOT FINAL part352 12/01/2012
Labeler - SHISEIDO AMERICA INC. (782677132)
Establishment
Name Address ID/FEI Business Operations
SHISEIDO AMERICA INC. 782677132 MANUFACTURE(52686-335) , ANALYSIS(52686-335)
Establishment
Name Address ID/FEI Business Operations
Davlyn Industries Inc 624436254 MANUFACTURE(52686-335)

Revised: 2/2013
Document Id: 0801ab22-8145-4711-b95c-3b786b1ceafb
Set id: 5b3cc278-efaa-4adc-a5fb-9833243d2c0d
Version: 2
Effective Time: 20130207
 
SHISEIDO AMERICA INC.