Your browser does not support JavaScript! SHISEIDO SUN PROTECTION EYE (OCTINOXATE, OCTOCRYLENE, AND ZINC OXIDE) CREAM [SHISEIDO AMERICA INC.]
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SHISEIDO SUN PROTECTION EYE (octinoxate, octocrylene, and zinc oxide) cream
[SHISEIDO AMERICA INC.]


Category DEA Schedule Marketing Status
HUMAN OTC DRUG LABEL OTC monograph not final
NOTE: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.
Drug Label Sections

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 - 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 DRUG LABELItem Code (Source)NDC:52686-335
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (OCTINOXATE) OCTINOXATE479 mg  in 16.5 g
OCTOCRYLENE (OCTOCRYLENE) OCTOCRYLENE495 mg  in 16.5 g
ZINC OXIDE (ZINC OXIDE) ZINC OXIDE1749 mg  in 16.5 g
Inactive Ingredients
Ingredient NameStrength
WATER 
ISOHEXADECANE 
GLYCERIN 
BUTYLENE GLYCOL 
DIPROPYLENE GLYCOL 
ISODODECANE 
TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) 
XYLITOL 
METHYL GLUCETH-10 
DIMETHICONE 
PEG/PPG-14/7 DIMETHYL ETHER 
ZINC MYRISTATE 
.ALPHA.-TOCOPHEROL ACETATE, DL- 
GLYCYRRHIZINATE DIPOTASSIUM 
SCUTELLARIA BAICALENSIS ROOT 
ONONIS SPINOSA ROOT 
ECTOINE 
SOPHORA FLAVESCENS ROOT 
ISOSTEARIC ACID 
EDETATE TRISODIUM 
ALCOHOL 
ALUMINUM OXIDE 
TRIETHOXYCAPRYLYLSILANE 
BUTYLATED HYDROXYTOLUENE 
.ALPHA.-TOCOPHEROL 
SYZYGIUM JAMBOS LEAF 
PHENOXYETHANOL 
TITANIUM DIOXIDE 
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:52686-335-601 in 1 CARTON
116.5 g in 1 TUBE
2NDC:52686-335-611 in 1 CARTON
2NDC:52686-335-801.65 g in 1 POUCH
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart35212/01/2012
Labeler - SHISEIDO AMERICA INC. (782677132)
Establishment
NameAddressID/FEIBusiness Operations
SHISEIDO AMERICA INC.782677132MANUFACTURE(52686-335), ANALYSIS(52686-335)
Establishment
NameAddressID/FEIBusiness Operations
Davlyn Industries Inc624436254MANUFACTURE(52686-335)

Revised: 2/2013
 
SHISEIDO AMERICA INC.

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