SHISEIDO EXTRA SMOOTH SUN PROTECTION N- octinoxate, octocrylene, and zinc oxide 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 EXTRA SMOOTH SUN PROTECTION CREAM N

Drug Facts

ACTIVE INGREDIENTS:Purpose
OCTINOXATE 4.9%Sunscreen
OCTOCRYLENE 3.0%Sunscreen
ZINC OXIDE 12.5%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, ISODODECANE, BUTYLENE GLYCOL, CYCLOMETHICONE, DIMETHICONE, POLYMETHYL METHACRYLATE, LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE, GLYCERIN, SD ALCOHOL 40-B, DISTEARDIMONIUM HECTORITE, XYLITOL, METHYL GLUCETH-10, SCUTELLARIA BAICALENSIS ROOT EXTRACT, ONONIS SPINOSA ROOT EXTRACT, ECTOIN, HYDROGENATED POLYDECENE, HYDROGEN DIMETHICONE, ISOSTEARIC ACID, TRISODIUM EDTA, SILICA, PEG-150, POLYBUTYLENE GLYCOL/PPG-9/1 COPOLYMER, ALUMINA, BHT, TRIETHOXYCAPRYLYLSILANE, SYZYGIUM JAMBOS LEAF EXTRACT, TOCOPHEROL, PHENOXYETHANOL, FRAGRANCE, TITANIUM DIOXIDE,

Other information

Questions or comments?

Call toll free 1-800-906-7503

SHISEIDO AMERICA INC.
NEW YORK, N.Y. 10022

SHISEIDO DIST.
NEW YORK•PARIS•MILANO

PRINCIPAL DISPLAY PANEL - 50 mL Tube Carton

SHISEIDO
GINZA TOKYO

Extra Smooth
Sun Protection Cream N

38

BROAD SPECTRUM
SPF 38

For Face

WATER RESISTANT
(80 MINUTES)

SUNSCREEN

50mL NET WT. 2 OZ.

PRINCIPAL DISPLAY PANEL - 50 mL Tube Carton
SHISEIDO EXTRA SMOOTH SUN PROTECTION N 
octinoxate, octocrylene, and zinc oxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58411-348
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE2766 mg  in 56.45 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE1694 mg  in 56.45 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE7056 mg  in 56.45 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
ISODODECANE (UNII: A8289P68Y2)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
CYCLOMETHICONE (UNII: NMQ347994Z)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
GLYCERIN (UNII: PDC6A3C0OX)  
XYLITOL (UNII: VCQ006KQ1E)  
METHYL GLUCETH-10 (UNII: N0MWT4C7WH)  
SCUTELLARIA BAICALENSIS ROOT (UNII: 7J95K7ID2S)  
ONONIS SPINOSA ROOT (UNII: FD2FMC53M1)  
ECTOINE (UNII: 7GXZ3858RY)  
HYDROGENATED POLYDECENE (550 MW) (UNII: U333RI6EB7)  
ISOSTEARIC ACID (UNII: X33R8U0062)  
EDETATE TRISODIUM (UNII: 420IP921MB)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
POLYETHYLENE GLYCOL 7000 (UNII: Q0JET65GEL)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
SYZYGIUM JAMBOS LEAF (UNII: 407Z4W5LFF)  
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58411-348-601 in 1 CARTON02/01/2013
156.45 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart35202/01/2013
Labeler - SHISEIDO AMERICAS CORPORATION (193691821)
Establishment
NameAddressID/FEIBusiness Operations
SHISEIDO AMERICA INC.782677132MANUFACTURE(58411-348) , ANALYSIS(58411-348)

Revised: 12/2019
Document Id: 693ece25-c1cd-4ceb-ba3e-15190d527a5a
Set id: cc6904d8-f037-4f5d-9a73-d1c77ec7832a
Version: 2
Effective Time: 20191227
 
SHISEIDO AMERICAS CORPORATION