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

DIMETHICONE, WATER, DIPROPYLENE GLYCOL, ETHYLHEXYL PALMITATE, SD ALCOHOL 40-B, PEG-10 DIMETHICONE, TALC, POLYBUTYLENE GLYCOL/PPG-9/1 COPOLYMER, TRIMETHYLSILOXYSILICATE, XYLITOL, GLYCERIN, PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE, METHYL GLUCETH-10, SCUTELLARIA BAICALENSIS ROOT EXTRACT, ECTOIN, ISOSTEARIC ACID, HYDROGEN DIMETHICONE, DISTEARDIMONIUM HECTORITE, BUTYLENE GLYCOL, CALCIUM STEARATE, TRISODIUM EDTA, 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 - 100 mL Bottle Carton

SHISEIDO
GINZA TOKYO

Extra Smooth
Sun Protection Lotion N

38

BROAD SPECTRUM
SPF 38

For Face/Body

WATER RESISTANT
(80 MINUTES)

SUNSCREEN

100mL 3.3 FL. OZ.

PRINCIPAL DISPLAY PANEL - 100 mL Bottle Carton
SHISEIDO EXTRA SMOOTH SUN PROTECTION N 
octinoxate, octocrylene, and zinc oxide lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58411-349
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE5424 mg  in 110.7 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE3321 mg  in 110.7 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE13.84 g  in 110.7 g
Inactive Ingredients
Ingredient NameStrength
DIMETHICONE (UNII: 92RU3N3Y1O)  
WATER (UNII: 059QF0KO0R)  
DIPROPYLENE GLYCOL (UNII: E107L85C40)  
ETHYLHEXYL PALMITATE (UNII: 2865993309)  
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)  
TALC (UNII: 7SEV7J4R1U)  
TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN)  
XYLITOL (UNII: VCQ006KQ1E)  
GLYCERIN (UNII: PDC6A3C0OX)  
METHYL GLUCETH-10 (UNII: N0MWT4C7WH)  
SCUTELLARIA BAICALENSIS ROOT (UNII: 7J95K7ID2S)  
ECTOINE (UNII: 7GXZ3858RY)  
ISOSTEARIC ACID (UNII: X33R8U0062)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
CALCIUM STEARATE (UNII: 776XM7047L)  
EDETATE TRISODIUM (UNII: 420IP921MB)  
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:58411-349-101 in 1 CARTON02/01/2013
1110.7 g in 1 BOTTLE; 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(58411-349) , ANALYSIS(58411-349)

Revised: 12/2019
Document Id: 2f505a5b-2e88-4822-ade2-5822af259fce
Set id: 9b25a036-5fd1-4977-875f-3f51e368a6c7
Version: 2
Effective Time: 20191227
 
SHISEIDO AMERICAS CORPORATION