FDA.reportPublic FDA data

SHISEIDO EXTRA SMOOTH SUN PROTECTION LOTION N

Manufacturer
SHISEIDO AMERICA INC.
Effective date
2018-12-13
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-02 00:42:59

Label at a glance#

ProductSHISEIDO EXTRA SMOOTH SUN PROTECTION N
Active ingredientOCTINOXATE, OCTOCRYLENE, ZINC OXIDE
Label structure10 sections

Indications and 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

Dosage and administration

For sunscreen use: apply liberally 15 minutes before sun exposure reapply: after 80 minutes of swimming or sweating immediately after towel drying 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: lim...

Storage and handling

protect this product in this container from excessive heat and direct sun.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

OTC - PURPOSE SECTION

ACTIVE INGREDIENTS:Purpose
OCTINOXATE 4.9%Sunscreen
OCTOCRYLENE 3.0%Sunscreen
ZINC OXIDE 12.5%Sunscreen

Uses

INDICATIONS & USAGE SECTION

  • 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

WARNINGS SECTION

OTC - DO NOT USE SECTION

For external use only

Do not use on damaged or broken skin

OTC - WHEN USING SECTION

When using this product keep out of eyes. Rinse with water to remove.

OTC - STOP USE SECTION

Stop use and ask a doctor if rash occurs

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

For sunscreen use:

  • apply liberally 15 minutes before sun exposure
  • reapply:
    • after 80 minutes of swimming or sweating
    • immediately after towel drying
    • 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

INACTIVE INGREDIENT SECTION

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

STORAGE AND HANDLING SECTION

  • protect this product in this container from excessive heat and direct sun.

Questions or comments?

OTC - QUESTIONS SECTION

Call toll free 1-800-906-7503

SPL UNCLASSIFIED SECTION

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

SHISEIDO DIST.
NEW YORK • PARIS • MILANO

PRINCIPAL DISPLAY PANEL - 100mL Bottle Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

SHISEIDO

Anti-Aging Suncare

38

Extra Smooth
Sun Protection Lotion N

BROAD SPECTRUM
SPF 38

For Face/Body

WATER RESISTANT
(80 MINUTES)

SUNSCREEN

100mL 3.3 FL. OZ.

PRINCIPAL DISPLAY PANEL - 100mL Bottle Carton
PRINCIPAL DISPLAY PANEL - 100mL Bottle Carton

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
52686-337-102023-11-29C16284748780-19d75b9cf-e966-f424-e053-dadaa90a57ceSHISEIDO EXTRA SMOOTH SUN PROTECTION LOTION N
52686-337-102020-01-31C16284748780-19d75b9cf-e966-f424-e053-dadaa90a57ceSHISEIDO EXTRA SMOOTH SUN PROTECTION LOTION N

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
OCTINOXATEACTIVE INGREDIENT4Y5P7MUD511
OCTOCRYLENEACTIVE INGREDIENT5A68WGF6WM1
ZINC OXIDEACTIVE INGREDIENTSOI2LOH54Z1
OCTINOXATEACTIVE MOIETY4Y5P7MUD511
OCTOCRYLENEACTIVE MOIETY5A68WGF6WM1
ZINC OXIDEACTIVE MOIETYSOI2LOH54Z1
.ALPHA.-TOCOPHEROLINACTIVE INGREDIENTH4N855PNZ11
ALUMINUM OXIDEINACTIVE INGREDIENTLMI26O69331
BUTYLATED HYDROXYTOLUENEINACTIVE INGREDIENT1P9D0Z171K1
BUTYLENE GLYCOLINACTIVE INGREDIENT3XUS85K0RA1
CALCIUM STEARATEINACTIVE INGREDIENT776XM7047L1
DIMETHICONEINACTIVE INGREDIENT92RU3N3Y1O1
DIPROPYLENE GLYCOLINACTIVE INGREDIENTE107L85C401
ECTOINEINACTIVE INGREDIENT7GXZ3858RY1
EDETATE TRISODIUMINACTIVE INGREDIENT420IP921MB1
ETHYLHEXYL PALMITATEINACTIVE INGREDIENT28659933091
GLYCERININACTIVE INGREDIENTPDC6A3C0OX1
ISOSTEARIC ACIDINACTIVE INGREDIENTX33R8U00621
METHYL GLUCETH-10INACTIVE INGREDIENTN0MWT4C7WH1
PEG-10 DIMETHICONE (600 CST)INACTIVE INGREDIENT8PR7V1SVM01
PHENOXYETHANOLINACTIVE INGREDIENTHIE492ZZ3T1
SCUTELLARIA BAICALENSIS ROOTINACTIVE INGREDIENT7J95K7ID2S1
SYZYGIUM JAMBOS LEAFINACTIVE INGREDIENT407Z4W5LFF1
TALCINACTIVE INGREDIENT7SEV7J4R1U1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JP1
TRIETHOXYCAPRYLYLSILANEINACTIVE INGREDIENTLDC331P08E1
TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8)INACTIVE INGREDIENT5041RX63GN1
WATERINACTIVE INGREDIENT059QF0KO0R1
XYLITOLINACTIVE INGREDIENTVCQ006KQ1E1

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 28 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
52686-33752686-337-10

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 26 matching rows.

Name, UNII, Kind table
NameUNIIKind
DIMETHICONE92RU3N3Y1OIACT
WATER059QF0KO0RIACT
DIPROPYLENE GLYCOLE107L85C40IACT
ETHYLHEXYL PALMITATE2865993309IACT
PEG-10 DIMETHICONE (600 CST)8PR7V1SVM0IACT
TALC7SEV7J4R1UIACT
TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8)5041RX63GNIACT
XYLITOLVCQ006KQ1EIACT
GLYCERINPDC6A3C0OXIACT
METHYL GLUCETH-10N0MWT4C7WHIACT
SCUTELLARIA BAICALENSIS ROOT7J95K7ID2SIACT
ECTOINE7GXZ3858RYIACT
ISOSTEARIC ACIDX33R8U0062IACT
BUTYLENE GLYCOL3XUS85K0RAIACT
CALCIUM STEARATE776XM7047LIACT
EDETATE TRISODIUM420IP921MBIACT
ALUMINUM OXIDELMI26O6933IACT
BUTYLATED HYDROXYTOLUENE1P9D0Z171KIACT
TRIETHOXYCAPRYLYLSILANELDC331P08EIACT
SYZYGIUM JAMBOS LEAF407Z4W5LFFIACT
.ALPHA.-TOCOPHEROLH4N855PNZ1IACT
PHENOXYETHANOLHIE492ZZ3TIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
OCTINOXATE4Y5P7MUD51ACTIB
OCTOCRYLENE5A68WGF6WMACTIB
ZINC OXIDESOI2LOH54ZACTIB

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 4 · 234 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
TITANIUM DIOXIDETITANIUM DIOXIDE15FIX9V2JPCAPSULE, LIQUID FILLED / ORAL12 mgExact identifier — unii candidate
40 equally ranked IID candidates
TALCTALC7SEV7J4R1UCAPSULE, DELAYED RELEASE / ORAL420 mgExact identifier — unii candidate
35 equally ranked IID candidates
TITANIUM DIOXIDETITANIUM DIOXIDE15FIX9V2JPPOWDER, FOR SUSPENSION / ORAL297 mgExact identifier — unii candidate
40 equally ranked IID candidates
TALCTALC7SEV7J4R1UTABLET / RECTAL32.4 mgExact identifier — unii candidate
35 equally ranked IID candidates
BUTYLATED HYDROXYTOLUENEBUTYLATED HYDROXYTOLUENE1P9D0Z171KLOTION / TOPICAL1000 mgExact identifier — unii candidate
32 equally ranked IID candidates
PHENOXYETHANOLPHENOXYETHANOLHIE492ZZ3TCREAM, AUGMENTED / TOPICAL10 mgExact identifier — unii candidate
6 equally ranked IID candidates
TITANIUM DIOXIDETITANIUM DIOXIDE15FIX9V2JPGRANULE, FOR SUSPENSION / ORAL143 mgExact identifier — unii candidate
40 equally ranked IID candidates
TALCTALC7SEV7J4R1UTABLET / BUCCAL15 mgExact identifier — unii candidate
35 equally ranked IID candidates
TALCTALC7SEV7J4R1UPOWDER / TOPICAL9235 mgExact identifier — unii candidate
35 equally ranked IID candidates
TALCTALC7SEV7J4R1ULOZENGE / ORAL50 mgExact identifier — unii candidate
35 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXINJECTION / SUBCUTANEOUS450 mgExact identifier — unii candidate
75 equally ranked IID candidates
BUTYLATED HYDROXYTOLUENEBUTYLATED HYDROXYTOLUENE1P9D0Z171KTABLET / SUBLINGUAL0.13 mgExact identifier — unii candidate
32 equally ranked IID candidates
BUTYLATED HYDROXYTOLUENEBUTYLATED HYDROXYTOLUENE1P9D0Z171KSOAP / TOPICAL0.02 %w/wExact identifier — unii candidate
32 equally ranked IID candidates
TITANIUM DIOXIDETITANIUM DIOXIDE15FIX9V2JPSUPPOSITORY / VAGINALNAExact identifier — unii candidate
40 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXLIQUID / TOPICAL2.5 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXCLOTH / TOPICAL0.05 mg/mgExact identifier — unii candidate
75 equally ranked IID candidates
TITANIUM DIOXIDETITANIUM DIOXIDE15FIX9V2JPCREAM / TOPICAL80 mgExact identifier — unii candidate
40 equally ranked IID candidates
TITANIUM DIOXIDETITANIUM DIOXIDE15FIX9V2JPFILM / BUCCAL3 mgExact identifier — unii candidate
40 equally ranked IID candidates
TALCTALC7SEV7J4R1UTABLET, EXTENDED RELEASE / ORAL300 mgExact identifier — unii candidate
35 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXGEL / TRANSDERMAL500 mgExact identifier — unii candidate
75 equally ranked IID candidates
TALCTALC7SEV7J4R1UGRANULE, FOR SUSPENSION / ORAL296 mgExact identifier — unii candidate
35 equally ranked IID candidates
TALCTALC7SEV7J4R1UTABLET, SUGAR COATED / ORALNAExact identifier — unii candidate
35 equally ranked IID candidates
TALCTALC7SEV7J4R1UTABLET, COATED / ORAL320.75 mgExact identifier — unii candidate
35 equally ranked IID candidates
XYLITOLXYLITOLVCQ006KQ1EPASTE / ORAL180 mgExact identifier — unii candidate
12 equally ranked IID candidates
CALCIUM STEARATECALCIUM STEARATE776XM7047LTABLET / ORAL280 mgExact identifier — unii candidate
12 equally ranked IID candidates
CALCIUM STEARATECALCIUM STEARATE776XM7047LTABLET, FILM COATED / ORAL16 mgExact identifier — unii candidate
12 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSUSPENSION / AURICULAR (OTIC)0.05 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
XYLITOLXYLITOLVCQ006KQ1ESUSPENSION, EXTENDED RELEASE / ORAL9000 mgExact identifier — unii candidate
12 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSOAP / TOPICAL0.76 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
TALCTALC7SEV7J4R1UCAPSULE, EXTENDED RELEASE / ORAL5119 mgExact identifier — unii candidate
35 equally ranked IID candidates
XYLITOLXYLITOLVCQ006KQ1ETABLET, EXTENDED RELEASE / ORAL2752 mgExact identifier — unii candidate
12 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXDROPS / ORAL300 mg/1mlExact identifier — unii candidate
75 equally ranked IID candidates
TALCTALC7SEV7J4R1UTABLET, ORALLY DISINTEGRATING / ORAL80 mgExact identifier — unii candidate
35 equally ranked IID candidates
BUTYLATED HYDROXYTOLUENEBUTYLATED HYDROXYTOLUENE1P9D0Z171KSOLUTION / TOPICAL3 mgExact identifier — unii candidate
32 equally ranked IID candidates
TALCTALC7SEV7J4R1UTABLET, DELAYED RELEASE / ORAL349 mgExact identifier — unii candidate
35 equally ranked IID candidates
TITANIUM DIOXIDETITANIUM DIOXIDE15FIX9V2JPFILM, EXTENDED RELEASE / TRANSDERMALNAExact identifier — unii candidate
40 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXTABLET / PERIODONTAL0.53 mgExact identifier — unii candidate
75 equally ranked IID candidates
CALCIUM STEARATECALCIUM STEARATE776XM7047LTABLET, ORALLY DISINTEGRATING / ORAL112 mgExact identifier — unii candidate
12 equally ranked IID candidates
.ALPHA.-TOCOPHEROL.ALPHA.-TOCOPHEROLH4N855PNZ1SYSTEM / TOPICAL0.1 mgExact identifier — unii candidate
10 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSOLUTION / NASAL25 mg/1mlExact identifier — unii candidate
75 equally ranked IID candidates
CALCIUM STEARATECALCIUM STEARATE776XM7047LTABLET, CHEWABLE / ORAL240 mgExact identifier — unii candidate
12 equally ranked IID candidates
CALCIUM STEARATECALCIUM STEARATE776XM7047LPOWDER / ORAL600 mgExact identifier — unii candidate
12 equally ranked IID candidates
TITANIUM DIOXIDETITANIUM DIOXIDE15FIX9V2JPDROPS / ORALNAExact identifier — unii candidate
40 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSYSTEM / TOPICAL18144 mgExact identifier — unii candidate
75 equally ranked IID candidates
TITANIUM DIOXIDETITANIUM DIOXIDE15FIX9V2JPCAPSULE, DELAYED RELEASE / ORAL55 mgExact identifier — unii candidate
40 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXTABLET, FILM COATED / ORAL1.55 mgExact identifier — unii candidate
75 equally ranked IID candidates
ISOSTEARIC ACIDISOSTEARIC ACIDX33R8U0062CREAM / TOPICAL100 mgExact identifier — unii candidate
3 equally ranked IID candidates
PHENOXYETHANOLPHENOXYETHANOLHIE492ZZ3TAEROSOL, FOAM / TOPICAL72 mgExact identifier — unii candidate
6 equally ranked IID candidates
TITANIUM DIOXIDETITANIUM DIOXIDE15FIX9V2JPSHAMPOO, SUSPENSION / TOPICAL3 %w/vExact identifier — unii candidate
40 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSUSPENSION, EXTENDED RELEASE / ORAL2000 mgExact identifier — unii candidate
75 equally ranked IID candidates
TITANIUM DIOXIDETITANIUM DIOXIDE15FIX9V2JPCAPSULE, COATED / ORAL17 mgExact identifier — unii candidate
40 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSUSPENSION / OPHTHALMIC58 mgExact identifier — unii candidate
75 equally ranked IID candidates
.ALPHA.-TOCOPHEROL.ALPHA.-TOCOPHEROLH4N855PNZ1TABLET, CHEWABLE / ORAL0.1 mgExact identifier — unii candidate
10 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXDROPS / NASAL10 mg/1mlExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXAEROSOL / TOPICAL3 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
TALCTALC7SEV7J4R1UCAPSULE, COATED PELLETS / ORAL14 mgExact identifier — unii candidate
35 equally ranked IID candidates
.ALPHA.-TOCOPHEROL.ALPHA.-TOCOPHEROLH4N855PNZ1TABLET, EXTENDED RELEASE / ORAL4 mgExact identifier — unii candidate
10 equally ranked IID candidates
TALCTALC7SEV7J4R1UTABLET, CHEWABLE / ORAL202 mgExact identifier — unii candidate
35 equally ranked IID candidates
XYLITOLXYLITOLVCQ006KQ1EFILM, SOLUBLE / ORAL29 mgExact identifier — unii candidate
12 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSOLUTION / OPHTHALMIC6 %w/vExact identifier — unii candidate
75 equally ranked IID candidates

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
f658e52d-f993-487d-98e8-c9ae8e0ac90eee828f83-137a-4a0a-917d-86e97fe6c72e2023-10-18WarningsExact identifier
spl set id: ee828f83-137a-4a0a-917d-86e97fe6c72e

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.