SHISEIDO EXTRA SMOOTH SUN PROTECTION LOTION N SPF 38•PA++ FOR FACE/BODY

Manufacturer: SHISEIDO AMERICA INC.
Effective date: 2010-01-27
Label type: HUMAN OTC DRUG LABEL
Version: 1
Source: legacy-cache
Hydrated at: 2026-08-02 01:54:26

Label at a glance#

ProductSHISEIDO SUNCARE EXTRA SMOOTH

Active ingredientOctinoxate, Zinc Oxide

Label structure10 sections

Indications and uses

helps prevent sunburn higher SPF gives more sunburn protection retains SPF after 80 minutes of activity in the water

Dosage and administration

apply generously to face and body before sun exposure. children under 6 months of age: ask a doctor. reapply as needed or after towel drying, swimming or perspiring.

Storage and handling

high sun protection product. Sun alert: Limiting sun exposure, wearing protective clothing, and using sunscreens may reduce the risks of skin aging, skin cancer, and other harmful effects of the sun. Broad spectrum sunscreen; provides protection against UVA and UVB radiation.

Contacts and useful links#

PhoneLabel contact1-800-906-7503

Websitewww.shiseido.com

www.shiseido.com

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

OTC - PURPOSE SECTION

Active ingredients	Purpose
OCTINOXATE 7.4%	Sunscreen
ZINC OXIDE 9.6%	Sunscreen

Uses

INDICATIONS & USAGE SECTION

helps prevent sunburn
higher SPF gives more sunburn protection
retains SPF after 80 minutes of activity in the water

Warnings

WARNINGS SECTION

For external use only

When using this product

OTC - WHEN USING SECTION

keep out of eyes. Rinse with water to remove.

Stop use and ask a doctor if

OTC - STOP USE SECTION

rash or irritation develops and lasts.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

apply generously to face and body before sun exposure.
children under 6 months of age: ask a doctor.
reapply as needed or after towel drying, swimming or perspiring.

Other information

STORAGE AND HANDLING SECTION

high sun protection product.
Sun alert: Limiting sun exposure, wearing protective clothing, and using sunscreens may reduce the risks of skin aging, skin cancer, and other harmful effects of the sun.
Broad spectrum sunscreen; provides protection against UVA and UVB radiation.

Inactive ingredients

INACTIVE INGREDIENT SECTION

CYCLOMETHICONE, WATER, DIPROPYLENE GLYCOL, DIMETHICONE, SD ALCOHOL 40-B, TALC, POLYBUTYLENE GLYCOL/PPG-9/1 COPOLYMER, TRIMETHYLSILOXYSILICATE, GLYCERIN, PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE, XYLITOL, METHYL GLUCETH-10, SCUTELLARIA BAICALENSIS ROOT EXTRACT, ECTOIN, ISOSTEARIC ACID, TRIETHOXYCAPRYLYLSILANE, DISTEARDIMONIUM HECTORITE, ALUMINUM HYDROXIDE, BUTYLENE GLYCOL, CALCIUM STEARATE, STEARIC ACID, TRISODIUM EDTA, BHT, SYZYGIUM JAMBOS LEAF EXTRACT, PHENOXYETHANOL, FRAGRANCE, TITANIUM DIOXIDE

Questions?

OTC - QUESTIONS SECTION

1-800-906-7503

SPL UNCLASSIFIED SECTION

SHISEIDO AMERICA INC. NEW YORK, N.Y. 10022
MADE IN U.S.A.
SHISEIDO DIST. NEW YORK • PARIS • MILANO
GLO. 12605

www.shiseido.com

PRINCIPAL DISPLAY PANEL - 100 mL Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

SHISEIDO

Anti-Aging Suncare
UVA and UVB Protection

38
Extra Smooth
Sun Protection Lotion N

SPF 38•PA++

For Face/Body

VERY WATER-RESISTANT

SUNSCREEN

100mL 3.3 FL. OZ.

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
52686-223-10	2023-09-26	C162847	48780-1	9d75b9cf-d3c7-f424-e053-dadaa90a57ce	SHISEIDO EXTRA SMOOTH SUN PROTECTION LOTION N SPF 38•PA++ FOR FACE/BODY
52686-223-10	2020-01-31	C162847	48780-1	9d75b9cf-d3c7-f424-e053-dadaa90a57ce	SHISEIDO EXTRA SMOOTH SUN PROTECTION LOTION N SPF 38•PA++ FOR FACE/BODY

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
Octinoxate	ACTIVE INGREDIENT	4Y5P7MUD51	1
Zinc Oxide	ACTIVE INGREDIENT	SOI2LOH54Z	1
Octinoxate	ACTIVE MOIETY	4Y5P7MUD51	1
Zinc	ACTIVE MOIETY	J41CSQ7QDS	1

Products#

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

DailyMed product names page 1 of 1 · 5 matching rows.

SHISEIDO SUNCARE EXTRA SMOOTH
Octinoxate and Zinc Oxide
Octinoxate
Zinc Oxide
Zinc

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
52686-223	52686-223-10

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 2 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
Octinoxate	4Y5P7MUD51	ACTIB
Zinc Oxide	SOI2LOH54Z	ACTIB

Source Document#

Source XML

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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
d5e72053-f321-46de-88f9-88fcd0878d61			53e1a869-7320-40be-831a-4b54238ca72c	2023-09-26	Warnings	Exact identifier spl set id: 53e1a869-7320-40be-831a-4b54238ca72c

Reported adverse events (FAERS/openFDA)#

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