DR NIKKO SHEER SUNSCREEN

Manufacturer: Cit Co., Ltd.
Effective date: 2018-08-13
Label type: HUMAN OTC DRUG LABEL
Version: 1
Source: full-release
Hydrated at: 2026-05-31 22:56:35

Label at a glance#

ProductDR NIKKO SHEER SUNSCREEN

Active ingredientOCTINOXATE, ENSULIZOLE, OCTISALATE

Label structure8 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

octinoxate, octisalate, ensulizole

INACTIVE INGREDIENT SECTION

water, glycerin, dipropylene glycol, etc.

OTC - PURPOSE SECTION

helps prevent sunburn

WARNINGS SECTION

1. If the following symptoms occur after product use, stop using the product immediately and consult a dermatologist (continuous use can exacerbate the symptoms).
1) Occurrence of red spots, swelling, itchiness, and other irritation
2) If the symptoms above occur after the application area is exposed to direct sunlight

2. Do not use on open wounds, eczema, and other irritations
3. Precaution for Storage and Handling
1) Close the lid after use
2) Keep out of reach of infants and children
3) Do not to store in a place with high/low temperature and exposed to direct sunlight

4. Use as avoiding eye areas.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

INDICATIONS & USAGE SECTION

Apply liberally 15 minutes before sun exposure

DOSAGE & ADMINISTRATION SECTION

external use only

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

label

Product Linked Resources#

Resource, Code type, Value table
Resource	Code type	Value	Equivalent identifiers	Source image
Barcode	EAN-13	0861232000448	GTIN-13: 0861232000448 EAN-13: 0861232000448 GTIN-12: 861232000448 UPC-A: 861232000448 GTIN storage (14 digits): 00861232000448	label.jpg

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
69133-050-01	2021-01-29	C162847	48780-1	ba0f9c33-0e71-a910-e053-dadaa90a0b85	734b1a67-ee62-1f8a-e053-2a91aa0a994c

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
69133-050-01	DR NIKKO SHEER SUNSCREEN	50 mL in 1 TUBE	CREAM	50		1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
69133-050	DR NIKKO SHEER SUNSCREEN (OCTINOXATE) CREAM [CIT CO., LTD.]	1	Legacy NDC, 1 package rows	20180813_734b1a67-ee62-1f8a-e053-2a91aa0a994c.zip

Products#

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

DailyMed product names page 1 of 1 · 6 matching rows.

DR NIKKO SHEER SUNSCREEN
octinoxate
WATER
GLYCERIN
ENSULIZOLE
OCTISALATE

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
69133-050	69133-050-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 5 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
WATER	059QF0KO0R	IACT
GLYCERIN	PDC6A3C0OX	IACT
OCTINOXATE	4Y5P7MUD51	ACTIB
ENSULIZOLE	9YQ9DI1W42	ACTIB
OCTISALATE	4X49Y0596W	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
734b1adf-ad78-45cb-e053-2a91aa0a8f0c			734b1a67-ee62-1f8a-e053-2a91aa0a994c	2018-08-13	Warnings	Exact identifier spl id: 734b1adf-ad78-45cb-e053-2a91aa0a8f0c spl set id: 734b1a67-ee62-1f8a-e053-2a91aa0a994c

Reported adverse events (FAERS/openFDA)#

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