FDA.reportPublic FDA data

Sunscreen

Manufacturer
MAIDORA CO.,LTD
Effective date
2025-11-20
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 02:35:21

Label at a glance#

ProductSunscreen
Active ingredientOCTINOXATE
Label structure8 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION


Octinoxate

OTC - PURPOSE SECTION


helps prevent sunburn

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

keep out of reach of children

INDICATIONS & USAGE SECTION


helps prevent sunburn
apply liberally 15 minutes before sun exposure
after 80 minutes of swimming or sweating

immediately after towel drying

WARNINGS SECTION


keep out of eyes. Rinse with water to remove

DOSAGE & ADMINISTRATION SECTION


helps prevent sunburn

INACTIVE INGREDIENT SECTION

Water,Propylene Glycol,Dimethicone,Sodium Dilauramidoglutamide Lysine,Tocopheryl Acetate,Butylene Glycol,Acrylates/C10-30 Alkyl Acrylate Crosspolymer,Carbomer,Ceteareth-10,Sodium Hydroxide,BHT,Methylparaben

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

11

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
87243-123-35Sunscreen5 in 1 BOXCREAM51
87243-123-35Sunscreen1 in 1 CANISTERCREAM11

Products#

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

DailyMed product names page 1 of 1 · 14 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
87243-12387243-123-35

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Name, UNII, Kind table
NameUNIIKind
BENZALDEHYDE PROPYLENE GLYCOL ACETALELQ3FTL5B1IACT
SODIUM DILAURAMIDOGLUTAMIDE LYSINEMNJ7VPT2R5IACT
CETEARETH-10K9YLE2L8PAIACT
BHT1P9D0Z171KIACT
METHYLPARABENA2I8C7HI9TIACT
ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER (60000 MPA.S)8Z5ZAL5H3VIACT
CARBOMER0A5MM307FCIACT
OCTINOXATE4Y5P7MUD51ACTIB
WATER059QF0KO0RIACT
(4-METHOXYPHENYL)DIPHENYLMETHANOLD117S0GBOTIACT
DIMETHICONE 20H8YMB5QY0DIACT
SODIUM HYDROXIDE55X04QC32IIACT

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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
SunscreenJAPANESE SUNSCREEN SPF 50 SUPER WATER GEL SUNSCREEN 4.22FLOZ(125G) REFILLMAIDORA CO.,LTD44136f78-8789-8185-e063-6394a90ad8482025-11-20WarningsExact identifier
ndc (package): 87243-123-35
ndc (product): 87243-123
ndc11 (package): 87243012335
spl id: 44136f78-878a-8185-e063-6394a90ad848
spl set id: 44136f78-8789-8185-e063-6394a90ad848

Reported adverse events (FAERS/openFDA)#

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