FDA.reportPublic FDA data

WKND UNDERWATER SUN WHITE

Manufacturer
SURFCODE | Natuzen Co.,Ltd.
Effective date
2019-12-23
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:02:15

Label at a glance#

ProductWKND UNDERWATER SUN WHITE
Active ingredientTitanium Dioxide, Octocrylene, Homosalate, Octisalate, Avobenzone
Label structure6 sections

Label contents#

Full prescribing information#

ACTIVE INGREDIENT

OTC - ACTIVE INGREDIENT SECTION

Active ingredients: Titanium Dioxide 24.25%, Octocrylene 10.00%, Homosalate 10.00%, Ethylhexyl Salicylate 5.00%, Butyl Methoxydibenzoylmethane 3.00%

INACTIVE INGREDIENT

INACTIVE INGREDIENT SECTION

Inactive Ingredients: Isopropyl Myristate, Triethyl Citrate, Ceresin, Talc, Methyl Methacrylate Crosspolymer, Euphorbia Cerifera (Candelilla) Wax, Cetyl Ethyhexanoate, Microcrystalline Wax, Polyethylene, Beeswax, Bis-EthylHexylOxyphenol Methoxyphenyl Triazine, Dimethicone, Silica Dimethyl Silylate, Phenoxyethanol

PURPOSE

OTC - PURPOSE SECTION

Purpose: Sunscreen

WARNINGS

WARNINGS SECTION

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

DESCRIPTION

DESCRIPTION SECTION

USES:

- Help prevent sunburn

- Higher SPF gives more sunburn protection

- Retains SPF after 180 minutes of activity in the water or sweating

DIRECTION: Apply liberally and uniformly to all exposed areas before sun exposure.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Image of cartonImage of carton

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
71192-030-022022-01-28C16284748780-1d6a99b39-9f6a-a426-e053-dadaa90af4c20c30c05d-e76b-472e-ad0c-22723d353d95

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71192-030-01WKND UNDERWATER SUN WHITE18 g in 1 CONTAINERSTICK182
71192-030-02WKND UNDERWATER SUN WHITE1 in 1 CARTONSTICK12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71192-030WKND UNDERWATER SUN WHITE (TITANIUM DIOXIDE, OCTOCRYLENE, HOMOSALATE, OCTISALATE, AVOBENZONE) STICK [SURFCODE]2Legacy NDC, 2 package rows20191223_0c30c05d-e76b-472e-ad0c-22723d353d95.zip

Products#

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

DailyMed product names page 1 of 1 · 9 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
71192-03071192-030-01, 71192-030-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 7 matching rows.

Name, UNII, Kind table
NameUNIIKind
Titanium Dioxide15FIX9V2JPACTIB
Octocrylene5A68WGF6WMACTIB
HomosalateV06SV4M95SACTIB
Octisalate4X49Y0596WACTIB
AvobenzoneG63QQF2NOXACTIB
Isopropyl Myristate0RE8K4LNJSIACT
Triethyl Citrate8Z96QXD6UMIACT

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
a5595583-af14-4f08-a0ec-23567c85b15f0c30c05d-e76b-472e-ad0c-22723d353d952019-12-23WarningsExact identifier
spl id: a5595583-af14-4f08-a0ec-23567c85b15f
spl set id: 0c30c05d-e76b-472e-ad0c-22723d353d95

Reported adverse events (FAERS/openFDA)#

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