FDA.reportPublic FDA data

WIKLAR UV COVER SHIELD

Manufacturer
Fanipinkorea Co., Ltd.
Effective date
2018-06-14
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 22:55:56

Label at a glance#

ProductWIKLAR UV COVER SHIELD
Active ingredientOCTINOXATE, ZINC OXIDE, OCTISALATE, TITANIUM DIOXIDE
Label structure8 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Octinoxate 7.00%

Zinc Oxide 4.6%
Octisalate 4.50%
Titanium Dioxide 1.00%

OTC - PURPOSE SECTION

Sunscreen

INDICATIONS & USAGE SECTION

Helps prevent sunburn

DOSAGE & ADMINISTRATION SECTION

Apply liberally 15 minutes before sun exposure.

Reapply at least every two 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 of higher and other sun protection measures including: 1) Limited time in the sun, especially from 10 am to 2 pm. 2) Wear long-sleeve shirts, pants, hats, and sunglasses
Ask a doctor to use for children under 6 months

WARNINGS SECTION

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 using and ask a doctor if rash occurs.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of the children. If product is swallowed, get medical help or contact a poison control center right away.

INACTIVE INGREDIENT SECTION

Water, Cyclopentasiloxane, C12-15 Alkyl Benzoate, Glycerin, Dicaprylyl Carbonate, Bis-Ethylhexyloxyphenol, Methoxyphenyl Triazine, Cetyl PEG/PPG-10/1 Dimethicone, Isoamyl p-Methoxycinnamate, Niacinamide, Glyceryl Behenate/Eicosadioate, Disteardimonium Hectorite, Nylon-12, Cyclohexasiloxane, Ozokerite, Sodium Chloride, Polyhydroxystearic Acid, Sorbitan Isostearate, Hydrogen Dimethicone, Triethyl Citrate, Phenoxyethanol
Dimethicone Crosspolymer, Aluminum Stearate, Trimethylsiloxysilicate, Butylene Glycol, Alumina, Ethylhexylglycerin, Snail Secretion Filtrate, Tocopheryl Acetate, Sodium Hyaluronate, Silkworm Cocoon Extract, Propolis Extract, Beta-Glucan, Adenosine, Disodium EDTA, Ethyl Hexanediol, 1,2-Hexanediol, Fragrance

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage description

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
ZINC CATION Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
d676a241-be05-4740-b3ee-1a5f2ed422d2Product name420180615
dd8bd48f-20d6-43c7-b471-3ae872868afaProduct name320180125
d41954ff-bc63-4b2c-aba0-9146707659d7Product name220151117

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
71460-001-022020-01-31C16284748780-19d75b9cf-fa3d-f424-e053-dadaa90a57ceDrug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71460-001-01WIKLAR UV COVER SHIELD50 g in 1 CONTAINERCREAM502
71460-001-02WIKLAR UV COVER SHIELD1 in 1 CARTONCREAM12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71460-001WIKLAR UV COVER SHIELD (OCTINOXATE, ZINC OXIDE, OCTISALATE, TITANIUM DIOXIDE) CREAM [FANIPINKOREA CO., LTD.]2Legacy NDC, 2 package rows20180615_f1a9532e-589d-4070-83e9-fe44279bab3a.zip

Products#

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

DailyMed product names page 1 of 2 · 41 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
71460-00171460-001-01, 71460-001-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 38 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
CYCLOMETHICONE 50THT5PCI0RIACT
ALKYL (C12-15) BENZOATEA9EJ3J61HQIACT
GLYCERINPDC6A3C0OXIACT
DICAPRYLYL CARBONATE609A3V1SUAIACT
BEMOTRIZINOLPWZ1720CBHIACT
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 3)G300307ZXPIACT
AMILOXATE376KTP06K8IACT
NIACINAMIDE25X51I8RD4IACT
GLYCERYL BEHENATE/EICOSADIOATE73CJJ317SRIACT
DISTEARDIMONIUM HECTORITEX687XDK09LIACT
NYLON-12446U8J075BIACT
CYCLOMETHICONE 6XHK3U310BAIACT
CERESINQ1LS2UJO3AIACT
SODIUM CHLORIDE451W47IQ8XIACT
POLYHYDROXYSTEARIC ACID (2300 MW)YXH47AOU0FIACT
SORBITAN ISOSTEARATE01S2G2C1E4IACT
HYDROGEN DIMETHICONE (20 CST)12Z59IF64NIACT
TRIETHYL CITRATE8Z96QXD6UMIACT
PHENOXYETHANOLHIE492ZZ3TIACT
DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE)UF7620L1W6IACT
ALUMINUM STEARATEU6XF9NP8HMIACT
TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8)5041RX63GNIACT
BUTYLENE GLYCOL3XUS85K0RAIACT
ALUMINUM OXIDELMI26O6933IACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
HYALURONATE SODIUMYSE9PPT4THIACT
BOMBYX MORI FIBER6LK42KUV6WIACT
PROPOLIS WAX6Y8XYV2NOFIACT
ADENOSINEK72T3FS567IACT
EDETATE DISODIUM7FLD91C86KIACT
ETHOHEXADIOLM9JGK7U88VIACT
1,2-HEXANEDIOLTR046Y3K1GIACT
OCTINOXATE4Y5P7MUD51ACTIB
ZINC OXIDESOI2LOH54ZACTIM
OCTISALATE4X49Y0596WACTIB
TITANIUM DIOXIDE15FIX9V2JPACTIB

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
6ea1ceaa-0d2a-5e6e-e053-2991aa0ac2f3f1a9532e-589d-4070-83e9-fe44279bab3a2018-06-14WarningsExact identifier
spl id: 6ea1ceaa-0d2a-5e6e-e053-2991aa0ac2f3
spl set id: f1a9532e-589d-4070-83e9-fe44279bab3a

Reported adverse events (FAERS/openFDA)#

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