FDA.reportPublic FDA data

JAYJUN WAKEPURE CALMING SUN

Manufacturer
JAYJUN COSMETIC Co.,Ltd. | Shinsegae Intercos Korea Inc.
Effective date
2020-06-24
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:18:52

Label at a glance#

ProductJAYJUN WAKEPURE CALMING SUN
Active ingredientHOMOSALATE, OCTISALATE, TITANIUM DIOXIDE, OCTOCRYLENE
Label structure9 sections

Label contents#

Full prescribing information#

ACTIVE INGREDIENTS

OTC - ACTIVE INGREDIENT SECTION

HOMOSALATE 8.0%
ETHYLHEXYL SALICYLATE 4.5%
TITANIUM DIOXIDE 1.75%
OCTOCRYLENE 1.5%

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

WATER (AQUA), BUTYLENE GLYCOL, PROPANEDIOL, C12-15 ALKYL BENZOATE, DIETHYLAMINO HYDROXYBENZOYL HEXYL BENZOATE, DIBUTYL ADIPATE, CAPRYLYL METHICONE, 1,2-HEXANEDIOL, BIS-ETHYLHEXYLOXYPHENOL METHOXYPHENYL TRIAZINE,
PENTYLENE GLYCOL, FRAGRANCE (PARFUM), ALUMINUM STEARATE, AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER, POLYHYDROXYSTEARIC ACID, CETYL HYDROXYETHYLCELLULOSE, CELLULOSE GUM, HYDROXYPROPYL METHYLCELLULOSE,
POLYACRYLATE CROSSPOLYMER-6, ALUMINA, CARAPA GUAIANENSIS SEED OIL, ETHYLHEXYLGLYCERIN, XANTHAN GUM, t-BUTYL ALCOHOL, PANTHENOL, ECTOIN, CALAMINE, HOUTTUYNIA CORDATA EXTRACT, CYMBOPOGON SCHOENANTHUS EXTRACT,
HYDROGENATED LECITHIN, TOCOPHEROL, HAMAMELIS VIRGINIANA (WITCH HAZEL) LEAF EXTRACT, XYLITYLGLUCOSIDE, PHASEOLUS RADIATUS SEED EXTRACT, CENTELLA ASIATICA EXTRACT, RUMEX CRISPUS ROOT EXTRACT, PERILLA FRUTESCENS LEAF EXTRACT,
CERAMIDE 3, ANHYDROXYLITOL, XYLITOL, DIPROPYLENE GLYCOL, GLYCERYL STEARATE, ARTEMISIA PRINCEPS LEAF EXTRACT, ROSA HYBRID FLOWER EXTRACT, PRUNUS SERRULATA FLOWER EXTRACT, PRUNUS PERSICA (PEACH) FLOWER EXTRACT,
ROSMARINUS OFFICINALIS (ROSEMARY) LEAF EXTRACT, LAVANDULA ANGUSTIFOLIA (LAVENDER) FLOWER EXTRACT, CENTAUREA CYANUS FLOWER WATER, CALENDULA OFFICINALIS FLOWER EXTRACT, ANTHEMIS NOBILIS FLOWER WATER

PURPOSE

OTC - PURPOSE SECTION

Sunscreen

WARNINGS

WARNINGS SECTION

For external use only. Discontinue use if irritation occurs. Keep away from children.

DESCRIPTION

DESCRIPTION SECTION

Uses:
A weightless waterproof suncare with UV protection that protects skin.

Directions:
Followed by regular skincare regimen, apply over the face evenly before sun exposure.

Other information

OTHER SAFETY INFORMATION

Store at room temperature

PACKAGE LABEL: Tube

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Image of tubeImage of tube

PACKAGE LABEL: Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Image of cartonImage of carton

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
70920-111-022022-01-28C16284748780-1d6a99b39-f619-a426-e053-dadaa90af4c28c094870-359d-424b-8739-bbc392171cac

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70920-111-01JAYJUN WAKEPURE CALMING SUN50 mL in 1 TUBECREAM501
70920-111-02JAYJUN WAKEPURE CALMING SUN1 in 1 CARTONCREAM11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70920-111JAYJUN WAKEPURE CALMING SUN (HOMOSALATE, ETHYLHEXYL SALICYLATE, TITANIUM DIOXIDE, OCTOCRYLENE) CREAM [JAYJUN COSMETIC CO.,LTD.]1Legacy NDC, 2 package rows20200625_8c094870-359d-424b-8739-bbc392171cac.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
70920-11170920-111-01, 70920-111-02

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
HOMOSALATEV06SV4M95SACTIB
OCTISALATE4X49Y0596WACTIB
TITANIUM DIOXIDE15FIX9V2JPACTIB
OCTOCRYLENE5A68WGF6WMACTIB
Water059QF0KO0RIACT
BUTYLENE GLYCOL3XUS85K0RAIACT
PROPANEDIOL5965N8W85TIACT

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
f1782c58-bbe2-4284-be4a-f3bff86b230a8c094870-359d-424b-8739-bbc392171cac2020-06-24WarningsExact identifier
spl id: f1782c58-bbe2-4284-be4a-f3bff86b230a
spl set id: 8c094870-359d-424b-8739-bbc392171cac

Reported adverse events (FAERS/openFDA)#

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