FDA.reportPublic FDA data

PROVENCE CALENDULA NO SEBUM SUN BLOCK

Manufacturer
NATURE REPUBLIC CO., LTD. | Kolmar Korea Co., Ltd.
Effective date
2017-02-14
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-02 01:19:38

Label at a glance#

ProductPROVENCE CALENDULA NO SEBUM SUN BLOCK SPF45
Active ingredientOCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDE, OCTISALATE
Label structure6 sections

Label contents#

Full prescribing information#

ACTIVE INGREDIENT

OTC - ACTIVE INGREDIENT SECTION

Active Ingredients: ETHYLHEXYL METHOXYCINNAMATE 6.80%, TITANIUM DIOXIDE 5.18%, ZINC OXIDE 5.00%, ETHYLHEXYL SALICYLATE 4.50%

INACTIVE INGREDIENT

INACTIVE INGREDIENT SECTION

Inactive Ingredients: WATER,CYCLOPENTASILOXANE,DIPROPYLENE GLYCOL,METHYL METHACRYLATE CROSSPOLYMER,PEG-10 DIMETHICONE,DIMETHICONE,DICAPRYLYL CARBONATE,MICA,DISTEARDIMONIUM HECTORITE,GLYCERIN,POLYMETHYL METHACRYLATE,MAGNESIUM SULFATE,VISCUM ALBUM (MISTLETOE) LEAF EXTRACT,CENTELLA ASIATICA EXTRACT,PORTULACA OLERACEA EXTRACT,ALUMINUM HYDROXIDE,BIS-ETHYLHEXYLOXYPHENOL METHOXYPHENYL TRIAZINE,PHENOXYETHANOL,VINYL DIMETHICONE/METHICONE SILSESQUIOXANE CROSSPOLYMER,STEARIC ACID,TALC,FRAGRANCE,DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER,METHICONE,CAPRYLYL GLYCOL,POLYGLYCERYL-6 POLYRICINOLEATE,OCTYLDODECANOL,MICROCRYSTALLINE CELLULOSE,GLYCERYL CAPRYLATE,TRIETHOXYCAPRYLYLSILANE,ECHIUM PLANTAGINEUM SEED OIL,CELLULOSE GUM,CALENDULA OFFICINALIS FLOWER EXTRACT,IRON OXIDES(CI 77491),CARDIOSPERMUM HALICACABUM FLOWER/LEAF/VINE EXTRACT,HELIANTHUS ANNUUS (SUNFLOWER) SEED OIL UNSAPONIFIABLES

PURPOSE

OTC - PURPOSE SECTION

Purpose: Sunscreen [UV PROTECTION] A moisture-rich daily sun block. Air-light, matte-finish oil sunblock.

CAUTIONS

WARNINGS SECTION

CAUTIONS: For external use only. Avoid contact with eyes and mouth. Discontinue use if signs of irritation or rashes appear. Keep out of reach of children. Replace the cap after use.

HOW TO USE

DESCRIPTION SECTION

HOW TO USE: Take an adequate amount of the product and thoroughly apply on the areas exposed to the UV rays.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Image of cartonImage of carton

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-138806173420421GTIN-13: 8806173420421
EAN-13: 8806173420421
GTIN storage (14 digits): 08806173420421		provence calendula no sebum sun block carton.jpg

Products#

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

DailyMed product names page 1 of 1 · 8 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
51346-44851346-448-01, 51346-448-02

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
NameUNIIKind
OCTINOXATE4Y5P7MUD51ACTIB
TITANIUM DIOXIDE15FIX9V2JPACTIB
ZINC OXIDESOI2LOH54ZACTIM
OCTISALATE4X49Y0596WACTIB
WATER059QF0KO0RIACT

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
96e25a91-0949-4060-8e65-71de3ba9f29fbb11d58e-ed99-42e5-9b74-2a58a57911dc2017-02-14WarningsExact identifier
spl id: 96e25a91-0949-4060-8e65-71de3ba9f29f
spl set id: bb11d58e-ed99-42e5-9b74-2a58a57911dc

Reported adverse events (FAERS/openFDA)#

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