FDA.reportPublic FDA data

PROVENCE CALENDULA MILD SUN BLOCK

Manufacturer
NATURE REPUBLIC CO., LTD.
Effective date
2015-05-19
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-02 01:31:56

Label at a glance#

ProductPROVENCE CALENDULA MILD SUN BLOCK
Active ingredientOCTINOXATE, OCTISALATE, TITANIUM DIOXIDE
Label structure7 sections

Label contents#

Full prescribing information#

ACTIVE INGREDIENT

OTC - ACTIVE INGREDIENT SECTION

ACTIVE INGREDIENTS: ETHYLHEXYL METHOXYCINNAMATE 6.80%, ETHYLHEXYL SALICYLATE 4.50%, TITANIUM DIOXIDE 1.19%

INACTIVE INGREDIENT

INACTIVE INGREDIENT SECTION

INACTIVE INGREDIENTS: WATER, HOMOSALATE,DICAPRYLYL CARBONATE,CYCLOPENTASILOXANE,DIETHYLAMINO HYDROXYBENZOYL HEXYL BENZOATE,DIPROPYLENE GLYCOL,GLYCERYL STEARATE,PEG-100 STEARATE,1,2-HEXANEDIOL,BUTYLENE GLYCOL,C12-20 ALKYL GLUCOSIDE,C14-22 ALCOHOLS,CETEARYL ALCOHOL,VISCUM ALBUM (MISTLETOE) LEAF EXTRACT,CENTELLA ASIATICA EXTRACT,PORTULACA OLERACEA EXTRACT,SILICA,PHENOXYETHANOL,FRAGRANCE,OLETH-10,ALUMINUM STEARATE,OCTYLDODECANOL,ISODECETH-6,HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER,POLYACRYLATE-13,ALLANTOIN,GLYCINE SOJA (SOYBEAN) LIPIDS,XANTHAN GUM,POLYISOBUTENE,POLYSORBATE 20,ALUMINA,POLYURETHANE-11,ECHIUM PLANTAGINEUM SEED OIL,SIMETHICONE,ANTHEMIS NOBILIS FLOWER WATER,CALENDULA OFFICINALIS FLOWER EXTRACT,CARDIOSPERMUM HALICACABUM FLOWER/LEAF/VINE EXTRACT,HELIANTHUS ANNUUS (SUNFLOWER) SEED OIL UNSAPONIFIABLES

PURPOSE

OTC - PURPOSE SECTION

Purpose: Sunscreen [UV Protection]

CAUTIONS

WARNINGS SECTION

CAUTIONS: 1. For external use only. 2. Discontinue use if signs of irritation or rashes appear. 3. Keep out of reach of children 4. Replace the cap after use.

KEEP OUT OF REACH OF CHILDREN

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

KEEP OUT OF REACH OF CHILDREN

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-138806173420391GTIN-13: 8806173420391
EAN-13: 8806173420391
GTIN storage (14 digits): 08806173420391		provence calendula mild sun block carton.jpg

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
51346-286-012020-02-20C16284748780-19d75b9d1-205b-f424-e053-dadaa90a57ce2e601c3d-b075-43c3-9d8f-8826f084f6ed
51346-286-012020-01-31C16284748780-19d75b9d1-205b-f424-e053-dadaa90a57ce2e601c3d-b075-43c3-9d8f-8826f084f6ed

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
OCTINOXATEACTIVE INGREDIENT4Y5P7MUD511
OCTISALATEACTIVE INGREDIENT4X49Y0596W1
TITANIUM DIOXIDEACTIVE INGREDIENT15FIX9V2JP1
OCTINOXATEACTIVE MOIETY4Y5P7MUD511
OCTISALATEACTIVE MOIETY4X49Y0596W1
TITANIUM DIOXIDEACTIVE MOIETY15FIX9V2JP1
WATERINACTIVE INGREDIENT059QF0KO0R1

Products#

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

DailyMed product names page 1 of 1 · 6 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
51346-28651346-286-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 4 matching rows.

Name, UNII, Kind table
NameUNIIKind
OCTINOXATE4Y5P7MUD51ACTIB
OCTISALATE4X49Y0596WACTIB
TITANIUM DIOXIDE15FIX9V2JPACTIB
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
01a4b19f-5237-4748-b6ad-5ee0b12d46012e601c3d-b075-43c3-9d8f-8826f084f6ed2015-05-19WarningsExact identifier
spl id: 01a4b19f-5237-4748-b6ad-5ee0b12d4601
spl set id: 2e601c3d-b075-43c3-9d8f-8826f084f6ed

Reported adverse events (FAERS/openFDA)#

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