FDA.reportPublic FDA data

PROVENCE CALENDULA AQUA SUN

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 01:31:57

Label at a glance#

ProductPROVENCE CALENDULA AQUA SUN
Active ingredientOCTINOXATE, OCTISALATE, HOMOSALATE
Label structure7 sections

Label contents#

Full prescribing information#

ACTIVE INGREDIENT

OTC - ACTIVE INGREDIENT SECTION

ACTIVE INGREDIENTS: ETHYLHEXYL METHOXYCINNAMATE 6.50%, ETHYLHEXYL SALICYLATE 4.40%, HOMOSALATE 4.40%

INACTIVE INGREDIENT

INACTIVE INGREDIENT SECTION

Inactive Ingredients: WATER, DIETHYLAMINO HYDROXYBENZOYL HEXYL BENZOATE,DICAPRYLYL CARBONATE,ALCOHOL DENAT.,BUTYLENE GLYCOL,BIS-ETHYLHEXYLOXYPHENOL METHOXYPHENYL TRIAZINE,BEHENYL ALCOHOL,FRAGRANCE(PARFUM),TRIETHANOLAMINE,GLYCERYL CAPRYLATE,PHENOXYETHANOL,CARBOMER,CAPRYLYL GLYCOL,ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER,DISODIUM EDTA,CALENDULA OFFICINALIS FLOWER EXTRACT,ANTHEMIS NOBILIS FLOWER WATER,SODIUM BENZOATE,CITRIC ACID,POTASSIUM SORBATE

PURPOSE

OTC - PURPOSE SECTION

Purpose: Sunscreen [UV Protection]

CAUTIONS

WARNINGS SECTION

CAUTIONS: 1. For external use only. 2. Avoid contact with eyes and mouth. 3. Discontinue use if signs of irritation or rashes appear. 4. Keep out of reach of children. 5. 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-138806173422784GTIN-13: 8806173422784
EAN-13: 8806173422784
GTIN storage (14 digits): 08806173422784		provence calendula aqua sun carton.jpg

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
51346-283-012021-07-05C16284748780-19d75b9d0-9de4-f424-e053-dadaa90a57ce8f4fc901-6e98-4dab-9aa5-3dd4c77ec24e
51346-283-012020-01-31C16284748780-19d75b9d0-9de4-f424-e053-dadaa90a57ce8f4fc901-6e98-4dab-9aa5-3dd4c77ec24e

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
HOMOSALATEACTIVE INGREDIENTV06SV4M95S1
OCTINOXATEACTIVE INGREDIENT4Y5P7MUD511
OCTISALATEACTIVE INGREDIENT4X49Y0596W1
HOMOSALATEACTIVE MOIETYV06SV4M95S1
OCTINOXATEACTIVE MOIETY4Y5P7MUD511
OCTISALATEACTIVE MOIETY4X49Y0596W1
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
51346-28351346-283-01

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
HOMOSALATEV06SV4M95SACTIB
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
fda5d86b-4a6c-463b-84fb-64997e29e1018f4fc901-6e98-4dab-9aa5-3dd4c77ec24e2021-07-05WarningsExact identifier
spl set id: 8f4fc901-6e98-4dab-9aa5-3dd4c77ec24e

Reported adverse events (FAERS/openFDA)#

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