FDA.reportPublic FDA data

PROVENCE CALENDULA FRESH 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 01:31:56

Label at a glance#

ProductPROVENCE CALENDULA FRESH SUN
Active ingredientOCTINOXATE, OCTISALATE
Label structure7 sections

Label contents#

Full prescribing information#

ACTIVE INGREDIENT

OTC - ACTIVE INGREDIENT SECTION

Active Ingredient: ETHYLHEXYL METHOXYCINNAMATE 6.00%, ETHYLHEXYL SALICYLATE 3.00%

INACTIVE INGREDIENT

INACTIVE INGREDIENT SECTION

Inactive Ingredients: WATER, BUTYLENE GLYCOL, CYCLOPENTASILOXANE,ALCOHOL, ISOAMYL P-METHOXYCINNAMATE,DIETHYLAMINO HYDROXYBENZOYL HEXYL BENZOATE,1,2-HEXANEDIOL,TRIETHANOLAMINE,DIPROPYLENE GLYCOL,PEG/PPG-30/10 DIMETHICONE,SILICA,CARBOMER,VISCUM ALBUM (MISTLETOE) LEAF EXTRACT,CENTELLA ASIATICA EXTRACT,PORTULACA OLERACEA EXTRACT,CETETH-10,FRAGRANCE,PHENOXYETHANOL,BEHENYL ALCOHOL,ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER,OCTYLDODECANOL,CALENDULA OFFICINALIS FLOWER EXTRACT,ECHIUM PLANTAGINEUM SEED OIL,SODIUM HYALURONATE,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. 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-138806173420551GTIN-13: 8806173420551
EAN-13: 8806173420551
GTIN storage (14 digits): 08806173420551		provence calendula fresh sun carton.jpg

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
51346-285-012020-02-20C16284748780-19d75b9d0-70ff-f424-e053-dadaa90a57ce116a7fb1-d479-47fb-9486-ba3c8d383932
51346-285-012020-01-31C16284748780-19d75b9d0-70ff-f424-e053-dadaa90a57ce116a7fb1-d479-47fb-9486-ba3c8d383932

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
OCTINOXATEACTIVE INGREDIENT4Y5P7MUD511
OCTISALATEACTIVE INGREDIENT4X49Y0596W1
OCTINOXATEACTIVE MOIETY4Y5P7MUD511
OCTISALATEACTIVE MOIETY4X49Y0596W1
BUTYLENE GLYCOLINACTIVE INGREDIENT3XUS85K0RA1
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
51346-28551346-285-01

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
WATER059QF0KO0RIACT
BUTYLENE GLYCOL3XUS85K0RAIACT

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 1 · 2 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
BUTYLENE GLYCOLBUTYLENE GLYCOL3XUS85K0RASYSTEM / TRANSDERMAL8.12 mgExact identifier — unii candidate
2 equally ranked IID candidates
BUTYLENE GLYCOLBUTYLENE GLYCOL3XUS85K0RASYSTEM / TOPICAL1400 mgExact identifier — unii candidate
2 equally ranked IID candidates

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
16f1c17f-09f9-4554-b2c4-86be779166a5116a7fb1-d479-47fb-9486-ba3c8d3839322015-05-19WarningsExact identifier
spl id: 16f1c17f-09f9-4554-b2c4-86be779166a5
spl set id: 116a7fb1-d479-47fb-9486-ba3c8d383932

Reported adverse events (FAERS/openFDA)#

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