FDA.reportPublic FDA data

PROVENCE CALENDULA 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 SUN
Active ingredientZINC OXIDE, TITANIUM DIOXIDE
Label structure7 sections

Label contents#

Full prescribing information#

ACTIVE INGREDIENT

OTC - ACTIVE INGREDIENT SECTION

ACTIVE INGREDIENTS: ZINC OXIDE 12.48%, TITANIUM DIOXIDE 2.00%

INACTIVE INGREDIENT

INACTIVE INGREDIENT SECTION

INACTIVE INGREDIENTS: CYCLOPENTASILOXANE, WATER, ISODODECANE, BUTYLENE GLYCOL,DICAPRYLYL ETHER,GLYCERIN,METHYL METHACRYLATE CROSSPOLYMER, ALCOHOL,BIOSACCHARIDE GUM-1,CAPRYLYL METHICONE,NIACINAMIDE,CAPRYLIC/CAPRIC/SUCCINIC TRIGLYCERIDE,PEG-10 DIMETHICONE,POLYMETHYLSILSESQUIOXANE,DIMETHICONE,MAGNESIUM SULFATE,VISCUM ALBUM (MISTLETOE) LEAF EXTRACT,CENTELLA ASIATICA EXTRACT,PORTULACA OLERACEA EXTRACT,METHICONE,SILICA,PHENOXYETHANOL,POLYGLYCERYL-6 POLYRICINOLEATE,ALUMINUM HYDROXIDE,DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER,FRAGRANCE,CAPRYLYL GLYCOL,STEARIC ACID,GLYCERYL CAPRYLATE,TOCOPHERYL ACETATE,ADENOSINE,POLYURETHANE-11,CALENDULA OFFICINALIS FLOWER EXTRACT

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: Shake the product 3-5 times before use. Then evenly apply an appropriate amount on areas exposed to UV rays.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Image of cartonImage of carton

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
51346-287-012021-07-05C16284748780-19d75b9d0-c8d7-f424-e053-dadaa90a57ceaa8ddba3-4906-4e3b-b049-f61bacc25261
51346-287-012020-01-31C16284748780-19d75b9d0-c8d7-f424-e053-dadaa90a57ceaa8ddba3-4906-4e3b-b049-f61bacc25261

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
TITANIUM DIOXIDEACTIVE INGREDIENT15FIX9V2JP1
ZINC OXIDEACTIVE INGREDIENTSOI2LOH54Z1
TITANIUM DIOXIDEACTIVE MOIETY15FIX9V2JP1
ZINC CATIONACTIVE MOIETY13S1S8SF371
ISODODECANEINACTIVE INGREDIENTA8289P68Y21
WATERINACTIVE INGREDIENT059QF0KO0R1

Products#

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

DailyMed product names page 1 of 1 · 7 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
51346-28751346-287-01

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
ZINC OXIDESOI2LOH54ZACTIM
TITANIUM DIOXIDE15FIX9V2JPACTIB
WATER059QF0KO0RIACT
ISODODECANEA8289P68Y2IACT

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
68b10ae0-5d35-49eb-a8b6-4189fc2d04c2aa8ddba3-4906-4e3b-b049-f61bacc252612021-07-05WarningsExact identifier
spl set id: aa8ddba3-4906-4e3b-b049-f61bacc25261

Reported adverse events (FAERS/openFDA)#

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