FDA.reportPublic FDA data

PROVENCE FOUNDATION

Manufacturer
NATURE REPUBLIC CO., LTD.
Effective date
2013-05-27
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-02 01:40:47

Label at a glance#

ProductPROVENCE FOUNDATION SPF31 PA PLUS PLUS NO 23
Active ingredientTitanium Dioxide, OCTINOXATE, Zinc Oxide
Label structure8 sections

Indications and uses

How to Use: Apply an appropriate amount to the skin evenly.

Dosage and administration

How to Use: Apply an appropriate amount to the skin evenly.

Label contents#

Full prescribing information#

ACTIVE INGREDIENT

OTC - ACTIVE INGREDIENT SECTION

Active Ingredients: Titanium Dioxide 10.43%, Ethylhexyl Methoxycinnamate 4%, Zinc Oxide 0.98%

INACTIVE INGREDIENT

INACTIVE INGREDIENT SECTION

Inactive Ingredients:
Water, Cyclopentasiloxane, Trimethylsiloxysilicate, Diphenylsiloxy Phenyl Trimethicone, Butylene Glycol, PEG-10 Dimethicone, Cyclohexasiloxane, Glycerin, Niacinamide, Butylene Glycol Dicaprylate/Dicaprate, Iron Oxides (CI 77492), Tribehenin, Sodium Chloride,
Neopentyl Glycol Diheptanoate, Disteardimonium Hectorite, Phenoxyethanol, Sorbitan Isostearate, Dimethicone, Methyl Methacrylate Crosspolymer, Lauryl PEG-9 Polydimethylsiloxyethyl Dimethicone, Iron Oxides (CI 77491), Triethoxycaprylylsilane, Dimethicone/Divinyldimethicone/Silsesquioxane Crosspolymer, Dimethiconol, Iron Oxides (CI 77499), Aluminum Hydroxide, Fragrance(Parfum), Stearic Acid, Dimethicone Crosspolymer, Ethylhexylglycerin, Disodium EDTA, Adenosine, Copernicia Cerifera (Carnauba) Wax, Rosmarinus Officinalis (Rosemary) Leaf Extract, Rosa Canina Fruit Oil, Glyceryl Behenate/Eicosadioate

PURPOSE

OTC - PURPOSE SECTION

PURPOSE: Sunscreen

WARNINGS

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.

KEEP OUT OF REACH OF CHILDREN

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

KEEP OUT OF REACH OF CHILDREN

INDICATIONS AND USAGE

INDICATIONS & USAGE SECTION

How to Use: Apply an appropriate amount to the skin evenly.

DOSAGE AND ADMINISTRATION

DOSAGE & ADMINISTRATION SECTION

How to Use: Apply an appropriate amount to the skin evenly.

PACKAGE LABEL. PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Image of cartonImage of carton

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
51346-203-012021-07-13C16284748780-19d75b9d0-67f9-f424-e053-dadaa90a57ce39dede64-218b-406b-b976-2fc04fe6ebb3
51346-203-012020-01-31C16284748780-19d75b9d0-67f9-f424-e053-dadaa90a57ce39dede64-218b-406b-b976-2fc04fe6ebb3

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
OCTINOXATEACTIVE INGREDIENT4Y5P7MUD511
Titanium DioxideACTIVE INGREDIENT15FIX9V2JP1
Zinc OxideACTIVE INGREDIENTSOI2LOH54Z1
OCTINOXATEACTIVE MOIETY4Y5P7MUD511
TITANIUM DIOXIDEACTIVE MOIETY15FIX9V2JP1
ZINC CATIONACTIVE MOIETY13S1S8SF371
Diphenylsiloxy Phenyl TrimethiconeINACTIVE INGREDIENTI445L28B121
WaterINACTIVE INGREDIENT059QF0KO0R1

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
51346-20351346-203-01

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
Titanium Dioxide15FIX9V2JPACTIB
OCTINOXATE4Y5P7MUD51ACTIB
Zinc OxideSOI2LOH54ZACTIM
Water059QF0KO0RIACT
Diphenylsiloxy Phenyl TrimethiconeI445L28B12IACT

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
2d829d58-368a-4df9-a20f-a9efd86d287739dede64-218b-406b-b976-2fc04fe6ebb32021-07-13WarningsExact identifier
spl set id: 39dede64-218b-406b-b976-2fc04fe6ebb3

Reported adverse events (FAERS/openFDA)#

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