FDA.reportPublic FDA data

TRUFFLE EX SUN

Manufacturer
NATURE REPUBLIC CO., LTD.
Effective date
2012-08-17
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-02 01:46:26

Label at a glance#

ProductTRUFFLE EX SUN SPF50 PLUS PA PLUS PLUS PLUS
Active ingredientOCTINOXATE, OCTISALATE, ZINC OXIDE, TITANIUM DIOXIDE
Label structure8 sections

Indications and uses

How to Use: Apply an appropriate amount, and gently pat it into these areas to enhance its absorption into your skin.

Dosage and administration

How to Use: Apply an appropriate amount, and gently pat it into these areas to enhance its absorption into your skin.

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Active Ingredients:
ETHYLHEXYL METHOXYCINNAMATE 7.5%, ETHYLHEXYL SALICYLATE 5%, ZINC OXIDE 4.8%, TITANIUM DIOXIDE 2.5%

Inactive Ingredient

INACTIVE INGREDIENT SECTION

Inactive Ingredients:
WATER, CYCLOPENTASILOXANE, DIPROPYLENE GLYCOL, CYCLOMETHICONE, PEG-10 DIMETHICONE, NIACINAMIDE, POLYMETHYLSILSESQUIOXANE, POLYSILICONE-11, DIMETHICONE, DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER,
DISTEARDIMONIUM HECTORITE, ISODECYL NEOPENTANOATE, MAGNESIUM SULFATE, METHYL METHACRYLATE CROSSPOLYMER, TUBER MELANOSPORUM EXTRACT, PHENOXYETHANOL, CALCIUM ALUMINUM BOROSILICATE, ALUMINUM HYDROXIDE, ALUMINUM STEARATE, FRAGRANCE, METHICONE, CAPRYLYL GLYCOL, GLYCERYL CAPRYLATE, POLYGLYCERYL-6 POLYRICINOLEATE, AGARICUS BISPORUS (MUSHROOM) EXTRACT, CORTHELLUS SHIITAKE (MUSHROOM) EXTRACT, GANODERMA LUCIDUM (MUSHROOM) EXTRACT, HERICIUM ERINACEUM (MUSHROOM) EXTRACT, INONOTUS OBLIQUUS (MUSHROOM) EXTRACT, PHELLINUS LINTEUS EXTRACT, PLEUROTUS OSTREATUS (MUSHROOM) EXTRACT, SARCODON ASPRATUS EXTRACT, TRAMETES VERSICOLOR EXTRACT, TREMELLA FUCIFORMIS (MUSHROOM) EXTRACT, BUTYLENE GLYCOL, SALMON EGG EXTRACT, ADENOSINE, LAURETH-12, ETHYLHEXYLGLYCERIN, 1,2-HEXANEDIOL, TROPOLONE

Purpose

OTC - PURPOSE SECTION

Purpose: Triple functions of wrinkle improvement, brightening and UV protection.

WARNINGS

WARNINGS SECTION

Cautions:
For external use only.
Avoid contact with eyes and mouth.
Discontinue use if signs of irritation or rash 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:

Keep out of reach of children

INDICATIONS AND USAGE

INDICATIONS & USAGE SECTION

How to Use:
Apply an appropriate amount, and gently pat it into these areas to enhance its absorption into your skin.

DOSAGE AND ADMINISTRATION

DOSAGE & ADMINISTRATION SECTION

How to Use:
Apply an appropriate amount, and gently pat it into these areas to enhance its absorption into your skin.

PACKAGE LABEL. PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Image of cartonImage of carton

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-138809344261427GTIN-13: 8809344261427
EAN-13: 8809344261427
GTIN storage (14 digits): 08809344261427		truffle ex sun carton.jpg

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
51346-002-012021-07-09C16284748780-19d75b9d0-fd30-f424-e053-dadaa90a57ce4b431a0b-c7ff-4caa-8b4f-0f4f5d4f400f
51346-002-012020-01-31C16284748780-19d75b9d0-fd30-f424-e053-dadaa90a57ce4b431a0b-c7ff-4caa-8b4f-0f4f5d4f400f

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
OCTINOXATEACTIVE INGREDIENT4Y5P7MUD511
OCTISALATEACTIVE INGREDIENT4X49Y0596W1
TITANIUM DIOXIDEACTIVE INGREDIENT15FIX9V2JP1
ZINC OXIDEACTIVE INGREDIENTSOI2LOH54Z1
OCTINOXATEACTIVE MOIETY4Y5P7MUD511
OCTISALATEACTIVE MOIETY4X49Y0596W1
TITANIUM DIOXIDEACTIVE MOIETY15FIX9V2JP1
ZINC OXIDEACTIVE MOIETYSOI2LOH54Z1
CYCLOMETHICONEINACTIVE INGREDIENTNMQ347994Z1
CYCLOMETHICONE 5INACTIVE INGREDIENT0THT5PCI0R1
DIMETHICONEINACTIVE INGREDIENT92RU3N3Y1O1
DIPROPYLENE GLYCOLINACTIVE INGREDIENTE107L85C401
ISODECYL NEOPENTANOATEINACTIVE INGREDIENTW60VYE24XC1
LAURETH-12INACTIVE INGREDIENTOAH19558U11
NIACINAMIDEINACTIVE INGREDIENT25X51I8RD41
WATERINACTIVE INGREDIENT059QF0KO0R1

Products#

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

DailyMed product names page 1 of 1 · 14 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
51346-00251346-002-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Name, UNII, Kind table
NameUNIIKind
OCTINOXATE4Y5P7MUD51ACTIM
OCTISALATE4X49Y0596WACTIM
ZINC OXIDESOI2LOH54ZACTIM
TITANIUM DIOXIDE15FIX9V2JPACTIM
WATER059QF0KO0RIACT
CYCLOMETHICONE 50THT5PCI0RIACT
DIPROPYLENE GLYCOLE107L85C40IACT
CYCLOMETHICONENMQ347994ZIACT
LAURETH-12OAH19558U1IACT
DIMETHICONE92RU3N3Y1OIACT
NIACINAMIDE25X51I8RD4IACT
ISODECYL NEOPENTANOATEW60VYE24XCIACT

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 · 15 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
DIPROPYLENE GLYCOLDIPROPYLENE GLYCOLE107L85C40SYSTEM / TRANSDERMAL6 mgExact identifier — unii candidate
3 equally ranked IID candidates
CYCLOMETHICONECYCLOMETHICONENMQ347994ZCREAM / TOPICAL13 %w/wExact identifier — unii candidate
5 equally ranked IID candidates
NIACINAMIDENIACINAMIDE25X51I8RD4INJECTION / INTRAVENOUS2.5 %w/vExact identifier — unii candidate
4 equally ranked IID candidates
CYCLOMETHICONECYCLOMETHICONENMQ347994ZAEROSOL, FOAM / TOPICAL5.26 %w/wExact identifier — unii candidate
5 equally ranked IID candidates
CYCLOMETHICONE 5CYCLOMETHICONE 50THT5PCI0RCREAM, AUGMENTED / TOPICAL260 mgExact identifier — unii candidate
3 equally ranked IID candidates
CYCLOMETHICONECYCLOMETHICONENMQ347994ZCREAM, AUGMENTED / TOPICAL7.6 %w/wExact identifier — unii candidate
5 equally ranked IID candidates
CYCLOMETHICONECYCLOMETHICONENMQ347994ZSOLUTION / TOPICAL11.57 %w/vExact identifier — unii candidate
5 equally ranked IID candidates
DIPROPYLENE GLYCOLDIPROPYLENE GLYCOLE107L85C40FILM, EXTENDED RELEASE / TRANSDERMAL296 mgExact identifier — unii candidate
3 equally ranked IID candidates
NIACINAMIDENIACINAMIDE25X51I8RD4GEL / TOPICAL25 mgExact identifier — unii candidate
4 equally ranked IID candidates
NIACINAMIDENIACINAMIDE25X51I8RD4INJECTION / INTRAMUSCULAR2.5 %w/vExact identifier — unii candidate
4 equally ranked IID candidates
DIPROPYLENE GLYCOLDIPROPYLENE GLYCOLE107L85C40FILM, EXTENDED RELEASE / BUCCAL30 mgExact identifier — unii candidate
3 equally ranked IID candidates
CYCLOMETHICONECYCLOMETHICONENMQ347994ZLOTION / TOPICAL3510 mgExact identifier — unii candidate
5 equally ranked IID candidates
CYCLOMETHICONE 5CYCLOMETHICONE 50THT5PCI0RAEROSOL / TOPICAL2.5 %w/wExact identifier — unii candidate
3 equally ranked IID candidates
CYCLOMETHICONE 5CYCLOMETHICONE 50THT5PCI0RAEROSOL, FOAM / TOPICAL144 mgExact identifier — unii candidate
3 equally ranked IID candidates
NIACINAMIDENIACINAMIDE25X51I8RD4CREAM / TOPICALNAExact identifier — unii candidate
4 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
f71c2071-c4d3-43cd-ab04-4827fd23e93d4b431a0b-c7ff-4caa-8b4f-0f4f5d4f400f2021-07-08WarningsExact identifier
spl set id: 4b431a0b-c7ff-4caa-8b4f-0f4f5d4f400f

Reported adverse events (FAERS/openFDA)#

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