TRUFFLE EX SUN SPF50 PLUS PA PLUS PLUS PLUS- octinoxate, octisalate, zinc oxide, titanium dioxide cream

TRUFFLE EX SUN by

Drug Labeling and Warnings

TRUFFLE EX SUN by is a Otc medication manufactured, distributed, or labeled by NATURE REPUBLIC CO., LTD.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

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

Inactive Ingredient

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

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

WARNINGS

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

Keep out of reach of children:

Keep out of reach of children

INDICATIONS AND USAGE

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.

PACKAGE LABEL. PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

TRUFFLE EX SUN  SPF50 PLUS PA PLUS PLUS PLUS
octinoxate, octisalate, zinc oxide, titanium dioxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51346-002
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	3.75 g  in 50 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	2.50 g  in 50 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	2.40 g  in 50 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	1.25 g  in 50 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
DIPROPYLENE GLYCOL (UNII: E107L85C40)
CYCLOMETHICONE (UNII: NMQ347994Z)
LAURETH-12 (UNII: OAH19558U1)
DIMETHICONE (UNII: 92RU3N3Y1O)
NIACINAMIDE (UNII: 25X51I8RD4)
ISODECYL NEOPENTANOATE (UNII: W60VYE24XC)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51346-002-01	50 mL in 1 CARTON

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	03/01/2012

Labeler - NATURE REPUBLIC CO., LTD. (631172020)

Registrant - NATURE REPUBLIC CO., LTD. (631172020)

Establishment
Name	Address	ID/FEI	Business Operations
NATURE REPUBLIC CO., LTD.		631172020	manufacture(51346-002)