PROVENCE CALENDULA SUN- zinc oxide, titanium dioxide liquid

PROVENCE CALENDULA SUN by

Drug Labeling and Warnings

PROVENCE CALENDULA 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: ZINC OXIDE 12.48%, TITANIUM DIOXIDE 2.00%

INACTIVE INGREDIENT

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

Purpose: Sunscreen [UV Protection]

CAUTIONS

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

KEEP OUT OF REACH OF CHILDREN

HOW TO USE

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

INGREDIENTS AND APPEARANCE

PROVENCE CALENDULA SUN 
zinc oxide, titanium dioxide liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51346-287
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	6.24 mg  in 50 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	1.00 mg  in 50 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
ISODODECANE (UNII: A8289P68Y2)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51346-287-01	50 mL in 1 CARTON; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	02/01/2015

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(51346-287)