PROVENCE CALENDULA WATERPROOF SUN BLOCK- zinc oxide, octinoxate, titanium dioxide, octisalate cream

PROVENCE CALENDULA WATERPROOF SUN BLOCK by

Drug Labeling and Warnings

PROVENCE CALENDULA WATERPROOF SUN BLOCK 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 13.82%, ETHYLHEXYL METHOXYCINNAMATE 6.80%, TITANIUM DIOXIDE 5.66%, ETHYLHEXYL SALICYLATE 4.50%

INACTIVE INGREDIENT

INACTIVE INGREDIENTS: WATER,CYCLOPENTASILOXANE, DIPROPYLENE GLYCOL,PEG-10 DIMETHICONE,CAPRYLYL METHICONE,GLYCERIN,DIMETHICONE,DISTEARDIMONIUM HECTORITE,MAGNESIUM SULFATE,ALUMINUM HYDROXIDE,VISCUM ALBUM (MISTLETOE) LEAF EXTRACT,CENTELLA ASIATICA EXTRACT,PORTULACA OLERACEA EXTRACT,BIS-ETHYLHEXYLOXYPHENOL METHOXYPHENYL TRIAZINE,STEARIC ACID,PHENOXYETHANOL,POLYGLYCERYL-6 POLYRICINOLEATE,POLYMETHYLSILSESQUIOXANE,SILICA,METHICONE,CAPRYLYL GLYCOL,DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER,FRAGRANCE,PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE,TRIETHOXYCAPRYLYLSILANE,OCTYLDODECANOL,MICROCRYSTALLINE CELLULOSE,ALOE BARBADENSIS LEAF JUICE,GLYCERYL CAPRYLATE,TOCOPHERYL ACETATE,BUTYLENE GLYCOL,EUTERPE OLERACEA FRUIT EXTRACT,MALPIGHIA EMARGINATA (ACEROLA) FRUIT EXTRACT,TERMINALIA FERDINANDIANA FRUIT EXTRACT,ECHIUM PLANTAGINEUM SEED OIL,CELLULOSE GUM,POLYURETHANE-11,CALENDULA OFFICINALIS FLOWER EXTRACT,CHAMOMILLA RECUTITA (MATRICARIA) FLOWER/LEAF EXTRACT,SODIUM HYALURONATE,CARDIOSPERMUM HALICACABUM FLOWER/LEAF/VINE EXTRACT,HELIANTHUS ANNUUS (SUNFLOWER) SEED OIL UNSAPONIFIABLES

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: Take an adequate amount of the product and thoroughly apply on the areas exposed to the UV rays.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

PROVENCE CALENDULA WATERPROOF SUN BLOCK 
zinc oxide, octinoxate, titanium dioxide, octisalate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51346-290
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	7.87 mg  in 57 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	3.87 mg  in 57 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	3.22 mg  in 57 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	2.56 mg  in 57 mL

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51346-290-01	57 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(51346-290)