PROVENCE CALENDULA AQUA SUN GE L by NATURE REPUBLIC CO., LTD. / Cosmecca Korea Co., Ltd.

PROVENCE CALENDULA AQUA SUN GE L by

Drug Labeling and Warnings

PROVENCE CALENDULA AQUA SUN GE L by is a Otc medication manufactured, distributed, or labeled by NATURE REPUBLIC CO., LTD., Cosmecca Korea Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

PROVENCE CALENDULA AQUA SUN GE L- octinoxate, octocrylene, octisalate, avobenzone gel 
NATURE REPUBLIC CO., LTD.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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ACTIVE INGREDIENT

ACTIVE INGREDIENT: Ethylhexyl Methoxycinnamate 7%, Octocrylene 5%, Ethylhexyl Salicylate 4.5%, Butyl Methoxydibenzoylmethane 4%

INACTIVE INGREDIENT

INACTIVE INGREDIENTS: Water, Alcohol Denat., Methyl Methacrylate Crosspolymer, Dipropylene Glycol, Bis-Ethylhexyloxyphenol Methoxyphenyl Triazine, Methoxy PEG/PPG-25/4 Dimethicone, Bis-PEG/PPG-20/5 PEG/PPG-20/5 Dimethicone, Sodium Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Caprylic/Capric Triglyceride, Isohexadecane, Dimethicone, Polysorbate 80, Caprylyl Glycol, Fragrance, Ethylhexylglycerin,1,2-Hexanediol, BHT, Sodium Hydroxide, Disodium EDTA, Calendula Officinalis Flower Extract, Anthemis Nobilis Flower Water, Sea Water, Sodium Benzoate, Butylene Glycol, Citric Acid, Phenoxyethanol, Potassium sorbate, Hydrolyzed Hyaluronic Acid

PURPOSE

PURPOSE: Sunscreen

Warnings

Warnings: For external use only Avoid contact with eyes. Discontinue use if signs of irritation or rashes appear. Replace the cap after use. Keep out of reach of children

DESCRIPTION

Indications & Usage: This is gel-type sun block.

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PROVENCE CALENDULA AQUA SUN GE L 
octinoxate, octocrylene, octisalate, avobenzone gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51346-449
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Octinoxate (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	Octinoxate	4.2 g  in 60 mL
Octocrylene (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	Octocrylene	3.0 g  in 60 mL
Octisalate (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	Octisalate	2.7 g  in 60 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	2.4 g  in 60 mL

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51346-449-02	1 in 1 CARTON	02/01/2015	12/01/2018
1	NDC: 51346-449-01	60 mL in 1 CONTAINER; 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	12/01/2018

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(51346-449)

Revised: 2/2020

Document Id: e1f2395e-4217-4fb5-910d-a982608b0a40

34390-5

Set id: 5c5e4a12-fb82-4d16-8e91-7a011d931018

Version: 2

Effective Time: 20200214