PURE FOUNDATION 23 NATURAL BEIGE by NATURE REPUBLIC CO., LTD. / Cosmecca Korea Co., Ltd.

PURE FOUNDATION 23 NATURAL BEIGE by

Drug Labeling and Warnings

PURE FOUNDATION 23 NATURAL BEIGE 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]

PURE FOUNDATION 23 NATURAL BEIGE SPF40- titanium dioxide, zinc oxide cream 
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 INGREDIENTS: TITANIUM DIOXIDE (CI 77891) 10.88%, ZINC OXIDE (CI 77947) 5.76%

INACTIVE INGREDIENT

INACTIVE INGREDIENTS: Water,Cyclopentasiloxane,Butylene Glycol Dicaprylate/Dicaprate,Butylene Glycol,Diethylhexyl Carbonate,Glycerin,Dimethicone,Orbignya Oleifera Seed Oil,Niacinamide,Cetyl PEG/PPG-10/1 Dimethicone,Cyclohexasiloxane,Iron Oxides (CI 77492),Sodium Chloride,Caprylyl Methicone,Lauryl PEG-9 Polydimethylsiloxyethyl Dimethicone,Disteardimonium Hectorite,Calcium Stearate,Sorbitan Olivate,Sorbitan Isostearate,Beeswax,Hydrogenated Castor Oil Isostearate,Ozokerite,Iron Oxides (CI 77491),Triethyl Citrate,Hydrogen Dimethicone,Caprylyl Glycol,Phenoxyethanol,Triethoxycaprylylsilane,Iron Oxides (CI 77499),Fragrance,Dimethicone Crosspolymer,Ethylhexylglycerin,1,2-Hexanediol,Adenosine,Disodium EDTA,PEG-12 Dimethicone,Rosmarinus Officinalis (Rosemary) Leaf Extract,Hibiscus Sabdariffa Flower Extract,Nelumbo Nucifera Flower Extract,Helichrysum Arenarium Extract,Buddleja Davidii Extract,Thymus Vulgaris (Thyme) Flower/Leaf Extract,Eucalyptus Globulus Leaf Extract

PURPOSE

Purpose: Sunscreen

Cautions

Cautions: 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

How to use

How to use: Use at the last step of skincare. Evenly apply all over the face for flawless-looking skin.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PURE FOUNDATION 23 NATURAL BEIGE  SPF40
titanium dioxide, zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51346-462
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Titanium dioxide (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	Titanium dioxide	1.63 g  in 15 mL
Zinc oxide (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	0.86 g  in 15 mL

Inactive Ingredients
Ingredient Name	Strength
Water (UNII: 059QF0KO0R)
Butylene Glycol (UNII: 3XUS85K0RA)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51346-462-01	15 mL in 1 CARTON; Type 0: Not a Combination Product	02/01/2015	11/01/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	02/01/2015	11/01/2019

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(51346-462)

Revised: 2/2020

Document Id: a98f23b5-fbb5-4a68-91f1-76af812d0987

34390-5

Set id: 05f330ce-5137-4f2e-bf06-69e6e47cccc2

Version: 2

Effective Time: 20200219

 

NATURE REPUBLIC CO., LTD.