PURE COLOR CRE AM 02 NATURAL BEIGE by NATURE REPUBLIC CO., LTD. / Cosmecca Korea Co., Ltd.

PURE COLOR CRE AM 02 NATURAL BEIGE by

Drug Labeling and Warnings

PURE COLOR CRE AM 02 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 COLOR CRE AM 02 NATURAL BEIGE- octinoxate, titanium dioxide 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: ETHYLHEXYL METHOXYCINNAMATE 6.00%, TITANIUM DIOXIDE (CI 77891) 5.35%

INACTIVE INGREDIENT

Inactive ingredients: Water, Cyclopentasiloxane, Phenyl Trimethicone,Dimethicone,Butylene Glycol,Cyclohexasiloxane,Dipropylene Glycol,Alcohol Denat.,Diglycerin,Caprylic/Capric Glycerides,Niacinamide,Glyceryl Stearate,Polypropylsilsesquioxane,Cetyl Ethylhexanoate,Methylene Bis-benzotriazolyl Tetramethylbutylphenol,Potassium Cetyl Phosphate,Propanediol,Cetearyl Alcohol,Propylene Glycol,PEG-100 Stearate,Iron Oxides (CI 77492),Dimethicone/Vinyl Dimethicone Crosspolymer,Caprylyl Glycol,Sodium Acrylate/Sodium Acryloyldimethyl Taurate Co polymer,Acrylates/C10-30 Alkyl Acrylate Crosspolymer,Phenoxyethanol,Tromethamine,Sodium Polyacrylate,Iron Oxides (CI 77491),Isohexadecane,Glycerin,Polyhydroxystearic Acid,Fragrance,Polysorbate 80,Hemerocallis Fulva Flower Extract,Hedera Helix (Ivy) Leaf/Stem Extract,Sansevieria Trifasciata Leaf Extract,Nymphaea Odorata Root Extract,Myriophyllum Spicatum Extract,Hibiscus Sabdariffa Flower Extract,Rosmarinus Officinalis (Rosemary) Leaf Extract,Thymus Vulgaris (Thyme) Flower/Leaf Extract,Iron Oxides (CI 77499),1,2-Hexanediol,Ethylhexylglycerin,Nelumbo Nucifera Flower Extract,Adenosine,BHT,Disodium EDTA,Polyquaternium-7,Buddleja Davidii Extract,Helichrysum Arenarium Extract,Acrylamidopropyltrimonium Chloride/Acrylamide Copo lymer,Eucalyptus Globulus Leaf Extract

PURPOSE

Purpose: [Sunscreen] The complexion color cream for high-coverage and perfect complexion while hides imperfections,

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: After basic skin care, apply an appropriate amount to the entire face in a gentle tapping motion.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PURE COLOR CRE AM 02 NATURAL BEIGE 
octinoxate, titanium dioxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51346-458
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	0.90 g  in 15 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	0.80 g  in 15 mL

Inactive Ingredients
Ingredient Name	Strength
Water (UNII: 059QF0KO0R)
Phenyl Trimethicone (UNII: DR0K5NOJ4R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51346-458-02	1 in 1 CARTON	02/01/2015	11/01/2019
1	NDC: 51346-458-01	15 mL in 1 TUBE; 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	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(51346-458)

Revised: 2/2020

Document Id: 8e447c5e-fb81-4d20-a783-9c30dab1b5b7

34390-5

Set id: 4edb739c-55ff-405f-b8c9-25e75dfbdd5d

Version: 2

Effective Time: 20200219