PURE COLOR 01 BRIGHT PINK- 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 INGREDIETNS: 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,Dimethicone/Vinyl Dimethicone Crosspolymer,Caprylyl Glycol,Sodium Acrylate/Sodium Acryloyldimethyl Taurate Co polymer,Acrylates/C10-30 Alkyl Acrylate Crosspolymer,Phenoxyethanol,Tromethamine,Iron Oxides (CI 77492),Sodium Polyacrylate,Isohexadecane,Glycerin,Polyhydroxystearic Acid,Fragrance,Polysorbate 80,Hedera Helix (Ivy) Leaf/Stem Extract,Nymphaea Odorata Root Extract,Sansevieria Trifasciata Leaf Extract,Hemerocallis Fulva Flower Extract,Myriophyllum Spicatum Extract,Hibiscus Sabdariffa Flower Extract,Rosmarinus Officinalis (Rosemary) Leaf Extract,Thymus Vulgaris (Thyme) Flower/Leaf Extract,Iron Oxides (CI 77491),Ethylhexylglycerin,1,2-Hexanediol,Nelumbo Nucifera Flower Extract,Adenosine,BHT,Iron Oxides (CI 77499),Disodium EDTA,Polyquaternium-7,Buddleja Davidii Extract,Helichrysum Arenarium Extract,Acrylamidopropyltrimonium Chloride/Acrylamide Co polymer,Eucalyptus Globulus Leaf Extract

PURPOSE

Purpose: Sunscreen [UV Protection], Skin Protectant [Brightening, Wrinkle-Improvement]

CAUTIONS

CAUTIONS: 1. For external use only. 2. Avoid contact with eyes and mouth. 3. Discontinue use if signs of irritation or rashes appear. 4. Keep out of reach of children 5. Replace the cap after use.

KEEP OUT OF REACH OF CHILDREN

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

Image of carton

PURE COLOR 01 BRIGHT PINK 
octinoxate, titanium dioxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51346-293
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE0.90 mg  in 15 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE0.80 mg  in 15 mL
Inactive Ingredients
Ingredient NameStrength
Water (UNII: 059QF0KO0R)  
Phenyl Trimethicone (UNII: DR0K5NOJ4R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:51346-293-0115 mL in 1 CARTON; Type 0: Not a Combination Product02/01/201512/30/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35202/01/201512/30/2017
Labeler - NATURE REPUBLIC CO., LTD. (631172020)
Registrant - NATURE REPUBLIC CO., LTD. (631172020)
Establishment
NameAddressID/FEIBusiness Operations
Cosmecca Korea Co., Ltd.688830827manufacture(51346-293)

Revised: 8/2018
 
NATURE REPUBLIC CO., LTD.