Drug Labeling and Warnings

Drug Details [pdf]

COLLAGEN DREAM 50 RADIANCE ALL IN ONE TONE UP- octinoxate, titanium dioxide, octocrylene 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 7.50%, Titanium Dioxide 4.72%, Octocrylene 2.00%

INACTIVE INGREDIENT

Inactive ingredients: Soluble Collagen,Butylene Glycol,Glycerin,C12-15 Alkyl Benzoate,Caprylyl Methicone,Dimethicone,Niacinamide,Cyclopentasiloxane,Butyl Methoxydibenzoylmethane,Cyclohexasiloxane,Pentylene Glycol,C14-22 Alcohols,Cetearyl Alcohol,Phenoxyethanol,Glyceryl Stearate,PEG-100 Stearate,Polyacrylate-13,Polyhydroxystearic Acid,Potassium Cetyl Phosphate,Silica,Ammonium Acryloyldimethyltaurate/VP Copolymer,Fragrance(Parfum),Polyisobutene,Aluminum Hydroxide,C12-20 Alkyl Glucoside,Stearic Acid,Polysorbate 20,Adenosine,Sorbitan Isostearate,Ethylhexylglycerin,Water,Disodium EDTA,Triethoxycaprylylsilane,Xanthan Gum,Iron Oxides (CI 77491),Iron Oxides (CI 77492),Sea Water,Euterpe Oleracea Fruit Extract,PEG-40 Hydrogenated Castor Oil,1,2-Hexanediol,Caprylyl Glycol,Hydroxyethyl Ethylcellulose

PURPOSE

Purpose: Sunscreen

WARNINGS

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

DESCRIPTION

Indications & Usage: Collagen Dream All In One Radiance Tone Up Cream helps improve skin complexion while protecting the skin from UV rays.

Dosage & Administration: At the last step of skincare, apply an appropriate amount on the face starting from the center of the face; working outwards, gently pat to promote absorption into the skin.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

COLLAGEN DREAM 50 RADIANCE ALL IN ONE TONE UP 
octinoxate, titanium dioxide, octocrylene cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51346-432
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Octinoxate (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	Octinoxate	3.75 g  in 50 mL
Titanium Dioxide (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	Titanium Dioxide	2.36 g  in 50 mL
Octocrylene (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	Octocrylene	1.00 g  in 50 mL

Inactive Ingredients
Ingredient Name	Strength
Butylene Glycol (UNII: 3XUS85K0RA)
Glycerin (UNII: PDC6A3C0OX)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51346-432-02	1 in 1 CARTON	12/01/2016	12/01/2018
1	NDC: 51346-432-01	50 mL in 1 BOTTLE; 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	12/01/2016	12/01/2018

Labeler - NATURE REPUBLIC CO., LTD. (631172020)

Registrant - NATURE REPUBLIC CO., LTD. (631172020)

Establishment
Name	Address	ID/FEI	Business Operations
Cosmax, Inc.		689049693	manufacture(51346-432)

Revised: 9/2019

Document Id: 60ea47ee-af16-4809-9c98-fdd0402051e5

34390-5

Set id: a2550eb7-3dbf-44b9-a529-9a42b0a118c7

Version: 2

Effective Time: 20190917