EASYDEW DAILY BABY SMOOTHING SUN by DN Company Co., Ltd. / Cosmax, Inc.

EASYDEW DAILY BABY SMOOTHING SUN by

Drug Labeling and Warnings

EASYDEW DAILY BABY SMOOTHING SUN by is a Otc medication manufactured, distributed, or labeled by DN Company Co., Ltd., Cosmax, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

EASYDEW DAILY BABY SMOOTHING SUN- titanium dioxide lotion 
DN Company 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 3.57%

INACTIVE INGREDIENT

Inactive ingredients: Water, Cyclomethicone, Propanediol, Phenyl Trimethicone, PPG-14 Butyl Ether, Pentylene Glycol, Polyglyceryl-10 Laurate, Salvia Hispanica Seed Extract, Centella Asiatica Extract, Houttuynia Cordata Extract, Polyglyceryl-2 Caprate, Ammonium Acryloyldimethyltaurate/VP Copolymer, Sodium Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Dimethicone Crosspolymer, Panthenol, Polyisobutene, Sucrose Stearate, Fructooligosaccharides, Saccharide Hydrolysate, Simmondsia Chinensis (Jojoba) Seed Oil, Dimethiconol, Stearic Acid, Alumina, Pullulan, 1,2-Hexanediol, Glyceryl Caprylate, Ethylhexylglycerin, Xanthan Gum, Squalane, Alcohol, Caprylic/Capric Triglyceride, Sorbitan Oleate, Caprylyl/Capryl Glucoside, Glycerin, Hydrogenated Lecithin, Marrubium Vulgare Extract, Moringa Oleifera Seed Oil, Sodium Stearoyl Glutamate, Pinus Pinaster Bark Extract, Ceramide NP, Phytosphingosine, Disodium EDTA, Sodium Ascorbyl Phosphate, sh-Oligopeptide-1, Citric Acid

PURPOSE

Purpose: Sunscreen

WARNINGS

Warnings: For external use only. Keep out of reach of children. Do not use in wounds, eczemas or dermatitis. If you develop rash, itchiness or irritation, discontinue the use. Keep in a cool and dry place.

DESCRIPTION

Uses: Help prevent sunburn. If used as directed with other sun protection measures (See Directions), decreases the risk of skin cancer and early skin aging caused by the sun

Directions: At the last stage of your skincare routine, evenly apply onto easily exposed areas such as face, neck, arms and legs. Recommend that you wipe away the product with Easydew Daily sun cleansing tissue and wash.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

EASYDEW DAILY BABY SMOOTHING SUN 
titanium dioxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 60565-210
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Titanium Dioxide (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	Titanium Dioxide	2.14 g  in 60 mL

Inactive Ingredients
Ingredient Name	Strength
Water (UNII: 059QF0KO0R)
Propanediol (UNII: 5965N8W85T)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 60565-210-02	1 in 1 CARTON	06/01/2017	11/01/2019
1	NDC: 60565-210-01	60 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	06/01/2017	11/01/2019

Labeler - DN Company Co., Ltd. (688369859)

Registrant - DN Company Co., Ltd. (688369859)

Establishment
Name	Address	ID/FEI	Business Operations
Cosmax, Inc.		689049693	manufacture(60565-210)

Revised: 12/2019

Document Id: 91d77f8f-ceb8-4112-a7b2-35bc3011602e

34390-5

Set id: 1a2d5ddc-3c63-48d8-901b-7ff846d988ee

Version: 3

Effective Time: 20191230

 

DN Company Co., Ltd.