Easydew Daily Baby Care Sun by DN Company Co., Ltd. / Cosmax, Inc.

Easydew Daily Baby Care Sun by

Drug Labeling and Warnings

Easydew Daily Baby Care 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 CARE SUN- homosalate, octisalate, titanium dioxide, avobenzone, octinoxate cream 
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 Ingredient: Homosalate 10.0%, Ethylhexyl Salicylate 5.0%, Titanium Dioxide 3.8%, Butyl Methoxydibenzoylmethane 3.0%, Ethylhexyl Methoxycrylene 3.0%

INACTIVE INGREDIENT

Inactive Ingredients: Water, Butyloctyl Salicylate, Butylene Glycol, Diisobutyl Adipate, Dicaprylyl Carbonate, Cyclopentasiloxane, 1,2-Hexanediol, Aluminum Starch Octenylsuccinate, Caprylyl Methicone, Potassium Cetyl Phosphate, Triceteareth-4 Phosphate, Glycol Stearate, Silica, Glyceryl Stearate, Sorbitan Sesquioleate, Phenoxyethanol, PEG-2 Stearate, PEG-100 Stearate, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Caprylyl Glycol, Tromethamine, Fragrance(Parfum), Sodium Polyacrylate, Ethylhexyl Stearate, Dimethicone, Disodium EDTA, Xanthan Gum, Caprylic/Capric Triglyceride, Alcohol, Trideceth-6, Hydrogenated Lecithin, Propylene Glycol, Hydrogenated Phosphatidylcholine, Alcohol Denat., Sodium Stearoyl Glutamate, Ceramide 3, Cholesterol, Sodium Ascorbyl Phosphate, sh-Oligopeptide-1, Pinus Pumilio Bark Extract, Poterium Officinale Root Extract, Veronica Officinalis Extract

PURPOSE

Purpose: Sunscreen

WARNINGS

Warnings: For external use only. Keep out of reach of children. Avoid contact with eyes. If eye contact occurs, rinse immediately with water and if it is necessary, contact an ophthalmologist. Discontinue use if signs of irritation and/or rash appear. Keep in a cool and dry place.

DESCRIPTION

Use: 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.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

EASYDEW DAILY BABY CARE SUN 
homosalate, octisalate, titanium dioxide, avobenzone, octinoxate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 60565-070
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Homosalate (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	Homosalate	6.0 g  in 60 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	3.0 g  in 60 mL
Titanium Dioxide (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	Titanium Dioxide	2.2 g  in 60 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	1.8 g  in 60 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	1.8 g  in 60 mL

Inactive Ingredients
Ingredient Name	Strength
Water (UNII: 059QF0KO0R)
Butyloctyl Salicylate (UNII: 2EH13UN8D3)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 60565-070-02	1 in 1 CARTON	07/15/2016	11/01/2019
1	NDC: 60565-070-01	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	07/15/2016	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(60565-070)

Revised: 12/2019

Document Id: ea16dd64-e14c-4c6f-bae3-301976899963

34390-5

Set id: 7a02d1f7-2d01-401c-baef-46095b3e7d24

Version: 3

Effective Time: 20191230

 

DN Company Co., Ltd.