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

Image of cartonImage of carton

EASYDEW DAILY BABY SMOOTHING SUN 
titanium dioxide lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 60565-210
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Titanium Dioxide (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) Titanium Dioxide2.14 g  in 60 mL
Inactive Ingredients
Ingredient NameStrength
Water (UNII: 059QF0KO0R)  
Propanediol (UNII: 5965N8W85T)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 60565-210-021 in 1 CARTON06/01/201711/01/2019
1NDC: 60565-210-0160 mL in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35206/01/201711/01/2019
Labeler - DN Company Co., Ltd. (688369859)
Registrant - DN Company Co., Ltd. (688369859)
Establishment
NameAddressID/FEIBusiness Operations
Cosmax, Inc.689049693manufacture(60565-210)

Revised: 12/2019
 
DN Company Co., Ltd.