DO GOOD HYDRA HEALING COLOR CORRECTOR- octinoxate, titanium dioxide, octisalate cream 
WOOREE Colourone 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 6.70%, Titanium Dioxide 6.45%, Ethylhexyl Salicylate 2.50%

INACTIVE INGREDIENT

Inactive ingredients:

Water, Cyclopentasiloxane, Butylene Glycol, Dicaprylyl Carbonate, Isononyl Isononanoate, Phenyl Trimethicone, Cetyl PEG/PPG-10/1 Dimethicone, Glycerin, Niacinamide, Pentylene Glycol, Methyl Methacrylate Crosspolymer, Beeswax, Cyclohexasiloxane, Disteardimonium Hectorite, Polyglyceryl-2 Diisostearate, Polyglyceryl-4 Diisostearate/Polyhydroxystearate/Sebacate, Magnesium Sulfate, Phenoxyethanol, Polymethylsilsesquioxane, Aluminum Hydroxide, Iron Oxides (CI 77492), Stearic Acid, Chromium Oxide Greens (CI 77288), Iron Oxides (CI 77491), Dimethicone, Mica (CI 77019), Dimethicone Crosspolymer, Fragrance(Parfum), Ethylhexylglycerin, Triethoxycaprylylsilane, Polyester-1, Silica Dimethyl Silylate, Adenosine, Disodium EDTA, Hydrogenated Castor Oil Isostearate, Madecassoside, Asiaticoside, Asiatic Acid, Madecassic Acid, Centella Asiatica Leaf Extract

PURPOSE

Purpose: Sunscreen

WARNINGS

Warnings:

For external use only.

Avoid contact with eyes.

Discontinue use if signs of irritation or rashes appear.

Replace the cap after use.

Keep out of reach of children

DESCRIPTION

Uses:

- Helps prevent sunburn

- If used as directed with other sun protection measures (See Directions), decreases the risk of skin cancer and early skin aging by the sun.

Directions:

Apply liberally 15 minutes before sun exposure

Reapply at least every 2 hours

Use a water resistant sunscreen if swimming or sweating

Sun Protection Measures: Spending time in the sun increases your risk of skin cancer and early skin aging.

To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including: Limit time in the sun, especially from 10 a.m. – 2 p.m.

Wear long-sleeved shirts, pants, hats and sunglasses

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Image of carton

DO GOOD HYDRA HEALING COLOR CORRECTOR 
octinoxate, titanium dioxide, octisalate cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72058-070
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Octinoxate (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) Octinoxate3.35 g  in 50 mL
Titanium Dioxide (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) Titanium Dioxide3.22 g  in 50 mL
Octisalate (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) Octisalate1.25 g  in 50 mL
Inactive Ingredients
Ingredient NameStrength
Water (UNII: 059QF0KO0R)  
Butylene Glycol (UNII: 3XUS85K0RA)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:72058-070-021 in 1 CARTON01/02/2018
1NDC:72058-070-0150 mL in 1 CONTAINER; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35201/02/2018
Labeler - WOOREE Colourone Co.,Ltd (694492496)
Registrant - WOOREE Colourone Co.,Ltd (694492496)
Establishment
NameAddressID/FEIBusiness Operations
Cosmax, Inc.689049693manufacture(72058-070)

Revised: 2/2018
Document Id: 6f691d0b-cb4b-459c-9e74-a107ef55551f
Set id: 40bd7643-9fcd-4380-8224-4a13dc64fe0e
Version: 1
Effective Time: 20180226
 
WOOREE Colourone Co.,Ltd