CARIBBEAN COCONUT CALMING MASK- witch hazel patch 
SANSUNG LIFE & SCIENCE 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: Hamamelis Virginiana (Witch Hazel) Water 0.1%

INACTIVE INGREDIENT

Inactive Ingredients: Water, Butylene Glycol, 1,2-Hexanediol, Chamomilla Recutita (Matricaria) Flower Extract, Glycerin, Cocos Nucifera (Coconut) Fruit Extract Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Portulaca Oleracea Extract, Acer Saccharum (Sugar Maple) Extract, Betaine, Ethylhexylglycerin, Caprylyl Glycol, Arnica Montana Flower Extract, Xanthan Gum, Hamamelis Virginiana (Witch Hazel) Water, Cocos Nucifera (Coconut) Oil, Fragrance, Artemisia Capillaris Flower Extract, Houttuynia Cordata Extract, Ecklonia Cava Extract, Artemisia Absinthium Extract, Saururus Chinensis Extract, Ledum Palustre Extract, Achillea Millefolium Extract, Leontopodium Alpinum Extract, Gentiana Lutea Root Extract, Opuntia Ficus-Indica Extract, Hydrogenated Lecithin, Panthenol, Sodium Benzoate, Niacinamide, Tocopheryl Acetate, Potassium Sorbate, Citric Acid, Retinyl Palmitate, Biotin, Ascorbic Acid, Folic Acid, Dipotassium Glycyrrhizate, Ceramide 3, Glyceryl Linolenate, Glyceryl Linoleate, Glyceryl Arachidonate

PURPOSE

Purpose: Skin Protectant

WARNINGS

Warnings: For external use only. Avoid contact with eyes. Not for human consumption. Discontinue use if irritation occurs. If irritation persists, consult a physician. Use immediately after opening. Store in cool and dry place. Keep out of reach of children.

KEEP OUT OF REACH OF CHILDREN

KEEP OUT OF REACH OF CHILDREN

INDICATIONS & USAGE

Indication and usage: Step 1. Take out mask from pouch and remove protective film from either side of the mask. Step 2. Apply to cleansed face and smooth to fit facial contours. Step 3. Leave mask on face for 20~25 minutes. Step 4. Discard mask and lightly pat face to help absorb serum into skin.

DOSAGE & ADMINISTRATION

Dosage and administration: 2-3 times a week. Each mask is for one time use only.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Image of cello pack

CARIBBEAN COCONUT CALMING MASK 
witch hazel patch
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69424-230
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Witch Hazel (UNII: 101I4J0U34) (WITCH HAZEL - UNII:101I4J0U34) Witch Hazel0.03 mg  in 30 mL
Inactive Ingredients
Ingredient NameStrength
Water (UNII: 059QF0KO0R)  
Butylene Glycol (UNII: 3XUS85K0RA)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69424-230-0130 mL in 1 CELLO PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34703/01/2015
Labeler - SANSUNG LIFE & SCIENCE CO., LTD. (689524929)
Registrant - SANSUNG LIFE & SCIENCE CO., LTD. (689524929)
Establishment
NameAddressID/FEIBusiness Operations
SANSUNG LIFE & SCIENCE CO., LTD.689524929manufacture(69424-230)

Revised: 5/2015
Document Id: d5d1963e-72ff-4367-92b9-55379934c0bc
Set id: 854919ba-5808-4bf2-9e0c-8217dbb7962d
Version: 1
Effective Time: 20150529
 
SANSUNG LIFE & SCIENCE CO., LTD.