UNIWELL NATURAL ESSENCE- dimethicone emulsion 
uniwell 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.

----------

Drug Facts

DIMETHICONE 1.875%

Skin Protectant

Helps prevent and temporarily protects chafed, chapped or cracked skin.
Helps prevent and protect from the drying effects of wind and cold weather.


Apply as needed.

For external use only.
Do not use on deep or puncture wounds, animal bites, or serious burns.
Stop use and ask a doctor if condition worsen, symptoms last more than 7 days or clean up and occur again within a few days.

Keep out of reach of the children. If product is swallowed, get medical help or contact a poison control center right away.

Water, Butylene Glycol, Glycerin, 1,2-Hexanediol, Niacinamide, Dimethicone/Vinyl Dimethicone Crosspolymer, Squalane, Arginine, Carbomer, Propanediol, Polyacrylate-13, Hydroxyacetophenone, Polyisobutene, Citrus Aurantium Dulcis (Orange) Oil, Allantoin, Dipotassium Glycyrrhizate, Adenosine, Ethylhexylglycerin, Polysorbate 20, Phenoxyethanol, Theobroma Cacao (Cocoa) Extract, Sorbitan Isostearate, Disodium EDTA, Beta-Glucan, Dextrin, Ecklonia cava Extract, Glycine Soja (Soybean) Sprout Extract, Triticum Vulgare (Wheat) Sprout Extract, Brassica Oleracea Italica (Broccoli) Sprout Extract, Camellia Oleifera Leaf Extract, Magnolia Liliflora Flower Extract, Eugenia Caryophyllus (Clove) Bud Extract, Sophora Japonica Flower Extract, Lavandula Angustifolia (Lavender) Oil, Citrus Limon (Lemon) Peel Oil, Alcohol, Phenoxyethanol, Sodium Hyaluronate

image description

UNIWELL NATURAL ESSENCE 
dimethicone emulsion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71502-002
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE0.937 mg  in 50 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
Butylene Glycol (UNII: 3XUS85K0RA)  
Glycerin (UNII: PDC6A3C0OX)  
1,2-Hexanediol (UNII: TR046Y3K1G)  
NIACINAMIDE (UNII: 25X51I8RD4)  
Squalane (UNII: GW89575KF9)  
Arginine (UNII: 94ZLA3W45F)  
Propanediol (UNII: 5965N8W85T)  
POLYACRYLAMIDE (1500 MW) (UNII: 5D6TC4BRWV)  
2-HYDROXYACETOPHENONE (UNII: DQ1N9R01IA)  
POLYISOBUTYLENE (1000 MW) (UNII: 5XB3A63Y52)  
ORANGE OIL (UNII: AKN3KSD11B)  
Allantoin (UNII: 344S277G0Z)  
GLYCYRRHIZINATE DIPOTASSIUM (UNII: CA2Y0FE3FX)  
Adenosine (UNII: K72T3FS567)  
Ethylhexylglycerin (UNII: 147D247K3P)  
Polysorbate 20 (UNII: 7T1F30V5YH)  
COCOA (UNII: D9108TZ9KG)  
SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4)  
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
ECKLONIA CAVA (UNII: UXX2N5V39P)  
SOYBEAN (UNII: L7HT8F1ZOD)  
WHEAT SPROUT (UNII: 3K32950CI0)  
BROCCOLI SPROUT (UNII: 128UH9LOAE)  
CAMELLIA OLEIFERA LEAF (UNII: 5077EL0C60)  
MAGNOLIA LILIIFLORA FLOWER (UNII: SVM28292LH)  
CLOVE (UNII: K48IKT5321)  
STYPHNOLOBIUM JAPONICUM FLOWER (UNII: 644C3CSB6E)  
LAVENDER OIL (UNII: ZBP1YXW0H8)  
LEMON OIL (UNII: I9GRO824LL)  
ALCOHOL (UNII: 3K9958V90M)  
Phenoxyethanol (UNII: HIE492ZZ3T)  
HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:71502-002-021 in 1 PACKAGE06/12/2017
1NDC:71502-002-0150 mL in 1 CONTAINER; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34706/12/2017
Labeler - uniwell LTD (694646565)
Registrant - uniwell LTD (694646565)
Establishment
NameAddressID/FEIBusiness Operations
Cosmecca Korea Co., Ltd.688830827manufacture(71502-002)

Revised: 6/2017
Document Id: cfdcb8e6-9a69-4480-8587-28ad3b3ce5a8
Set id: 5d4d3fc1-1172-4193-bac2-ff97d8132488
Version: 2
Effective Time: 20170612
 
uniwell LTD