28 REMEDY BALANCING DAY MOISTURIZER- dimethicone cream 
NoTS 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: Dimethicone 1.00%

INACTIVE INGREDIENT

Inactive Ingredients:

Water, Butylene Glycol, Hyaluronic Acid, Cyclopen tasiloxane, Glycerin, Niacinamide, Biosaccharide Gum-1, Cetyl Ethylhexanoate, Cyclohexasiloxane, Aloe Barbadensis Leaf Juice, Trehalose, Silica, Palmitic Acid, Propylene Glycol, Phenoxyetha nol, C12-16 Alcohols, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Chlorphenesin, Triethanol amine, Hydrogenated Lecithin, Glyceryl Acrylate/ Acrylic Acid Copolymer, Aloe Barbadensis Leaf Juice Powder, Adenosine, Disodium EDTA, Centella Asiatica Extract, Rosa Centifolia Flower Water, Human Oligopeptide-1, Opuntia Ficus-Indica Callus Culture Extract, Salix Alba (Willow) Bark Extract, Lactobacillus/Soybean Ferment Extract, Portulaca Oleracea Extract, Origanum Vulgare Leaf Extract, Cinnamomum Cassia Bark Extract, Scutellaria Baicalensis Root Extract, Chamaecyparis Obtusa Leaf Extract, Allium Sativum (Garlic) Bulb Extract, Brassica Oleracea Italica (Broccoli) Extract, Vaccinium Angusti folium (Blueberry) Fruit Extract, Spinacia Oleracea (Spinach) Leaf Extract, Salicornia Herbacea Extract, Vitis Vinifera (Grape) Fruit Extract, Juglans Regia (Walnut) Seed Extract, Camellia Sinensis Leaf Extract, Solanum Lycopersicum (Tomato) Fruit Extract, Avena Sativa (Oat) Meal Extract, Anthemis Nobilis Flower Extract

PURPOSE

Purpose: Skin Protectant

WARNINGS

Warnings:

Stop use and ask dermatologist or doctor if

•signs of redness, skin swelling, itchy spots, irritation or rash and other appear

•the above signs appear in the applied area by direct rays of the sun

Do not use over

•wounds rashes inflammations other troubled areas.

When using

•Avoid the eye area

•must close the cap after using

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children:

If swallowed, get medical help or contact a Poison Control Center right away.

Uses

Uses: Moisturizing and Protecting skin

Directions

Directions:

•Wash your face and dry

•Dispense appropriate amount on your hand

•Apply over your face using your fingers

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Image of carton

28 REMEDY BALANCING DAY MOISTURIZER 
dimethicone cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69716-010
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Dimethicone (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) Dimethicone0.45 mg  in 45 mL
Inactive Ingredients
Ingredient NameStrength
Water (UNII: 059QF0KO0R)  
Cyclomethicone (UNII: NMQ347994Z)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69716-010-0145 mL in 1 CARTON; Type 0: Not a Combination Product03/01/201512/01/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34703/01/201512/01/2018
Labeler - NoTS Co.,Ltd (689004599)
Registrant - NoTS Co.,Ltd (689004599)
Establishment
NameAddressID/FEIBusiness Operations
Nowcos.Co.,Ltd689914984manufacture(69716-010)

Revised: 12/2018
 
NoTS Co.,Ltd