ROUND AROUND ESSENTIAL BOOSTING HYDRATOR- dimethicone cream
CJ OliveNetworks 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 2.08%

INACTIVE INGREDIENT

Inactive ingredients: POLYGLYCERYL-10 STEARATE,GLYCERYL STEARATE,PEG-100 STEARATE,SOLUBLE COLLAGEN,DISODIUM EDTA,CARBOMER,TROMETHAMINE,BUTYROSPERMUM PARKII (SHEA) BUTTER,CETEARYL ALCOHOL,POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE,STEARIC ACID,ALOE BARBADENSIS LEAF JUICE,CAMELLIA JAPONICA SEED OIL,CAMELLIA SINENSIS SEED OIL,HELIANTHUS ANNUUS (SUNFLOWER) SEED OIL,MACADAMIA INTEGRIFOLIA SEED OIL,OLEA EUROPAEA (OLIVE) FRUIT OIL,SIMMONDSIA CHINENSIS (JOJOBA) SEED OIL,SODIUM HYALURONATE,OCTYLDODECANOL,INULIN LAURYL CARBAMATE,ECHIUM PLANTAGINEUM SEED OIL,CERAMIDE NP,DISODIUM STEAROYL GLUTAMATE,HELIANTHUS ANNUUS (SUNFLOWER) SEED OIL UNSAPONIFIABLES

PURPOSE

Purpose: Skin Protectant

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

Uses

Uses: The excellent moisturizing & protecting effect of the 2nd skin barrier similar to skin structure. Supplying essential nutrients of seven kinds of fermented moisturizing oil.

Directions

Directions: Apply a moderate amount of this hydrator after skin toner and stoke gently to get it absorbed.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Image of carton

ROUND AROUND ESSENTIAL BOOSTING HYDRATOR
dimethicone cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:71596-003
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Dimethicone (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O)	Dimethicone	2.49 g in 120 mL

Ingredient Name	Strength
Inactive Ingredients
POLYGLYCERYL-10 STEARATE (UNII: 90TF85HH91)
PEG-100 STEARATE (UNII: YD01N1999R)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:71596-003-02	1 in 1 CARTON	07/01/2017	12/01/2018
1	NDC:71596-003-01	120 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part347	07/01/2017	12/01/2018

Labeler - CJ OliveNetworks Co., Ltd. (688271303)

Registrant - CJ OliveNetworks Co., Ltd. (688271303)

Name	Address	ID/FEI	Business Operations
Establishment
Kolmar Korea Co., Ltd.		689512611	manufacture(71596-003)

Revised: 1/2019

Document Id: 1cd4fb86-7567-4c24-82b8-9a1a26772d5d

Set id: a5535259-a069-4572-ad50-cef0e83372dc

Version: 2

Effective Time: 20190124

CJ OliveNetworks Co., Ltd.