ROUND AROUND ESSENTIAL BOOSTING HYDRATOR- dimethicone liquid

United States - English - NLM (National Library of Medicine)

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Active ingredient:
Dimethicone (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O)
Available from:
CJ OliveNetworks Co., Ltd.
Administration route:
TOPICAL
Prescription type:
OTC DRUG
Therapeutic indications:
Purpose: Skin protectant Uses: Helps improve skin elasticity. Helps skin moisturizing.
Authorization status:
OTC monograph final
Authorization number:
71596-064-01, 71596-064-02

ROUND AROUND ESSENTIAL BOOSTING HYDRATOR- dimethicone liquid

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.

----------

ACTIVE INGREDIENT

Active ingredients: Dimethicone 2.08%

INACTIVE INGREDIENT

Inactive ingredients:

CHAMAECYPARIS OBTUSA WATER, METHYLPROPANEDIOL, CYCLOPENTASILOXANE,

BUTYLENE GLYCOL, GLYCERIN, HYDROGENATED POLY(C6-14 OLEFIN), NEOPENTYL

GLYCOL DIHEPTANOATE, POLYGLYCERYL-3 METHYLGLUCOSE DISTEARATE, WATER,

1,2-HEXANEDIOL, BETAINE, PENTYLENE GLYCOL, HYDROXYETHYL ACRYLATE/SODIUM

ACRYLOYLDIMETHYL TAURATE COPOLYMER, SQUALANE, GLYCERYL STEARATE, PEG-

100 STEARATE, PHENOXYETHANOL, CARBOMER, POLYSORBATE 20, TROMETHAMINE,

ETHYLHEXYLGLYCERIN, SODIUM STEAROYL GLUTAMATE, DIMETHICONE/VINYL

DIMETHICONE CROSSPOLYMER, HYDROGENATED POLYISOBUTENE, FRAGRANCE,

POLYSORBATE 60, ALCOHOL, ARGANIA SPINOSA KERNEL OIL, HYDROGENATED

LECITHIN, ISONONYL ISONONANOATE, POLYGLYCERYL-10 STEARATE, DISODIUM

EDTA, BUTYROSPERMUM PARKII (SHEA) BUTTER, CETEARYL ALCOHOL,

POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE, STEARIC ACID, SORBITAN

ISOSTEARATE, 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, AMARANTHUS CAUDATUS SEED

EXTRACT, ULMUS DAVIDIANA ROOT EXTRACT, CENTELLA ASIATICA EXTRACT, FICUS

CARICA (FIG) FRUIT EXTRACT, INULIN LAURYL CARBAMATE, MONASCUS EXTRACT,

CNIDIUM OFFICINALE ROOT EXTRACT, GLYCYRRHIZA GLABRA (LICORICE) ROOT

EXTRACT, PAEONIA LACTIFLORA ROOT EXTRACT, PUERARIA THUNBERGIANA ROOT

EXTRACT, ECHIUM PLANTAGINEUM SEED OIL, PORTULACA OLERACEA EXTRACT,

SOLUBLE COLLAGEN, XANTHAN GUM, CERAMIDE NP, DISODIUM STEAROYL

GLUTAMATE, ALOE BARBADENSIS LEAF JUICE, TOCOPHEROL, CARDIOSPERMUM

HALICACABUM FLOWER/LEAF/VINE EXTRACT, HELIANTHUS ANNUUS (SUNFLOWER)

SEED OIL UNSAPONIFIABLES

PURPOSE

Purpose: Skin protectant

WARNINGS

Warnings:

1. Stop using the product if any red rash, swelling or irritation occurs. Consult with dermatologist.

2. Do not use on the abnormal areas like wounded, eczema or dermatitis areas.

3. Keep out of reach of children.

4. Avoid direct sunlight.

KEEP OUT OF REACH OF CHILDREN

KEEP OUT OF REACH OF CHILDREN

Us es

Uses:

Helps improve skin elasticity.

Helps skin moisturizing.

Directions

Directions:

Apply a moderate amount of this product after skin toner or serum and stroke gently to get it absorbed.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

ROUND AROUND ESSENTIAL BOOSTING HYDRATOR

dimethicone liquid

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:7159 6 -0 6 4

Route of Administration

TOPICAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

Dimethico ne (UNII: 9 2RU3N3Y1O) (DIMETHICONE - UNII:9 2RU3N3Y1O)

Dime thic o ne

2.49 g in 120 mL

CJ OliveNetworks Co., Ltd.

Inactive Ingredients

Ingredient Name

Stre ng th

CHAMAECYPARIS O BTUSA WO O D O IL (UNII: P2OMP71Y6 2)

METHYLPRO PANEDIO L (UNII: N8 F53B3R4R)

Packag ing

#

Item Code

Package Description

Marketing Start

Date

Marketing End

Date

1

NDC:7159 6 -0 6 4-

1 in 1 CARTON

0 7/0 1/20 19

1

NDC:7159 6 -0 6 4-

120 mL in 1 CONTAINER; Type 0 : No t a Co mbinatio n

Pro duc t

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

OTC mo no graph final

pa rt347

0 7/0 1/20 19

Labeler -

CJ OliveNetworks Co., Ltd. (688271303)

Registrant -

CJ OliveNetworks Co., Ltd. (688271303)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

Ko lmar Ko rea Co ., Ltd.

6 8 9 5126 11

ma nufa c ture (7159 6 -0 6 4)

Revised: 8/2019

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