SIERO LABBRA SATIN POPPY RED- dimethicone gel

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

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Active ingredient:
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O)
Available from:
JNG KOREA CO.,LTD.
INN (International Name):
DIMETHICONE
Composition:
DIMETHICONE 2.1 g in 7.5 mL
Administration route:
TOPICAL
Prescription type:
OTC DRUG
Therapeutic indications:
Purpose: Skin Protectant Uses: It gives bright and vivid color for smooth, matte texture lips and cheeks.
Authorization status:
OTC monograph final
Authorization number:
71472-190-01, 71472-190-02

SIERO LABBRA SATIN POPPY RED- dimethicone gel

JNG KOREA 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 28.0%

INACTIVE INGREDIENT

Inactive ingredients: HYDROGENATED POLYISOBUTENE, SILICA, DIISOSTEARYL MALATE,

KAOLIN, HELIANTHUS ANNUUS (SUNFLOWER) SEED OIL, DIMETHICONE

CROSSPOLYMER, BIS-DIGLYCERYL POLYACYLADIPATE-2, POLYETHYLENE, RED 7

LAKE(CI 15850:1), YELLOW 5 LAKE(CI 19140), PHENOXYETHANOL, CAPRYLYL GLYCOL, CI

45410, RED 6 (CI 15850), GLYCERYL CAPRYLATE, TOCOPHERYL ACETATE, FRAGRANCE,

TOCOPHEROL, ROSA CANINA FRUIT OIL, EUCALYPTUS GLOBULUS LEAF OIL, GLYCERIN,

WATER, RHODODENDRON FERRUGINEUM EXTRACT

PURPOSE

Purpose: Skin Protectant

WARNINGS

Warnings: - There may by cracks or cakiness due to the nature of product formulations, but there is no

problem with the product. Please do not worry about it. - Keep away from direct sunlight and high

temperature. - 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

KEEP OUT OF REACH OF CHILDREN

Us es

Uses: It gives bright and vivid color for smooth, matte texture lips and cheeks.

Directions

Directions: Apply a moderate amount to the lips and cheeks.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

SIERO LABBRA SATIN POPPY RED

dimethicone gel

JNG KOREA CO.,LTD.

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:71472-19 0

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)

DIMETHICONE

2.1 g in 7.5 mL

Inactive Ingredients

Ingredient Name

Stre ng th

KAO LIN (UNII: 24H4NWX5CO)

Packag ing

#

Item Code

Package Description

Marketing Start

Date

Marketing End Date

1

NDC:71472-19 0 -

1 in 1 CARTON

0 6 /0 1/20 17

1

NDC:71472-19 0 -0 1

7.5 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 6 /0 1/20 17

Labeler -

JNG KOREA CO.,LT D. (557796103)

Registrant -

JNG KOREA CO.,LT D. (557796103)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

JNG KOREA CO.,LTD.

55779 6 10 3

re la be l(71472-19 0 )

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

Ko lmar Ko rea Co ., Ltd.

6 8 9 8 4716 7

ma nufa c ture (71472-19 0 )

Revised: 6/2017

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