SIERO LABBRA SATIN BRITISH ORANGE- 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.

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ACTIVE INGREDIENT

Active ingredients: DIMETHICONE 28.0%

INACTIVE INGREDIENT

Inactive ingredients: HYDROGENATED POLYISOBUTENE, SILICA, KAOLIN, HELIANTHUS ANNUUS (SUNFLOWER) SEED OIL, DIISOSTEARYL MALATE, DIMETHICONE CROSSPOLYMER, BIS-DIGLYCERYL POLYACYLADIPATE-2, POLYETHYLENE, TITANIUM DIOXIDE, RED 6 (CI 15850), YELLOW 6 LAKE(CI 15985), CALCIUM ALUMINUM BOROSILICATE, MICA, PHENOXYETHANOL, CAPRYLYL GLYCOL, GLYCERYL CAPRYLATE, TOCOPHERYL ACETATE, FRAGRANCE, RED 7 LAKE(CI 15850:1), IRON OXIDES(CI 77499), TOCOPHEROL, TIN OXIDE, 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

Uses

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

Image of carton

SIERO LABBRA SATIN BRITISH ORANGE 
dimethicone gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71472-150
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE2.1 g  in 7.5 mL
Inactive Ingredients
Ingredient NameStrength
KAOLIN (UNII: 24H4NWX5CO)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:71472-150-021 in 1 CARTON06/01/2017
1NDC:71472-150-017.5 mL in 1 CONTAINER; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34706/01/2017
Labeler - JNG KOREA CO.,LTD. (557796103)
Registrant - JNG KOREA CO.,LTD. (557796103)
Establishment
NameAddressID/FEIBusiness Operations
JNG KOREA CO.,LTD.557796103relabel(71472-150)
Establishment
NameAddressID/FEIBusiness Operations
Kolmar Korea Co., Ltd.689847167manufacture(71472-150)

Revised: 6/2017
Document Id: 30d945e5-260b-4555-b256-23b69dbcb512
Set id: a906e501-1001-47ac-a8a2-a471c0d1ab5d
Version: 1
Effective Time: 20170629
 
JNG KOREA CO.,LTD.