LIP BALM - octinoxate oxybenzone dimethicone lipstick 
Tri-Coastal Design Company Inc.

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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Drug Facts

Active Ingredient

Octyl Methoxycinnamate 6%

Oxybenzone 6%

Dimethicone 1%



Purpose

Sunscreen
Skin Protectant

Uses

Warnings


Directions

Inactive Ingredients

BHA, BHT, Caprylic/Capric Triglyceride, Cera Microcristallina, Flavor, Lanolin, Mineral Oil (Paraffinum Liquidum), Ozokerite, Petrolatum, Phenyl Trimethicone, Polyethylene, Propylparaben, PVP/Eicosene Copolymer, Tocopheryl Acetate

Package Label

Package Label
image of package label









LIP BALM 
octinoxate oxybenzone dimethicone lipstick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49852-202
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE6 g  in 100 g
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE6 g  in 100 g
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE6 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
BUTYLATED HYDROXYANISOLE (UNII: REK4960K2U)  
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
LANOLIN (UNII: 7EV65EAW6H)  
MINERAL OIL (UNII: T5L8T28FGP)  
PETROLATUM (UNII: 4T6H12BN9U)  
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:49852-202-055 in 1 BOX
1NDC:49852-202-353.5 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35202/28/2010
Labeler - Tri-Coastal Design Company Inc. (609734900)
Establishment
NameAddressID/FEIBusiness Operations
Guangzhou St Eva Fine Chemical Co Ltd 528039793manufacture

Revised: 2/2010
Document Id: f5b7726a-b83a-4df8-8642-d56ec01793c4
Set id: 1261d499-c2e1-473b-8407-bd0d0cf1c52a
Version: 1
Effective Time: 20100212
 
Tri-Coastal Design Company Inc.