LIP BALM- octinoxate oxybenzone dimethicone lipstick

Lip Balm by

Drug Labeling and Warnings

Lip Balm by is a Otc medication manufactured, distributed, or labeled by Tri-Coastal Design Company Inc. , Guangzhou St Eva Fine Chemical Co Ltd . Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

Octyl Methoxycinnamate 6%

Oxybenzone 6%

Dimethicone 1%

Purpose

Sunscreen
Skin Protectant

Uses

• Helps prevent sunburn
• Temporarily protects and relieves chapped lips
  

Warnings

• Keep out of eyes. Stop use if rash or irritation occurs. Keep out of reach of children. For external use only.
  

Directions

• Apply liberally before sun exposure and as needed.
  

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

INGREDIENTS AND APPEARANCE

LIP BALM 
octinoxate oxybenzone dimethicone lipstick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49852-202
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	6 g  in 100 g
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	6 g  in 100 g
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O)	DIMETHICONE	6 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49852-202-05	5 in 1 BOX
1	NDC: 49852-202-35	3.5 g in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	02/28/2010

Labeler - Tri-Coastal Design Company Inc. (609734900)

Establishment
Name	Address	ID/FEI	Business Operations
Guangzhou St Eva Fine Chemical Co Ltd		528039793	manufacture