LIP BALM SPF 15- octinoxate oxybenzone ointment

Lip Balm SPF 15 by

Drug Labeling and Warnings

Lip Balm SPF 15 by is a Otc medication manufactured, distributed, or labeled by Fercy Personal Care Products Co Limited. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

Octinoxate  7.5%
Oxybenzone 3%

PURPOSE

sunscreen

USE

helps protect against sunbum and chapped lips

Warning

For external use only
keep out of eyes.
stop use if skin rash occurs.
keep out of reach of children.

Directions

Apply to lips prior to sun exposure.
apply to lips when dry or chapped.

Keep out of reach of children

Keep out of reach of children
not recommended for children under six months of age

Inactive Ingredient

Mineral Oil,Paraffin,Beeswax,Ethylhexyl Palmitate,Ricinus Communis,ALOE,Tocopherol,Propylparaben,Methylparaben

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

LIP BALM SPF 15 
octinoxate oxybenzone ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 50260-800
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	3 g  in 100 g
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	7.5 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
Mineral Oil (UNII: T5L8T28FGP)	27.5 g  in 100 g
Paraffin (UNII: I9O0E3H2ZE)	26 g  in 100 g
White Wax (UNII: 7G1J5DA97F)	23 g  in 100 g
Ethylhexyl Palmitate (UNII: 2865993309)	6 g  in 100 g
Ricinus Communis Seed (UNII: 7EK4SFN1TX)	4 g  in 100 g
ALOE (UNII: V5VD430YW9)	1 g  in 100 g
ALPHA-Tocopherol (UNII: H4N855PNZ1)	1 g  in 100 g
Propylparaben (UNII: Z8IX2SC1OH)	0.5 g  in 100 g
Methylparaben (UNII: A2I8C7HI9T)	0.5 g  in 100 g

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 50260-800-01	2.8 g in 1 TUBE
2	NDC: 50260-800-02	3 g in 1 TUBE
3	NDC: 50260-800-03	4 g in 1 TUBE
4	NDC: 50260-800-04	4.2 g in 1 TUBE
5	NDC: 50260-800-05	4.8 g in 1 TUBE
6	NDC: 50260-800-06	5 g in 1 TUBE
7	NDC: 50260-800-07	6 g in 1 TUBE
8	NDC: 50260-800-08	8 g in 1 TUBE
9	NDC: 50260-800-09	9 g in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	12/09/2010

Labeler - Fercy Personal Care Products Co Limited (529623870)

Establishment
Name	Address	ID/FEI	Business Operations
Fercy Personal Care Products Co Limited		529623870	manufacture