LIP BALM UNFLAVORED- octinoxate, octisalate, oxybenzone stick

Lip Balm by

Drug Labeling and Warnings

Lip Balm by is a Otc medication manufactured, distributed, or labeled by Aztex Enterprises. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

PURPOSE

Uses

Helps protect against sunburn and chapped lips.

WARNINGS

Warnings:

Stop use if skin rash occurs.

INDICATIONS & USAGE

Directions

+Apply to lips prior to sun exposure

+Apply to lips when dry or chapped

INACTIVE INGREDIENT

Inactive Ingredients

Aloe Barbadensis Leaf Extract

Beeswax

Caprylic/Capric Triglyceride

Castor Oil

Euphorbia Cerifera(Candelilla Wax)

Glycine Soja (soybean) Oil

Propylparaben

Methylparaben

Saccharin

ACTIVE INGREDIENT

SPF 15 SUNSCREEN LIPBALM 4.2g

Drug Facts

Active Ingredient Purpose

Octinoxate (7.3%) sunscreen

Octisalate (2%) sunscreen

Oxybenzone (3%) sunscreen

PRINCIPAL DISPLAY PANEL

AZX SPORT

Lip Balm - Unlfavored l SPF 15

INGREDIENTS AND APPEARANCE

LIP BALM  UNFLAVORED
octinoxate, octisalate, oxybenzone stick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 75887-002
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	0.3 g  in 4.2 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	0.08 g  in 4.2 g
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	0.13 g  in 4.2 g

Inactive Ingredients
Ingredient Name	Strength
ALOE VERA LEAF (UNII: ZY81Z83H0X)
YELLOW WAX (UNII: 2ZA36H0S2V)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
CASTOR OIL (UNII: D5340Y2I9G)
CANDELILLA WAX (UNII: WL0328HX19)
SOYBEAN (UNII: L7HT8F1ZOD)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
METHYLPARABEN (UNII: A2I8C7HI9T)
SACCHARIN (UNII: FST467XS7D)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 75887-002-01	4.2 g in 1 APPLICATOR; Type 0: Not a Combination Product	01/13/2011

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	01/13/2011

Labeler - Aztex Enterprises (253232326)

Registrant - Aztex Enterprises (253232326)

Establishment
Name	Address	ID/FEI	Business Operations
Aztex Enterprises		253232326	manufacture(75887-002)