BELLAGIO LIP MOISTURIZER SPF 15- octinoxate, octisalate, and oxybenzone ointment

Bellagio Lip Moisturizer SPF 15 by

Drug Labeling and Warnings

Bellagio Lip Moisturizer SPF 15 by is a Otc medication manufactured, distributed, or labeled by Lifetech Resources, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

DRUG FACTS

ACTIVE INGREDIENTS

Octinoxate 7.0%, Octisalate 4.0%, Oxybenzone 3.5%.

PURPOSE

Sunscreen.

USE

Helps prevent sunburn. Higher SPF gives more sunburn protection.

DIRECTIONS FOR USE

Apply evenly and liberally on to lips.

INACTIVE INGREDIENTS

Ricinus Communis (Castor) Seed Oil, Petrolatum, Beeswax, Euphorbia Cerifera (Candelilla) Wax, Cetearyl Alcohol, Tribehenin, Simmondsia Chinensis (Jojoba) Seed Oil, Butyrospermum Parkii (Shea Butter), Tocopheryl Acetate, Stevioside.

PRINCIPAL DISPLAY PANEL - 4.25G Tube Label

BELLAGIO®
LIP
MOISTURIZER
SPF 15

0.15 OZ /
4.25G

INGREDIENTS AND APPEARANCE

BELLAGIO LIP MOISTURIZER SPF 15 
octinoxate, octisalate, and oxybenzone ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 65643-333
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	64.26 mg  in 1 g
Octisalate (UNII: 4X49Y0596W) (Octisalate - UNII:4X49Y0596W)	Octisalate	36.72 mg  in 1 g
Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y)	Oxybenzone	32.13 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
Castor Oil (UNII: D5340Y2I9G)
Petrolatum (UNII: 4T6H12BN9U)
Yellow Wax (UNII: 2ZA36H0S2V)
Candelilla Wax (UNII: WL0328HX19)
Cetostearyl Alcohol (UNII: 2DMT128M1S)
Tribehenin (UNII: 8OC9U7TQZ0)
Jojoba Oil (UNII: 724GKU717M)
Shea Butter (UNII: K49155WL9Y)
.ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N)

Product Characteristics
Color	YELLOW	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 65643-333-20	4.25 g in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part352	02/01/2009

Labeler - Lifetech Resources, LLC (622559110)

Establishment
Name	Address	ID/FEI	Business Operations
Lifetech Resources, LLC		622559110	MANUFACTURE