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Name:Bellagio Lip Moisturizer Spf 15
Manufacturer:Lifetech Resources, Llc
Category:Over-the-counter (OTC) Marketed Drugs


BELLAGIO® LIP MOISTURIZER SPF 15

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

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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BELLAGIO®
LIP MOISTURIZER
SPF 15

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

Principal Display Panel - 4.25G Tube Label

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 DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Octinoxate (Octinoxate) Octinoxate 64.26 mg  in 1 g
Octisalate (Octisalate) Octisalate 36.72 mg  in 1 g
Oxybenzone (Oxybenzone) Oxybenzone 32.13 mg  in 1 g
Inactive Ingredients
Ingredient Name Strength
Castor Oil  
Petrolatum  
Yellow Wax  
Candelilla Wax  
Cetostearyl Alcohol  
Tribehenin  
Jojoba Oil  
Shea Butter  
.ALPHA.-TOCOPHEROL ACETATE, D-  
Product Characteristics
Color YELLOW Score     
Shape Size
Flavor Imprint Code
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:65643-333-20 4.25 g in 1 TUBE None

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 Operations
Lifetech Resources, LLC 622559110 MANUFACTURE

Revised: 09/2010 Lifetech Resources, LLC



Source: http://dailymed.nlm.nih.gov
Reproduced with permission of U.S. National Library of Medicine


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