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Name:Bellagio Sunscreen Spf 30
Manufacturer:Lifetech Resources, Llc
Category:Over-the-counter (OTC) Marketed Drugs


BELLAGIO® SUNSCREEN SPRAY SPF 30

BELLAGIO SUNSCREEN SPF 30 - octinoxate, octocrylene, oxybenzone and octisalate spray 
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®
SUNSCREEN
SPRAY
SPF 30

DRUG FACTS

ACTIVE INGREDIENTS

Octocrylene 7.0%, Octinoxate 7.0%, Oxybenzone 6.0%, Octisalate 5.0%

PURPOSE

Sunscreen

USE

Helps prevent sunburn. Higher SPF gives more sunburn protection.

DIRECTIONS FOR USE

Apply evenly and liberally to all exposed areas before sun exposure. Ensure complete coverage. Reapply as needed or after swimming, towel drying, perspiring, or vigorous activity. Ask a doctor before use on children under 6 months of age.

WARNING

For external use only.

When using this product keep out of eyes. Rinse with water to remove.

Stop use and ask a doctor if rash or irritation develops and lasts.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

INACTIVE INGREDIENTS

Caprylic/Capric Triglyceride, Cyclopentasiloxane, VP/Hexadecene Copolymer, Retinyl Palmitate, Tocopheryl Acetate, Tetrahexyldecyl Ascorbate.

PRINCIPAL DISPLAY PANEL - 237 ML Bottle Label

BELLAGIO®

SUNSCREEN
SPRAY

SPF 30

8 FL OZ / 237 ML

Principal Display Panel - 237 ML Bottle Label

BELLAGIO SUNSCREEN SPF 30 
octinoxate, octocrylene, oxybenzone, and octisalate spray
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:65643-329
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Octinoxate (Octinoxate) Octinoxate 68.32 mg  in 1 mL
Octocrylene (Octocrylene) Octocrylene 68.32 mg  in 1 mL
Oxybenzone (Oxybenzone) Oxybenzone 58.56 mg  in 1 mL
Octisalate (Octisalate) Octisalate 48.8 mg  in 1 mL
Inactive Ingredients
Ingredient Name Strength
Medium-Chain Triglycerides  
Cyclomethicone 5  
Vitamin A Palmitate  
.ALPHA.-TOCOPHEROL ACETATE, D-  
Product Characteristics
Color YELLOW Score     
Shape Size
Flavor Imprint Code
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:65643-329-11 237 mL in 1 BOTTLE, SPRAY None

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

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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