BELLAGIO SUNSCREEN SPF 15- octinoxate, avobenzone, and octisalate spray

Bellagio Sunscreen SPF 15 by

Drug Labeling and Warnings

Bellagio Sunscreen 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 7.5%, Avobenzone 2.0%, 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, Tocopheryl Acetate, Retinyl Palmitate, Tetrahexyldecyl Ascorbate, Fragrance.

PRINCIPAL DISPLAY PANEL - 237 ML Bottle Label

BELLAGIO®
SUNSCREEN
SPRAY
SPF 15

8 FL OZ / 237 ML

INGREDIENTS AND APPEARANCE

BELLAGIO SUNSCREEN SPF 15 
octinoxate, avobenzone, and octisalate spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 65643-330
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	71.85 mg  in 1 mL
Avobenzone (UNII: G63QQF2NOX) (Avobenzone - UNII:G63QQF2NOX)	Avobenzone	19.16 mg  in 1 mL
Octisalate (UNII: 4X49Y0596W) (Octisalate - UNII:4X49Y0596W)	Octisalate	47.9 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
Medium-Chain Triglycerides (UNII: C9H2L21V7U)
Cyclomethicone 5 (UNII: 0THT5PCI0R)
Vitamin A Palmitate (UNII: 1D1K0N0VVC)
.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: 65643-330-12	237 mL in 1 BOTTLE, SPRAY

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	Business Operations
Lifetech Resources, LLC		622559110	MANUFACTURE