BELLAGIO SUNSCREEN SPF 30- homosalate, octinoxate, octocrylene, and oxybenzone lotion

Bellagio Sunscreen SPF 30 by

Drug Labeling and Warnings

Bellagio Sunscreen SPF 30 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

Homosalate 10.0%, Octinoxate 7.0 %, Octocrylene 6.5 %, Oxybenzone 5.5 %

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

Water, Acrylates Copolymer, Cyclopentasiloxane, Cetearyl Alcohol, Ceteareth-20, Polysorbate 60, Butylene Glycol, Potassium Cetyl Phosphate, Stearyl Alcohol, Dimethicone, Sorbitan Stearate, Cetearyl Methicone, Simmondsia Chinensis (Jojoba) Seed Oil, Aloe Barbadensis Leaf Juice, Butyrospermum Parkii (Shea Butter), Tocopheryl Acetate, Calendula Officinalis Flower Extract, Chamomilla Recutita (Matricaria) Flower Extract, Xanthan Gum, Aminomethyl Propanol, Disodium EDTA, Sodium Benzoate, Potassium Sorbate, Phenoxyethanol, Fragrance.

PRINCIPAL DISPLAY PANEL - 237 ML Tube Label

BELLAGIO®
SUNSCREEN
LOTION
SPF 30

8 FL OZ / 237 ML

INGREDIENTS AND APPEARANCE

BELLAGIO SUNSCREEN SPF 30 
homosalate, octinoxate, octocrylene, and oxybenzone lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 65643-334
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Homosalate (UNII: V06SV4M95S) (Homosalate - UNII:V06SV4M95S)	Homosalate	100.7 mg  in 1 mL
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	70.49 mg  in 1 mL
Octocrylene (UNII: 5A68WGF6WM) (Octocrylene - UNII:5A68WGF6WM)	Octocrylene	65.455 mg  in 1 mL
Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y)	Oxybenzone	55.385 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
Water (UNII: 059QF0KO0R)
Cyclomethicone 5 (UNII: 0THT5PCI0R)
Cetostearyl Alcohol (UNII: 2DMT128M1S)
POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)
Polysorbate 60 (UNII: CAL22UVI4M)
Butylene Glycol (UNII: 3XUS85K0RA)
Potassium Cetyl Phosphate (UNII: 03KCY6P7UT)
Stearyl Alcohol (UNII: 2KR89I4H1Y)
Dimethicone (UNII: 92RU3N3Y1O)
Sorbitan Monostearate (UNII: NVZ4I0H58X)
Jojoba Oil (UNII: 724GKU717M)
Aloe Vera Leaf (UNII: ZY81Z83H0X)
Shea Butter (UNII: K49155WL9Y)
.ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N)
Calendula Officinalis Flower (UNII: P0M7O4Y7YD)
CHAMOMILE (UNII: FGL3685T2X)
Xanthan Gum (UNII: TTV12P4NEE)
Aminomethylpropanol (UNII: LU49E6626Q)
Edetate Disodium (UNII: 7FLD91C86K)
Sodium Benzoate (UNII: OJ245FE5EU)
Potassium Sorbate (UNII: 1VPU26JZZ4)
Phenoxyethanol (UNII: HIE492ZZ3T)

Product Characteristics
Color	WHITE	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 65643-334-17	237 mL in 1 TUBE

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