BELLAGIO SUNSCREEN SPF 8- octinoxate and oxybenzone lotion

Bellagio Sunscreen SPF 8 by

Drug Labeling and Warnings

Bellagio Sunscreen SPF 8 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 5.0%, Oxybenzone 3.0%

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

Water, Acrylates Copolymer, Ethylhexyl Isononanoate, Caprylic/Capric Triglyceride, Cetyl Alcohol, Dimethicone, Cetearyl Alcohol, Ceteareth-20, Potassium Cetyl Phosphate, Polysorbate 60, Sorbitan Stearate, Squalane, Sodium PCA, Camellia Sinensis Leaf Extract, Chamomilla Recutita (Matricaria) Flower Extract, Symphytum Officinale Rhizome/Root Extract, Cucumis Sativus (Cucumber) Fruit Extract, Tocopheryl Acetate, Sodium Hyaluronate, Retinyl Palmitate, Aminomethyl Propanol, Disodium EDTA, Sodium Benzoate, Potassium Sorbate, Imidazolidinyl Urea, Fragrance.

PRINCIPAL DISPLAY PANEL - 237 ML Tube Label

BELLAGIO®
SUNSCREEN
LOTION
SPF 8

8 FL OZ / 237 ML

INGREDIENTS AND APPEARANCE

BELLAGIO SUNSCREEN SPF 8 
octinoxate and oxybenzone lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 65643-327
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	49.7 mg  in 1 mL
Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y)	Oxybenzone	29.82 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
Water (UNII: 059QF0KO0R)
Medium-Chain Triglycerides (UNII: C9H2L21V7U)
Cetyl Alcohol (UNII: 936JST6JCN)
Dimethicone (UNII: 92RU3N3Y1O)
Cetostearyl Alcohol (UNII: 2DMT128M1S)
POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)
Potassium Cetyl Phosphate (UNII: 03KCY6P7UT)
Polysorbate 60 (UNII: CAL22UVI4M)
Sorbitan Monostearate (UNII: NVZ4I0H58X)
Squalane (UNII: GW89575KF9)
Sodium Pyrrolidone Carboxylate (UNII: 469OTG57A2)
CHAMOMILE (UNII: FGL3685T2X)
COMFREY ROOT (UNII: M9VVZ08EKQ)
FRUIT (UNII: C2AIY4ERZC)
HYPERICUM PERFORATUM (UNII: XK4IUX8MNB)
ASIAN GINSENG (UNII: CUQ3A77YXI)
.ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
Vitamin A Palmitate (UNII: 1D1K0N0VVC)
Aminomethylpropanol (UNII: LU49E6626Q)
Edetate Disodium (UNII: 7FLD91C86K)
Sodium Benzoate (UNII: OJ245FE5EU)
Potassium Sorbate (UNII: 1VPU26JZZ4)
Imidurea (UNII: M629807ATL)

Product Characteristics
Color	WHITE	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 65643-327-16	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