BELLAGIO SUNSCREEN SPF 8- octinoxate and oxybenzone lotion 
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
LOTION
SPF 8

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

PRINCIPAL DISPLAY PANEL - 237 ML Tube Label
BELLAGIO SUNSCREEN SPF 8 
octinoxate and oxybenzone lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:65643-327
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate49.7 mg  in 1 mL
Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y) Oxybenzone29.82 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
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
ColorWHITEScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:65643-327-16237 mL in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart35201/01/2009
Labeler - Lifetech Resources, LLC (622559110)
Establishment
NameAddressID/FEIBusiness Operations
Lifetech Resources, LLC622559110MANUFACTURE

Revised: 9/2010
Document Id: 55008b6a-5c98-42b9-8acf-cbddd81e76d6
Set id: 97a31203-7bbd-4b67-a860-0d30de428bdf
Version: 1
Effective Time: 20100913
 
Lifetech Resources, LLC