Bellagio Sunscreen SPF 8

Dosage form: lotion
Ingredients: Octinoxate 49.7mg in 1mL, Oxybenzone 29.82mg in 1mL
Labeler: Lifetech Resources, LLC
NDC Code: 65643-327

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.

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

BELLAGIO SUNSCREEN SPF 8 
octinoxate and oxybenzone lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:65643-327
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Octinoxate (Octinoxate) Octinoxate49.7 mg  in 1 mL
Oxybenzone (Oxybenzone) Oxybenzone29.82 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
Water 
Medium-Chain Triglycerides 
Cetyl Alcohol 
Dimethicone 
Cetostearyl Alcohol 
POLYOXYL 20 CETOSTEARYL ETHER 
Potassium Cetyl Phosphate 
Polysorbate 60 
Sorbitan Monostearate 
Squalane 
Sodium Pyrrolidone Carboxylate 
CHAMOMILE 
COMFREY ROOT 
FRUIT 
HYPERICUM PERFORATUM 
ASIAN GINSENG 
.ALPHA.-TOCOPHEROL ACETATE, D- 
HYALURONATE SODIUM 
Vitamin A Palmitate 
Aminomethylpropanol 
Edetate Disodium 
Sodium Benzoate 
Potassium Sorbate 
Imidurea 
Product Characteristics
ColorWHITEScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage Description
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/FEIOperations
Lifetech Resources, LLC622559110MANUFACTURE

Revised: 09/2010
 
Lifetech Resources, LLC

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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