Bellagio Sunscreen SPF 45

Dosage form: lotion
Ingredients: Homosalate 143.22mg in 1mL, Octinoxate 66.495mg in 1mL, Octisalate 51.15mg in 1mL, Oxybenzone 51.15mg in 1mL, Zinc Oxide 28.03mg in 1mL
Labeler: Lifetech Resources, LLC
NDC Code: 65643-335

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 45

DRUG FACTS

ACTIVE INGREDIENTS

Homosalate 14.00%, Octinoxate 6.50%, Octisalate 5.00%, Oxybenzone 5.00%, Zinc Oxide 2.74%

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, Caprylic/Capric Triglyceride, Cyclopentasiloxane, Polysorbate 60, Polysorbate 20, Glycerin, Cetearyl Alcohol, Ceteareth-20, Sorbitan Stearate, Potassium Cetyl Phosphate, Dimethicone, Butyrospermum Parkii (Shea Butter), Squalane, Sodium PCA, Panthenol, Tocopheryl Acetate, Xanthan Gum, Triethoxycaprylylsilane, Disodium EDTA, Sodium Benzoate, Potassium Sorbate, Imidazolidinyl Urea.

PRINCIPAL DISPLAY PANEL - 237 ML Tube Label

BELLAGIO®
SUNSCREEN
LOTION
SPF 45

8 FL OZ / 237 ML

BELLAGIO SUNSCREEN SPF 45 
homosalate, octinoxate, octisalate, oxybenzone, and zinc oxide lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:65643-335
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Homosalate (Homosalate) Homosalate143.22 mg  in 1 mL
Octinoxate (Octinoxate) Octinoxate66.495 mg  in 1 mL
Octisalate (Octisalate) Octisalate51.15 mg  in 1 mL
Oxybenzone (Oxybenzone) Oxybenzone51.15 mg  in 1 mL
Zinc Oxide (Zinc Oxide) Zinc Oxide28.03 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
Water 
Medium-Chain Triglycerides 
Cyclomethicone 5 
Polysorbate 60 
Cetostearyl Alcohol 
POLYOXYL 20 CETOSTEARYL ETHER 
Polysorbate 20 
Sorbitan Monostearate 
Potassium Cetyl Phosphate 
Dimethicone 
Shea Butter 
Squalane 
Sodium Pyrrolidone Carboxylate 
Panthenol 
.ALPHA.-TOCOPHEROL ACETATE, D- 
Xanthan Gum 
Edetate Disodium 
Sodium Benzoate 
Potassium Sorbate 
Imidurea 
OCTYLTRIETHOXYSILANE 
Product Characteristics
ColorWHITEScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:65643-335-18237 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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