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Name:Bellagio Sunscreen Spf 45
Manufacturer:Lifetech Resources, Llc
Category:Over-the-counter (OTC) Marketed Drugs


BELLAGIO® SUNSCREEN LOTION SPF 45

BELLAGIO SUNSCREEN SPF 45 - homosalate, octinoxate, octisalate, oxybenzone and zinc oxide 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 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

Principal Display Panel - 237 ML Tube Label

BELLAGIO SUNSCREEN SPF 45 
homosalate, octinoxate, octisalate, oxybenzone, and zinc oxide lotion
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:65643-335
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Homosalate (Homosalate) Homosalate 143.22 mg  in 1 mL
Octinoxate (Octinoxate) Octinoxate 66.495 mg  in 1 mL
Octisalate (Octisalate) Octisalate 51.15 mg  in 1 mL
Oxybenzone (Oxybenzone) Oxybenzone 51.15 mg  in 1 mL
Zinc Oxide (Zinc Oxide) Zinc Oxide 28.03 mg  in 1 mL
Inactive Ingredients
Ingredient Name Strength
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
Color WHITE Score     
Shape Size
Flavor Imprint Code
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:65643-335-18 237 mL in 1 TUBE None

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 Operations
Lifetech Resources, LLC 622559110 MANUFACTURE

Revised: 09/2010 Lifetech Resources, LLC



Source: http://dailymed.nlm.nih.gov
Reproduced with permission of U.S. National Library of Medicine


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