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


BELLAGIO® CHILDREN'S SUNSCREEN LOTION SPF 45

BELLAGIO CHILDRENS 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®
CHILDREN'S
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, Caprylic/Capric Triglyceride, Acrylates Copolymer, Cyclopentasiloxane, Polysorbate 60, Cetearyl Alcohol, Ceteareth-20, Glycerin, Potassium Cetyl Phosphate, Sorbitan Stearate, VP/Hexadecene Copolymer, Polysorbate 20, Dimethicone, Butyrospermum Parkii (Shea Butter), Squalane, Panthenol, Sodium PCA, Tocopheryl Acetate, Persea Gratissima (Avocado) Oil, Macadamia Ternifolia Seed Oil, Aloe Barbadensis Leaf Extract, Calendula Officinalis Flower Extract, Chamomilla Recutita (Matricaria) Flower Extract, Xanthan Gum, Triethoxycaprylylsilane, Disodium EDTA, Imidazolidinyl Urea, Sodium Benzoate, Potassium Sorbate.

PRINCIPAL DISPLAY PANEL - 118 ML Tube Label

BELLAGIO®
CHILDREN'S
SUNSCREEN
LOTION
SPF 45

4 FL OZ / 118 ML

Principal Display Panel - 118 ML Tube Label

BELLAGIO CHILDRENS SUNSCREEN SPF 45 
homosalate, octinoxate, octisalate, oxybenzone, and zinc oxide lotion
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:65643-336
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Homosalate (Homosalate) Homosalate 141.904 mg  in 1 mL
Octinoxate (Octinoxate) Octinoxate 65.884 mg  in 1 mL
Octisalate (Octisalate) Octisalate 50.68 mg  in 1 mL
Oxybenzone (Oxybenzone) Oxybenzone 50.68 mg  in 1 mL
Zinc Oxide (Zinc Oxide) Zinc Oxide 27.773 mg  in 1 mL
Inactive Ingredients
Ingredient Name Strength
Water  
Cetostearyl Alcohol  
POLYOXYL 20 CETOSTEARYL ETHER  
Cyclomethicone 5  
Sorbitan Monostearate  
Glycerin  
Potassium Cetyl Phosphate  
Polysorbate 60  
Polysorbate 20  
Medium-Chain Triglycerides  
Dimethicone  
Shea Butter  
Sodium Pyrrolidone Carboxylate  
Panthenol  
.ALPHA.-TOCOPHEROL ACETATE, D-  
Aloe Vera Leaf  
Avocado  
Macadamia Oil  
Calendula Officinalis Flower  
CHAMOMILE  
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:65643-336-19 118 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 02/01/2009

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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