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Name:Bellagio Sunscreen For Face Spf 30
Manufacturer:Lifetech Resources, Llc
Category:Over-the-counter (OTC) Marketed Drugs


BELLAGIO® SUNSCREEN LOTION FOR FACE SPF 30

BELLAGIO SUNSCREEN FOR FACE SPF 30 - octinoxate, octocrylene, octisalate 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 FOR FACE
SPF 30

DRUG FACTS

ACTIVE INGREDIENTS

Octinoxate 7.50%, Octocrylene 6.00%, Octisalate 5.00%, Zinc Oxide 2.94%

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, Ethylhexyl Isononanoate, Acrylates Copolymer, Butylene Glycol, Cetyl Alcohol, PEG-100 Stearate, Sorbitan Stearate, Polysorbate-60, Glyceryl Stearate, Dimethicone, Squalane, Hydroxylated Lecithin, Xanthan Gum, Allantoin, Tocopheryl Acetate, Centella Asiatica Extract, Echinacea Angustifolia Extract, Vitis Vinifera (Grape) Seed Extract, Citrus Medica Limonum (Lemon) Peel Extract, Melissa Officinalis Extract, Citric Acid, Triethoxycaprylylsilane, Imidazolidinyl Urea, Sodium Benzoate, Disodium EDTA, Potassium Sorbate.

PRINCIPAL DISPLAY PANEL - 118 ML Tube Label

BELLAGIO®
SUNSCREEN
LOTION FOR FACE
SPF 30

4 FL OZ / 118 ML

PRINCIPAL DISPLAY PANEL - 118 ML Tube Label

BELLAGIO SUNSCREEN FOR FACE SPF 30 
octinoxate, octocrylene, octisalate, and zinc oxide lotion
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:65643-325
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Octinoxate (Octinoxate) Octinoxate 74.25 mg  in 1 mL
Octocrylene (Octocrylene) Octocrylene 59.4 mg  in 1 mL
Octisalate (Octisalate) Octisalate 49.5 mg  in 1 mL
Zinc Oxide (Zinc Oxide) Zinc Oxide 29.106 mg  in 1 mL
Inactive Ingredients
Ingredient Name Strength
Water  
Butylene Glycol  
Cetyl Alcohol  
Polyoxyl 100 Stearate  
Sorbitan Monostearate  
Polysorbate 60  
Glyceryl Monostearate  
Dimethicone  
Squalane  
Xanthan Gum  
Allantoin  
.ALPHA.-TOCOPHEROL ACETATE, D-  
CENTELLA ASIATICA  
ECHINACEA ANGUSTIFOLIA  
Lemon Peel  
MELISSA OFFICINALIS  
Citric Acid Monohydrate  
Imidurea  
Sodium Benzoate  
Edetate Disodium  
Potassium Sorbate  
Product Characteristics
Color WHITE Score     
Shape Size
Flavor Imprint Code
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:65643-325-14 118 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 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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