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Name:Bilboa Kids Sunscreen Spf 50 Plus
Manufacturer:Cadey S.r.l.
Category:Over-the-counter (OTC) Marketed Drugs


Bilboa Kids Sunscreen Lotion SPF 50 Plus

BILBOA KIDS SUNSCREEN SPF 50 PLUS  - homosalate, octisalate, oxybenzone and zinc oxide lotion 
Cadey S.r.l.

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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Bilboa Kids Sunscreen Lotion SPF 50 Plus

Active Ingredients                                                     Purpose

Homosalate 13%, Octisalate 3%,
Oxybenzone 6%, Zinc Oxide 11.52%                         Sunscreen

Uses
- Helps prevent sunburn
- Higher SPF gives more sunburn protection
- Provides high protection against sunburn
- Retains SPF after 40 minutes of activity in the water

Warnings
For external use only

UV exposure from the sun increases the risk of skin cancer, premature skin aging, and other skin damage. It is important to decrease UV exposure by limiting time in the sun, wearing protective clothing, and using a sunscreen

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

Directions
- Apply generously and evenly before sun exposure and as needed
- Children under 6 months of age: ask a doctor
- Reapply as need or after toweling drying, swimming, or perspiring

Inactive ingredients Water, Dicaprylyl Carbonate, Butyloctyl Salicylate, Glycerin, Polyglyceryl-2 Dipolyhydroxystearate, Polyglyceryl-3 Diisostearate, Hydrogenated Castor Oil, Stearyl/Octadodecyl Citrate Crosspolymer, Potassium Olivoyl Pca, Shorea Stenoptera Seed Butter, Dimethicone, Phenoxyethanol, Magnesium Sulfate, Sodium Chloride, Synthetic Beeswax, Triethoxycaprylylsilane, Fragrance, Ethylhexylglycerin, Stearalkonium Hectorite, Tropolone, Propylene Carbonate, Benzyl Salicylate, Limonene, Linalool, Geraniol, Butylphenyl Methylpropional, Citronellol, Coumarin, Hexyl Cinnamal, Alpha-Isomethyl Ionone, Hydroxyisohexyl 3-Cyclohexene Carboxaldehyde.

Questions? visit www.cadeyusa.com

Bilboa Kids Sunscreen Lotion Spf 50+ comes from Cadey’s Italian experience and is specifically developed to protect kids’ delicate skin. Provides your child with broad spectrum UVA/UVB protection and water-resistant. Dermatologically tested - Aminobenzoic acid (PABA) - free

Made In Italy
Manufactured for Cadey Srl
Distributed by RBY LLC
5816 Avian Place
Concord NC 28025

cadey

BILBOA KIDS  6 months of age and up  Sunscreen Lotion  Broad spectrum UVA/UVB protection  Moisturizing and soothing formula  Protects delicate skin against sunburn     50+ SPF  Water-resistant  6.76 fl oz (200 ML)  Made In Italy  Manufactured for Cadey Srl  Distributed by RBY LLC  5816 Avian Place  Concord NC 28025  cadey  8 51055 00306 1

BilboaKids50ABilboaKids50B


BILBOA KIDS SUNSCREEN SPF 50 PLUS 
homosalate, octisalate, oxybenzone, zinc oxide lotion
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:76070-130
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
HOMOSALATE (HOMOSALATE) HOMOSALATE 13 mL  in 100 mL
OCTISALATE (OCTISALATE) OCTISALATE 3 mL  in 100 mL
OXYBENZONE (OXYBENZONE) OXYBENZONE 6 mL  in 100 mL
ZINC OXIDE (ZINC OXIDE) ZINC OXIDE 11.52 mL  in 100 mL
Inactive Ingredients
Ingredient Name Strength
WATER  
DICAPRYLYL CARBONATE  
BUTYLOCTYL SALICYLATE  
GLYCERIN  
HYDROGENATED CASTOR OIL  
DIMETHICONE  
PHENOXYETHANOL  
MAGNESIUM SULFATE, UNSPECIFIED  
SODIUM CHLORIDE  
TRIETHOXYCAPRYLYLSILANE  
ETHYLHEXYLGLYCERIN  
TROPOLONE  
PROPYLENE CARBONATE  
BENZYL SALICYLATE  
LINALOOL, DL-  
GERANIOL  
BUTYLPHENYL METHYLPROPIONAL  
COUMARIN  
.ALPHA.-HEXYLCINNAMALDEHYDE  
ISOMETHYL-.ALPHA.-IONONE  
HYDROXYISOHEXYL 3-CYCLOHEXENE CARBOXALDEHYDE  
Product Characteristics
Color      Score     
Shape Size
Flavor Imprint Code
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:76070-130-06 1 BOTTLE ( BOTTLE) in 1 PACKAGE contains a BOTTLE
1 200 mL in 1 BOTTLE This package is contained within the PACKAGE (76070-130-06)

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part352 03/08/2011

Labeler - Cadey S.r.l. (428414261)
Establishment
Name Address ID/FEI Operations
Safosa S.p.A. 429518632 manufacture

Revised: 05/2011 Cadey S.r.l.



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


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