Bilboa Kids Sunscreen SPF 50 Plus

Dosage form: lotion
Ingredients: HOMOSALATE 13mL in 100mL, OCTISALATE 3mL in 100mL, OXYBENZONE 6mL in 100mL, ZINC OXIDE 11.52mL in 100mL
Labeler: Cadey S.r.l.
NDC Code: 76070-130

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.

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

BILBOA KIDS SUNSCREEN SPF 50 PLUS 
homosalate, octisalate, oxybenzone, zinc oxide lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76070-130
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HOMOSALATE (HOMOSALATE) HOMOSALATE13 mL  in 100 mL
OCTISALATE (OCTISALATE) OCTISALATE3 mL  in 100 mL
OXYBENZONE (OXYBENZONE) OXYBENZONE6 mL  in 100 mL
ZINC OXIDE (ZINC OXIDE) ZINC OXIDE11.52 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
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 
Packaging
#Item CodePackage Description
1NDC:76070-130-061 BOTTLE (BOTTLE) in 1 PACKAGE
1200 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35203/08/2011
Labeler - Cadey S.r.l. (428414261)
Establishment
NameAddressID/FEIOperations
Safosa S.p.A.429518632manufacture

Revised: 05/2011
 
Cadey S.r.l.

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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