BILBOA KIDS SUNSCREEN SPF 50 PLUS- homosalate, octisalate, oxybenzone, zinc oxide lotion

Bilboa Kids Sunscreen SPF 50 Plus by

Drug Labeling and Warnings

Bilboa Kids Sunscreen SPF 50 Plus by is a Otc medication manufactured, distributed, or labeled by Cadey S.r.l., Safosa S.p.A.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredients                                                     Purpose

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

PURPOSE

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

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

When using this product - keep out of eyes. Rinse with water to remove

STOP USE

Stop use and ask a doctor if - rash or irritation develops and lasts

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children If swallowed, get medical help or contact a Poison Control Center right away

DOSAGE & ADMINISTRATION

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 INGREDIENT

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

Questions? visit www.cadeyusa.com

DESCRIPTION

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

PRINCIPAL DISPLAY PANEL

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

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

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	13 mL  in 100 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	3 mL  in 100 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	6 mL  in 100 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	11.52 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
GLYCERIN (UNII: PDC6A3C0OX)
HYDROGENATED CASTOR OIL (UNII: ZF94AP8MEY)
DIMETHICONE (UNII: 92RU3N3Y1O)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
MAGNESIUM SULFATE, UNSPECIFIED (UNII: DE08037SAB)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
TROPOLONE (UNII: 7L6DL16P1T)
PROPYLENE CARBONATE (UNII: 8D08K3S51E)
BENZYL SALICYLATE (UNII: WAO5MNK9TU)
LINALOOL, DL- (UNII: D81QY6I88E)
GERANIOL (UNII: L837108USY)
BUTYLPHENYL METHYLPROPIONAL (UNII: T7540GJV69)
COUMARIN (UNII: A4VZ22K1WT)
.ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I)
ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)
HYDROXYISOHEXYL 3-CYCLOHEXENE CARBOXALDEHYDE (UNII: QUE43B9Z2Q)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 76070-130-06	1 in 1 PACKAGE
1		200 mL in 1 BOTTLE

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	Business Operations
Safosa S.p.A.		429518632	manufacture