Label: BILBOA KIDS SUNSCREEN SPF 50 PLUS- homosalate, octisalate, oxybenzone, zinc oxide lotion
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Contains inactivated NDC Code(s)
NDC Code(s): 76070-130-06 - Packager: Cadey S.r.l.
- Category: HUMAN OTC DRUG LABEL
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.
Drug Label Information
Updated May 6, 2011
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- ACTIVE INGREDIENT
- PURPOSE
- WARNINGS
- WHEN USING
- STOP USE
- KEEP OUT OF REACH OF CHILDREN
- DOSAGE & ADMINISTRATION
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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
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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 28025cadey
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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
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INGREDIENTS AND APPEARANCE
BILBOA KIDS SUNSCREEN SPF 50 PLUS
homosalate, octisalate, oxybenzone, zinc oxide lotionProduct 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