FDA.reportPublic FDA data

Bilboa Kids Sunscreen Lotion SPF 50 Plus

Manufacturer
Cadey S.r.l. | Safosa S.p.A.
Effective date
2011-05-06
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 22:27:55

Label at a glance#

ProductBilboa Kids Sunscreen SPF 50 Plus
Active ingredientHOMOSALATE, OCTISALATE, OXYBENZONE, ZINC OXIDE
Label structure12 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active Ingredients                                                     Purpose

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

OTC - PURPOSE SECTION

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 SECTION

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

OTC - WHEN USING SECTION

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

OTC - STOP USE SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

DOSAGE & ADMINISTRATION SECTION

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 SECTION

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.

DESCRIPTION SECTION

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

PACKAGE LABEL.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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

BilboaKids50ABilboaKids50ABilboaKids50BBilboaKids50B

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
76070-130-062019-10-29C16284748780-1960f7f55-d5e9-8e05-e053-dbdaa90a074aBilboa Kids Sunscreen Lotion SPF 50 Plus

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76070-130-06Bilboa Kids Sunscreen SPF 50 Plus200 mL in 1 BOTTLELOTION2002
76070-130-06Bilboa Kids Sunscreen SPF 50 Plus1 in 1 PACKAGELOTION12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76070-130BILBOA KIDS SUNSCREEN SPF 50 PLUS (HOMOSALATE, OCTISALATE, OXYBENZONE, ZINC OXIDE) LOTION [CADEY S.R.L.]2Legacy NDC, 2 package rows20110509_354ef99d-a94d-438d-b62f-c91b2107e266.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
HOMOSALATEACTIVE INGREDIENTV06SV4M95S2
OCTISALATEACTIVE INGREDIENT4X49Y0596W2
OXYBENZONEACTIVE INGREDIENT95OOS7VE0Y2
ZINC OXIDEACTIVE INGREDIENTSOI2LOH54Z2
HOMOSALATEACTIVE MOIETYV06SV4M95S2
OCTISALATEACTIVE MOIETY4X49Y0596W2
OXYBENZONEACTIVE MOIETY95OOS7VE0Y2
ZINC OXIDEACTIVE MOIETYSOI2LOH54Z2
.ALPHA.-HEXYLCINNAMALDEHYDEINACTIVE INGREDIENT7X6O37OK2I2
BENZYL SALICYLATEINACTIVE INGREDIENTWAO5MNK9TU2
BUTYLOCTYL SALICYLATEINACTIVE INGREDIENT2EH13UN8D32
BUTYLPHENYL METHYLPROPIONALINACTIVE INGREDIENTT7540GJV692
COUMARININACTIVE INGREDIENTA4VZ22K1WT2
DICAPRYLYL CARBONATEINACTIVE INGREDIENT609A3V1SUA2
DIMETHICONEINACTIVE INGREDIENT92RU3N3Y1O2
ETHYLHEXYLGLYCERININACTIVE INGREDIENT147D247K3P2
GERANIOLINACTIVE INGREDIENTL837108USY2
GLYCERININACTIVE INGREDIENTPDC6A3C0OX2
HYDROGENATED CASTOR OILINACTIVE INGREDIENTZF94AP8MEY2
HYDROXYISOHEXYL 3-CYCLOHEXENE CARBOXALDEHYDEINACTIVE INGREDIENTQUE43B9Z2Q2
ISOMETHYL-.ALPHA.-IONONEINACTIVE INGREDIENT9XP4LC555B2
LINALOOL, DL-INACTIVE INGREDIENTD81QY6I88E2
MAGNESIUM SULFATE, UNSPECIFIEDINACTIVE INGREDIENTDE08037SAB2
PHENOXYETHANOLINACTIVE INGREDIENTHIE492ZZ3T2
PROPYLENE CARBONATEINACTIVE INGREDIENT8D08K3S51E2
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8X2
TRIETHOXYCAPRYLYLSILANEINACTIVE INGREDIENTLDC331P08E2
TROPOLONEINACTIVE INGREDIENT7L6DL16P1T2
WATERINACTIVE INGREDIENT059QF0KO0R2

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 27 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
76070-13076070-130-06

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 25 matching rows.

Name, UNII, Kind table
NameUNIIKind
HOMOSALATEV06SV4M95SACTIB
OCTISALATE4X49Y0596WACTIB
OXYBENZONE95OOS7VE0YACTIB
ZINC OXIDESOI2LOH54ZACTIB
WATER059QF0KO0RIACT
DICAPRYLYL CARBONATE609A3V1SUAIACT
BUTYLOCTYL SALICYLATE2EH13UN8D3IACT
GLYCERINPDC6A3C0OXIACT
HYDROGENATED CASTOR OILZF94AP8MEYIACT
DIMETHICONE92RU3N3Y1OIACT
PHENOXYETHANOLHIE492ZZ3TIACT
MAGNESIUM SULFATE, UNSPECIFIEDDE08037SABIACT
SODIUM CHLORIDE451W47IQ8XIACT
TRIETHOXYCAPRYLYLSILANELDC331P08EIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
TROPOLONE7L6DL16P1TIACT
PROPYLENE CARBONATE8D08K3S51EIACT
BENZYL SALICYLATEWAO5MNK9TUIACT
LINALOOL, DL-D81QY6I88EIACT
GERANIOLL837108USYIACT
BUTYLPHENYL METHYLPROPIONALT7540GJV69IACT
COUMARINA4VZ22K1WTIACT
.ALPHA.-HEXYLCINNAMALDEHYDE7X6O37OK2IIACT
ISOMETHYL-.ALPHA.-IONONE9XP4LC555BIACT
HYDROXYISOHEXYL 3-CYCLOHEXENE CARBOXALDEHYDEQUE43B9Z2QIACT

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 4 · 234 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XGEL / OPHTHALMIC0.9 %w/vExact identifier — unii candidate
134 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XINJECTION / INTRAMUSCULAR1486 mgExact identifier — unii candidate
134 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XSOLUTION / EPIDURAL0.9 %w/vExact identifier — unii candidate
134 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXELIXIR / ORAL5621 mgExact identifier — unii candidate
75 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XSOLUTION / INTRAVENOUS90 mgExact identifier — unii candidate
134 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXFILM, EXTENDED RELEASE / BUCCAL34 mgExact identifier — unii candidate
75 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XSOLUTION/ DROPS / AURICULAR (OTIC)18 mgExact identifier — unii candidate
134 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSOLUTION / NASAL25 mg/1mlExact identifier — unii candidate
75 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XSUSPENSION/ DROPS / AURICULAR (OTIC)3 mgExact identifier — unii candidate
134 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXCREAM / VAGINAL60 mgExact identifier — unii candidate
75 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XSOLUTION / NASAL330 mgExact identifier — unii candidate
134 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXTABLET / PERIODONTAL0.53 mgExact identifier — unii candidate
75 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XINJECTION / INTRADERMAL7 mgExact identifier — unii candidate
134 equally ranked IID candidates
HYDROGENATED CASTOR OILHYDROGENATED CASTOR OILZF94AP8MEYLIQUID / TOPICAL0.24 %w/wExact identifier — unii candidate
12 equally ranked IID candidates
HYDROGENATED CASTOR OILHYDROGENATED CASTOR OILZF94AP8MEYTABLET / SUBLINGUAL1.6 mgExact identifier — unii candidate
12 equally ranked IID candidates
PHENOXYETHANOLPHENOXYETHANOLHIE492ZZ3TCREAM, AUGMENTED / TOPICAL10 mgExact identifier — unii candidate
6 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XINJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS1800 mgExact identifier — unii candidate
134 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XPOWDER, FOR SUSPENSION / ENDOTRACHEAL46.76 mgExact identifier — unii candidate
134 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XINJECTION / INTRA-ARTICULAR26 mgExact identifier — unii candidate
134 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSYSTEM / IONTOPHORESIS168.1 mgExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXINJECTION / SUBCUTANEOUS450 mgExact identifier — unii candidate
75 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XINJECTION, SUSPENSION / INTRA-ARTICULAR26 mgExact identifier — unii candidate
134 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XLIQUID / SUBCUTANEOUS0.7 %w/vExact identifier — unii candidate
134 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXLIQUID / ORAL2400 mgExact identifier — unii candidate
75 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XINJECTION, SOLUTION / INTRACAUDAL210 mgExact identifier — unii candidate
134 equally ranked IID candidates
PHENOXYETHANOLPHENOXYETHANOLHIE492ZZ3TAEROSOL, FOAM / TOPICAL72 mgExact identifier — unii candidate
6 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XCAPSULE, EXTENDED RELEASE / ORAL41 mgExact identifier — unii candidate
134 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXINJECTION, SOLUTION / INTRAMUSCULAR15 %w/vExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSUSPENSION/ DROPS / ORAL750 mgExact identifier — unii candidate
75 equally ranked IID candidates
MAGNESIUM SULFATE, UNSPECIFIEDMAGNESIUM SULFATEDE08037SABTABLET, COATED / ORALNAExact identifier — unii candidate
6 equally ranked IID candidates
MAGNESIUM SULFATE, UNSPECIFIEDMAGNESIUM SULFATEDE08037SABCAPSULE / ORALNAExact identifier — unii candidate
6 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXCONCENTRATE / ORAL1800 mgExact identifier — unii candidate
75 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XSOLUTION / SUBCUTANEOUS90 mgExact identifier — unii candidate
134 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XPOWDER / TOPICALNAExact identifier — unii candidate
134 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXCLOTH / TOPICAL0.05 mg/mgExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXFILM, EXTENDED RELEASE / TRANSDERMAL306.2 mgExact identifier — unii candidate
75 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XLIQUID / INTRAMUSCULAR17 mgExact identifier — unii candidate
134 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XLIQUID / NASAL7.4 mg/1mlExact identifier — unii candidate
134 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XINJECTION, SOLUTION, CONCENTRATE / INTRAMUSCULAR0.86 %w/vExact identifier — unii candidate
134 equally ranked IID candidates
MAGNESIUM SULFATE, UNSPECIFIEDMAGNESIUM SULFATEDE08037SABTABLET, FILM COATED / ORAL14 mgExact identifier — unii candidate
6 equally ranked IID candidates
MAGNESIUM SULFATE, UNSPECIFIEDMAGNESIUM SULFATEDE08037SABTABLET / ORAL2.9 mgExact identifier — unii candidate
6 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSOLUTION/ DROPS / AURICULAR (OTIC)25 mgExact identifier — unii candidate
75 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XSYSTEM / IONTOPHORESIS3.1 mgExact identifier — unii candidate
134 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XINJECTION / INTRATUMOR1.2 %w/vExact identifier — unii candidate
134 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XINJECTION, POWDER, FOR SOLUTION / INTRA-ARTERIAL1.35 mgExact identifier — unii candidate
134 equally ranked IID candidates
PROPYLENE CARBONATEPROPYLENE CARBONATE8D08K3S51EOINTMENT / TOPICAL3000 mgExact identifier — unii candidate
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XSOLUTION / RECTALNAExact identifier — unii candidate
134 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XINJECTION, SOLUTION / SUBARACHNOID0.9 %w/vExact identifier — unii candidate
134 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XINJECTION, SOLUTION / SUBCUTANEOUS1486 mgExact identifier — unii candidate
134 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XINJECTION, SOLUTION / INTRATHECAL131 mgExact identifier — unii candidate
134 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXGEL / OPHTHALMIC0.88 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XINJECTION / INTRAVASCULAR0.86 %w/vExact identifier — unii candidate
134 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XINHALANT / RESPIRATORY (INHALATION)3 mgExact identifier — unii candidate
134 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XSUSPENSION / RESPIRATORY (INHALATION)43 mgExact identifier — unii candidate
134 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XDROPS / ORALNAExact identifier — unii candidate
134 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXDROPS / ORAL300 mg/1mlExact identifier — unii candidate
75 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XINJECTION, SUSPENSION / INTRAVITREAL6 mgExact identifier — unii candidate
134 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XSUSPENSION/ DROPS / TOPICAL0.23 %w/vExact identifier — unii candidate
134 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXTABLET, CHEWABLE / ORAL12 mgExact identifier — unii candidate
75 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XINJECTION, SUSPENSION / SOFT TISSUE26 mgExact identifier — unii candidate
134 equally ranked IID candidates

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
4bde1f2c-9b3f-4b8f-a43a-6902d4207a1f354ef99d-a94d-438d-b62f-c91b2107e2662011-05-06WarningsExact identifier
spl id: 4bde1f2c-9b3f-4b8f-a43a-6902d4207a1f
spl set id: 354ef99d-a94d-438d-b62f-c91b2107e266

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.