Otc - Active Ingredient
Active Ingredients Purpose
Homosalate 13%, Octisalate 3%,
Oxybenzone 6%, Zinc Oxide 11.52% Sunscreen
Bilboa Kids Sunscreen Spf 50 Plus
FDA Label NDC 76070-130
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Cadey S.r.l. for the product Bilboa Kids Sunscreen Spf 50 Plus (NDC 76070-130). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding otc - active ingredient, otc - purpose, warnings, otc - when using, otc - stop use, otc - keep out of reach of children, dosage & administration, inactive ingredient, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - 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
Otc - When Using
When using this product - keep out of eyes. Rinse with water to remove
Otc - Stop Use
Stop use and ask a doctor if - rash or irritation develops and lasts
Otc - 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.
Otc - 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
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
Bilboakids50a (Bilboakidsspf50 A)
Bilboakids50b (Bilboakidsspf50 B)
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