Otc - Active Ingredient
Active Ingredients Purpose
Avobenzone 3%, Homosalate 13%,
Octisalate 3%, Octocrylene 2%, Oxybenzone 6% Sunscreen
Bilboa Capri Sunscreen Spf 50 Plus
FDA Label NDC 76070-120
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 Capri Sunscreen Spf 50 Plus (NDC 76070-120). 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, Butyloctyl Salicylate, Ethylhexyl Methoxycrylene, Dicaprylyl Carbonate, Stearyl/octadodecyl Citrate Crosspolymer, Pentaerythrityl Distearate, Dimethicone, Phenoxyethanol, Sodium Stearoyl Glutamate, Sodium Polyacrylate, Fragrance, Ethylhexylglycerin, Tropolone, Disodium Edta, Tetrasodium Edta, Benzyl Salicylate, Geraniol, Aloe Barbadensis Leaf Extract, Coumarin, Maltodextrin.
Otc - Questions
Questions? visit www.cadeyusa.com
Description
Bilboa Capri, inspired by one of the best-known Mediterranean islands, comes from Cadey’s Italian experience. The 50+ Lotion provides UVA/UVB sunscreen protection against sunburn. It is also enriched with moisturizes and soothing Aloe and Vitamin E. 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 Caprl Sunscreen Lotion Broad spectrum UVA/UVB protection Moisturizing and soothing formula 50+ SPF Water-resistant With Aloe 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 00304 7
Bilboacapri50a (Bilboacaprispf50 A)
Bilboacapri50b (Bilboacaprispf50 B)
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