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Name:Bilboa Capri Sunscreen Spf 15
Manufacturer:Cadey S.r.l.
Category:Over-the-counter (OTC) Marketed Drugs


Bilboa Capri Sunscreen Lotion SPF 15

BILBOA CAPRI SUNSCREEN SPF 15  - avobenzone, octisalate, octocrylene and oxybenzone lotion 
Cadey S.r.l.

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.

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Bilboa Capri Sunscreen Lotion SPF 15

Active Ingredients                                   Purpose

Avobenzone 2%, Octisalate 5%,
Octocrylene 3%, Oxybenzone 2%           Sunscreen

Uses

- Helps prevent sunburn
- Higher SPF gives more sunburn protection
- Provides moderate protection against sunburn
- Retains SPF after 40 minutes of activity in the water

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

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

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

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 ingredients Water, Butyloctyl Salicylate, Dicaprylyl Carbonate, Stearyl/octadodecyl Citrate Crosspolymer, Ethylhexyl Methoxycrylene, Pentaerythrityl Distearate, Dimethicone, Phenoxyethanol, Sodium Polyacrylate, Sodium Stearoyl Glutamate, Fragrance, Ethylhexylglycerin, Tropolone, Disodium Edta, Tetrasodium Edta, Benzyl Salicylate, Geraniol, Aloe Barbadensis Leaf Extract, Coumarin, Maltodextrin.

Questions? visit www.cadeyusa.com

Bilboa Capri, inspired by one of the best-known Mediterranean islands, comes from Cadey’s Italian experience. The 15 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

BILBOA Caprl  Sunscreen Lotion  Broad spectrum UVA/UVB protection  Moisturizing and soothing formula  15 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  00300 9

BilboaCapri15A
BilboaCapri15B

BILBOA CAPRI SUNSCREEN SPF 15 
avobenzone, octisalate, octocrylene, oxybenzone lotion
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:76070-100
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
AVOBENZONE (AVOBENZONE) AVOBENZONE 2 mL  in 100 mL
OCTISALATE (OCTISALATE) OCTISALATE 5 mL  in 100 mL
OCTOCRYLENE (OCTOCRYLENE) OCTOCRYLENE 3 mL  in 100 mL
OXYBENZONE (OXYBENZONE) OXYBENZONE 2 mL  in 100 mL
Inactive Ingredients
Ingredient Name Strength
WATER  
BUTYLOCTYL SALICYLATE  
DICAPRYLYL CARBONATE  
DIMETHICONE  
PHENOXYETHANOL  
ETHYLHEXYLGLYCERIN  
TROPOLONE  
EDETATE DISODIUM  
EDETATE SODIUM  
BENZYL SALICYLATE  
GERANIOL  
ALOE VERA LEAF  
COUMARIN  
MALTODEXTRIN  
Product Characteristics
Color      Score     
Shape Size
Flavor Imprint Code
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:76070-100-06 1 BOTTLE ( BOTTLE) in 1 PACKAGE contains a BOTTLE
1 200 mL in 1 BOTTLE This package is contained within the PACKAGE (76070-100-06)

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 Operations
Safosa S.p.A. 429518632 manufacture

Revised: 05/2011 Cadey S.r.l.



Source: http://dailymed.nlm.nih.gov
Reproduced with permission of U.S. National Library of Medicine


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