BILBOA CAPRI SUNSCREEN SPF 15 - avobenzone, octisalate, octocrylene, 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 TypeHUMAN OTC DRUGItem Code (Source)NDC:76070-100
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE2 mL  in 100 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE5 mL  in 100 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE3 mL  in 100 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE2 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
TROPOLONE (UNII: 7L6DL16P1T)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
EDETATE SODIUM (UNII: MP1J8420LU)  
BENZYL SALICYLATE (UNII: WAO5MNK9TU)  
GERANIOL (UNII: L837108USY)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
COUMARIN (UNII: A4VZ22K1WT)  
MALTODEXTRIN (UNII: 7CVR7L4A2D)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:76070-100-061 in 1 PACKAGE
1200 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35203/08/2011
Labeler - Cadey S.r.l. (428414261)
Establishment
NameAddressID/FEIBusiness Operations
Safosa S.p.A.429518632manufacture

Revised: 5/2011
Document Id: 0d3e268a-efe3-4641-894b-90a7d954a01c
Set id: 84051a7c-4927-4936-92c7-c4d823aeb083
Version: 2
Effective Time: 20110506
 
Cadey S.r.l.