BILBOA CAPRI SUNSCREEN SPF 30- avobenzone, homosalate, octisalate, octocrylene, oxybenzone lotion

Bilboa Capri Sunscreen SPF 30 by

Drug Labeling and Warnings

Bilboa Capri Sunscreen SPF 30 by is a Otc medication manufactured, distributed, or labeled by Cadey S.r.l., Safosa S.p.A.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredients                                                      Purpose

Avobenzone 3%, Homosalate 13%,
Octisalate 3%, Octocrylene 2%, Oxybenzone 6%        Sunscreen

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

WHEN USING

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

STOP USE

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

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, Dicaprylyl Carbonate, Ethylhexyl Methoxycrylene, 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.

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 30 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

PRINCIPAL DISPLAY PANEL

BILBOA Caprl  Sunscreen Lotion  Broad spectrum UVA/UVB protection  Moisturizing and soothing formula  30 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 00302 3

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

BILBOA CAPRI SUNSCREEN SPF 30 
avobenzone, homosalate, octisalate, octocrylene, oxybenzone lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 76070-110
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	3 mL  in 100 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	13 mL  in 100 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	3 mL  in 100 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	2 mL  in 100 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	6 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 76070-110-06	1 in 1 PACKAGE
1		200 mL in 1 BOTTLE

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	Business Operations
Safosa S.p.A.		429518632	manufacture