Bilboa Capri Sunscreen Lotion Spf 50 Plus

Bilboa Capri Sunscreen Lotion Spf 50 Plus
SPL v2
SPL
SPL Set ID a8fe4036-936f-4da5-a300-c87588d24852
Route
TOPICAL
Published
Effective Date 2011-03-08
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Avobenzone (3 mL) Homosalate (13 mL) Octisalate (2 mL) Octocrylene (6 mL) Oxybenzone
Inactive Ingredients
Water Butyloctyl Salicylate Dicaprylyl Carbonate Dimethicone Phenoxyethanol Ethylhexylglycerin Tropolone Edetate Disodium Edetate Sodium Benzyl Salicylate Geraniol Aloe Vera Leaf Coumarin Maltodextrin

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2011-03-08

Description

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


Medication Information

Warnings and Precautions

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

Dosage and 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

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

Section 50565-1

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

Section 50566-9

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

Section 50567-7

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

Section 51727-6

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.

Section 51945-4

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

Section 53413-1

Questions? visit www.cadeyusa.com

Section 55105-1

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

Section 55106-9

Active Ingredients                                                      Purpose

Avobenzone 3%, Homosalate 13%,

Octisalate 3%, Octocrylene 2%, Oxybenzone 6%        Sunscreen


Structured Label Content

Dosage and Administration (34068-7)

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

Warnings and Precautions (34071-1)

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

Description (34089-3)

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

Section 50565-1 (50565-1)

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

Section 50566-9 (50566-9)

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

Section 50567-7 (50567-7)

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

Section 51727-6 (51727-6)

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.

Section 51945-4 (51945-4)

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

Section 53413-1 (53413-1)

Questions? visit www.cadeyusa.com

Section 55105-1 (55105-1)

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

Section 55106-9 (55106-9)

Active Ingredients                                                      Purpose

Avobenzone 3%, Homosalate 13%,

Octisalate 3%, Octocrylene 2%, Oxybenzone 6%        Sunscreen


Advanced Ingredient Data


Raw Label Data

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