Bilboa Kids Sunscreen Lotion Spf 50 Plus

Bilboa Kids Sunscreen Lotion Spf 50 Plus
SPL v2
SPL
SPL Set ID 354ef99d-a94d-438d-b62f-c91b2107e266
Route
TOPICAL
Published
Effective Date 2011-03-08
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Homosalate (13 mL) Octisalate (3 mL) Oxybenzone (6 mL) Zinc Oxide (11.52 mL)
Inactive Ingredients
Water Dicaprylyl Carbonate Butyloctyl Salicylate Glycerin Hydrogenated Castor Oil Dimethicone Phenoxyethanol Magnesium Sulfate, Unspecified Sodium Chloride Triethoxycaprylylsilane Ethylhexylglycerin Tropolone Propylene Carbonate Benzyl Salicylate Linalool, Dl- Geraniol Butylphenyl Methylpropional Coumarin .alpha.-hexylcinnamaldehyde Isomethyl-.alpha.-ionone Hydroxyisohexyl 3-cyclohexene Carboxaldehyde

Identifiers & Packaging

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

Description

Active Ingredients                                                     Purpose Homosalate 13%, Octisalate 3%, Oxybenzone 6%, Zinc Oxide 11.52%                         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 Kids Sunscreen Lotion Spf 50+ comes from Cadey’s Italian experience and is specifically developed to protect kids’ delicate skin. Provides your child with broad spectrum UVA/UVB protection and water-resistant. 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, Dicaprylyl Carbonate, Butyloctyl Salicylate, Glycerin, Polyglyceryl-2 Dipolyhydroxystearate, Polyglyceryl-3 Diisostearate, Hydrogenated Castor Oil, Stearyl/Octadodecyl Citrate Crosspolymer, Potassium Olivoyl Pca, Shorea Stenoptera Seed Butter, Dimethicone, Phenoxyethanol, Magnesium Sulfate, Sodium Chloride, Synthetic Beeswax, Triethoxycaprylylsilane, Fragrance, Ethylhexylglycerin, Stearalkonium Hectorite, Tropolone, Propylene Carbonate, Benzyl Salicylate, Limonene, Linalool, Geraniol, Butylphenyl Methylpropional, Citronellol, Coumarin, Hexyl Cinnamal, Alpha-Isomethyl Ionone, Hydroxyisohexyl 3-Cyclohexene Carboxaldehyde.

Section 51945-4

BILBOA KIDS  6 months of age and up  Sunscreen Lotion  Broad spectrum UVA/UVB protection  Moisturizing and soothing formula  Protects delicate skin against sunburn     50+ SPF  Water-resistant  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 00306 1

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

Homosalate 13%, Octisalate 3%,

Oxybenzone 6%, Zinc Oxide 11.52%                         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 Kids Sunscreen Lotion Spf 50+ comes from Cadey’s Italian experience and is specifically developed to protect kids’ delicate skin. Provides your child with broad spectrum UVA/UVB protection and water-resistant. 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, Dicaprylyl Carbonate, Butyloctyl Salicylate, Glycerin, Polyglyceryl-2 Dipolyhydroxystearate, Polyglyceryl-3 Diisostearate, Hydrogenated Castor Oil, Stearyl/Octadodecyl Citrate Crosspolymer, Potassium Olivoyl Pca, Shorea Stenoptera Seed Butter, Dimethicone, Phenoxyethanol, Magnesium Sulfate, Sodium Chloride, Synthetic Beeswax, Triethoxycaprylylsilane, Fragrance, Ethylhexylglycerin, Stearalkonium Hectorite, Tropolone, Propylene Carbonate, Benzyl Salicylate, Limonene, Linalool, Geraniol, Butylphenyl Methylpropional, Citronellol, Coumarin, Hexyl Cinnamal, Alpha-Isomethyl Ionone, Hydroxyisohexyl 3-Cyclohexene Carboxaldehyde.

Section 51945-4 (51945-4)

BILBOA KIDS  6 months of age and up  Sunscreen Lotion  Broad spectrum UVA/UVB protection  Moisturizing and soothing formula  Protects delicate skin against sunburn     50+ SPF  Water-resistant  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 00306 1

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

Homosalate 13%, Octisalate 3%,

Oxybenzone 6%, Zinc Oxide 11.52%                         Sunscreen


Advanced Ingredient Data


Raw Label Data

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