Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID 96d2d0f1-dbde-4b66-9b2c-9d07f7547066
Route
TOPICAL
Published
Effective Date 2017-12-13
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Zinc Cation (51.4 mg) Titanium Dioxide (73.6 mg)
Inactive Ingredients
Water Medium-chain Triglycerides Ethylhexyl Palmitate Dimethicone Glycerin Polyglyceryl-3 Ricinoleate Methylpropanediol Aloe Polyhydroxystearic Acid (2300 Mw) Aluminum Stearate Tocopherol Zinc Stearate Magnesium Sulfate, Unspecified Form Simmondsia Chinensis Seed Vitis Vinifera Seed Hydrogenated Castor Oil Almond Oil Ubiquinone Q2 Camellia Oleifera Leaf Hyaluronate Sodium .alpha.-bisabolol, (+)- Panthenol Tetrahexyldecyl Ascorbate Carrageenan Dextrose, Unspecified Form Triethoxycaprylylsilane Aluminum Oxide Xanthan Gum Sodium Benzoate Potassium Sorbate Citric Acid Monohydrate Thymus Vulgaris Leaf Spearmint Oil Clary Sage Oil Santalum Spicatum Oil Rosa Damascena Flower Oil Peppermint Oil Citrus Reticulata Leaf Oil Patchouli Oil Orange Oil Myrrh Oil Lime Oil Lemon Oil Lavender Oil Grapefruit Oil Abies Sibirica Leaf Oil Eucalyptus Globulus Leaf Juniperus Virginiana Oil Bergamot Oil Tangerine Pelargonium Graveolens Flower Oil Galbanum Oil Triethyl Citrate Vanillin Ethyl Vanillin Limonene, (+)- Linalool, (+)- Benzyl Alcohol Geraniol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2017-12-11

Description

Titanium Dioxide - 7.36% Zinc Oxide - 5.14%


Medication Information

Warnings and Precautions

For external use only.

Indications and Usage

Helps prevent sunburn

if used as directed with other sun protection measures, decreases the risk of skin cancer and early skin aging caused by the sun.

Dosage and Administration

apply liberally 15 minutes before sun exposure.

use a water resistant sunscreen if swimming or sweating.

reapply:

immidiately aftr swimming, sweating or towel drying.

at least every 2 hours.

children under 6months: ask doctor

Sun protection measures:

Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease the risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protector measures including:

limit time in the sun, especially from 10:00 am to 2:00 pm.

wear long sleaved shirts, pants, hats and sun glasses.

Description

Titanium Dioxide - 7.36% Zinc Oxide - 5.14%

Section 50565-1

if product is swallowed, get medical help or contact a Poison Control Center right away.

Section 50566-9

Stop use and ask a doctor if rash occurs.

Section 50567-7

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

Section 50570-1

do not use on damaged or broken skin.

Section 51727-6

Water (Aqua), Caprylic/Capric Triglyceride, Ethylhexyl Palmitate, Dimethicone, Glycerin, Polyglyceryl-3 Ricinoleate, Methylpropanediol, Aloe Barbadensis Leaf Juice, Polyhydroxystearic Acid, Aluminum Stearate, Tocopherol, Zinc Stearare, Magnesium Sulfate, Simmondsia Chinesis (Jojoba) Seed Oil, Vitis Vinifera (Grape) Seed Oil, Hydrogenated Castor oil, Prunus Amygdalus Dulcis (Sweet Almond) Oil, Ubiquinone, Camellia Oleifera Leaf Extract, Sodium Hyaluronate, Vitis Vinifera (Grape) Seed Extract, Bisabolol, Panthenol, Tetrahexyldecyl Ascorbate, Carrageenan, Glucose, Myristoyl Pentapeptide-11, Triethoxycaprylylsilane, Alumina, Xanthan Gum, Sodium Benzoate, Potassium Sorbate, Citric Acid, Thymus Vulgaris (Thyme) Flower/Leaf Oil, Mentha Virdis (Spearmint) Leaf Oil, Fusanus Spicatus Wood Oil, Salvia Sclarea (Clary) Oil, Rosa Damascena Flower Oil, Mentha Piperita (Peppermint) Oil, Citrus Reticulata (Tangerine) Leaf Oil, Pogostemon Cablin Oil, Citrus Aurantium Dulcis (Orange) Peel Oil, Myritica Fragrans (Nutmeg) Kernel Oil, Commiphora Myrrha Oil, Citrus Aurantifolia (Lime) Oil, Citrus Limon (Lemon) Peel Oil, Lavandula Angustifolia (Lavender) Oil, Citrus Grandis (Grapefruit) Peel oil, Abies Sibirica Oil, Eucalyptus Globulus Leaf Oil, Juniperus Virginiana Oil, Citrus Aurantium Bergamia (Bergamot) Fruit Extract, Citrus Nobilis (Mandarin Orange) Peel Oil, Pelargonium Graveolens Flower Oil, Ferula Galbaniflua (Galbanum) Resin Oil, Triethyl Citrate, Vanillin, ethyl Vanillin, Limonene, Linalool, benzyl Alcohol, Geraniol.

Section 51945-4

Distributed By:

The Soleil Group, LLC.

Bronxville, NY 10708

Energie 43

1271 EC Huizen, Netherlands

www.soleiltoujours.com

MADE IN U.S.A.

Section 55106-9

Titanium Dioxide - 7.36%

Zinc Oxide - 5.14%

Section 60561-8

May stain or damage some fabrics or surfaces. Avoid long term storage above 40C (120F). Protect the product in this container from excessive heat and direct sunlight.


Structured Label Content

Indications and Usage (34067-9)

Helps prevent sunburn

if used as directed with other sun protection measures, decreases the risk of skin cancer and early skin aging caused by the sun.

Dosage and Administration (34068-7)

apply liberally 15 minutes before sun exposure.

use a water resistant sunscreen if swimming or sweating.

reapply:

immidiately aftr swimming, sweating or towel drying.

at least every 2 hours.

children under 6months: ask doctor

Sun protection measures:

Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease the risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protector measures including:

limit time in the sun, especially from 10:00 am to 2:00 pm.

wear long sleaved shirts, pants, hats and sun glasses.

Warnings and Precautions (34071-1)

For external use only.

Section 50565-1 (50565-1)

if product is 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 occurs.

Section 50567-7 (50567-7)

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

Section 50570-1 (50570-1)

do not use on damaged or broken skin.

Section 51727-6 (51727-6)

Water (Aqua), Caprylic/Capric Triglyceride, Ethylhexyl Palmitate, Dimethicone, Glycerin, Polyglyceryl-3 Ricinoleate, Methylpropanediol, Aloe Barbadensis Leaf Juice, Polyhydroxystearic Acid, Aluminum Stearate, Tocopherol, Zinc Stearare, Magnesium Sulfate, Simmondsia Chinesis (Jojoba) Seed Oil, Vitis Vinifera (Grape) Seed Oil, Hydrogenated Castor oil, Prunus Amygdalus Dulcis (Sweet Almond) Oil, Ubiquinone, Camellia Oleifera Leaf Extract, Sodium Hyaluronate, Vitis Vinifera (Grape) Seed Extract, Bisabolol, Panthenol, Tetrahexyldecyl Ascorbate, Carrageenan, Glucose, Myristoyl Pentapeptide-11, Triethoxycaprylylsilane, Alumina, Xanthan Gum, Sodium Benzoate, Potassium Sorbate, Citric Acid, Thymus Vulgaris (Thyme) Flower/Leaf Oil, Mentha Virdis (Spearmint) Leaf Oil, Fusanus Spicatus Wood Oil, Salvia Sclarea (Clary) Oil, Rosa Damascena Flower Oil, Mentha Piperita (Peppermint) Oil, Citrus Reticulata (Tangerine) Leaf Oil, Pogostemon Cablin Oil, Citrus Aurantium Dulcis (Orange) Peel Oil, Myritica Fragrans (Nutmeg) Kernel Oil, Commiphora Myrrha Oil, Citrus Aurantifolia (Lime) Oil, Citrus Limon (Lemon) Peel Oil, Lavandula Angustifolia (Lavender) Oil, Citrus Grandis (Grapefruit) Peel oil, Abies Sibirica Oil, Eucalyptus Globulus Leaf Oil, Juniperus Virginiana Oil, Citrus Aurantium Bergamia (Bergamot) Fruit Extract, Citrus Nobilis (Mandarin Orange) Peel Oil, Pelargonium Graveolens Flower Oil, Ferula Galbaniflua (Galbanum) Resin Oil, Triethyl Citrate, Vanillin, ethyl Vanillin, Limonene, Linalool, benzyl Alcohol, Geraniol.

Section 51945-4 (51945-4)

Distributed By:

The Soleil Group, LLC.

Bronxville, NY 10708

Energie 43

1271 EC Huizen, Netherlands

www.soleiltoujours.com

MADE IN U.S.A.

Section 55106-9 (55106-9)

Titanium Dioxide - 7.36%

Zinc Oxide - 5.14%

Section 60561-8 (60561-8)

May stain or damage some fabrics or surfaces. Avoid long term storage above 40C (120F). Protect the product in this container from excessive heat and direct sunlight.


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