Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID 316c2132-ab81-47f6-8e80-71e9252a2663
Route
TOPICAL
Published
Effective Date 2017-12-13
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Zinc Cation (50.0 mg) Titanium Dioxide (48.0 mg)
Inactive Ingredients
Aloe Medium-chain Triglycerides Glycerin Ethylhexyl Palmitate Cetyl Alcohol Cetostearyl Alcohol Polyhydroxystearic Acid (2300 Mw) Vitis Vinifera Seed Sodium Stearoyl Glutamate Glyceryl Stearate Se Cetearyl Glucoside Sorbitan Monostearate Tetrahexyldecyl Ascorbate Malus Domestica Flower Simmondsia Chinensis Seed Hyaluronate Sodium Carrageenan Dextrose, Unspecified Form Tocopherol .alpha.-bisabolol, (+/-)- Benzylidene Dimethoxydimethylindanone Tetrahydrodiferuloylmethane Glyceryl Isostearate Water Aluminum Stearate Aluminum Oxide Microcrystalline Cellulose Carboxymethylcellulose Sodium, Unspecified Form Phenoxyethanol Xanthan Gum Ethylhexylglycerin Caprylyl Glycol Lecithin, Soybean Citric Acid Monohydrate Edetate Disodium Thymus Vulgaris Leaf Spearmint Oil Santalum Spicatum Oil Rosa Damascena Flower Oil Peppermint Oil Citrus Reticulata Leaf Oil Patchouli Oil Orange Peel Nutmeg Oil Myrrh Oil Lime Oil Lemon Oil Lavender Oil Grapefruit Peel Abies Sibirica Leaf Oil Eucalyptus Globulus Leaf Juniperus Virginiana Oil Bergamot Oil Mandarin Oil Galbanum Oil Triethyl Citrate Vanillin Ethyl Vanillin Limonene Oxide, (+)- Linalool, (+)- Benzyl Alcohol Geraniol Citronellol Acetate, (r)-

Identifiers & Packaging

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

Description

Titanium Dioxide - 4.80% Zinc Oxide - 5.00%


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 - 4.80% Zinc Oxide - 5.00%

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

Aloe Barbadensis Leaf Juice, Caprylic/Capric Triglyceride, Ethylhexyl Palmitate, Glycerin, Cetearyl Alcohol, Cetyl Alcohol, Polyhydroxysteari Acid, Vitis Vinifera (Grape) Seed Oil, Sodium Stearoyl Glutamate, Glyceryl Stearate, Cetearyl Glucoside, Sorbitan Stearate, Tetrahexyldecyl Ascorbate, Pichia/Resveratrol Ferment Extract, Malus Domestica Fruit Cell Culture Extract, Simmondsia Chinesis (Jojoba) Seed Oil, Sodium Hyaluronate, Carrageenan, Glucose, Tocopherol, Myristoyl Pentapeptide-11, Bisabolol, Benzylidene Dimethoxydimethylindanone, Tetrahydrodiferuloylmethane, Glyceryl Isostearate, Water (Aqua), Aluminum Stearate, Alumina, Microcrystalline Cellulose, Cellulose Gum, Phenoxyethanol, Xanthan Gum, Ethylhexylglycerin, Caprylyl Glycol, Lecithin, Citric Acid, Disodium EDTA, Thymus Vulgaris (Thyme) Flower/Leaf Oil, Mentha Viridis (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, Myristica 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, Feraniol, Citronellol.

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 - 4.80%

Zinc Oxide - 5.00%

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)

Aloe Barbadensis Leaf Juice, Caprylic/Capric Triglyceride, Ethylhexyl Palmitate, Glycerin, Cetearyl Alcohol, Cetyl Alcohol, Polyhydroxysteari Acid, Vitis Vinifera (Grape) Seed Oil, Sodium Stearoyl Glutamate, Glyceryl Stearate, Cetearyl Glucoside, Sorbitan Stearate, Tetrahexyldecyl Ascorbate, Pichia/Resveratrol Ferment Extract, Malus Domestica Fruit Cell Culture Extract, Simmondsia Chinesis (Jojoba) Seed Oil, Sodium Hyaluronate, Carrageenan, Glucose, Tocopherol, Myristoyl Pentapeptide-11, Bisabolol, Benzylidene Dimethoxydimethylindanone, Tetrahydrodiferuloylmethane, Glyceryl Isostearate, Water (Aqua), Aluminum Stearate, Alumina, Microcrystalline Cellulose, Cellulose Gum, Phenoxyethanol, Xanthan Gum, Ethylhexylglycerin, Caprylyl Glycol, Lecithin, Citric Acid, Disodium EDTA, Thymus Vulgaris (Thyme) Flower/Leaf Oil, Mentha Viridis (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, Myristica 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, Feraniol, Citronellol.

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 - 4.80%

Zinc Oxide - 5.00%

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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