Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID 0d7072f8-e808-5270-e063-6294a90a1ffa
Route
TOPICAL
Published
Effective Date 2023-12-26
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Zinc Oxide (21 g)
Inactive Ingredients
Rosa X Damascena Flower Oil Green Tea Leaf Sorbitan Isostearate Aluminum Oxide Lecithin, Soybean Sunflower Oil Titanium Dioxide Ferric Oxide Red Isostearic Acid Ethylhexylglycerin Phytate Sodium Glycerin Cetostearyl Alcohol Polyglyceryl-3 Laurate Water Dimethicone Tetrahexyldecyl Ascorbate Soybean Oil Polyhydroxystearic Acid (2300 Mw) Rosa Damascena Flower Medium-chain Triglycerides Dicaprylyl Carbonate Candelilla Wax Jojoba Oil Polyglyceryl-3 Pentaricinoleate Hydrolyzed Jojoba Esters (acid Form) Xanthan Gum Rice Bran Mica Sodium Stearoyl Lactylate Tocopherol Triethoxycaprylylsilane Coconut Water Endospermum Moluccanum Whole Hydroxyethyl Acrylate/sodium Acryloyldimethyl Taurate Copolymer (100000 Mpa.s At 1.5%) Phenoxyethanol Coco Glucoside Coco-caprylate/caprate Moringa Oleifera Seed Oil Sorbitan Monostearate 1,2-hexanediol Caprylyl Glycol Magnesium Oxide Starch, Tapioca Citric Acid Monohydrate Phytosteryl Macadamiate Sodium Benzoate Ferrosoferric Oxide Coconut Alkanes Glyceryl Monostearate Apple Sheanut Hyaluronate Sodium Potassium Sorbate Ferric Oxide Yellow

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2023-12-26

Description

Active Ingredient: Zinc Oxide - 21%


Medication Information

Warnings and Precautions

Warning:

For external use only

Indications and Usage

Uses:

Helps prevent sunburn.

If you used as directed with other sun protection measures ( See Directions), decreases the risk of skin cancer and early skin aging caused by the sun.

Dosage and Administration

Direction:

Apply liberally and evenly 15 minutes before sun exposure. reapply at least every 2 hours. Use a water resistant sunscreen if swimming or sweating: immediately after towel drying. At least every 2 hours. children under 6 months of age: Ask a doctor

Sun Protection Measures: Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including: limit time in the sun, especially from 10 a.m. – 2 p.m., wear long sleeved shirts, pants, hats, and sunglasses.

Description

Active Ingredient: Zinc Oxide - 21%

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 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

Inactive ingredients:

Water /Aqua/Eau, Caprylic/Capric Triglyceride, Coconut Alkanes, Dimethicone, Glycerin, Dicaprylyl Carbonate, Cetearyl Alcohol, Candelilla/Jojoba/Rice Bran Polyglyceryl-3 Esters, Glyceryl Stearate, Mica, Helianthus Annuus (Sunflower) Seed Oil, Phenoxyethanol, Sodium Stearoyl Lactylate, Coco-Glucoside, Pyrus Malus (Apple) Fruit Extract, Coco-Caprylate/Caprate, Rosa Damascena Flower Water, Isostearic Acid, Lecithin, Polyglyceryl-3 Polyricinoleate, Polyhydroxystearic Acid, Hydrolyzed Jojoba Esters, Ethylhexylglycerin, Moringa Oleifera Seed Oil, Tetrahexyldecyl Ascorbate, Tocopherol, Sorbitan Stearate, Triethoxycaprylylsilane, Sodium Phytate, Xanthan Gum, Rosa Damascena Flower Extract, Cocos Nucifera (Coconut) Liquid, Endosperm, 1,2-Hexanediol, Caprylyl Glycol, Butyrospermum Parkii (Shea) Nut Extract, Rosa Damascena Flower Oil, Sodium Hyaluronate, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Camellia Sinensis Leaf Extract, Glycine Soja (Soybean) Oil, Phytosterols, Sorbitan Isostearate, Potassium Sorbate, Sodium Benozate, Alumina, Magnesium Oxide, Tapioca Starch, Citric Acid, Titanium Dioxide (CI 77891), Iron Oxides (CI 77491,CI77492,CI77499)

Section 51945-4

Section 55105-1

Purpose: Sunscreen

Section 55106-9

Active Ingredient: Zinc Oxide - 21%

Section 60561-8

Other information:

Protect the product in this container from excessive heat and direct sun.


Structured Label Content

Indications and Usage (34067-9)

Uses:

Helps prevent sunburn.

If you used as directed with other sun protection measures ( See Directions), decreases the risk of skin cancer and early skin aging caused by the sun.

Dosage and Administration (34068-7)

Direction:

Apply liberally and evenly 15 minutes before sun exposure. reapply at least every 2 hours. Use a water resistant sunscreen if swimming or sweating: immediately after towel drying. At least every 2 hours. children under 6 months of age: Ask a doctor

Sun Protection Measures: Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including: limit time in the sun, especially from 10 a.m. – 2 p.m., wear long sleeved shirts, pants, hats, and sunglasses.

Warnings and Precautions (34071-1)

Warning:

For external use only

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 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)

Inactive ingredients:

Water /Aqua/Eau, Caprylic/Capric Triglyceride, Coconut Alkanes, Dimethicone, Glycerin, Dicaprylyl Carbonate, Cetearyl Alcohol, Candelilla/Jojoba/Rice Bran Polyglyceryl-3 Esters, Glyceryl Stearate, Mica, Helianthus Annuus (Sunflower) Seed Oil, Phenoxyethanol, Sodium Stearoyl Lactylate, Coco-Glucoside, Pyrus Malus (Apple) Fruit Extract, Coco-Caprylate/Caprate, Rosa Damascena Flower Water, Isostearic Acid, Lecithin, Polyglyceryl-3 Polyricinoleate, Polyhydroxystearic Acid, Hydrolyzed Jojoba Esters, Ethylhexylglycerin, Moringa Oleifera Seed Oil, Tetrahexyldecyl Ascorbate, Tocopherol, Sorbitan Stearate, Triethoxycaprylylsilane, Sodium Phytate, Xanthan Gum, Rosa Damascena Flower Extract, Cocos Nucifera (Coconut) Liquid, Endosperm, 1,2-Hexanediol, Caprylyl Glycol, Butyrospermum Parkii (Shea) Nut Extract, Rosa Damascena Flower Oil, Sodium Hyaluronate, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Camellia Sinensis Leaf Extract, Glycine Soja (Soybean) Oil, Phytosterols, Sorbitan Isostearate, Potassium Sorbate, Sodium Benozate, Alumina, Magnesium Oxide, Tapioca Starch, Citric Acid, Titanium Dioxide (CI 77891), Iron Oxides (CI 77491,CI77492,CI77499)

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Purpose: Sunscreen

Section 55106-9 (55106-9)

Active Ingredient: Zinc Oxide - 21%

Section 60561-8 (60561-8)

Other information:

Protect the product in this container from excessive heat and direct sun.


Advanced Ingredient Data


Raw Label Data

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