SPL v1
SPL
SPL Set ID 14a85a88-c9a2-94ea-e063-6394a90a4e14
Route
TOPICAL
Published
Effective Date 2024-03-27
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Zinc Oxide (20 g)
Inactive Ingredients
Triethoxycaprylylsilane Niacinamide Glycerin Coco Glucoside Pongamia Pinnata Seed Hectorite Safflower Oil Tetrasodium Glutamate Diacetate Anhydrous Citric Acid Ethylhexylglycerin Ferric Oxide Red Dicaprylyl Carbonate Hydroxyethyl Acrylate/sodium Acryloyldimethyl Taurate Copolymer (45000 Mpa.s At 1%) Dimethicone Ethylhexyl Methoxycrylene Sorbitan Monooleate Medium-chain Triglycerides Polysorbate 60 Stannic Oxide Sodium Stearoyl Glutamate Coconut Oil Caprylyl Glycol Sorbitan Isostearate Cetostearyl Alcohol Titanium Dioxide Mica Tocopherol Theobroma Grandiflorum Seed Butter Isononyl Isononanoate Acai Oil Hydroxyethyl Cellulose, Unspecified Gluconolactone Sodium Benzoate Water Butyloctyl Salicylate Polysorbate 20 Phenoxyethanol Carboxymethylcellulose Sodium, Unspecified Form Polyhydroxystearic Acid (2300 Mw) Microcrystalline Cellulose

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-03-27

Description

Drug Facts Active Ingredients Purpose Zinc Oxide (20.00%)......Sunscreen


Medication Information

Warnings and Precautions

Warnings:

• For external use only.

• Do not use on damaged or broken skin.

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

remove.

• Stop use and ask a doctor if rash occurs.

• Keep out of reach of children. If product is swallowed, get

medical help or contact a Poison Control Center right away.

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 10am - 2pm.

• Wear long-sleeved shirts, pants, hats, and sunglasses.

Indications and Usage

Uses:

• Helps prevent sunburn.

Directions:

• Apply generously and evenly 15 minutes before sun exposure.

• Children under 6 months of age: ask a doctor.

• Reapply at least every 2 hours.

• Use a water-resistant sunscreen if swimming or sweating.

Dosage and Administration

Dosage: Evenly and generously apply to skin.

Administration: Topical

Description

Drug Facts Active Ingredients Purpose Zinc Oxide (20.00%)......Sunscreen

Section 50565-1

Keep out of reach of children.

Section 51727-6

Aqua (Water, Eau), Butyloctyl Salicylate, Caprylic/Capric Triglyceride, Caprylyl Glycol, Carthamus Tinctorius Oleosomes, Cellulose Gum, Cetearyl Alcohol, Citric Acid, Coco-Glucoside, Cocos Nucifera (Coconut) Oil, Dicaprylyl Carbonate, Diisooctyl Succinate, Dimethicone, Ethylene/Propylene/Styrene Copolymer, Ethylhexyl Methoxycrylene, Ethylhexylglycerin, Euterpe Oleracea (Açaí) Fruit Oil, Gluconolactone, Glycerin, Hectorite, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Hydroxyethylcellulose, Iron Oxides (CI 77491), Iron Oxides (CI 77499), Isononyl Isononanoate, Maleated Soybean Oil Glyceryl/Octyldodecanol Esters, Mica (CI 77019), Microcrystalline Cellulose, Niacinamide, Parfum (Fragrance), Phenoxyethanol, Polyhydroxystearic Acid, Polysorbate 20, Polysorbate 60, Pongamia Pinnata Seed Extract, Sodium Benzoate, Sodium Stearoyl Glutamate, Sorbitan Isostearate, Sorbitan Oleate, Tetrasodium Glutamate Diacetate, Theobroma Grandiflorum (Cupuaçu) Seed Butter, Tin Oxide (CI 77861), Titanium Dioxide (CI 77891), Tocopherol, Triethoxycaprylylsilane, Benzyl Salicylate, Citronellol, Limonene.

Section 51945-4

Section 55105-1

Sunscreen

Section 55106-9

Drug Facts

Active Ingredients Purpose

Zinc Oxide (20.00%)......Sunscreen


Structured Label Content

Indications and Usage (34067-9)

Uses:

• Helps prevent sunburn.

Directions:

• Apply generously and evenly 15 minutes before sun exposure.

• Children under 6 months of age: ask a doctor.

• Reapply at least every 2 hours.

• Use a water-resistant sunscreen if swimming or sweating.

Dosage and Administration (34068-7)

Dosage: Evenly and generously apply to skin.

Administration: Topical

Warnings and Precautions (34071-1)

Warnings:

• For external use only.

• Do not use on damaged or broken skin.

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

remove.

• Stop use and ask a doctor if rash occurs.

• Keep out of reach of children. If product is swallowed, get

medical help or contact a Poison Control Center right away.

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 10am - 2pm.

• Wear long-sleeved shirts, pants, hats, and sunglasses.

Section 50565-1 (50565-1)

Keep out of reach of children.

Section 51727-6 (51727-6)

Aqua (Water, Eau), Butyloctyl Salicylate, Caprylic/Capric Triglyceride, Caprylyl Glycol, Carthamus Tinctorius Oleosomes, Cellulose Gum, Cetearyl Alcohol, Citric Acid, Coco-Glucoside, Cocos Nucifera (Coconut) Oil, Dicaprylyl Carbonate, Diisooctyl Succinate, Dimethicone, Ethylene/Propylene/Styrene Copolymer, Ethylhexyl Methoxycrylene, Ethylhexylglycerin, Euterpe Oleracea (Açaí) Fruit Oil, Gluconolactone, Glycerin, Hectorite, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Hydroxyethylcellulose, Iron Oxides (CI 77491), Iron Oxides (CI 77499), Isononyl Isononanoate, Maleated Soybean Oil Glyceryl/Octyldodecanol Esters, Mica (CI 77019), Microcrystalline Cellulose, Niacinamide, Parfum (Fragrance), Phenoxyethanol, Polyhydroxystearic Acid, Polysorbate 20, Polysorbate 60, Pongamia Pinnata Seed Extract, Sodium Benzoate, Sodium Stearoyl Glutamate, Sorbitan Isostearate, Sorbitan Oleate, Tetrasodium Glutamate Diacetate, Theobroma Grandiflorum (Cupuaçu) Seed Butter, Tin Oxide (CI 77861), Titanium Dioxide (CI 77891), Tocopherol, Triethoxycaprylylsilane, Benzyl Salicylate, Citronellol, Limonene.

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Sunscreen

Section 55106-9 (55106-9)

Drug Facts

Active Ingredients Purpose

Zinc Oxide (20.00%)......Sunscreen


Advanced Ingredient Data


Raw Label Data

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