SPL v1
SPL
SPL Set ID 2cd22172-78cb-32f3-e063-6394a90a395d
Route
TOPICAL
Published
Effective Date 2024-12-18
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Zinc Oxide (188 mg)
Inactive Ingredients
C13-15 Alkane Propanediol Powdered Cellulose Polyglyceryl-4 Oleate 1,2-hexanediol Coco-caprylate/caprate Magnolia Officinalis Bark Trisodium Ethylenediamine Disuccinate Tocopherol Glycerin Polyglyceryl-6 Polyricinoleate Polyglyceryl-6 Oleate Coconut Juice Pongamia Pinnata Seed Hydroxyapatite Chimyl Alcohol Dicaprylyl Carbonate Polyhydroxystearic Acid (2300 Mw) Isoamyl Laurate Caprylic/capric Triglyceride Dimethicone, Unspecified Squalane Silicon Dioxide Karum Seed Oil Hydroxyacetophenone Aloe Vera Leaf Cucumber Haematococcus Pluvialis Naringin Lauroyl Lysine Water Xanthan Gum Dunaliella Salina Sodium Chloride

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-12-18

Description

Zinc Oxide 18.8%

Purpose

Sunscreen


Medication Information

Purpose

Sunscreen

Description

Zinc Oxide 18.8%

Uses:

• Helps prevent sunburn.

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

Section 50565-1

Keep out of reach of children.

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 51945-4

Section 69718-5

Purpose:

Sunscreen

Warnings:

• For external use only

Directions:

• Apply liberally to face and body 15 minutes before sun exposure.

• Use a water resistant sunscreen if swimming or sweating.

• Reapply 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 your time in the sun, especially from 10 a.m. – 2 p.m.

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

Active Ingredient:

Zinc Oxide 18.8%

Other Information:

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

Inactive Ingredients:

Water (Aqua), Glycerin, Isoamyl Laurate, Silica, Caprylic/Capric Triglyceride, Dimethicone, C13-15 Alkane, Squalane, Hydroxyapatite, Dicaprylyl Carbonate, Polyhydroxystearic Acid, Propanediol, Cellulose, Polyglyceryl-4 Oleate, Polyglyceryl-6 Polyricinoleate, Sodium Chloride, 1,2-Hexanediol, Polyglyceryl-6 Oleate, Coco-Caprylate/Caprate, Maris Limus Extract, Pongamia Glabra Seed Oil, Lauroyl Lysine, Aloe Barbadensis Leaf Juice, Cocos Nucifera (Coconut) Fruit Juice, Cucumis Sativus (Cucumber) Fruit Extract, Chimyl Alcohol, Magnolia Officinalis Bark Extract, Pongamia Pinnata Seed Extract, Trisodium Ethylenediamine Disuccinate, Xanthan Gum, Dunaliella Salina Extract, Haematococcus Pluvialis Extract, Hydroxyacetophenone, Tocopherol, Naringin


Structured Label Content

Uses: (USES:)

• Helps prevent sunburn.

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

Section 50565-1 (50565-1)

Keep out of reach of children.

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 51945-4 (51945-4)

Section 69718-5 (69718-5)

Purpose: (PURPOSE:)

Sunscreen

Warnings: (WARNINGS:)

• For external use only

Directions: (DIRECTIONS:)

• Apply liberally to face and body 15 minutes before sun exposure.

• Use a water resistant sunscreen if swimming or sweating.

• Reapply 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 your time in the sun, especially from 10 a.m. – 2 p.m.

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

Active Ingredient: (ACTIVE INGREDIENT:)

Zinc Oxide 18.8%

Other Information: (OTHER INFORMATION:)

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

Inactive Ingredients: (INACTIVE INGREDIENTS:)

Water (Aqua), Glycerin, Isoamyl Laurate, Silica, Caprylic/Capric Triglyceride, Dimethicone, C13-15 Alkane, Squalane, Hydroxyapatite, Dicaprylyl Carbonate, Polyhydroxystearic Acid, Propanediol, Cellulose, Polyglyceryl-4 Oleate, Polyglyceryl-6 Polyricinoleate, Sodium Chloride, 1,2-Hexanediol, Polyglyceryl-6 Oleate, Coco-Caprylate/Caprate, Maris Limus Extract, Pongamia Glabra Seed Oil, Lauroyl Lysine, Aloe Barbadensis Leaf Juice, Cocos Nucifera (Coconut) Fruit Juice, Cucumis Sativus (Cucumber) Fruit Extract, Chimyl Alcohol, Magnolia Officinalis Bark Extract, Pongamia Pinnata Seed Extract, Trisodium Ethylenediamine Disuccinate, Xanthan Gum, Dunaliella Salina Extract, Haematococcus Pluvialis Extract, Hydroxyacetophenone, Tocopherol, Naringin


Advanced Ingredient Data


Raw Label Data

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