Drug Facts

Drug Facts
SPL v5
SPL
SPL Set ID 612c5730-c3b4-486e-8ce9-8a861f676fa8
Route
TOPICAL
Published
Effective Date 2024-08-14
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Zinc Cation (20 g)
Inactive Ingredients
Water Caprylic/capric/lauric Triglyceride Isoamyl Laurate Polyglyceryl-2 Oleate Hydrogenated Methyl Abietate Polyhydroxystearic Acid (2300 Mw) Glycine Sodium Chloride Polyglyceryl-2 Stearate Triethoxycaprylylsilane Glyceryl Caprate Caprylhydroxamic Acid Aloe Vera Leaf Coco-caprylate Macrocystis Pyrifera Allantoin

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-08-14

Description

Zinc Oxide 20%

Purpose

Purpose: Sunscreen


Medication Information

Purpose

Purpose: Sunscreen

Description

Zinc Oxide 20%

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

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 docor if rash occurs

Keep out of reach of children. If swalled, get medical help or contact a Poison Control Center right away.

Directions

• apply liberally 15 minutes before sun exposure

• reapply:

• after 80 minutes of swimming or sweating

• immediately after towel drying

• at least every 2 hours

• 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 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-sleeve shirts, pants, hats, and sunglasses

• children under 6 months: Ask a doctor

Other Information

• protect the product in this container from excessive

heat and direct sun

Active Ingredients

Zinc Oxide 20%

Inactive Ingredients

Water, Capric/Caprylic Triglyceride, Isoamyl Laurate, Polyglyceryl-2 Oleate, Hydrogenated Methyl Abietate, Polyhydrostearic Acide, Glycerin, Sodium Chloride, Polyglyceryl-2 Stearate, Triethoxycaprylylsilane, Glyceryl Caprylate, Caprylhydroxamic Acid, Aloe Barbadnesis Leaf Extract, Coco-Caprylate, Macrocystis Pyrifera (Sea Kelp) Extract, Allantoin, Natural Fragrance

Questions Or Comments?

Conctact us at www.kinfield.com

Principal Display Panel

Keep Out of Reach of Children

Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.


Structured Label Content

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

Purpose

Purpose: Sunscreen

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 docor if rash occurs

Keep out of reach of children. If swalled, get medical help or contact a Poison Control Center right away.

Directions

• apply liberally 15 minutes before sun exposure

• reapply:

• after 80 minutes of swimming or sweating

• immediately after towel drying

• at least every 2 hours

• 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 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-sleeve shirts, pants, hats, and sunglasses

• children under 6 months: Ask a doctor

Other Information

• protect the product in this container from excessive

heat and direct sun

Active Ingredients

Zinc Oxide 20%

Inactive Ingredients (Inactive ingredients)

Water, Capric/Caprylic Triglyceride, Isoamyl Laurate, Polyglyceryl-2 Oleate, Hydrogenated Methyl Abietate, Polyhydrostearic Acide, Glycerin, Sodium Chloride, Polyglyceryl-2 Stearate, Triethoxycaprylylsilane, Glyceryl Caprylate, Caprylhydroxamic Acid, Aloe Barbadnesis Leaf Extract, Coco-Caprylate, Macrocystis Pyrifera (Sea Kelp) Extract, Allantoin, Natural Fragrance

Questions Or Comments? (Questions or Comments?)

Conctact us at www.kinfield.com

Principal Display Panel

Keep Out of Reach of Children (Keep out of reach of children)

Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.


Advanced Ingredient Data


Raw Label Data

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