Drug Facts

Drug Facts
SPL v5
SPL
SPL Set ID cbdfd0ae-514b-4b53-98ad-4270163bd0df
Route
TOPICAL
Published
Effective Date 2024-08-14
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Zinc Cation (20.3 g)
Inactive Ingredients
Water Coco-caprylate Dicaprylyl Carbonate Cetyl Alcohol Microcrystalline Cellulose Lauryl Glucoside Propanediol Polyglyceryl-2 Dipolyhydroxystearate Phytanic Acid Cellulose Acetate Xanthan Gum Triethoxycaprylylsilane Polyhydroxystearic Acid (2300 Mw) Glycerin Diheptyl Succinate Capryloyl Glycerin/sebacic Acid Copolymer (2000 Mpa.s) Helianthus Annuus Whole Simmondsia Chinensis Seed Rosmarinus Officinalis Whole Glyceryl Stearate Citrate Glyceryl Stearate Se Caprylyl Glyceryl Ether Caprylhydroxamic Acid Mica Titanium Dihydride Brown Iron Oxide

Identifiers & Packaging

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

Description

Zinc Oxide 20.3%

Purpose

Purpose: Sunscreen


Medication Information

Purpose

Purpose: Sunscreen

Description

Zinc Oxide 20.3%

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:

• Use a water resistant sunscreen if swimming or sweating

• Reapply 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 20.3%

Inactive Ingredients

Water, Coco-Caprylate, Dicaprylyl Carbonate, Cetyl Alcohol, Microcrystalline Cellulose, Lauryl Glucoside, Propanediol, Polyglyceryl-2 Dipolyhydroxystearate, Phytic Acid, Cellulose Gum, Xanthan Gum, Triethoxycaprylylsilane, Polyhydroxystearic Acid, Glycerin, Capryloyl Glycerin/Sebacic Acid Copolymer, Diheptyl Succinate, Helianthus Annuus (Sunflower) Seed Oil, Simmondsia Chinensis (Jojoba) Seed Oil, Rosmarinus Officinalis (Rosemary) Leaf Extract, Glyceryl Stearate Citrate, Glyceryl Stearate, Caprylyl Glyceryl Ether, Caprylhydroxamic Acid, Mica, Iron Oxides, Titanium Dioxide, 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:

• Use a water resistant sunscreen if swimming or sweating

• Reapply 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 20.3%

Inactive Ingredients (Inactive ingredients)

Water, Coco-Caprylate, Dicaprylyl Carbonate, Cetyl Alcohol, Microcrystalline Cellulose, Lauryl Glucoside, Propanediol, Polyglyceryl-2 Dipolyhydroxystearate, Phytic Acid, Cellulose Gum, Xanthan Gum, Triethoxycaprylylsilane, Polyhydroxystearic Acid, Glycerin, Capryloyl Glycerin/Sebacic Acid Copolymer, Diheptyl Succinate, Helianthus Annuus (Sunflower) Seed Oil, Simmondsia Chinensis (Jojoba) Seed Oil, Rosmarinus Officinalis (Rosemary) Leaf Extract, Glyceryl Stearate Citrate, Glyceryl Stearate, Caprylyl Glyceryl Ether, Caprylhydroxamic Acid, Mica, Iron Oxides, Titanium Dioxide, 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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