Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID 768db334-2a0a-476d-8239-a517156c663b
Route
TOPICAL
Published
Effective Date 2017-12-19
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Zinc Oxide (120 mg)
Inactive Ingredients
Water Caprylic/capric/lauric Triglyceride Polyglyceryl-2 Sesquiisostearate Cetyl Octacosanoate Polysorbate 60 Peg-20 Sorbitan Stearate Phenoxyethanol Hyaluronate Sodium Caprylyl Glycol Hexylene Glycol Yeast Mannan Stearyl Alcohol Polyhydroxystearic Acid (2300 Mw) Isostearic Acid Polyglyceryl-3 Ricinoleate Ethylhexylglycerin Lecithin, Soybean Biosaccharide Gum-1 Camellia Sinensis Flower Shea Butter Malus Domestica Flower Xanthan Gum Glycerin Magnesium Sulfate Anhydrous Tocopheryl Nicotinate, D-.alpha. Allantoin Magnesium Stearate Aluminum Stearate Copernicia Alba Whole Oenothera Biennis Resorcinol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2017-12-18
Description

Active Ingredients: Zinc Oxide - 18.9%

Medication Information

Warnings and Precautions

For external use only.

Indications and Usage

Uses: Helps prevent sunburn. If used as directed with other sun protection measures (see Direction), decreases the risk of skin cancer and early skin aging caused by the sun.

Dosage and Administration

Directions:

  • Apply liberally 15 minutes prior to 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 the risk, regularly use a sunscreen with a broad spectrum SPF of 15 or higher and other sun protection measures including:
  • limit time in sun sun, especially from 10 am - 2 pm.
  • wear long-sleeve shirts, pants, hats and sunglasses.
  • Children under 6 months: Ask a doctor.
Description

Active Ingredients: Zinc Oxide - 18.9%

Section 50565-1

If product is 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

Keep out of eyes. Rinse with water to remove.

Section 50570-1

Do not use on damaged or broken skin.

Section 51727-6

Water, Caprilic/Capric Triglyceride, Polyglyceryl-2 Sesquiisostearate, Cetyl Octanoate, Cera Alba Beeswax, Sodium Hyaluronate, Caprylyl Glycol, Hexylene Glycol, Yeast Extract, Biosaccharide Gum-1, Camellia Sinensis Leaf Extract, Butyrospermum Parkii (Shea butter/Vit. A,E,F), Malus Domestica Fruit Cell Culture, Xanthan Gum, Glycerin, Lecithin, Xanthan Gum, Magnesium Sulfate, Tocopheryl Acetate, Allantoin, Magnesium Stearate, Aluminum Stearate, Isostearic Acid, Polyhydroxystearic Acid, Polyglyceryl-3 Ricinoleate, Phenoxyethanol, Ethylhexylglycerin, Copemicia Cerifera Wax, Oenothera Biennis Oil, Resorcinol.

Section 51945-4

Toll free in USA: 800.830.1491

Email: [email protected]

www.atzen.com

Developed in France. Made in USA.

Section 53413-1

Call toll free 1-800 830-1491 in the USA.

[email protected]

Section 55105-1

Purpose: Sunscreen

Section 55106-9

Active Ingredients:

Zinc Oxide - 18.9%

Section 60561-8

Protect this product from excessive heat and direct sun.

Structured Label Content

Indications and Usage (34067-9)

Uses: Helps prevent sunburn. If used as directed with other sun protection measures (see Direction), decreases the risk of skin cancer and early skin aging caused by the sun.

Dosage and Administration (34068-7)

Directions:

  • Apply liberally 15 minutes prior to 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 the risk, regularly use a sunscreen with a broad spectrum SPF of 15 or higher and other sun protection measures including:
  • limit time in sun sun, especially from 10 am - 2 pm.
  • wear long-sleeve shirts, pants, hats and sunglasses.
  • Children under 6 months: Ask a doctor.
Warnings and Precautions (34071-1)

For external use only.

Section 50565-1 (50565-1)

If product is 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)

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)

Water, Caprilic/Capric Triglyceride, Polyglyceryl-2 Sesquiisostearate, Cetyl Octanoate, Cera Alba Beeswax, Sodium Hyaluronate, Caprylyl Glycol, Hexylene Glycol, Yeast Extract, Biosaccharide Gum-1, Camellia Sinensis Leaf Extract, Butyrospermum Parkii (Shea butter/Vit. A,E,F), Malus Domestica Fruit Cell Culture, Xanthan Gum, Glycerin, Lecithin, Xanthan Gum, Magnesium Sulfate, Tocopheryl Acetate, Allantoin, Magnesium Stearate, Aluminum Stearate, Isostearic Acid, Polyhydroxystearic Acid, Polyglyceryl-3 Ricinoleate, Phenoxyethanol, Ethylhexylglycerin, Copemicia Cerifera Wax, Oenothera Biennis Oil, Resorcinol.

Section 51945-4 (51945-4)

Toll free in USA: 800.830.1491

Email: [email protected]

www.atzen.com

Developed in France. Made in USA.

Section 53413-1 (53413-1)

Call toll free 1-800 830-1491 in the USA.

[email protected]

Section 55105-1 (55105-1)

Purpose: Sunscreen

Section 55106-9 (55106-9)

Active Ingredients:

Zinc Oxide - 18.9%

Section 60561-8 (60561-8)

Protect this product from excessive heat and direct sun.

Advanced Ingredient Data

Raw Label Data

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Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:56:27.928832 · Updated: 2026-03-14T22:54:57.020531