SPL v2
SPL
SPL Set ID 247a323f-9a08-4717-8553-ebc9c519817b
Route
TOPICAL
Published
Effective Date 2024-04-12
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Zinc Cation (22 g)
Inactive Ingredients
C18-36 Acid Triglyceride Ppg-2 Myristyl Ether Propionate White Wax Medium-chain Triglycerides Stearyl Alcohol Pentaerythrityl Tetracaprylate/tetracaprate Butyloctyl Salicylate Polyhydroxystearic Acid (2300 Mw) C10-30 Cholesterol/lanosterol Esters

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2023-04-10
Description

Zinc Oxide 22%

Purpose

Sunscreen

Medication Information

Purpose

Sunscreen

Description

Zinc Oxide 22%

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 cased by the sun.
Warnings

For external use only

Do not useon damaged or broken skin.

When using this productavoid contact with eyes. If contact occurs, rinse with water.

Stop use and ask a doctor ifrash occurs.

Keep out of reach of children. If swallowed, get medical help or contact a poison control center immediately.

Directions

Apply liberally 15 minutes before sun exposure

Reapply: after 8o minutes of swimming or sweating

  • immediately after towel drying 
  • at least every 2 hours
  • Children under 6 months, 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 time in the sun, especially from 10am-2pm
  • wear long sleeved shirts, pants, hats and sunglasses.
Product Label

Active Ingredient

Zinc Oxide 22%

Other Information

Protect this product from excessive heat and direact sun

Inactive Ingredients

PPG-2 Myristyl Ether Propionate, C18-36 Acid Triglyceride, Beeswax, Pentaerythrityl Tetracaprylate /Tetracaprate, Caprylic/Capric Triglyceride, Polyhydroxystearic Acid, Stearyl Alcohol, Butyloctyl Salicylate, C10-30 Cholesterol/Lanosterol Esters

Question Or Comments?

1-888-546-3797

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 cased by the sun.
Purpose

Sunscreen

Warnings

For external use only

Do not useon damaged or broken skin.

When using this productavoid contact with eyes. If contact occurs, rinse with water.

Stop use and ask a doctor ifrash occurs.

Keep out of reach of children. If swallowed, get medical help or contact a poison control center immediately.

Directions

Apply liberally 15 minutes before sun exposure

Reapply: after 8o minutes of swimming or sweating

  • immediately after towel drying 
  • at least every 2 hours
  • Children under 6 months, 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 time in the sun, especially from 10am-2pm
  • wear long sleeved shirts, pants, hats and sunglasses.
Product Label (Product label)

Active Ingredient

Zinc Oxide 22%

Other Information

Protect this product from excessive heat and direact sun

Inactive Ingredients

PPG-2 Myristyl Ether Propionate, C18-36 Acid Triglyceride, Beeswax, Pentaerythrityl Tetracaprylate /Tetracaprate, Caprylic/Capric Triglyceride, Polyhydroxystearic Acid, Stearyl Alcohol, Butyloctyl Salicylate, C10-30 Cholesterol/Lanosterol Esters

Question Or Comments? (Question or Comments?)

1-888-546-3797

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:02:58.245928 · Updated: 2026-03-14T23:13:05.198485