3eda8a70-7c9e-e920-e063-6394a90a85a2

SPL v1
SPL
SPL Set ID 3eda8a70-7c9e-e920-e063-6394a90a85a2
Route
topical
Published
Effective Date 2025-09-17
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
zinc oxide (250 mg)
Inactive Ingredients
beef tallow olive oil shea butter rosemary oil tocopherol beeswax simmondsia chinensis (jojoba) seed wax propolis cera

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
otc monograph drug active Since 2025-09-17

Purpose

sunscreen

Description

Zinc Oxide 25%


Medication Information

Warnings

For external use only.

Do not use

• on broken or damaged skin

When using this product

• keep out of eyes. Rinse with water to remove

Stop use and ask a doctor if

• rash occurs

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

sunscreen

Directions

• apply generously and evenly 15 minutes before sun exposure

• reapply at least every 2 hours

• use a water resistant sunscreen if swimming or sweating

• 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 time in the sun, especially from 10 a.m. – 2 p.m.
  • wear long-sleeved shirts, pants, hats, and sunglasses
Other Information
  • protect the product in this container from excessive heat and direct sun
  • Do not use if the seal is broken
Inactive Ingredients

Tallow (Bovine), Olea Europaea (Olive) Fruit Oil, Butyrospermum Parkii (Shea) Butter, Jojoba Esters, Cera Alba (Beeswax), Rosmarinus Officinalis (Rosemary) Leaf Extract, Propolis Extract, Tocopherol

Description

Zinc Oxide 25%

Questions?
Section 50565-1

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

Section 51945-4



Active Ingredient

Zinc Oxide 25%


Structured Label Content

Warnings

For external use only.

Do not use

• on broken or damaged skin

When using this product

• keep out of eyes. Rinse with water to remove

Stop use and ask a doctor if

• rash occurs

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

sunscreen

Directions

• apply generously and evenly 15 minutes before sun exposure

• reapply at least every 2 hours

• use a water resistant sunscreen if swimming or sweating

• 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 time in the sun, especially from 10 a.m. – 2 p.m.
  • wear long-sleeved shirts, pants, hats, and sunglasses
Other Information
  • protect the product in this container from excessive heat and direct sun
  • Do not use if the seal is broken
Inactive Ingredients

Tallow (Bovine), Olea Europaea (Olive) Fruit Oil, Butyrospermum Parkii (Shea) Butter, Jojoba Esters, Cera Alba (Beeswax), Rosmarinus Officinalis (Rosemary) Leaf Extract, Propolis Extract, Tocopherol

Questions?
Section 50565-1 (50565-1)

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

Section 51945-4 (51945-4)



Active Ingredient

Zinc Oxide 25%


Advanced Ingredient Data


Raw Label Data

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