SPL v1
SPL
SPL Set ID df37b6b4-24b4-5b33-e053-2995a90aa4a3
Route
TOPICAL
Published
Effective Date 2022-05-24
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Zinc Cation (25 g)
Inactive Ingredients
Water Glycerin Polysorbate 60 Cetostearyl Alcohol Tocopherol Shea Butter Jojoba Oil Olive Oil

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2022-05-13
Description

Zinc Oxide 25%

Purpose

Sunscreen

Medication Information

Indications and Usage

Uses:

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

Sunscreen

Dosage and Administration

Directions

  • Apply generously and evenly to all skin exposed to sun 15 minutes before sun exposure
  • 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

Reapply after:

  • 40 minutes of swimming or sweating
  • Immediately after towel drying
  • at least every 2 hours
Description

Zinc Oxide 25%

Section 50565-1

Keep out of reach of children. If

product is swallowed, get medical help

or contact Poison Control Center right

away.

Section 50566-9

Stop use and ask doctor if rash appears

Section 50567-7

When using this product Keep out of eyes. Rinse with water to remove

Section 50570-1

Do not use on damaged or broken skin

Section 51945-4

Section 53413-1

Questions or comments? 888-850-3756 or Kindredbravely.com

Section 60561-8

Other Information: Protect this product from excessive heat and direct sun

Warnings

For External Use Only

Active Ingredients

Zinc Oxide 25%

Structured Label Content

Indications and Usage (34067-9)

Uses:

  • Helps prevent sunburn
  • If used as directed with other sun protection measures (see Directions), decreases risk of skin cancer and early skin aging caused by the sun.
Dosage and Administration (34068-7)

Directions

  • Apply generously and evenly to all skin exposed to sun 15 minutes before sun exposure
  • 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

Reapply after:

  • 40 minutes of swimming or sweating
  • Immediately after towel drying
  • at least every 2 hours
Section 50565-1 (50565-1)

Keep out of reach of children. If

product is swallowed, get medical help

or contact Poison Control Center right

away.

Section 50566-9 (50566-9)

Stop use and ask doctor if rash appears

Section 50567-7 (50567-7)

When using this product Keep out of eyes. Rinse with water to remove

Section 50570-1 (50570-1)

Do not use on damaged or broken skin

Section 51945-4 (51945-4)

Section 53413-1 (53413-1)

Questions or comments? 888-850-3756 or Kindredbravely.com

Section 60561-8 (60561-8)

Other Information: Protect this product from excessive heat and direct sun

Purpose

Sunscreen

Warnings

For External Use Only

Active Ingredients

Zinc Oxide 25%

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:00:13.808246 · Updated: 2026-03-14T23:00:36.247175