SPL v2
SPL
SPL Set ID 2409cea1-7077-dc12-e063-6294a90a4558
Route
TOPICAL
Published
Effective Date 2023-03-03
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Titanium Dioxide (4.04 g) Zinc Oxide (2.85 g)
Inactive Ingredients
Fragrance 13576 Sodium Polyacrylate (2500000 Mw) Azelaic Acid Hyaluronate Sodium Eugenol Stearic Acid Polyhydroxystearic Acid (2300 Mw) Dimethicone Medium-chain Triglycerides Glycerin Hydrogenated Soybean Lecithin Niacinamide Aluminum Oxide Benzyl Alcohol Ethylhexyl Methoxycrylene Dimethicone Crosspolymer Deanol Xanthan Gum Phenoxyethanol Citric Acid Monohydrate Tetrahexyldecyl Ascorbate .alpha.-tocopherol, D- Geraniol Copper Gluconate Triethoxycaprylylsilane Magnesium Aspartate Aminomethylpropanol Water Kukui Nut Oil Potassium Sorbate .beta.-citronellol, (r)- Sodium Potassium Aluminum Silicate Zinc Gluconate Sodium Benzoate Hydroxycitronellal Silicon Dioxide Soybean Oil

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
OTC MONOGRAPH DRUG Active Since 2022-12-07
Description

Titanium Dioxide - 4.04% Zinc Oxide - 2.85%

Medication Information

Warnings and Precautions

For external use only.

Indications and Usage
  • 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.
Dosage and Administration
  • Apply generously 15 minutes before sun exposure.
  • Use a water-resistant sunscreen if swimming or sweating.
  • Reapply at least every 2 hours.
  • Not for use on children
  • ​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 value of SPF 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.
Description

Titanium Dioxide - 4.04% Zinc Oxide - 2.85%

Section 50565-1

If swallowed, get medical help or contact a Poison Control Centre right away.

Section 50566-9

if rash occurs.

Section 50567-7

keep out of eyes. Rinse with water to remove.

Section 50570-1

on damaged or broken skin.

Section 51727-6

Water/Aqua/Eau, Dimethicone, Caprylic/Capric Triglyceride, Glycerin, Niacinamide, Ethylhexyl Methoxycrylene, Silica, Dimethicone/Vinyldimethicone Crosspolymer, Hydrogenated Lecithin, Dimethyl MEA, Xanthan Gum, Alumina, Sodium Potassium Aluminum Silicate, Phenoxyethanol, Citric Acid, Tetrahexyldecyl Ascorbate, Polyhydroxystearic Acid, Stearic Acid, Benzyl Alcohol, Sodium Polyacrylate, Fragrance (Parfum), Triethoxycaprylylsilane, Aleurites Moluccanus Seed Oil, Azelaic Acid, Glycine Soja (Soybean) Oil, Tocopherol, Magnesium Aspartate, Zinc Gluconate, Potassium Sorbate, Sodium Benzoate, Sodium Hyaluronate, Copper Gluconate, Aminomethyl Propanol, Citronellol, Geraniol, Hydroxycitronellal, Eugenol

Section 51945-4

Section 53413-1

1-888-823-7837

Section 55105-1

Sunscreen

Section 55106-9

Titanium Dioxide - 4.04%

Zinc Oxide - 2.85%

Structured Label Content

Indications and Usage (34067-9)
  • 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.
Dosage and Administration (34068-7)
  • Apply generously 15 minutes before sun exposure.
  • Use a water-resistant sunscreen if swimming or sweating.
  • Reapply at least every 2 hours.
  • Not for use on children
  • ​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 value of SPF 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.
Warnings and Precautions (34071-1)

For external use only.

Section 50565-1 (50565-1)

If swallowed, get medical help or contact a Poison Control Centre right away.

Section 50566-9 (50566-9)

if rash occurs.

Section 50567-7 (50567-7)

keep out of eyes. Rinse with water to remove.

Section 50570-1 (50570-1)

on damaged or broken skin.

Section 51727-6 (51727-6)

Water/Aqua/Eau, Dimethicone, Caprylic/Capric Triglyceride, Glycerin, Niacinamide, Ethylhexyl Methoxycrylene, Silica, Dimethicone/Vinyldimethicone Crosspolymer, Hydrogenated Lecithin, Dimethyl MEA, Xanthan Gum, Alumina, Sodium Potassium Aluminum Silicate, Phenoxyethanol, Citric Acid, Tetrahexyldecyl Ascorbate, Polyhydroxystearic Acid, Stearic Acid, Benzyl Alcohol, Sodium Polyacrylate, Fragrance (Parfum), Triethoxycaprylylsilane, Aleurites Moluccanus Seed Oil, Azelaic Acid, Glycine Soja (Soybean) Oil, Tocopherol, Magnesium Aspartate, Zinc Gluconate, Potassium Sorbate, Sodium Benzoate, Sodium Hyaluronate, Copper Gluconate, Aminomethyl Propanol, Citronellol, Geraniol, Hydroxycitronellal, Eugenol

Section 51945-4 (51945-4)

Section 53413-1 (53413-1)

1-888-823-7837

Section 55105-1 (55105-1)

Sunscreen

Section 55106-9 (55106-9)

Titanium Dioxide - 4.04%

Zinc Oxide - 2.85%

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

Back to search View SPL set listing Open on DailyMed ↗

Source: dailymed · Ingested: 2026-02-15T12:07:49.054547 · Updated: 2026-03-14T23:11:40.308391