SPL v2
SPL
SPL Set ID 254b4692-a459-6119-e063-6394a90a0a60
Route
TOPICAL
Published
Effective Date 2024-05-14
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Titanium Dioxide (4.17 g) Zinc Oxide (5.1 g)
Inactive Ingredients
Sorbitan Isostearate Sodium Lactate C12-15 Alkyl Benzoate Phenoxyethanol Bisabolol Isopropyl Titanium Triisostearate Sodium Benzoate Blue 1 Lake Aluminum Hydroxide Hydrogenated Soybean Lecithin Polyhydroxystearic Acid (2300 Mw) Polysorbate 20 Soybean Phosphatidylcholine Dimethicone/vinyl Dimethicone Crosspolymer (soft Particle) Water Hydroxyethyl Acrylate/sodium Acryloyldimethyl Taurate Copolymer (100000 Mpa.s At 1.5%) Glycerin Palmitoyl Tetrapeptide-7 Triethoxycaprylylsilane Isononyl Isononanoate Ethylhexyl Methoxycrylene Silica Tetrahexyldecyl Ascorbate Copper Tripeptide-1 Acetyl Hexapeptide-8 Niacinamide Isohexadecane Polysorbate 60 Mica Helianthus Annuus (sunflower) Seed Oil Ascorbyl Palmitate Palmitoyl Tripeptide-1 Rosemary Xanthan Gum Sodium Hyaluronate Stearic Acid Butylene Glycol Carbomer Tocopherol Dimethicone Potassium Sorbate Citric Acid

Identifiers & Packaging

Pill Appearance
Color: green
Marketing Status
OTC MONOGRAPH DRUG Active Since 2023-09-26
Description

Zinc Oxide 5.10% Titanium Dioxide 4.17%

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

For Sunscreen Use:

  • Apply liberally 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 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
Description

Zinc Oxide 5.10% Titanium Dioxide 4.17%

Section 50565-1
  • If swallowed, get medical help or contact a Poison Control Center immediately.
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
  • on damaged or broken skin
Section 51727-6

Water/Aqua/Eau, Glycerin, Dimethicone, Isononyl Isononanoate, Ethylhexyl Methoxycrylene, C12-15 Alkyl Benzoate, Niacinamide, Silica, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Hydrogenated Lecithin, Phenoxyethanol, Polysorbate 20, Stearic Acid, Tetrahexyldecyl Ascorbate, Polysilicone-11, Butylene Glycol, Aluminum Hydroxide, Isohexadecane, Phosphatidylcholine, Bisabolol, Citric Acid, Polyhydroxystearic Acid, Isopropyl Titanium Triisostearate, Xanthan Gum, Polysorbate 60, Sorbitan Isostearate, Copper Tripeptide-1, Mica, Carbomer, Potassium Sorbate, Sodium Hyaluronate, Sodium Lactate, Helianthus Annuus (Sunflower) Seed Oil, Sodium Benzoate, Acetyl Hexapeptide-8, Tocopherol, Rosmarinus Officinalis (Rosemary) Leaf Extract, Ascorbyl Palmitate, Palmitoyl Tripeptide-1, Palmitoyl Tetrapeptide-7, Triethoxycaprylylsilane, Blue 1 Lake (CI 42090), Titanium Dioxide (CI 77891)

Section 51945-4

Section 53413-1
  • 1-888-823-7837
Section 55105-1
  • Sunscreen
Section 55106-9
  • Zinc Oxide 5.10%
  • Titanium Dioxide 4.17%
Section 60561-8
  • Protect the product in this contaner from excessive heat and direct sun.

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)

For Sunscreen Use:

  • Apply liberally 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 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
Warnings and Precautions (34071-1)
  • For external use only.
Section 50565-1 (50565-1)
  • If swallowed, get medical help or contact a Poison Control Center immediately.
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)
  • on damaged or broken skin
Section 51727-6 (51727-6)

Water/Aqua/Eau, Glycerin, Dimethicone, Isononyl Isononanoate, Ethylhexyl Methoxycrylene, C12-15 Alkyl Benzoate, Niacinamide, Silica, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Hydrogenated Lecithin, Phenoxyethanol, Polysorbate 20, Stearic Acid, Tetrahexyldecyl Ascorbate, Polysilicone-11, Butylene Glycol, Aluminum Hydroxide, Isohexadecane, Phosphatidylcholine, Bisabolol, Citric Acid, Polyhydroxystearic Acid, Isopropyl Titanium Triisostearate, Xanthan Gum, Polysorbate 60, Sorbitan Isostearate, Copper Tripeptide-1, Mica, Carbomer, Potassium Sorbate, Sodium Hyaluronate, Sodium Lactate, Helianthus Annuus (Sunflower) Seed Oil, Sodium Benzoate, Acetyl Hexapeptide-8, Tocopherol, Rosmarinus Officinalis (Rosemary) Leaf Extract, Ascorbyl Palmitate, Palmitoyl Tripeptide-1, Palmitoyl Tetrapeptide-7, Triethoxycaprylylsilane, Blue 1 Lake (CI 42090), Titanium Dioxide (CI 77891)

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)
  • Zinc Oxide 5.10%
  • Titanium Dioxide 4.17%
Section 60561-8 (60561-8)
  • Protect the product in this contaner from excessive heat and direct sun.

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:08:51.081673 · Updated: 2026-03-14T23:13:16.476899