SPL v1
SPL
SPL Set ID 8f64c4fa-92ee-4af0-ab1b-6c3673f9a622
Route
TOPICAL
Published
Effective Date 2025-03-26
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Zinc Cation (20.2 g) Ci 77891 (6.8 g)
Inactive Ingredients
Cyclopentasiloxane Water Cocoyl Caprylocaprate Isononyl Isononanoate Polyglyceryl-3 Polydimethylsiloxyethyl Dimethicone (4000 Mpa.s) Methyl Methacrylate Glycerin Aluminum Hydroxide Stearic Acid Disteardimonium Hectorite Undaria Pinnatifida Triethoxysilylethyl Polydimethylsiloxyethyl Hexyl Dimethicone Astrocaryum Vulgare Kernel Oil Shea Butter Theobroma Grandiflorum Seed Butter Tetrahexyldecyl Ascorbate Dunaliella Salina Levomenol Ubidecarenone Ergothioneine Tremella Fuciformis Fruiting Body .alpha.-tocopherol Acetate Betaine Polyglyceryl-3 Diisostearate Caprylyl Glycol Caprylhydroxamic Acid Squalane Polyglyceryl-3 Pentaricinoleate Alkyl (c12-15) Benzoate Edetate Disodium Sodium Chloride Phenoxyethanol Ethylhexylglycerin Potassium Sorbate Sodium Benzoate Lavender Oil Orange Oil, Cold Pressed Hexamethylene Diisocyanate/trimethylol Hexyllactone Crosspolymer

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-03-19
Description

Zinc Oxide, 20.2% Titanium Dioxide, 6.8%

Purpose

Sunscreen

Medication Information

Purpose

Sunscreen

Description

Zinc Oxide, 20.2% Titanium Dioxide, 6.8%

Uses
  • Helps prevent sunburn
  • If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early
Warnings
  • For external use only
  • Do not use ondamaged or broken skin.
  • When using this productkeep out of eyes. Rinse with water to remove.
  • Stop use and ask a doctorif rash occurs.
  • Keep out of reach of children.If product is swallowed, get medical help or contact a Poison Control Center right away.
Directions
  • Apply liberally 15 minutes before sun exposure.
  • Reapply:
  • After 80 minutes of swimmingor 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 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, 20.2%

Titanium Dioxide, 6.8%

Other Information

Protect this product from excessive heat and direct sun.

Inactive Igredients

Cyclopentasiloxane, Water/Aqua/Eau, Coco-Caprylate/Caprate, Isononyl Isononanoate, Polyglyceryl-3 Polydimethylsiloxyethyl

Dimethicone, HDI/Trimethylol Hexyllactone Crosspolymer, Methyl Methacrylate Crosspolymer, Glycerin,Aluminum Hydroxide, Stearic Acid,

Disteardimonium Hectorite, Undaria Pinnatifida Extract, Triethoxysilylethyl Polydimethylsiloxyethyl Hexyl Dimethicone,Astrocaryum Tucuma Seed

Butter, Butyrospermum Parkii (Shea) Butter, Theobroma Grandiflorum Seed Butter, Tetrahexyldecyl Ascorbate,Dunaliella Salina Extract, Bisabolol, Ubiquinone,Ergothioneine, Tremella Fuciformis Sporocarp Extract, Tocopheryl Acetate,Betaine, Polyglyceryl-3 Diisostearate,Caprylyl Glycol, Caprylhydroxamic Acid, Squalane, Polyglyceryl-3 Polyricinoleate,C12-15 Alkyl Benzoate, Disodium EDTA, Sodium Chloride, Phenoxyethanol,

Ethylhexylglycerin, Potassium Sorbate, Sodium Benzoate, Lavandula Angustifolia (Lavender) Oil, Citrus Aurantium Dulcis (Orange) Peel Oil

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
Purpose

Sunscreen

Warnings
  • For external use only
  • Do not use ondamaged or broken skin.
  • When using this productkeep out of eyes. Rinse with water to remove.
  • Stop use and ask a doctorif rash occurs.
  • Keep out of reach of children.If product is swallowed, get medical help or contact a Poison Control Center right away.
Directions
  • Apply liberally 15 minutes before sun exposure.
  • Reapply:
  • After 80 minutes of swimmingor 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 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, 20.2%

Titanium Dioxide, 6.8%

Other Information (Other information)

Protect this product from excessive heat and direct sun.

Inactive Igredients (Inactive igredients)

Cyclopentasiloxane, Water/Aqua/Eau, Coco-Caprylate/Caprate, Isononyl Isononanoate, Polyglyceryl-3 Polydimethylsiloxyethyl

Dimethicone, HDI/Trimethylol Hexyllactone Crosspolymer, Methyl Methacrylate Crosspolymer, Glycerin,Aluminum Hydroxide, Stearic Acid,

Disteardimonium Hectorite, Undaria Pinnatifida Extract, Triethoxysilylethyl Polydimethylsiloxyethyl Hexyl Dimethicone,Astrocaryum Tucuma Seed

Butter, Butyrospermum Parkii (Shea) Butter, Theobroma Grandiflorum Seed Butter, Tetrahexyldecyl Ascorbate,Dunaliella Salina Extract, Bisabolol, Ubiquinone,Ergothioneine, Tremella Fuciformis Sporocarp Extract, Tocopheryl Acetate,Betaine, Polyglyceryl-3 Diisostearate,Caprylyl Glycol, Caprylhydroxamic Acid, Squalane, Polyglyceryl-3 Polyricinoleate,C12-15 Alkyl Benzoate, Disodium EDTA, Sodium Chloride, Phenoxyethanol,

Ethylhexylglycerin, Potassium Sorbate, Sodium Benzoate, Lavandula Angustifolia (Lavender) Oil, Citrus Aurantium Dulcis (Orange) Peel Oil

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:05:48.396852 · Updated: 2026-03-14T23:08:08.103878