SPL v1
SPL
SPL Set ID 93873c34-5c72-43c8-b6c2-c65b596191d7
Route
TOPICAL
Published
Effective Date 2025-03-27
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
Polyglyceryl-3 Pentaricinoleate Alkyl (c12-15) Benzoate Edetate Disodium Sodium Chloride Phenoxyethanol Ethylhexylglycerin Ferric Oxide Red Ferrosoferric Oxide Ferric Oxide Yellow Ergothioneine Tremella Fuciformis Fruiting Body .alpha.-tocopherol Acetate Betaine Lavender Oil Orange Oil, Cold Pressed Polyglyceryl-3 Diisostearate Peg/ppg-18/18 Dimethicone Caprylyl Glycol Triethoxycaprylylsilane Caprylhydroxamic Acid Squalane Cyclomethicone 5 Water Cocoyl Caprylocaprate Isononyl Isononanoate Polyglyceryl-3 Polydimethylsiloxyethyl Dimethicone (4000 Mpa.s) Glycerin Disteardimonium Hectorite Aluminum Hydroxide Stearic Acid Undaria Pinnatifida Triethoxysilylethyl Polydimethylsiloxyethyl Hexyl Dimethicone Astrocaryum Vulgare Kernel Oil Shea Butter Theobroma Grandiflorum Seed Butter Tetrahexyldecyl Ascorbate Dunaliella Salina Levomenol Ubidecarenone

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
Section 50565-1

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, Glycerin, Disteardimonium Hectorite, Aluminum Hydroxide, Stearic Acid, 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, Lavandula Angustifolia (Lavender) Oil, Citrus Aurantium Dulcis (Orange) Peel Oil, Polyglyceryl-3 Diisostearate, PEG/PPG-18/18 Dimethicone, Caprylyl Glycol, Triethoxycaprylylsilane, Caprylhydroxamic Acid, Squalane, Polyglyceryl-3 Polyricinoleate,

C12-15 Alkyl Benzoate, Disodium EDTA, Sodium Chloride, Phenoxyethanol, Ethylhexylglycerin, Iron Oxides (CI 77491, 77499, 77492)

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
Section 50565-1 (50565-1)

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, Glycerin, Disteardimonium Hectorite, Aluminum Hydroxide, Stearic Acid, 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, Lavandula Angustifolia (Lavender) Oil, Citrus Aurantium Dulcis (Orange) Peel Oil, Polyglyceryl-3 Diisostearate, PEG/PPG-18/18 Dimethicone, Caprylyl Glycol, Triethoxycaprylylsilane, Caprylhydroxamic Acid, Squalane, Polyglyceryl-3 Polyricinoleate,

C12-15 Alkyl Benzoate, Disodium EDTA, Sodium Chloride, Phenoxyethanol, Ethylhexylglycerin, Iron Oxides (CI 77491, 77499, 77492)

Advanced Ingredient Data

Raw Label Data

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Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:05:48.398297 · Updated: 2026-03-14T23:08:08.103878