SPL v1
SPL
SPL Set ID 3750f04b-7f9f-8793-e063-6294a90a9143
Route
TOPICAL
Published
Effective Date 2025-07-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Zinc Oxide (0.135 g) Titanium Dioxide (0.023 g)
Inactive Ingredients
Polysorbate 60 Ethylhexyl Palmitate 1,2-hexanediol Phymatolithon Calcareum Dimethylmethoxy Chromanol Pollia Condensata Fruit Isostearic Acid Coenochloris Signiensis Diatomaceous Earth Coco-glucoside Alpha-tocopherol Acetate Glycerin Lecithin, Soybean Ergothioneine Zinc Sulfate Green Tea Leaf Maltodextrin Sodium Gluconate Water Galactoarabinan Caprylhydroxamic Acid Alkyl (c12-15) Benzoate Argania Spinosa Kernel Oil Cetearyl Alcohol Sodium Stearoyl Glutamate Mannitol Alumina Xanthan Gum Caprylyl Glycol Stearic Acid Tropolone Benzyl Alcohol Bisabolol Caprylic/capric Triglyceride Polyhydroxystearic Acid (2300 Mw) Phenoxyethanol Ethylhexylglycerin

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-07-01
Description

Titanium Dioxide 2.35%, Zinc Oxide 13.5%

Purpose

Sunscreen.

Medication Information

Purpose

Sunscreen.

Description

Titanium Dioxide 2.35%, Zinc Oxide 13.5%

Section 51945-4

Use(s):
  • 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.
Purpose:

Sunscreen.

Warnings

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Warnings:
  • For external use only.
  • Do not use on damaged or broken skin.
  • When using this product keep out of eyes. Rinse with water to remove.
  • Stop use and ask a doctor if rash occurs.
  • Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Directions:
  • Shake well before use.
  • Apply liberally and evenly 15 minutes before sun exposure.
  • Use a water-resistant sunscreen if swimming or sweating.
  • Reapply at least every 2 hours.
  • 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 10a.m.-2p.m.
  • Wear long-sleeve shirts, pants, hats and sunglasses
  • Children under 6 months: Ask a doctor.
Other Information:
  • Protect this product from excessive heat and direct sun.
Active Ingredient(s)

Titanium Dioxide 2.35%, Zinc Oxide 13.5%

Inactive Ingredients:

Aqua (Water), C12-15 Alkyl Benzoate, Glycerin, Galactoarabinan, Ethylhexyl Palmitate, Argania Spinosa Kernel Oil, Tocopheryl Acetate (D-alpha), Caprylic/Capric Triglyceride, Polysorbate 60, Lithothamnion Calcareum Powder, Cetearyl Alcohol, Sodium Stearoyl Glutamate, Phenoxyethanol, Isostearic Acid, Coco-Glucoside, Xanthan Gum, Mannitol, Benzyl Alcohol, 1,2-Hexanediol, Caprylyl Glycol, Polyhydroxystearic Acid, Bisabolol (L-alpha), Alumina, Stearic Acid, Sodium Gluconate, Diatomaceous Earth, Caprylhydroxamic Acid, Ethylhexylglycerin, Zinc Sulfate, Tropolone, Maltodextrin, Camellia Sinensis (Green Tea) Leaf Extract, Camellia Sinensis (White Tea) Leaf Extract, Dimethylmethoxy Chromanol, Pollia Condensata Fruit Extract, Coenochloris Signiensis Extract, Lecithin, Ergothioneine

Structured Label Content

Section 51945-4 (51945-4)

Use(s):
  • 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.
Purpose:

Sunscreen.

Warnings (WARNINGS)

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Warnings: (WARNINGS:)
  • For external use only.
  • Do not use on damaged or broken skin.
  • When using this product keep out of eyes. Rinse with water to remove.
  • Stop use and ask a doctor if rash occurs.
  • Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Directions: (DIRECTIONS:)
  • Shake well before use.
  • Apply liberally and evenly 15 minutes before sun exposure.
  • Use a water-resistant sunscreen if swimming or sweating.
  • Reapply at least every 2 hours.
  • 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 10a.m.-2p.m.
  • Wear long-sleeve shirts, pants, hats and sunglasses
  • Children under 6 months: Ask a doctor.
Other Information:
  • Protect this product from excessive heat and direct sun.
Active Ingredient(s)

Titanium Dioxide 2.35%, Zinc Oxide 13.5%

Inactive Ingredients:

Aqua (Water), C12-15 Alkyl Benzoate, Glycerin, Galactoarabinan, Ethylhexyl Palmitate, Argania Spinosa Kernel Oil, Tocopheryl Acetate (D-alpha), Caprylic/Capric Triglyceride, Polysorbate 60, Lithothamnion Calcareum Powder, Cetearyl Alcohol, Sodium Stearoyl Glutamate, Phenoxyethanol, Isostearic Acid, Coco-Glucoside, Xanthan Gum, Mannitol, Benzyl Alcohol, 1,2-Hexanediol, Caprylyl Glycol, Polyhydroxystearic Acid, Bisabolol (L-alpha), Alumina, Stearic Acid, Sodium Gluconate, Diatomaceous Earth, Caprylhydroxamic Acid, Ethylhexylglycerin, Zinc Sulfate, Tropolone, Maltodextrin, Camellia Sinensis (Green Tea) Leaf Extract, Camellia Sinensis (White Tea) Leaf Extract, Dimethylmethoxy Chromanol, Pollia Condensata Fruit Extract, Coenochloris Signiensis Extract, Lecithin, Ergothioneine

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:06:24.787039 · Updated: 2026-03-14T23:09:10.710567