Broad Spectrum Spf 50+ Mineral Sunscreen

Broad Spectrum Spf 50+ Mineral Sunscreen
SPL v2
SPL
SPL Set ID f73f1321-bd3f-48e0-80e5-53ff63d5d29f
Route
TOPICAL
Published
Effective Date 2017-10-25
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Titanium Dioxide (100 mg) Zinc Cation
Inactive Ingredients
Water Helianthus Annuus Flowering Top Propanediol Aloe Vera Leaf Medium-chain Triglycerides Phenoxyethanol Caprylyl Glycol Chlorphenesin Stearic Acid Aluminum Oxide Carbomer Interpolymer Type A (allyl Sucrose Crosslinked) .alpha.-tocopherol Acetate Ion Sodium Hydroxide

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2017-10-25
Description

Titanium Dioxide 10% Zinc Oxide 10%

Purpose

Sunscreen

Medication Information

Purpose

Sunscreen

Description

Titanium Dioxide 10% Zinc Oxide 10%

Uses
  • 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
Warnings

For external use only

Directions
  • apply generously 15 minutes before sun exposure
  • reapply
  • after 80 minutes of swimming or sweating
  • immediately after towel drying
  • 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 value of 15 or higher andd 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
  • children under 6 months of age: Ask a doctor
Do Not Use
  • on damaged or broken skin
Other Information
  • protect the product in this container from excessive heat and direct sun
Package Labeling:

Active Ingredients

Titanium Dioxide 10% Zinc Oxide 10%

Inactive Ingredients

Water (Aqua/Eau), Helianthus Annuus (Sunflower) Seed Oil, Propanediol, Aloe Barbadensis Leaf Juice (Aloe Vera Gel from Aruba), Acetylated Hydrogenated Vegetable Glyceride, Polyglyceryl-3 Polyricinoleate, Fragrance (Parfum), Caprylic/Capric Triglyceride, Phenoxyethanol, Caprylyl Glycol, Chlorphenesin, Polyhydroxystearic Acid, Stearic Acid, Alumina, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Acrylates/Beheneth-25 Methacrylate Copolymer, Tocopheryl (Vitamin E) Acetate, Sodium Hydroxide.





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.

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 skin aging caused by the sun
Purpose

Sunscreen

Warnings

For external use only

Directions
  • apply generously 15 minutes before sun exposure
  • reapply
  • after 80 minutes of swimming or sweating
  • immediately after towel drying
  • 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 value of 15 or higher andd 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
  • children under 6 months of age: Ask a doctor
Do Not Use (Do not use)
  • on damaged or broken skin
Other Information
  • protect the product in this container from excessive heat and direct sun
Package Labeling:

Active Ingredients (Active ingredients)

Titanium Dioxide 10% Zinc Oxide 10%

Inactive Ingredients (Inactive ingredients)

Water (Aqua/Eau), Helianthus Annuus (Sunflower) Seed Oil, Propanediol, Aloe Barbadensis Leaf Juice (Aloe Vera Gel from Aruba), Acetylated Hydrogenated Vegetable Glyceride, Polyglyceryl-3 Polyricinoleate, Fragrance (Parfum), Caprylic/Capric Triglyceride, Phenoxyethanol, Caprylyl Glycol, Chlorphenesin, Polyhydroxystearic Acid, Stearic Acid, Alumina, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Acrylates/Beheneth-25 Methacrylate Copolymer, Tocopheryl (Vitamin E) Acetate, Sodium Hydroxide.





When Using This Product (When using this product)
  • keep out of eyes. Rinse with water to remove.
Stop Use and Ask A Doctor If (Stop use and ask a doctor if)

rash occurs

Keep Out of Reach of Children. (Keep out of reach of children.)

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

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:02:18.185047 · Updated: 2026-03-14T23:01:45.300207