Broad Spectrum Spf 50+ Faces Mineral Sunscreen

Broad Spectrum Spf 50+ Faces Mineral Sunscreen
SPL v2
SPL
SPL Set ID 37e6e685-4124-4ba3-8f24-cb037d0cba98
Route
TOPICAL
Published
Effective Date 2020-07-27
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Titanium Dioxide (100 mg) Zinc Cation (80 mg)
Inactive Ingredients
Water Butyloctyl Salicylate Medium-chain Triglycerides Aloe Vera Leaf Glyceryl Monostearate Cetearyl Isononanoate Polysorbate 60 Cetostearyl Alcohol Dimethicone Stearic Acid Polyoxyl 20 Cetostearyl Ether Propylene Glycol Coconut Oil Phenoxyethanol .alpha.-tocopherol Acetate Cetyl Palmitate Ceteareth-12 Caprylyl Glycol Chlorphenesin Jojoba Oil Ascorbic Acid Citric Acid Monohydrate Edetate Disodium Anhydrous Triethoxycaprylylsilane Aluminum Oxide

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2020-06-15
Description

Titanium Dioxide 10% Zinc Oxide 8%

Purpose

Sunscreen

Medication Information

Purpose

Sunscreen

Description

Titanium Dioxide 10% Zinc Oxide 8%

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. 
  • 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:  Sun Protection Measures.
  • 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.
Drug Facts

Other Information
  • protect the product in this container from excessive heat and direct sun.
Package Labeling:

Active Ingredients

Titanium Dioxide 10% Zinc Oxide 8%

Inactive Ingredients

Water (Aqua/Eau), Butyloctyl Salicilate, Caprylic/Capric Triglyceride, Aloe Barbadensis Leaf Juice (Aloe Vera Gel from Aruba), Glyceryl Stearate, Cetearyl Isononanoate, Polysorbate 60, VP/Eicosene Copolymer, Cetearyl Alcohol, Dimethicone Crosspolymer, Dimethicone, Stearic  Acid, Ceteareth-20, Propylene Glycol, Fragrance (Parfum), Cocos Nucifera Palmitate, Ceteareth-12, Caprylyl Glycol, Chlorphenesin, Simmondsia Chinensis (Jojoba) Seed Oil, Ascorbic Acid (Vitamin C), Citric Acid, Disodium EDTA Powder, Triethoxycaprylylsilane, Alumina, Polyhydroxystearic Acid.



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. 
  • 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:  Sun Protection Measures.
  • 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.
Drug Facts

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 8%

Inactive Ingredients (Inactive ingredients)

Water (Aqua/Eau), Butyloctyl Salicilate, Caprylic/Capric Triglyceride, Aloe Barbadensis Leaf Juice (Aloe Vera Gel from Aruba), Glyceryl Stearate, Cetearyl Isononanoate, Polysorbate 60, VP/Eicosene Copolymer, Cetearyl Alcohol, Dimethicone Crosspolymer, Dimethicone, Stearic  Acid, Ceteareth-20, Propylene Glycol, Fragrance (Parfum), Cocos Nucifera Palmitate, Ceteareth-12, Caprylyl Glycol, Chlorphenesin, Simmondsia Chinensis (Jojoba) Seed Oil, Ascorbic Acid (Vitamin C), Citric Acid, Disodium EDTA Powder, Triethoxycaprylylsilane, Alumina, Polyhydroxystearic Acid.



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: 2026-02-15T12:02:16.631008 · Updated: 2026-03-14T23:01:41.296752