broad spectrum spf 30 mineral sunscreen

broad spectrum spf 30 mineral sunscreen
SPL v2
SPL
SPL Set ID 59e3fbc5-d66d-4dbf-a271-6885ecd961b0
Route
topical
Published
Effective Date 2020-07-27
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
titanium dioxide (80 mg) zinc cation
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
Purpose

Sunscreen

Description

Titanium Dioxide 8% Zinc Oxide 8%

Medication Information

Warnings

For external use only.

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

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



Description

Titanium Dioxide 8% Zinc Oxide 8%

Do Not Use
  • on damaged or broken skin.
Drug Facts

Active Ingredients

Titanium Dioxide 8% Zinc Oxide 8%

Package Labeling:59ml

Package Labeling:177ml

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

Warnings

For external use only.

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

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



Do Not Use (Do not use)
  • on damaged or broken skin.
Drug Facts

Active Ingredients (Active ingredients)

Titanium Dioxide 8% Zinc Oxide 8%

Package Labeling:59ml (package Labeling:59ml)

Package Labeling:177ml (package Labeling:177ml)

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: 2026-02-15T12:02:16.641883 · Updated: 2026-03-14T23:01:42.949822