broad spectrum water resistant spf 30 mineral sunscreen

broad spectrum water resistant spf 30 mineral sunscreen
SPL v2
SPL
SPL Set ID 21e32767-fa63-4bbc-8d3a-c7f4dd80522e
Route
topical
Published
Effective Date 2017-10-25
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
titanium dioxide (80 mg) zinc cation (100 mg)
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
Purpose

Sunscreen

Description

Titanium Dioxide 8%Zinc Oxide 10%

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

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





Description

Titanium Dioxide 8%Zinc Oxide 10%

Do Not Use
  • on damaged or broken skin
Package Labeling:

Active Ingredients

Titanium Dioxide 8%Zinc Oxide 10%

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
  • 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
Other Information
  • protect the product in this container from excessive heat and direct sun
Inactive Ingredients (Inactive ingredients)

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





Do Not Use (Do not use)
  • on damaged or broken skin
Package Labeling:

Active Ingredients (Active ingredients)

Titanium Dioxide 8%Zinc Oxide 10%

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: 2026-02-15T12:02:16.606655 · Updated: 2026-03-14T23:01:41.296752