Mineral Sunscreen

Mineral Sunscreen
SPL v2
SPL
SPL Set ID b7847d4f-2517-4b58-8e31-676c9d6e484d
Route
TOPICAL
Published
Effective Date 2025-11-21
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Zinc Cation (15 g)
Inactive Ingredients
Aqua Coco-caprylate/caprate Polyglyceryl-3 Pentaricinoleate Isostearic Acid Dibutyl Adipate C12-15 Alkyl Benzoate Glycerin Polyester-7 Neopentyl Glycol Diheptanoate Butyloctyl Salicylate Squalane Vinylpyrrolidone/eicosene Copolymer Polyglyceryl-2 Oleate Polyhydroxystearic Acid (2300 Mw) Polyglyceryl-2 Stearate Asparagus Racemosus Root Picrorhiza Kurroa Root Cyperus Rotundus Root Sodium Chloride Phenoxyethanol Caprylyl Glycol Edetate Sodium Tocotrienols Ectoin Tocopherol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-03-04

Description

Zinc Oxide 15%

Purpose

Sunscreen


Medication Information

Purpose

Sunscreen

Description

Zinc Oxide 15%

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.
Section 50565-1

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

Section 51945-4

Mineral Sunscreen Broad Spectrum SPF 50 PA++++ 5 mL/0.17 fl.OZ

Mineral Sunscreen Broad Spectrum SPF 50 PA++++ 50 mL/1.7 fl.OZ

Warnings

For external use only.

Do not useon damaged or broken skin.

When using this productkeep out of eyes.

Rinse with water to remove.

Stop use and ask a doctorif rash occurs.

Directions
  • Shake well.
  • Apply liberally 15 minutes before sun exposure.
  • Reapply:
    • After 40 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 and 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: ask a doctor.
Drug Facts

Questions?

Email us at or visit

Other Information

Protect this product from excessive heat and direct sun.

Active Ingredients

Zinc Oxide 15%

Inactive Ingredients

Aqua, Coco-Caprylate/Caprate, Polyglyceryl-3 Polyricinoleate, Isostearic Acid, Dibutyl Adipate, C12-15 Alkyl Benzoate, Glycerin, Polyester-7, Neopentyl Glycol Diheptanoate, Butyloctyl Salicylate, Squalane, VP/Eicosene Copolymer, Polyglyceryl-2 Oleate, Polyhydroxystearic Acid, Polyglyceryl-2 Stearate, Asparagus Racemosus (Asparagus) Root Extract, Picrorhiza Kurroa (Picrorhiza) Root Extract, Cyperus Rotundas (Nut Grass) Root Extract, Sodium Chloride, Phenoxyethanol, Caprylyl Glycol, Sodium EDTA, Tocopherol, Tocotrienols, Ectoin.


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.
Section 50565-1 (50565-1)

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

Section 51945-4 (51945-4)

Mineral Sunscreen Broad Spectrum SPF 50 PA++++ 5 mL/0.17 fl.OZ

Mineral Sunscreen Broad Spectrum SPF 50 PA++++ 50 mL/1.7 fl.OZ

Purpose

Sunscreen

Warnings

For external use only.

Do not useon damaged or broken skin.

When using this productkeep out of eyes.

Rinse with water to remove.

Stop use and ask a doctorif rash occurs.

Directions
  • Shake well.
  • Apply liberally 15 minutes before sun exposure.
  • Reapply:
    • After 40 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 and 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: ask a doctor.
Drug Facts

Questions?

Email us at or visit

Other Information

Protect this product from excessive heat and direct sun.

Active Ingredients (Active ingredients)

Zinc Oxide 15%

Inactive Ingredients

Aqua, Coco-Caprylate/Caprate, Polyglyceryl-3 Polyricinoleate, Isostearic Acid, Dibutyl Adipate, C12-15 Alkyl Benzoate, Glycerin, Polyester-7, Neopentyl Glycol Diheptanoate, Butyloctyl Salicylate, Squalane, VP/Eicosene Copolymer, Polyglyceryl-2 Oleate, Polyhydroxystearic Acid, Polyglyceryl-2 Stearate, Asparagus Racemosus (Asparagus) Root Extract, Picrorhiza Kurroa (Picrorhiza) Root Extract, Cyperus Rotundas (Nut Grass) Root Extract, Sodium Chloride, Phenoxyethanol, Caprylyl Glycol, Sodium EDTA, Tocopherol, Tocotrienols, Ectoin.


Advanced Ingredient Data


Raw Label Data

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