Drug Facts

Drug Facts
SPL v3
SPL
SPL Set ID 91bf07ed-0be4-43c9-b5f3-4e8eb892bca5
Route
TOPICAL
Published
Effective Date 2024-11-20
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Zinc Cation (10.9 g)
Inactive Ingredients
Medium-chain Triglycerides Alkyl (c12-15) Benzoate Dibutyl Adipate Butyloctyl Salicylate Polyglyceryl-2 Dipolyhydroxystearate Triethoxycaprylylsilane Polyglyceryl-4 Diisostearate/polyhydroxystearate/sebacate Magnesium Stearate Hydrogenated Castor Oil Panthenol .alpha.-tocopherol Acetate Lanthanum Chloride Magnesium Chloride Calcium Chloride Benzyl Alcohol Chlorphenesin Benzoic Acid Sorbic Acid Dehydroacetic Acid Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-02-01

Description

Zinc Oxide 10.9%

Purpose

Sunscreen


Medication Information

Purpose

Sunscreen

Description

Zinc Oxide 10.9%

Uses
  • Helps prevent sunburn
  • If used as direacted with other sun protection measures (see directions), decreases the risk of skin cancer and early aging skin caused by the sun
Warnings
  • For external use only 
  • Do not use on damagedor broken skin
  • When using this productkeep out of eyes. Rinse with water to remove
  • Stop use and ask a doctorif rash occurs
  • Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.
Directions
  • Apply liberally 15 minutes before sun exposure 
  • reapply: After 40 minutes of swimming or sweating, immediately after towel drying and at least every 2 hours 
  • Sun Protection MeasuresSpending 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 of 15 or higher and other sun protection measures including: 
  • Limit time in the sun, especially from 10 a.m.to 2 p.m.
  • Wear long-sleeve shirts, pants, hats, and sunglasses 
  • Children under 6 months: Ask a doctor.
Product Label

Active Ingredient

Zinc Oxide 10.9%

Other Information
  • Give particular attention to coverage of arms and legs. 
  • In water infested by Sea Lice, Safe Sea should also be applied under the bathing suit. 
  • Jellyfish can be dangerous. This product should not be considered a recommendation to go into jellyfish infested water, nor is it a guarantee against stings. 
  • In case of sting do not use Safe Sea as a treatment - seek medical attention.*Tested against Sea nettle (Chrysaora), Atlantic Box jellyfish (Chiropsalmus) & Rhopilema. Data on file. 
  • Protect this product from excessive heat and direct sun.
Inactive Ingredients

Benzoic Acid, Benzyl Alcohol, Butyloctyl Salicylate, C12-15 Alkyl Benzoate, Calcium Chloride, Caprylic / Capric triglyceride, Chlorphenisine, Dehydroacetic Acid, Dibutyl Adipate, Hydrogenated Castor Oil, Lanthanum Chloride, Magnesium Chloride, Magnesium Stearate, Panthenol, Polyglyceryl-2 Dipolyhydroxystearate, Polyglyceryl-4 Diisostearate /Polyhydroxystearate/Sebacate, Sorbic Acid, Tocopheryl Acetate, Triethoxycaprylylsilane, Water


Structured Label Content

Uses
  • Helps prevent sunburn
  • If used as direacted with other sun protection measures (see directions), decreases the risk of skin cancer and early aging skin caused by the sun
Purpose

Sunscreen

Warnings
  • For external use only 
  • Do not use on damagedor broken skin
  • When using this productkeep out of eyes. Rinse with water to remove
  • Stop use and ask a doctorif rash occurs
  • Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.
Directions
  • Apply liberally 15 minutes before sun exposure 
  • reapply: After 40 minutes of swimming or sweating, immediately after towel drying and at least every 2 hours 
  • Sun Protection MeasuresSpending 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 of 15 or higher and other sun protection measures including: 
  • Limit time in the sun, especially from 10 a.m.to 2 p.m.
  • Wear long-sleeve shirts, pants, hats, and sunglasses 
  • Children under 6 months: Ask a doctor.
Product Label (Product label)

Active Ingredient (Active ingredient)

Zinc Oxide 10.9%

Other Information
  • Give particular attention to coverage of arms and legs. 
  • In water infested by Sea Lice, Safe Sea should also be applied under the bathing suit. 
  • Jellyfish can be dangerous. This product should not be considered a recommendation to go into jellyfish infested water, nor is it a guarantee against stings. 
  • In case of sting do not use Safe Sea as a treatment - seek medical attention.*Tested against Sea nettle (Chrysaora), Atlantic Box jellyfish (Chiropsalmus) & Rhopilema. Data on file. 
  • Protect this product from excessive heat and direct sun.
Inactive Ingredients (Inactive ingredients)

Benzoic Acid, Benzyl Alcohol, Butyloctyl Salicylate, C12-15 Alkyl Benzoate, Calcium Chloride, Caprylic / Capric triglyceride, Chlorphenisine, Dehydroacetic Acid, Dibutyl Adipate, Hydrogenated Castor Oil, Lanthanum Chloride, Magnesium Chloride, Magnesium Stearate, Panthenol, Polyglyceryl-2 Dipolyhydroxystearate, Polyglyceryl-4 Diisostearate /Polyhydroxystearate/Sebacate, Sorbic Acid, Tocopheryl Acetate, Triethoxycaprylylsilane, Water


Advanced Ingredient Data


Raw Label Data

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