Drug Facts

Drug Facts
SPL v3
SPL
SPL Set ID f6cf9454-552b-486e-a38b-ab3c183b24a1
Route
TOPICAL
Published
Effective Date 2023-06-08
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Zinc Cation (210 mg)
Inactive Ingredients
Panthenol .alpha.-tocopherol Acetate Lanthanum Chloride Magnesium Chloride Calcium Chloride Benzyl Alcohol Chlorphenesin Benzoic Acid Sorbic Acid Dehydroacetic Acid Water Alkyl (c12-15) Benzoate Medium-chain Triglycerides Dibutyl Adipate Butyloctyl Salicylate Polyglyceryl-2 Dipolyhydroxystearate Isopropyl Myristate Bis-octyldodecyl Dimer Dilinoleate/propanediol Copolymer Triethoxycaprylylsilane Magnesium Stearate Hydrogenated Castor Oil

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2023-06-20

Description

Zinc oxide 21%

Purpose

Sunscreen


Medication Information

Purpose

Sunscreen

Description

Zinc oxide 21%

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 damaged or broken skin.
  • 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 product is swallowed, get medical help or contact a Poison Control Center right away.
Directions
  • Apply liberally 15 minutes before sun exposure
  • reapply: after 80 minutes of swimming or sweating, immediately after towel drying and at least every 2 hours
  • Sun protection Measure- Spending time in the sun increase your 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 10a.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 21%

Other Information
  • Give perticular 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 be considered a recommendation to go into jellyfish infested water, nor is it guarantee against stings.
  • In case of stings do not use Safe sea as a treatement - seek medical attention. *Tested against sea nettle (Chrysaora), Atlantic box jellyfish (Chiropsalmus) & Rhopilema.Data on file.
  • Protect this product from excessive heat and direact sun.
Inactive Ingredients

Benzoic acid, Benzyl alcohol, Bis-Octyldodecyl, Dimer Dilinoleate/ Propanediol copolymer, Butyloctyl Salicylate, C12 -15 Alkyl benzoate, Calcium chloride, Caprylic / Capric triglyceride, Chlorphenesin, Dehydroacetic acid, Dibutyl Adipate, Hydrogenated Caster oil, Isopropyl Myristate, Lanthanum chloride, Magnesium Chloride, Magnesium stearate, Panthenol, Polyglycerly-2Dipolyhydroxystearate, 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 damaged or broken skin.
  • 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 product is swallowed, get medical help or contact a Poison Control Center right away.
Directions
  • Apply liberally 15 minutes before sun exposure
  • reapply: after 80 minutes of swimming or sweating, immediately after towel drying and at least every 2 hours
  • Sun protection Measure- Spending time in the sun increase your 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 10a.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 21%

Other Information (Other information)
  • Give perticular 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 be considered a recommendation to go into jellyfish infested water, nor is it guarantee against stings.
  • In case of stings do not use Safe sea as a treatement - seek medical attention. *Tested against sea nettle (Chrysaora), Atlantic box jellyfish (Chiropsalmus) & Rhopilema.Data on file.
  • Protect this product from excessive heat and direact sun.
Inactive Ingredients (Inactive ingredients)

Benzoic acid, Benzyl alcohol, Bis-Octyldodecyl, Dimer Dilinoleate/ Propanediol copolymer, Butyloctyl Salicylate, C12 -15 Alkyl benzoate, Calcium chloride, Caprylic / Capric triglyceride, Chlorphenesin, Dehydroacetic acid, Dibutyl Adipate, Hydrogenated Caster oil, Isopropyl Myristate, Lanthanum chloride, Magnesium Chloride, Magnesium stearate, Panthenol, Polyglycerly-2Dipolyhydroxystearate, Sorbic acid, Tocopheryl Acetate, Triethoxycaprylylsilane, water.


Advanced Ingredient Data


Raw Label Data

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