Safe Sea Spf 40

Safe Sea Spf 40
SPL v10
SPL
SPL Set ID c900b88b-1de1-4df9-af84-d9001e1d4764
Route
TOPICAL
Published
Effective Date 2025-11-24
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Octocrylene (100 mg) Homosalate (50 mg) Octisalate (30 mg) Avobenzone
Inactive Ingredients
Stearyl Dimethicone (400 Mpa.s At 50c) Cetyl Dimethicone 25 Vinylpyrrolidone/hexadecene Copolymer Panthenol .alpha.-tocopherol Acetate Lanthanum Chloride Magnesium Chloride Calcium Chloride Chlorphenesin Phaeodactylum Tricornutum Polysulfated Glycosaminoglycan Lauryl Peg/ppg-18/18 Methicone Saccharomyces Cerevisiae Propanediol Water Dibutyl Adipate Alkyl (c12-15) Benzoate Cyclomethicone 5 Dicaprylyl Ether Peg-30 Dipolyhydroxystearate Isopropyl Myristate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2021-01-01

Description

Octocrylene 10%                                                                     Sunscreen Homosalate 10%                                                                     Sunscreen Octisalate 5%                                                                          Sunscreen Avobenzone 3%                                                                       Sunscreen

Purpose

Octocrylene 10%                                                                     Sunscreen Homosalate 10%                                                                     Sunscreen Octisalate 5%                                                                          Sunscreen Avobenzone 3%                                                                       Sunscreen


Medication Information

Purpose

Octocrylene 10%                                                                     Sunscreen Homosalate 10%                                                                     Sunscreen Octisalate 5%                                                                          Sunscreen Avobenzone 3%                                                                       Sunscreen

Description

Octocrylene 10%                                                                     Sunscreen Homosalate 10%                                                                     Sunscreen Octisalate 5%                                                                          Sunscreen Avobenzone 3%                                                                       Sunscreen

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 55105-1

Warning
  • 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 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 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

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

C12-15 Alkyl Benzoate, Calcium Chloride, Cetyl Dimethicone, Chlorphenesin, Cyclopentasiloxane, Dibutyl Adipate, Dicetyl Phthalate, Dimethicone, Fragrance, Glycoproteins, Glycosaminoglycans, Hydrogenated Castor Oil, Laureth-9, PEG/PPG-18/18 Methicone, Magnesium Chloride, Panthenol, PEG-30 Dipolyhydroxystearate, Plankton Extract, Propanediol, Stearyl Dimethicone, Tocopheryl Acetate, VP/Hexadecene Copolymer, Water.

Active Ingredients                                                                   purpose

Octocrylene 10%                                                                     Sunscreen

Homosalate 10%                                                                     Sunscreen

Octisalate 5%                                                                          Sunscreen

Avobenzone 3%                                                                       Sunscreen


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 55105-1 (55105-1)

Warning
  • 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 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 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)

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)

C12-15 Alkyl Benzoate, Calcium Chloride, Cetyl Dimethicone, Chlorphenesin, Cyclopentasiloxane, Dibutyl Adipate, Dicetyl Phthalate, Dimethicone, Fragrance, Glycoproteins, Glycosaminoglycans, Hydrogenated Castor Oil, Laureth-9, PEG/PPG-18/18 Methicone, Magnesium Chloride, Panthenol, PEG-30 Dipolyhydroxystearate, Plankton Extract, Propanediol, Stearyl Dimethicone, Tocopheryl Acetate, VP/Hexadecene Copolymer, Water.

Active Ingredients                                                                   purpose (Active Ingredients                                                                   Purpose)

Octocrylene 10%                                                                     Sunscreen

Homosalate 10%                                                                     Sunscreen

Octisalate 5%                                                                          Sunscreen

Avobenzone 3%                                                                       Sunscreen


Advanced Ingredient Data


Raw Label Data

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