Safe Sea Spf Sport 65

Safe Sea Spf Sport 65
SPL v1
SPL
SPL Set ID 0ed3242b-ac35-4d98-a777-1e44bb32a467
Route
TOPICAL
Published
Effective Date 2025-12-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Avobenzone (30 mg) Octocrylene (100 mg) Homosalate (50 mg) Octisalate
Inactive Ingredients
Water Dibutyl Adipate Polyglyceryl-2 Dipolyhydroxystearate Stearyl Dimethicone (400 Mpa.s At 50c) Cetyl Dimethicone 25 Hydrogenated Castor Oil Benzyl Alcohol Lanthanum Chloride Magnesium Chloride Calcium Chloride Chlorphenesin Panthenol .alpha.-tocopherol Acetate Dehydroacetic Acid Benzoic Acid Sorbic Acid Magnesium Stearate Saccharomyces Cerevisiae Polysulfated Glycosaminoglycan Phaeodactylum Tricornutum

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-11-24

Description

Active Ingredients                            Purpose Octocrylene 10%                                Sunscreen Homosalate 10%                                Sunscreen Octisalate 5%                                    Sunscreen Avobenzone 3%                                 Sunscreen


Medication Information

Description

Active Ingredients                            Purpose 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 50565-1

Section 55106-9

Active Ingredients                            Purpose

Octocrylene 10%                                Sunscreen

Homosalate 10%                                Sunscreen

Octisalate 5%                                    Sunscreen

Avobenzone 3%                                 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 
  • Keep out of reach of children. If the 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

Water, Dibutyl Adipate, Polyglyceryl 2 Dipolyhydroxystearate, Stearyl Dimethicone, Cetyl Dimethicone, Magnesium Stearate, Hydrogenated Castor Oil, Benzyl alcohol, Lanthanum Chloride, Magnesium Chloride, Calcium Chloride, Glycosaminoglycans, Glycoproteins, Plankton Extract, Parfum(Fragrance), Chlorphenisin, Panthenol, Tocopheryl Acetate, Dehydroacetic Acid, Benzoic Acid, Sorbic Acid 

Questions Or Comments?

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)

Section 55106-9 (55106-9)

Active Ingredients                            Purpose

Octocrylene 10%                                Sunscreen

Homosalate 10%                                Sunscreen

Octisalate 5%                                    Sunscreen

Avobenzone 3%                                 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 
  • Keep out of reach of children. If the 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 (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)

Water, Dibutyl Adipate, Polyglyceryl 2 Dipolyhydroxystearate, Stearyl Dimethicone, Cetyl Dimethicone, Magnesium Stearate, Hydrogenated Castor Oil, Benzyl alcohol, Lanthanum Chloride, Magnesium Chloride, Calcium Chloride, Glycosaminoglycans, Glycoproteins, Plankton Extract, Parfum(Fragrance), Chlorphenisin, Panthenol, Tocopheryl Acetate, Dehydroacetic Acid, Benzoic Acid, Sorbic Acid 

Questions Or Comments? (Questions or comments?)

Advanced Ingredient Data


Raw Label Data

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