Safe Sea Sunscreen 50 Spf

Safe Sea Sunscreen 50 Spf
SPL v9
SPL
SPL Set ID 53df3126-1136-490a-b339-5876ce89499e
Route
TOPICAL
Published
Effective Date 2025-12-01
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
Water Dibutyl Adipate Polyglyceryl-2 Dipolyhydroxystearate Stearyl Dimethicone (400 Mpa.s At 50c) Cetyl Dimethicone 25 Propylene Glycol Hydrogenated Castor Oil Benzyl Alcohol Lanthanum Chloride Magnesium Chloride Calcium Chloride Chlorphenesin Panthenol .alpha.-tocopherol Acetate Dehydroacetic Acid Benzoic Acid Sorbic Acid Phaeodactylum Tricornutum Saccharomyces Cerevisiae Polysulfated Glycosaminoglycan

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2021-04-30

Description

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


Medication Information

Warnings and Precautions

: ■ ■ 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  Warning For external use only

Indications and Usage

: ■ 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. Uses

Description

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

Section 50565-1

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

Section 51727-6

: Aqua, 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 Inactive Ingredients

Section 55106-9

: Active Ingredients

Octocrylene 10%

Homosalate 10%

Octisalate 5%

Avobenzone 3%

: Sunscreen Purpose

Section 59845-8

: ■ 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. Directions

Section 60561-8

: ■ 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. Other Information





Product Label

Questions Or Comments?

Structured Label Content

Indications and Usage (34067-9)

: ■ 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. Uses

Warnings and Precautions (34071-1)

: ■ ■ 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  Warning For external use only

Section 50565-1 (50565-1)

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

Section 51727-6 (51727-6)

: Aqua, 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 Inactive Ingredients

Section 55106-9 (55106-9)

: Active Ingredients

Octocrylene 10%

Homosalate 10%

Octisalate 5%

Avobenzone 3%

: Sunscreen Purpose

Section 59845-8 (59845-8)

: ■ 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. Directions

Section 60561-8 (60561-8)

: ■ 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. Other Information





Product Label (Product label)

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