Dermatone Sport Spf 50 Sunscreen Lotion

Dermatone Sport Spf 50 Sunscreen Lotion
SPL v2
SPL
SPL Set ID 0e60e5bb-b941-4114-933a-29480bff5960
Route
TOPICAL
Published
Effective Date 2025-12-24
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Avobenzone (6 g) Homosalate (3 g)
Inactive Ingredients
Octocrylene Aluminum Starch Octenylsuccinate Benzyl Alcohol Butyloctyl Salicylate Carbomer Sorbitol Dimethicone Edetate Disodium Ethylhexylglycerin Fragrance Clean Orc0600327 Phenoxyethanol Polyglyceryl-3 Distearate Sorbitan Isostearate Stearic Acid Triethanolamine Vinylpyrrolidone/eicosene Copolymer Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2022-06-26

Description

Active ingredients Avobenzone 3.0% Homosalate 10.0% Octocrylene 6.0%


Medication Information

Warnings and Precautions

WARNINGS

For external use only.

When using this product:

• keep out of eyes. Rinse with water to remove.

Stop use and ask a doctor ifrash occurs.

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

Indications and Usage

Uses

• Helps prevent sunburn, higher SPF gives more sunburn protection

Dosage and Administration

DIRECTIONS

• Apply liberally 15 minutes before sun exposure.

• Reapply:

after 80 minutes of swimming or sweating

immediately after towel drying

at least every 2 hours

٠For sunscreen use

٠apply to all areas of the skin exposed to the sun.

٠Reapply as needed or after towel drying, swimming, or sweating.

Description

Active ingredients Avobenzone 3.0% Homosalate 10.0% Octocrylene 6.0%

Section 50565-1

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

Section 51727-6

Aluminum Starch Octenylsuccinate

Benzyl Alcohol

Butyloctyl Salicylate

Carbomer

D-Glucitol

Dimethicone

Disodium EDTA

Ethylhexylglycerin

Fragrance

Phenoxyethanol

Polyglyceryl-3-Distearate

Sorbitan Isostearate

Stearic Acid

Triethanolamine

VP/Eicosene Copolymer

Water

Section 51945-4

Section 55105-1

Sunscreen

Section 55106-9

Active ingredients

Avobenzone 3.0%

Homosalate 10.0%

Octocrylene 6.0%


Structured Label Content

Indications and Usage (34067-9)

Uses

• Helps prevent sunburn, higher SPF gives more sunburn protection

Dosage and Administration (34068-7)

DIRECTIONS

• Apply liberally 15 minutes before sun exposure.

• Reapply:

after 80 minutes of swimming or sweating

immediately after towel drying

at least every 2 hours

٠For sunscreen use

٠apply to all areas of the skin exposed to the sun.

٠Reapply as needed or after towel drying, swimming, or sweating.

Warnings and Precautions (34071-1)

WARNINGS

For external use only.

When using this product:

• keep out of eyes. Rinse with water to remove.

Stop use and ask a doctor ifrash occurs.

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

Section 50565-1 (50565-1)

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

Section 51727-6 (51727-6)

Aluminum Starch Octenylsuccinate

Benzyl Alcohol

Butyloctyl Salicylate

Carbomer

D-Glucitol

Dimethicone

Disodium EDTA

Ethylhexylglycerin

Fragrance

Phenoxyethanol

Polyglyceryl-3-Distearate

Sorbitan Isostearate

Stearic Acid

Triethanolamine

VP/Eicosene Copolymer

Water

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Sunscreen

Section 55106-9 (55106-9)

Active ingredients

Avobenzone 3.0%

Homosalate 10.0%

Octocrylene 6.0%


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)