Dermatone Spf 30 Sunscreen Lotion

Dermatone Spf 30 Sunscreen Lotion
SPL v9
SPL
SPL Set ID 32e5bddf-a0b5-c511-e063-6294a90aaf66
Route
TOPICAL
Published
Effective Date 2022-06-26
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Homosalate (7 g) Octocrylene (5 g) Avobenzone (1.8 g)
Inactive Ingredients
Magnesium Disodium Edta Water Butyloctyl Salicylate Carbomer Homopolymer, Unspecified Type Polyglyceryl-3 Distearate Dimethicone Fragrance 13576 Methylparaben Propylparaben Sorbitan Isostearate Sorbitol Stearic Acid Trolamine Vinylpyrrolidone/eicosene Copolymer Benzyl Alcohol Aluminum Starch Octenylsuccinate Phenoxyethanol

Identifiers & Packaging

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

Active ingredients Avobenzone 3.0% Homosalate 15.0% Octisalate 5.0% Octocrylene 10.0%

Medication Information

Warnings and Precautions

WARNINGS

For external use only.

Highly Flammable: Do not apply or use product near heat, flame, or while smoking.

When using this product:

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

• Keep away from face to avoid breathing it.

• Do not puncture or incinerate, Contents under pressure

• Do not store at temperature above 120⁰F

Stop use and ask a doctor if rash occurs.

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

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

٠Hold container 4 to 6 inches from the skin to apply.

٠Do not spray directly into face. Spray on hands then apply to face.

٠Do not apply in windy conditions.

٠Use in a well-ventilated area.

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 15.0% Octisalate 5.0% Octocrylene 10.0%

Section 43684-0

Uses

• Helps prevent sunburn, higher SPF gives more sunburn protection

• retains SPF after XX minutes of activity in the water or sweating

• provides moderate protection against 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

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

Section 50567-7

When using this product:

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

• Keep away from face to avoid breathing it.

• Do not puncture or incinerate, Contents under pressure

• Do not store at temperature above 120⁰F

Stop use and ask a doctor if rash occurs.

Section 51727-6

Behenyl Alcohol

BHT

Butyloctyl Salocylate

Caprylyl Methicone

Dimethicone

Dimethyl Capramide

Disodium EDTA

Ethylhexyl Stearate

Ethylhexylglycerin

Glyceryl Stearate

Hydrated Silicia

PEG-100 Stearate

Phenoxyethanol

Polyester-8

Sodium Polyacrylate

Styrene/ Acrylate Copolymer

Trideceth-6

Trimethylsiloxysilicate

VP/Hexadecene Copolyer

Water

Xanthan Gum

Section 51945-4

Section 55105-1

Sunscreen

Section 55106-9

Active ingredients

Avobenzone 3.0%

Homosalate 15.0%

Octisalate 5.0%

Octocrylene 10.0%

Structured Label Content

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

٠Hold container 4 to 6 inches from the skin to apply.

٠Do not spray directly into face. Spray on hands then apply to face.

٠Do not apply in windy conditions.

٠Use in a well-ventilated area.

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.

Highly Flammable: Do not apply or use product near heat, flame, or while smoking.

When using this product:

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

• Keep away from face to avoid breathing it.

• Do not puncture or incinerate, Contents under pressure

• Do not store at temperature above 120⁰F

Stop use and ask a doctor if rash occurs.

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

Section 43684-0 (43684-0)

Uses

• Helps prevent sunburn, higher SPF gives more sunburn protection

• retains SPF after XX minutes of activity in the water or sweating

• provides moderate protection against 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)

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

Section 50567-7 (50567-7)

When using this product:

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

• Keep away from face to avoid breathing it.

• Do not puncture or incinerate, Contents under pressure

• Do not store at temperature above 120⁰F

Stop use and ask a doctor if rash occurs.

Section 51727-6 (51727-6)

Behenyl Alcohol

BHT

Butyloctyl Salocylate

Caprylyl Methicone

Dimethicone

Dimethyl Capramide

Disodium EDTA

Ethylhexyl Stearate

Ethylhexylglycerin

Glyceryl Stearate

Hydrated Silicia

PEG-100 Stearate

Phenoxyethanol

Polyester-8

Sodium Polyacrylate

Styrene/ Acrylate Copolymer

Trideceth-6

Trimethylsiloxysilicate

VP/Hexadecene Copolyer

Water

Xanthan Gum

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Sunscreen

Section 55106-9 (55106-9)

Active ingredients

Avobenzone 3.0%

Homosalate 15.0%

Octisalate 5.0%

Octocrylene 10.0%

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

Back to search View SPL set listing Open on DailyMed ↗

Source: dailymed · Ingested: 2026-02-15T12:05:55.672385 · Updated: 2026-03-14T23:08:21.075335