SPL v2
SPL
SPL Set ID 3636693a-ba81-5d49-e063-6394a90a3006
Route
TOPICAL
Published
Effective Date 2025-05-28
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Octisalate (5 g) Octocrylene (6 g) Avobenzone (3 g) Homosalate (10 g)
Inactive Ingredients
Aloe Barbadensis Leaf Juice Ascorbic Acid Butylparaben Caprylyl Glycol Cetyl Peg/ppg-10/1 Dimethicone (hlb 2) Dibutyl Adipate Ethylhexyl Methoxycrylene Ethylparaben Glycerin Isobutane Isobutylparaben Isododecane Methyl Dihydroabietate Methylparaben Octyldodecanol Peg-8 Peg-8 Dimethicone Phenoxyethanol Propylparaben Retinyl Palmitate Silica Sodium Chloride Sodium Citrate Sodium Propoxyhydroxypropyl Thiosulfate Silica Alpha-tocopherol Acetate Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-05-28

Description

Avobenzone 3.0%, Homosalate 10.0%, Octisalate 5.0%, Octocrylene 6.0%

Purpose

Sunscreen


Medication Information

Purpose

Sunscreen

Description

Avobenzone 3.0%, Homosalate 10.0%, Octisalate 5.0%, Octocrylene 6.0%

Uses

• helps prevent sunburn • If used as directed with other sun protectiion measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun.

Warnings

For external use only.

Flammable: 

• keep away from fire or flame

• wait 10 minutes after application before approaching a source of heat or flame, or before smoking

Directions

• Shake well

• hold container 4 to 6 inches from the skin to apply

• spray liberally and evenly by hand 15 minutes before sun exposure

• do not spray directly into face. Spray on hands then apply to face

• do not apply in windy conditions, use in well-ventilated area and avoid inhalation

• reapply:

• after 80 minues of swimming or sweating

• immediately after towel drying

• 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 10:00 a.m.-2:00 p.m.

• wear long-sleeve shirts, pants, hats, and sunglasses

• children under 6 months of age: Ask a doctor.

Do Not Use

• on damaged or broken skin.

Other Information

• protect the product in this container from excessive heat and direct sun

• may stain sime fabrics

Active Ingredients

Avobenzone 3.0%, Homosalate 10.0%, Octisalate 5.0%, Octocrylene 6.0%

Inactive Ingredients

Aloe Barbadensis Leaf Juice, Ascorbic Acid,

Butylparaben, Caprylyl Glycol, Cetyl

PEG/PPG-10/1 Dimethicone, Dibutyl

Adipate, Ethylhexyl Methoxycrylene,

Ethylparaben, Glycerin, Isobutane,

Isobutylparaben, Isododecane, Methyl

Dihydroabietate, Methylparaben,

Octyldodecanol, PEG-8, PEG-8 Dimethicone,

Phenoxyethanol, Phenylisopropyl

Dimethicone, Polyglyceryl-3

Stearate/Isostearate/Dimer Dilinoleate

Crosspolymer, Propylparaben, Retinyl

Palmitate, Silica, Sodium Chloride, Sodium

Citrate, Sodium Propoxyhydroxypropyl

Thiosulfate Silica, Tocopheryl Acetate, Water.

Questions Or Comments?

+1-866-306-9136

You may also report serious side effects to this phone number.

Mon - Fri 9:00 am - 5:00 pm EST

Principal Display Panel

When Using This Product

• avoid spraying eyes. Rinse with water to remove

• do not puncture or incinerate. Contents under pressure.

• do not store at temperature above 120 F

• use only as directed. Intentional misure by deliberately concentrating and inhaling the contents can be harmful or fatal

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 1-800-222-1222.


Structured Label Content

Uses

• helps prevent sunburn • If used as directed with other sun protectiion measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun.

Purpose

Sunscreen

Warnings

For external use only.

Flammable: 

• keep away from fire or flame

• wait 10 minutes after application before approaching a source of heat or flame, or before smoking

Directions

• Shake well

• hold container 4 to 6 inches from the skin to apply

• spray liberally and evenly by hand 15 minutes before sun exposure

• do not spray directly into face. Spray on hands then apply to face

• do not apply in windy conditions, use in well-ventilated area and avoid inhalation

• reapply:

• after 80 minues of swimming or sweating

• immediately after towel drying

• 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 10:00 a.m.-2:00 p.m.

• wear long-sleeve shirts, pants, hats, and sunglasses

• children under 6 months of age: Ask a doctor.

Do Not Use (Do not use)

• on damaged or broken skin.

Other Information

• protect the product in this container from excessive heat and direct sun

• may stain sime fabrics

Active Ingredients

Avobenzone 3.0%, Homosalate 10.0%, Octisalate 5.0%, Octocrylene 6.0%

Inactive Ingredients (Inactive ingredients)

Aloe Barbadensis Leaf Juice, Ascorbic Acid,

Butylparaben, Caprylyl Glycol, Cetyl

PEG/PPG-10/1 Dimethicone, Dibutyl

Adipate, Ethylhexyl Methoxycrylene,

Ethylparaben, Glycerin, Isobutane,

Isobutylparaben, Isododecane, Methyl

Dihydroabietate, Methylparaben,

Octyldodecanol, PEG-8, PEG-8 Dimethicone,

Phenoxyethanol, Phenylisopropyl

Dimethicone, Polyglyceryl-3

Stearate/Isostearate/Dimer Dilinoleate

Crosspolymer, Propylparaben, Retinyl

Palmitate, Silica, Sodium Chloride, Sodium

Citrate, Sodium Propoxyhydroxypropyl

Thiosulfate Silica, Tocopheryl Acetate, Water.

Questions Or Comments? (Questions or comments?)

+1-866-306-9136

You may also report serious side effects to this phone number.

Mon - Fri 9:00 am - 5:00 pm EST

Principal Display Panel

When Using This Product (When using this product)

• avoid spraying eyes. Rinse with water to remove

• do not puncture or incinerate. Contents under pressure.

• do not store at temperature above 120 F

• use only as directed. Intentional misure by deliberately concentrating and inhaling the contents can be harmful or fatal

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)

• rash occurs.

Keep Out of Reach of Children. (Keep out of reach of children.)

If product is swallowed, get medical help or contact a Poison Control Center right away 1-800-222-1222.


Advanced Ingredient Data


Raw Label Data

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