3636693a-ba81-5d49-e063-6394a90a3006

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

Purpose

Sunscreen

Description

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


Medication Information

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

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

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.

Other Information

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

• may stain sime fabrics

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.

Description

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

Principal Display Panel

Do Not Use

• on damaged or broken skin.

Active Ingredients

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

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

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

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

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

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.

Other Information

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

• may stain sime fabrics

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.

Principal Display Panel

Do Not Use (Do not use)

• on damaged or broken skin.

Active Ingredients

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

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

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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