2ee9b3dc-91cd-1af9-e063-6394a90a78e1

SPL v1
SPL
SPL Set ID 2ee9b3dc-91cd-1af9-e063-6394a90a78e1
Route
topical
Published
Effective Date 2025-02-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
octocrylene (7 g) homosalate (9 g) octisalate (4.5 g) avobenzone (2.7 g)
Inactive Ingredients
alpha-tocopherol acetate mineral oil caprylic/capric triglyceride caprylyl glycol dimethicone water panthenol isododecane isobutane alcohol aloe barbadensis leaf

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2025-02-01

Purpose

Sunscreen

Description

Avobenzone 2.7%, Homosalate 9.0%, Octisalate 4.5%, Octocrylene 7.0%.


Medication Information

Warnings

For external use only.

Flammable: Contents under pressure. Do not puncture or incinerate. Do not expose to heat, or store at temperatures above 120°F. Do not use in the presence of a flame or spark. Keep away from sources of ignition – No smoking. Intentional misuse by deliberately concentrating and inhaling the contents can be harmful or fatal.

May stain some fabrics.

Uses

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

Purpose

Sunscreen

Directions

• Shake well • Hold container 4 to 6 inches from the skin to apply • spray liberally and spread evenly by hand 15 minutes before sun exposure • do not spray directly into face. Spray on hands and then apply to face. • Do not apply in windy conditions • Use in a well-ventilated area • reapply:• after 80 minutes 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 value of 15 or higher and other sun protection measures including: • limit time in the sun, especially from 10 a.m. - 2 p.m. • wear long-sleeved shirts, pants, hats, and sunglasses. • children under 6 months: Ask a doctor

Other Information

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

Description

Avobenzone 2.7%, Homosalate 9.0%, Octisalate 4.5%, Octocrylene 7.0%.

Do Not Use

on damaged or broken skin.

Active Ingredients

Avobenzone 2.7%, Homosalate 9.0%, Octisalate 4.5%, Octocrylene 7.0%.

Inactive Ingredients:

Alcohol Denat., Isobutane, Caprylic/Capric Triglyceride, Isododecane, VA/Butyl Maleate/Isobornyl Acrylate Copolymer, Caprylyl Glycol, Dimethicone, Fragrance, Tocopheryl Acetate, Mineral Oil, Water, Panthenol, Aloe Barbadensis Leaf Extract.

Questions Or Comments?

Call 1-800-SafeSun, Mon-Fri

Principle Display Panel

BANANA

BOAT

New &

Improved

SPORT

CLEAR SUNSCREEN SPRAY

BROAD SPECTRUM SPF 60+

60+

PROTECTS

FROM UP TO 98%

OF BURNING RAYS

Oxybenzone Free

Sweat | Water Resistant

(80 Minutes)

NET WT 6 OZ (170g)

When Using This Product

• keep away from face to avoid breathing it • keep outof eyes. Rinse with water to remove.

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.


Structured Label Content

Warnings

For external use only.

Flammable: Contents under pressure. Do not puncture or incinerate. Do not expose to heat, or store at temperatures above 120°F. Do not use in the presence of a flame or spark. Keep away from sources of ignition – No smoking. Intentional misuse by deliberately concentrating and inhaling the contents can be harmful or fatal.

May stain some fabrics.

Uses

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

Purpose

Sunscreen

Directions

• Shake well • Hold container 4 to 6 inches from the skin to apply • spray liberally and spread evenly by hand 15 minutes before sun exposure • do not spray directly into face. Spray on hands and then apply to face. • Do not apply in windy conditions • Use in a well-ventilated area • reapply:• after 80 minutes 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 value of 15 or higher and other sun protection measures including: • limit time in the sun, especially from 10 a.m. - 2 p.m. • wear long-sleeved shirts, pants, hats, and sunglasses. • children under 6 months: Ask a doctor

Other Information

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

Do Not Use (Do not use)

on damaged or broken skin.

Active Ingredients

Avobenzone 2.7%, Homosalate 9.0%, Octisalate 4.5%, Octocrylene 7.0%.

Inactive Ingredients: (Inactive ingredients:)

Alcohol Denat., Isobutane, Caprylic/Capric Triglyceride, Isododecane, VA/Butyl Maleate/Isobornyl Acrylate Copolymer, Caprylyl Glycol, Dimethicone, Fragrance, Tocopheryl Acetate, Mineral Oil, Water, Panthenol, Aloe Barbadensis Leaf Extract.

Questions Or Comments? (Questions or comments?)

Call 1-800-SafeSun, Mon-Fri

Principle Display Panel

BANANA

BOAT

New &

Improved

SPORT

CLEAR SUNSCREEN SPRAY

BROAD SPECTRUM SPF 60+

60+

PROTECTS

FROM UP TO 98%

OF BURNING RAYS

Oxybenzone Free

Sweat | Water Resistant

(80 Minutes)

NET WT 6 OZ (170g)

When Using This Product (When using this product)

• keep away from face to avoid breathing it • keep outof eyes. Rinse with water to remove.

Stop Use and Ask A Doctor (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.


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Raw Label Data

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