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

Description

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

Purpose

Sunscreen


Medication Information

Purpose

Sunscreen

Description

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

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.

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.

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

Do Not Use

on damaged or broken skin.

Other Information

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

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

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

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.

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

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

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.


Advanced Ingredient Data


Raw Label Data

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