SPL v1
SPL
SPL Set ID 2edc79f8-aac5-15eb-e063-6394a90a9736
Route
TOPICAL
Published
Effective Date 2025-02-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Octocrylene (6 g) Octisalate (4.5 g) Homosalate (7.5 g) Avobenzone (2.7 g)
Inactive Ingredients
Caprylic/capric Triglyceride Isobutane Dimethicone Alcohol Caprylyl Glycol Panthenol Water Isododecane .alpha.-tocopherol Acetate Mineral Oil Aloe Barbadensis Leaf

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-02-01

Description

Avobenzone 2.7%, Homosalate 7.5%,Octisalate 4.5%, Octocrylene 6.0%

Purpose

Sunscreen


Medication Information

Purpose

Sunscreen

Description

Avobenzone 2.7%, Homosalate 7.5%,Octisalate 4.5%, Octocrylene 6.0%

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.

Stop Use

and ask a doctor if rash occurs.

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 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 sunlight

Active Ingredients

Avobenzone 2.7%, Homosalate 7.5%,Octisalate 4.5%, Octocrylene 6.0%

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

Principal Display Panel

BANANA

BOAT

New & Improved

SPORT

CLEAR SUNSCREEN SPRAY

BROAD SPECTRUM SPF 50

50

PROTECTS

FROM UP TO 98%

OF BURNING RAYS

Oxybenzone Free

Sweat | Water Resistant

(80 Minutes)

NET WT 6 OZ. (170g)

BONUS

33% MORE

8OZ VS 6OZ

BANANA

BOAT

New & Improved

SPORT

CLEAR SUNSCREEN SPRAY

BROAD SPECTRUM SPF 50

50

PROTECTS

FROM UP TO 98%

OF BURNING RAYS

Oxybenzone Free

Sweat | Water Resistant

(80 Minutes)

NET WT 8 OZ. (227g)

55%

MORE

FAMILY SIZE!

9.5 OZ VS 6 OZ

BANANA

BOAT

New & Improved

SPORT

CLEAR SUNSCREEN SPRAY

BROAD SPECTRUM SPF 50

50

PROTECTS

FROM UP TO 98%

OF BURNING RAYS

Oxybenzone Free

Sweat | Water Resistant

(80 Minutes)

NET WT 9.5 OZ. (269g)

BUY 2 & SAVE

BANANA

BOAT

New & Improved

SPORT

CLEAR SUNSCREEN SPRAY

BROAD SPECTRUM SPF 50

50

PROTECTS

FROM UP TO 98%

OF BURNING RAYS

Oxybenzone Free

Sweat | Water Resistant

(80 Minutes)

2- 6 OZ. (170g) CANS NET WT 12 OZ (350g)

When Using This Product

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

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

Stop Use (Stop use)

and ask a doctor if rash occurs.

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 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 sunlight

Active Ingredients

Avobenzone 2.7%, Homosalate 7.5%,Octisalate 4.5%, Octocrylene 6.0%

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

Principal Display Panel

BANANA

BOAT

New & Improved

SPORT

CLEAR SUNSCREEN SPRAY

BROAD SPECTRUM SPF 50

50

PROTECTS

FROM UP TO 98%

OF BURNING RAYS

Oxybenzone Free

Sweat | Water Resistant

(80 Minutes)

NET WT 6 OZ. (170g)

BONUS

33% MORE

8OZ VS 6OZ

BANANA

BOAT

New & Improved

SPORT

CLEAR SUNSCREEN SPRAY

BROAD SPECTRUM SPF 50

50

PROTECTS

FROM UP TO 98%

OF BURNING RAYS

Oxybenzone Free

Sweat | Water Resistant

(80 Minutes)

NET WT 8 OZ. (227g)

55%

MORE

FAMILY SIZE!

9.5 OZ VS 6 OZ

BANANA

BOAT

New & Improved

SPORT

CLEAR SUNSCREEN SPRAY

BROAD SPECTRUM SPF 50

50

PROTECTS

FROM UP TO 98%

OF BURNING RAYS

Oxybenzone Free

Sweat | Water Resistant

(80 Minutes)

NET WT 9.5 OZ. (269g)

BUY 2 & SAVE

BANANA

BOAT

New & Improved

SPORT

CLEAR SUNSCREEN SPRAY

BROAD SPECTRUM SPF 50

50

PROTECTS

FROM UP TO 98%

OF BURNING RAYS

Oxybenzone Free

Sweat | Water Resistant

(80 Minutes)

2- 6 OZ. (170g) CANS NET WT 12 OZ (350g)

When Using This Product (When using this product)

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

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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