SPL v3
SPL
SPL Set ID 7961ff9f-75db-4977-e053-2a91aa0ae628
Route
TOPICAL
Published
Effective Date 2018-10-31
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Avobenzone (1.6 g) Homosalate (4 g) Octocrylene (4.5 g)
Inactive Ingredients
.alpha.-tocopherol Acetate Caprylyl Glycol Diisopropyl Adipate Alcohol Alkyl (c12-15) Benzoate Butyloctyl Salicylate Isobutane Isododecane

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Completed Since 2018-10-31 Until 2026-12-01

Description

Avoebenzone 1.6%, Homosalate 4.0%, Octocrylene 4.5%

Purpose

Sunscreen


Medication Information

Purpose

Sunscreen

Description

Avoebenzone 1.6%, Homosalate 4.0%, Octocrylene 4.5%

Uses

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

Section 51945-4

BANANA

BOAT®

SPORT

ultra

CLEAR SUNSCREEN SPRAY

BROAD SPECTRUM SPF 15

15

CLINICALLY

PROVEN

UVA/UVB PROTECTION

SUPERIOR ENDURANCE

VS. SWEAT & WATER

FREE FROM

Oxybenzone

Octinoxate

Water Resistant

(80 Minutes)

NET WT 6 OZ. (170 g)

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 then apply to face do not apply in windy conditions • use in well-ventialated area • repply: • 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 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-sleeve shirts, pants, hats, and sunglasses • children under 6 months: Ask a doctor.

Do Not Use

on damaged or broken skin.

Other Information

• protect this product from excessive heat and direct sun

Active Ingredients

Avoebenzone 1.6%, Homosalate 4.0%, Octocrylene 4.5%

Inactive Ingredients

Alcohol Denat., Isobutane, Isododecane, Diisopropyl Adipate, VA/Butyl Maleate/Isobornyl Acrylate Copolymer, Caprylyl Glycol, Butyloctyl Salicylate, C12-15 Alkyl Benzoate, Fragrance, Tocopheryl Acetate.

Questions Or Comments?

Call 1 800 SafeSun, Mon-Fri

When Using This Product

• Keep away from face to avoid breathing it • keep out of 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 Posion 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 skin again caused by the sun.

Section 51945-4 (51945-4)

BANANA

BOAT®

SPORT

ultra

CLEAR SUNSCREEN SPRAY

BROAD SPECTRUM SPF 15

15

CLINICALLY

PROVEN

UVA/UVB PROTECTION

SUPERIOR ENDURANCE

VS. SWEAT & WATER

FREE FROM

Oxybenzone

Octinoxate

Water Resistant

(80 Minutes)

NET WT 6 OZ. (170 g)

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 then apply to face do not apply in windy conditions • use in well-ventialated area • repply: • 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 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-sleeve 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 this product from excessive heat and direct sun

Active Ingredients

Avoebenzone 1.6%, Homosalate 4.0%, Octocrylene 4.5%

Inactive Ingredients (Inactive ingredients)

Alcohol Denat., Isobutane, Isododecane, Diisopropyl Adipate, VA/Butyl Maleate/Isobornyl Acrylate Copolymer, Caprylyl Glycol, Butyloctyl Salicylate, C12-15 Alkyl Benzoate, Fragrance, Tocopheryl Acetate.

Questions Or Comments? (Questions or comments?)

Call 1 800 SafeSun, Mon-Fri

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.

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 Posion Control Center right away.


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Raw Label Data

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