cd235a0d-072b-a407-e053-2995a90a7b16

SPL v4
SPL
SPL Set ID cd235a0d-072b-a407-e053-2995a90a7b16
Route
topical
Published
Effective Date 2021-09-29
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
homosalate (9 g) octisalate (4.5 g) avobenzone (2.7 g) octocrylene (7 g)
Inactive Ingredients
alcohol caprylyl glycol dimethicone isobutane alkyl (c12-15) benzoate isododecane .alpha.-tocopherol acetate aloe vera leaf mineral oil panthenol ascorbyl palmitate water

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2021-10-15 Until 2026-10-01

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 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 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-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 this product from excessive heat and direct sun

Description

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

Principal Display Panel

BANANA

BOAT®

SPORT

ultra

CLEAR SUNSCREEN SPRAY

BROAD SPECTRUM SPF 65

65

CLINICALLY

PROVEN

UVA/UVB PROTECTION

HIGH ENDURANCE

VS. SWEAT & WATER

FREE FROM

Oxybenzone

Octinoxate

Water Resistant

(80 Minutes)

NET WT 6 OZ. (170 g)

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, Isododecane, C12-15 Alkyl Benzoate, VA/Butyl Maleate/Isobornyl Acrylate Copolymer, Caprylyl Glycol, Dimethicone, Fragrance, Tocopheryl Acetate, Ascorbyl Palmitate, Mineral Oil, Water, Panthenol, Aloe Barbadensis Leaf Extract.

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 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 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 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-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 this product from excessive heat and direct sun

Principal Display Panel

BANANA

BOAT®

SPORT

ultra

CLEAR SUNSCREEN SPRAY

BROAD SPECTRUM SPF 65

65

CLINICALLY

PROVEN

UVA/UVB PROTECTION

HIGH ENDURANCE

VS. SWEAT & WATER

FREE FROM

Oxybenzone

Octinoxate

Water Resistant

(80 Minutes)

NET WT 6 OZ. (170 g)

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, Isododecane, C12-15 Alkyl Benzoate, VA/Butyl Maleate/Isobornyl Acrylate Copolymer, Caprylyl Glycol, Dimethicone, Fragrance, Tocopheryl Acetate, Ascorbyl Palmitate, Mineral Oil, Water, Panthenol, Aloe Barbadensis Leaf Extract.

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 Poison Control Center right away.


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Raw Label Data

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