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

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 skin 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 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 this product 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, 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

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)

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

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



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-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 this product 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, 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

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)

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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