SPL v3
SPL
SPL Set ID 8a21acbe-2f3d-cf78-e053-2a95a90a77f6
Route
TOPICAL
Published
Effective Date 2019-05-31
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Octisalate (4.5 g) Homosalate (9 g) Octocrylene (7 g) Avobenzone (2.7 g)
Inactive Ingredients
.alpha.-tocopherol Acetate Alcohol Alkyl (c12-15) Benzoate Dimethicone Ascorbyl Palmitate Panthenol Caprylyl Glycol Mineral Oil Isobutane Isododecane Aloe Vera Leaf Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Completed Since 2019-03-06 Until 2026-12-01

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

May stain some fabrics.

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.

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 • Children under 6 months: Ask a doctor 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

Do Not Use

on damaged or broken skin

Active Ingredient

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

Other Information

Protect this product from excessive heat and direct sun.

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

55% MORE

FAMILY SIZE!

9.5 OZ VS 6 OZ

BANANA BOAT®

Light as air

CLEAR SUNSCREEN SPRAY

UVA/UVB BROAD SPECTRUM SPF 50+

50+

Weightless

Protection

ABSORBS QUICKLY &

NON-GREASY

Water Resistant

(80 Minutes)

NET WT 9.5 OZ. (269 g)

BANANA BOAT®

Light as air

CLEAR SUNSCREEN SPRAY

UVA/UVB BROAD SPECTRUM SPF 50+

50+

Weightless

Protection

ABSORBS QUICKLY &

NON-GREASY

Water Resistant

(80 Minutes)

NET WT 6 OZ. (170 g)

BANANA BOAT®

NEW!

Light as air

CLEAR SUNSCREEN SPRAY

UVA/UVB BROAD SPECTRUM SPF 50+

50+

Weightless Protection

ABSORBS QUICKLY & NON-GREASY

Water Resistant

(80 Minutes)

NET WT 1.8 OZ. (51g)

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

May stain some fabrics.

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.

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 • Children under 6 months: Ask a doctor 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

Do Not Use (Do not use)

on damaged or broken skin

Active Ingredient

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

Other Information

Protect this product from excessive heat and direct sun.

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

55% MORE

FAMILY SIZE!

9.5 OZ VS 6 OZ

BANANA BOAT®

Light as air

CLEAR SUNSCREEN SPRAY

UVA/UVB BROAD SPECTRUM SPF 50+

50+

Weightless

Protection

ABSORBS QUICKLY &

NON-GREASY

Water Resistant

(80 Minutes)

NET WT 9.5 OZ. (269 g)

BANANA BOAT®

Light as air

CLEAR SUNSCREEN SPRAY

UVA/UVB BROAD SPECTRUM SPF 50+

50+

Weightless

Protection

ABSORBS QUICKLY &

NON-GREASY

Water Resistant

(80 Minutes)

NET WT 6 OZ. (170 g)

BANANA BOAT®

NEW!

Light as air

CLEAR SUNSCREEN SPRAY

UVA/UVB BROAD SPECTRUM SPF 50+

50+

Weightless Protection

ABSORBS QUICKLY & NON-GREASY

Water Resistant

(80 Minutes)

NET WT 1.8 OZ. (51g)

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.


Advanced Ingredient Data


Raw Label Data

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