SPL v9
SPL
SPL Set ID 764401f3-4219-6e9b-e053-2991aa0a3ed2
Route
TOPICAL
Published
Effective Date 2018-10-15
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Avobenzone (3 g) Homosalate (10 g) Octisalate (5 g) Octocrylene (6 g)
Inactive Ingredients
Alkyl (c12-15) Benzoate Isohexadecane Cetyl Peg/ppg-10/1 Dimethicone (hlb 2) Aloe Vera Leaf Vitamin A Palmitate Ascorbic Acid Sodium Propoxyhydroxypropyl Thiosulfate Silica Sodium Citrate Methylparaben Ethylparaben Butylparaben Isobutylparaben Methyl Dihydroabietate Peg-8 Dimethicone Octyldodecanol .alpha.-tocopherol Acetate Water Isobutane Sodium Chloride Polyethylene Glycol 400 Caprylyl Glycol Propylparaben Silicon Dioxide Dibutyl Adipate Ethylhexyl Methoxycrylene Phenoxyethanol Glycerin

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Completed Since 2018-10-15 Until 2026-12-01

Description

Avobenzone 3%, Homosalate 10%, Octisalate 5%, Octocrylene 6%

Purpose

Sunscreen


Medication Information

Purpose

Sunscreen

Description

Avobenzone 3%, Homosalate 10%, Octisalate 5%, Octocrylene 6%

Uses

• helps prevent sunburn • if used as directed with other sun protection measures (see Direction ), decrease the risk of skin cancer and early skin aging caused by the sun.

Section 51945-4

BANANA

BOAT®

TEAR +

STING FREE

PEDIATRICIAN

TESTED

LIGHTWEIGHT

QUICK

ABSORBING

HIGH

ENDURANCE

VS. SWEAT &

WATER

LASTS AS

LONG AS THE

FUN DOES

FREE FROM

Oxybenzone

Octinoxate

2 - 9.5 OZ. Kids Sport SPF 50+ Sunscreen Lotion Spray Total Net WT 19 OZ. (538 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-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 3%, Homosalate 10%, Octisalate 5%, Octocrylene 6%

Inactive Ingredient

Water, Isobutane, Isohexadecane, C12-15 Alkyl Benzoate, Cetyl PEG/PPG-10/1 Dimethicone, Lauryl PEG-8 Dimethicone, Dibutyl Adipate, Ethylhexyl Methoxycrylene, Sodium Chloride, PEG-8, Phenoxyethanol, Caprylyl Glycol, Glycerin, Sodium Citrate, Methylparaben, Butylparaben, Ethylparaben, Isobutylparaben, Propylparaben, Methyl Dihydroabietate, Phenylisopropyl Dimethicone, Polyglyceryl-3 Stearate/Isostearate/Dimer Dilinoleate Crosspolymer, PEG-8 Dimethicone, Aloe Barbadensis Leaf Juice, Octyldodecanol, Retinyl Palmitate, Silica, Tocopheryl Acetate, Ascorbic Acid, Sodium Propoxyhydroxypropyl Thiosulfate Silica.

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

Uses

• helps prevent sunburn • if used as directed with other sun protection measures (see Direction ), decrease the risk of skin cancer and early skin aging caused by the sun.

Section 51945-4 (51945-4)

BANANA

BOAT®

TEAR +

STING FREE

PEDIATRICIAN

TESTED

LIGHTWEIGHT

QUICK

ABSORBING

HIGH

ENDURANCE

VS. SWEAT &

WATER

LASTS AS

LONG AS THE

FUN DOES

FREE FROM

Oxybenzone

Octinoxate

2 - 9.5 OZ. Kids Sport SPF 50+ Sunscreen Lotion Spray Total Net WT 19 OZ. (538 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-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 (Other information)

• protect this product from excessive heat and direct sun.

Active Ingredients

Avobenzone 3%, Homosalate 10%, Octisalate 5%, Octocrylene 6%

Inactive Ingredient

Water, Isobutane, Isohexadecane, C12-15 Alkyl Benzoate, Cetyl PEG/PPG-10/1 Dimethicone, Lauryl PEG-8 Dimethicone, Dibutyl Adipate, Ethylhexyl Methoxycrylene, Sodium Chloride, PEG-8, Phenoxyethanol, Caprylyl Glycol, Glycerin, Sodium Citrate, Methylparaben, Butylparaben, Ethylparaben, Isobutylparaben, Propylparaben, Methyl Dihydroabietate, Phenylisopropyl Dimethicone, Polyglyceryl-3 Stearate/Isostearate/Dimer Dilinoleate Crosspolymer, PEG-8 Dimethicone, Aloe Barbadensis Leaf Juice, Octyldodecanol, Retinyl Palmitate, Silica, Tocopheryl Acetate, Ascorbic Acid, Sodium Propoxyhydroxypropyl Thiosulfate Silica.

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.


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)