ab84b94b-8e04-605f-e053-2a95a90a8e34

SPL v4
SPL
SPL Set ID ab84b94b-8e04-605f-e053-2a95a90a8e34
Route
topical
Published
Effective Date 2020-07-29
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
homosalate (9 g) octocrylene (7 g) octisalate (4.5 g) avobenzone (2.7 g)
Inactive Ingredients
isododecane alkyl (c12-15) benzoate caprylyl glycol dimethicone menthyl lactate, (-)- aloe vera leaf mineral oil alcohol isobutane

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2020-07-29

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 presense 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

Inactive Ingredients

Alcohol Denat., Isobutane, C12-15 Alkyl Benzoate, Isododecane, VA/Butyl Maleate/Isobornyl Acrylate Copolymer, Caprylyl Glycol, Dimethicone, Fragrance, Menthyl Lactate, Mineral Oil, Aloe Barbadensis Leaf Extract

Description

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

Do Not Use

on damaged or broken skin

Active Ingredients

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

Primary Display Panel

Banana Boat®

SPORT

coolzone

CLEAR SUNSCREEN SPRAY

UVA/UVB BROAD SPECTRUM SPF 50+

50+

INSTANTLY

COOLS &

REFRESHES

LIGHTWEIGHT

FREE FROM

Oxybenzone

Octinoxate

Water Resistant

(80 Minutes)

NET WT 6 OZ. (170 g)

55%

MORE

FAMILY SIZE!

9.5 OZ VS 6 OZ

Banana Boat®

SPORT

coolzone

CLEAR SUNSCREEN SPRAY

UVA/UVB BROAD SPECTRUM SPF 50+

50+

INSTANTLY

COOLS &

REFRESHES

LIGHTWEIGHT

FREE FROM

Oxybenzone

Octinoxate

Water Resistant

(80 Minutes)

NET WT 9.5 OZ. (269 g)

BUY 2 & SAVE

Banana Boat®

SPORT

coolzone

CLEAR SUNSCREEN SPRAY

UVA/UVB BROAD SPECTRUM SPF 50+

50+

INSTANTLY

COOLS &

REFRESHES

LIGHTWEIGHT

FREE FROM

Oxybenzone

Octinoxate

Water Resistant

(80 Minutes)

2 - 6 OZ. (170 g) CANS TOTAL NET WT. 12 OZ. (340 g)

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 presense 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 (Other information)

• protect this product from excessive heat and direct sun

Inactive Ingredients (Inactive ingredients)

Alcohol Denat., Isobutane, C12-15 Alkyl Benzoate, Isododecane, VA/Butyl Maleate/Isobornyl Acrylate Copolymer, Caprylyl Glycol, Dimethicone, Fragrance, Menthyl Lactate, Mineral Oil, Aloe Barbadensis Leaf Extract

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%

Primary Display Panel

Banana Boat®

SPORT

coolzone

CLEAR SUNSCREEN SPRAY

UVA/UVB BROAD SPECTRUM SPF 50+

50+

INSTANTLY

COOLS &

REFRESHES

LIGHTWEIGHT

FREE FROM

Oxybenzone

Octinoxate

Water Resistant

(80 Minutes)

NET WT 6 OZ. (170 g)

55%

MORE

FAMILY SIZE!

9.5 OZ VS 6 OZ

Banana Boat®

SPORT

coolzone

CLEAR SUNSCREEN SPRAY

UVA/UVB BROAD SPECTRUM SPF 50+

50+

INSTANTLY

COOLS &

REFRESHES

LIGHTWEIGHT

FREE FROM

Oxybenzone

Octinoxate

Water Resistant

(80 Minutes)

NET WT 9.5 OZ. (269 g)

BUY 2 & SAVE

Banana Boat®

SPORT

coolzone

CLEAR SUNSCREEN SPRAY

UVA/UVB BROAD SPECTRUM SPF 50+

50+

INSTANTLY

COOLS &

REFRESHES

LIGHTWEIGHT

FREE FROM

Oxybenzone

Octinoxate

Water Resistant

(80 Minutes)

2 - 6 OZ. (170 g) CANS TOTAL NET WT. 12 OZ. (340 g)

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)