SPL v2
SPL
SPL Set ID 0c7b7571-7317-98bc-e063-6294a90aa29f
Route
TOPICAL
Published
Effective Date 2023-12-14
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Homosalate (9 g) Avobenzone (3 g) Octocrylene (6 g) Octisalate (4.5 g)
Inactive Ingredients
Water Lauryl Peg-8 Dimethicone (300 Cps) Isohexadecane Myrica Cerifera Fruit Wax Sodium Citrate Alkyl (c12-15) Benzoate Ethylhexyl Methoxycrylene Caprylyl Glycol Isobutane Cetyl Peg/ppg-10/1 Dimethicone (hlb 2) Sodium Chloride Phenoxyethanol Glycerin

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-01-01 Until 2027-10-01

Description

Avobenzone 3.0%, Homosalate 9.0%, Octisalate 4.5%, Octocrylene 6.0%

Purpose

Sunscreen


Medication Information

Purpose

Sunscreen

Description

Avobenzone 3.0%, Homosalate 9.0%, Octisalate 4.5%, Octocrylene 6.0%

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 3.0%, Homosalate 9.0%, Octisalate 4.5%, Octocrylene 6.0%

Inactive Ingredients:

Water, Isobutane, Isohexadecane, C12-15 Alkyl Benzoate, Cetyl PEG/PPG-10/1 Dimethicone, Lauryl PEG-8 Dimethicone, Myrica Cerifera (Bayberry) Fruit Wax, Ethylhexyl Methoxycrylene, Sodium Chloride, Glycerin, Phenoxyethanol, Caprylyl Glycol, Sodium Citrate.

Questions Or Comments?

Call 1-800-SafeSun, Mon-Fri

Principal Display Panel

BANANA

BOAT®

KiDS

SPORT

SUNSCREEN LOTION SPRAY

UVA/UVB BROAD SPECTRUM SPF 50+

50+

PROTECTS

FROM UP TO 98%

OF BURNING RAYS

tear free

Water Resistant

(80 Minutes)

SHAKE WELL BEFORE USE

NET WT 6 OZ. (170 g)

BONUS

33% MORE

8 OZ

VS

6 OZ

BANANA

BOAT®

KiDS

SPORT

SUNSCREEN LOTION SPRAY

UVA/UVB BROAD SPECTRUM SPF 50+

50+

PROTECTS

FROM UP TO 98%

OF BURNING RAYS

tear free

Water Resistant

(80 Minutes)

SHAKE WELL BEFORE USE

NET WT 8 OZ. (227 g)

55%

MORE

FAMILY SIZE!

9.5OZ VS 6OZ

BANANA

BOAT®

KiDS

SPORT

SUNSCREEN LOTION SPRAY

UVA/UVB BROAD SPECTRUM SPF 50+

50+

PROTECTS

FROM UP TO 98%

OF BURNING RAYS

tear free

Water Resistant

(80 Minutes)

SHAKE WELL BEFORE USE

NET WT 9.5 OZ. (269 g)

BUY 2 & SAVE!

BANANA

BOAT®

KiDS

SPORT

SUNSCREEN LOTION SPRAY

UVA/UVB BROAD SPECTRUM SPF 50+

50+

PROTECTS

FROM UP TO 98%

OF BURNING RAYS

tear free

Water Resistant

(80 Minutes)

SHAKE WELL BEFORE USE

2 - 6 OZ. (170 g) CANS TOTAL NET WT. 12 OZ. (340 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 3.0%, Homosalate 9.0%, Octisalate 4.5%, Octocrylene 6.0%

Inactive Ingredients:

Water, Isobutane, Isohexadecane, C12-15 Alkyl Benzoate, Cetyl PEG/PPG-10/1 Dimethicone, Lauryl PEG-8 Dimethicone, Myrica Cerifera (Bayberry) Fruit Wax, Ethylhexyl Methoxycrylene, Sodium Chloride, Glycerin, Phenoxyethanol, Caprylyl Glycol, Sodium Citrate.

Questions Or Comments? (Questions or comments?)

Call 1-800-SafeSun, Mon-Fri

Principal Display Panel

BANANA

BOAT®

KiDS

SPORT

SUNSCREEN LOTION SPRAY

UVA/UVB BROAD SPECTRUM SPF 50+

50+

PROTECTS

FROM UP TO 98%

OF BURNING RAYS

tear free

Water Resistant

(80 Minutes)

SHAKE WELL BEFORE USE

NET WT 6 OZ. (170 g)

BONUS

33% MORE

8 OZ

VS

6 OZ

BANANA

BOAT®

KiDS

SPORT

SUNSCREEN LOTION SPRAY

UVA/UVB BROAD SPECTRUM SPF 50+

50+

PROTECTS

FROM UP TO 98%

OF BURNING RAYS

tear free

Water Resistant

(80 Minutes)

SHAKE WELL BEFORE USE

NET WT 8 OZ. (227 g)

55%

MORE

FAMILY SIZE!

9.5OZ VS 6OZ

BANANA

BOAT®

KiDS

SPORT

SUNSCREEN LOTION SPRAY

UVA/UVB BROAD SPECTRUM SPF 50+

50+

PROTECTS

FROM UP TO 98%

OF BURNING RAYS

tear free

Water Resistant

(80 Minutes)

SHAKE WELL BEFORE USE

NET WT 9.5 OZ. (269 g)

BUY 2 & SAVE!

BANANA

BOAT®

KiDS

SPORT

SUNSCREEN LOTION SPRAY

UVA/UVB BROAD SPECTRUM SPF 50+

50+

PROTECTS

FROM UP TO 98%

OF BURNING RAYS

tear free

Water Resistant

(80 Minutes)

SHAKE WELL BEFORE USE

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