0c7b7571-7317-98bc-e063-6294a90aa29f

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

Purpose

Sunscreen

Description

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


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 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.

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

Description

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

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)

Do Not Use

on damaged or broken skin.

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

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 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.

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

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)

Do Not Use (Do not use)

on damaged or broken skin.

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

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.


Advanced Ingredient Data


Raw Label Data

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