SPL v1
SPL
SPL Set ID 45117885-c674-b58a-e063-6394a90af5f4
Route
TOPICAL
Published
Effective Date 2025-10-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Avobenzone (3 g) Octisalate (4.5 g) Octocrylene (6 g) Homosalate (9 g)
Inactive Ingredients
Glycerin C12-15 Alkyl Benzoate Isohexadecane Caprylyl Glycol Sodium Chloride Sodium Citrate Water Cetyl Peg/ppg-10/1 Dimethicone (hlb 2) Lauryl Peg-8 Dimethicone (300 Cps) Ethylhexyl Methoxycrylene Isobutane Myrica Cerifera Fruit Wax Phenoxyethanol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-11-01

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 container. 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 and then apply to face ■ do not apply in windy conditions ■ Use in a 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.

Other Information

■ protect the product in this container 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

New

BANANA BOAT

Sheer

Sensitive

SUNSCREEN LOTION SPRAY

UVA/UVB BROAD SPECTRUM SPF 50

50

Dermatologist

& Pediatrician

APPROVED

Water Resistant (80 minutes)

FRAGRANCE &

ALCOHOL FREE

6 FL. OZ. (170mL)

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 container. 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 and then apply to face ■ do not apply in windy conditions ■ Use in a 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.

Other Information

■ protect the product in this container 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

New

BANANA BOAT

Sheer

Sensitive

SUNSCREEN LOTION SPRAY

UVA/UVB BROAD SPECTRUM SPF 50

50

Dermatologist

& Pediatrician

APPROVED

Water Resistant (80 minutes)

FRAGRANCE &

ALCOHOL FREE

6 FL. OZ. (170mL)

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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