45117885-c674-b58a-e063-6394a90af5f4

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

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 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.

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 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

Other Information

■ protect the product in this container from excessive heat and direct sun

Description

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

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)

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 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.

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 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

Other Information

■ protect the product in this container from excessive heat and direct sun

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)

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

All Sections (JSON)