SPL v1
SPL
SPL Set ID 44fe0844-cb74-7a04-e063-6294a90aca15
Route
TOPICAL
Published
Effective Date 2025-10-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Avobenzone (2.7 g) Octocrylene (5 g) Homosalate (4 g) Octisalate
Inactive Ingredients
Caprylyl Glycol Sodium Polyacrylate (2500000 Mw) Phenoxyethanol .alpha.-tocopherol Acetate Dimethicone Peg-100 Stearate Chlorphenesin Water Silicon Dioxide Glyceryl Stearate Aloe Barbadensis Leaf Glycerin

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-10-01

Description

Avobenzone 2.7%, Homosalate 4.0%, Octisalate 4.0%, Octocrylene 5.0%

Purpose

Sunscreen


Medication Information

Purpose

Sunscreen

Description

Avobenzone 2.7%, Homosalate 4.0%, Octisalate 4.0%, Octocrylene 5.0%

Uses

■ helps prevent sunburn ■ if used as directed with other sun protection measures (see Directions ), decreases the risk of skin cancer and early aging caused by the sun.

Warnings

For external use only.



May stain some fabrics.

Directions

■ apply liberally 15 minutes before sun exposure ■ reapply: ■ after 80 minutes of swimming or sweating ■ immediately after towel drying ■ at least every 2 hours ■ S un 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.

Active Ingredients

Avobenzone 2.7%, Homosalate 4.0%, Octisalate 4.0%, Octocrylene 5.0%

​other Information

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

Inactive Ingredients:

Water, Glycerin, Dimethicone,Silica, Phenoxyethanol, Acrylates/C12‐22 Alkyl Methacrylate Copolymer, Caprylyl Glycol, Sodium Polyacrylate, Chlorphenesin, Disodium EDTA, Glyceryl Stearate, PEG‐100 Stearate, Tocopheryl Acetate, Aloe Barbadensis Leaf Juice.

Questions Or Comments?



Call 1-800-SafeSun, Mon-Fri

Principle Display Panel

New

BANANA BOAT

Sheer

Sensitive

FACE

SUNSCREEN LOTION

UVA/UVB BROAD SPECTRUM SPF 50

50

Dermatologist

& Pediatrician

APPROVED

Water Resistant (80 minutes)

FRAGRANCE &

ALCOHOL FREE*

*no ethanol/ethnyl alcohol

3 FL.OZ. (88mL)

When Using This Product

■ 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 aging caused by the sun.

Purpose

Sunscreen

Warnings

For external use only.



May stain some fabrics.

Directions

■ apply liberally 15 minutes before sun exposure ■ reapply: ■ after 80 minutes of swimming or sweating ■ immediately after towel drying ■ at least every 2 hours ■ S un 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.

Active Ingredients

Avobenzone 2.7%, Homosalate 4.0%, Octisalate 4.0%, Octocrylene 5.0%

​other Information (​Other Information)

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

Inactive Ingredients:

Water, Glycerin, Dimethicone,Silica, Phenoxyethanol, Acrylates/C12‐22 Alkyl Methacrylate Copolymer, Caprylyl Glycol, Sodium Polyacrylate, Chlorphenesin, Disodium EDTA, Glyceryl Stearate, PEG‐100 Stearate, Tocopheryl Acetate, Aloe Barbadensis Leaf Juice.

Questions Or Comments? (Questions or comments?)



Call 1-800-SafeSun, Mon-Fri

Principle Display Panel

New

BANANA BOAT

Sheer

Sensitive

FACE

SUNSCREEN LOTION

UVA/UVB BROAD SPECTRUM SPF 50

50

Dermatologist

& Pediatrician

APPROVED

Water Resistant (80 minutes)

FRAGRANCE &

ALCOHOL FREE*

*no ethanol/ethnyl alcohol

3 FL.OZ. (88mL)

When Using This Product (When using this product)

■ 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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