44fe0844-cb74-7a04-e063-6294a90aca15

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

Purpose

Sunscreen

Description

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


Medication Information

Warnings

For external use only.



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 aging caused by the sun.

Purpose

Sunscreen

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

Description

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

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

Warnings

For external use only.



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 aging caused by the sun.

Purpose

Sunscreen

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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