44ffd469-0205-846f-e063-6294a90af6b5

SPL v1
SPL
SPL Set ID 44ffd469-0205-846f-e063-6294a90af6b5
Route
topical
Published
Effective Date 2025-10-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
homosalate (7.5 g) avobenzone (2.7 g) octocrylene (5 g) octisalate (4.5 g)
Inactive Ingredients
peg-100 stearate phenoxyethanol caprylyl glycol chlorphenesin alpha-tocopherol acetate glyceryl stearate glycerin cetearyl alcohol sodium polyacrylate (2500000 mw) silica aloe barbadensis leaf xanthan gum edetate disodium water dimethicone

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2025-10-01

Purpose

Sunscreen

Description

Avobenzone 2.7%, Homosalate 7.5%,Octisalate 4.5%, 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

■ Shake well ■ apply liberally 15 minutes before sun exposure ■ 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 the product in this container from excessive heat and direct sun

Description

Avobenzone 2.7%, Homosalate 7.5%,Octisalate 4.5%, Octocrylene 5.0%

Principal Display Panel

New

BANANA BOAT

Sheer

Sensitive

SUNSCREEN LOTION

UVA/UVB BROAD SPECTRUM SPF 50

50

Dermatologist

& Pediatrician

APPROVED

Water Resistant (80 minutes)

FRAGRANCE &

ALCOHOL FREE

6 FL. OZ. (177mL)

New

BANANA BOAT

Sheer

Sensitive

SUNSCREEN LOTION

UVA/UVB BROAD SPECTRUM SPF 50

50

Dermatologist

& Pediatrician

APPROVED

Water Resistant (80 minutes)

FRAGRANCE &

ALCOHOL FREE

0.4 FL. OZ. (11.8mL)

Do Not Use

■ on damaged or broken skin.

Active Ingredients

Avobenzone 2.7%, Homosalate 7.5%,Octisalate 4.5%, Octocrylene 5.0%

Inactive Ingredients:

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

Questions Or Comments?

Call 1-800-SafeSun, Mon-Fr

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

■ Shake well ■ apply liberally 15 minutes before sun exposure ■ 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 the product in this container from excessive heat and direct sun

Principal Display Panel

New

BANANA BOAT

Sheer

Sensitive

SUNSCREEN LOTION

UVA/UVB BROAD SPECTRUM SPF 50

50

Dermatologist

& Pediatrician

APPROVED

Water Resistant (80 minutes)

FRAGRANCE &

ALCOHOL FREE

6 FL. OZ. (177mL)

New

BANANA BOAT

Sheer

Sensitive

SUNSCREEN LOTION

UVA/UVB BROAD SPECTRUM SPF 50

50

Dermatologist

& Pediatrician

APPROVED

Water Resistant (80 minutes)

FRAGRANCE &

ALCOHOL FREE

0.4 FL. OZ. (11.8mL)

Do Not Use (Do not use)

■ on damaged or broken skin.

Active Ingredients

Avobenzone 2.7%, Homosalate 7.5%,Octisalate 4.5%, Octocrylene 5.0%

Inactive Ingredients:

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

Questions Or Comments? (Questions or Comments?)

Call 1-800-SafeSun, Mon-Fr

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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