41376da3-5274-b133-e063-6394a90afa13

SPL v1
SPL
SPL Set ID 41376da3-5274-b133-e063-6394a90afa13
Route
topical
Published
Effective Date 2025-09-11
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
octocrylene (7.5 g) homosalate (9 g) avobenzone (3 g)
Inactive Ingredients
edetate disodium hydroxyacetophenone peg-100 stearate carbomer glyceryl stearate xanthan gum dimethicone phenoxyethanol sodium hydroxide water ethylhexyl palmitate glycerin chlorphenesin

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2025-09-11

Purpose

Sunscreen

Description

Avobenzone 3.0%, Homosalate 9.0%, Octocrylene 7.5%


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 • 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

Inactive Ingredients

Water, Ethylhexyl Palmitate,Glycerin, Dimethicone, Phenoxyethanol, Acrylates/ C12- 22 Alkyl Methacrylate Copolymer, Carbomer, Glyceryl Stearate, PEG-100 Stearate, Chlorphenesin, Xanthan Gum, Hydroxyacetophenone, Sodium Hydroxide, Disodium EDTA.

Description

Avobenzone 3.0%, Homosalate 9.0%, Octocrylene 7.5%

Do Not Use

• on damaged or broken skin.

Active Ingredients



Avobenzone 3.0%, Homosalate 9.0%, Octocrylene 7.5%

Questions Or Comments?

Call 1-800-SafeSun, Mon-Fri

When Using This Product

• keep out of eyes. Rinse with water to remove.

Prinicipal Display Panel

BANANA BOAT

KIDS

SPORT

SUNSCREEN LOTION

UVA/UVB BROAD SPECTRUM SPF 50

50

PROTECTS

FROM UP TO 98%

OF BURNING RAYS

won't run into eyes

Water Resistant

(80 Minutes)

6 FL OZ. (177 mL)

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 • 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

Inactive Ingredients

Water, Ethylhexyl Palmitate,Glycerin, Dimethicone, Phenoxyethanol, Acrylates/ C12- 22 Alkyl Methacrylate Copolymer, Carbomer, Glyceryl Stearate, PEG-100 Stearate, Chlorphenesin, Xanthan Gum, Hydroxyacetophenone, Sodium Hydroxide, Disodium EDTA.

Do Not Use (Do not use)

• on damaged or broken skin.

Active Ingredients



Avobenzone 3.0%, Homosalate 9.0%, Octocrylene 7.5%

Questions Or Comments? (Questions or Comments?)

Call 1-800-SafeSun, Mon-Fri

When Using This Product (When using this product)

• keep out of eyes. Rinse with water to remove.

Prinicipal Display Panel

BANANA BOAT

KIDS

SPORT

SUNSCREEN LOTION

UVA/UVB BROAD SPECTRUM SPF 50

50

PROTECTS

FROM UP TO 98%

OF BURNING RAYS

won't run into eyes

Water Resistant

(80 Minutes)

6 FL OZ. (177 mL)

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)