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

Description

Avobenzone 3.0%, Homosalate 9.0%, Octocrylene 7.5%

Purpose

Sunscreen


Medication Information

Purpose

Sunscreen

Description

Avobenzone 3.0%, Homosalate 9.0%, Octocrylene 7.5%

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 • 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

Do Not Use

• on damaged or broken skin.

Other Information

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

Active Ingredients



Avobenzone 3.0%, Homosalate 9.0%, Octocrylene 7.5%

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.

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

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 • 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

Do Not Use (Do not use)

• on damaged or broken skin.

Other Information

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

Active Ingredients



Avobenzone 3.0%, Homosalate 9.0%, Octocrylene 7.5%

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.

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

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