37c5dcf7-dc2d-624f-e063-6394a90ae992

SPL v5
SPL
SPL Set ID 37c5dcf7-dc2d-624f-e063-6394a90ae992
Route
topical
Published
Effective Date 2025-06-17
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
octisalate (4.5 g) octocrylene (6.5 g) avobenzone (2.7 g) homosalate (9 g)
Inactive Ingredients
sodium chloride menthol sodium hydroxide trimethylsiloxysilicate (m/q 0.8-1.0) caprylic/capric triglyceride cyclopentasiloxane propylene glycol cetyl peg/ppg-10/1 dimethicone (hlb 2) phenoxyethanol beeswax dimethicone polyglyceryl-3 diisostearate aloe barbadensis leaf juice xanthan gum .alpha.-tocopherol acetate water edetate disodium ethylhexylglycerin styrene/ammonium acrylate copolymer (300000 mw)

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2025-06-17

Purpose

Sunscreen

Description

Avobenzone 2.7%, Homosalate 9%, Octisalate 4.5%, Octocrylene 6.5%


Medication Information

Warnings

For external use only.

Flammable: 

• keep away from fire or flame

• wait 10 minutes after application before approaching a source of heat or flame, or before smoking

Uses

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

Purpose

Sunscreen

Directions

• Apply liberally 15 minutes before sun exposure

• reapply:

• after 80 minues 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 of 15 or higher and other sun protection measures including:

• limit time in the sun, especially from 10:00 a.m.-2:00 p.m.

• wear long-sleeve shirts, pants, hats, and sunglasses

• children under 6 months of age: Ask a doctor.

Other Information

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

• may stain some fabrics

Inactive Ingredients

WATER, PROPYLENE GLYCOL, STYRENE/ACRYLATES COPOLYMER, TRIMETHYLSILOXYSILICATE, CAPRYLIC/CAPRIC TRIGLYCERIDE, CYCLOPENTASILOXANE, CETYL PEG/PPG-10/1 DIMETHICONE, BEESWAX, DIMETHICONE, POLYGLYCERYL-3 DIISOSTEARATE, ALOE BARBADENSIS LEAF JUICE, SODIUM CHLORIDE, PHENOXYETHANOL, XANTHAN GUM, TOCOPHERYL ACETATE, ETHYLHEXYLGLYCERIN, MENTHOL, DISODIUM EDTA, SODIUM HYDROXIDE

Description

Avobenzone 2.7%, Homosalate 9%, Octisalate 4.5%, Octocrylene 6.5%

Principal Display Panel

Leader Sport Ultra Sunscreen Lotion SPF 50 Broad Spectrum NDC 70000-0697-1

Section 42229-5

*This product is not manufactured or distributed by

Edgewell Personal Care Brands, LLC, owner of the

registered trademark Banana Boat®.



DIST. BY CAH, DUBLIN, OH 43017

www.myleader.com 1-800-200-6313

Made in China

©2026 Cardinal Health. All other marks are the

property of their respective owners.

CIN 5915178 REV. 01/26

Do Not Use

• on damaged or broken skin.

Active Ingredients

Avobenzone 2.7%, Homosalate 9%, Octisalate 4.5%, Octocrylene 6.5%

Questions Or Comments?

+1-866-306-9136

You may also report serious side effects to this phone number.

Mon - Fri 9:00 a.m. - 5:00 p.m. EST

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 1-800-222-1222.


Structured Label Content

Warnings

For external use only.

Flammable: 

• keep away from fire or flame

• wait 10 minutes after application before approaching a source of heat or flame, or before smoking

Uses

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

Purpose

Sunscreen

Directions

• Apply liberally 15 minutes before sun exposure

• reapply:

• after 80 minues 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 of 15 or higher and other sun protection measures including:

• limit time in the sun, especially from 10:00 a.m.-2:00 p.m.

• wear long-sleeve shirts, pants, hats, and sunglasses

• children under 6 months of age: Ask a doctor.

Other Information

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

• may stain some fabrics

Inactive Ingredients (Inactive ingredients)

WATER, PROPYLENE GLYCOL, STYRENE/ACRYLATES COPOLYMER, TRIMETHYLSILOXYSILICATE, CAPRYLIC/CAPRIC TRIGLYCERIDE, CYCLOPENTASILOXANE, CETYL PEG/PPG-10/1 DIMETHICONE, BEESWAX, DIMETHICONE, POLYGLYCERYL-3 DIISOSTEARATE, ALOE BARBADENSIS LEAF JUICE, SODIUM CHLORIDE, PHENOXYETHANOL, XANTHAN GUM, TOCOPHERYL ACETATE, ETHYLHEXYLGLYCERIN, MENTHOL, DISODIUM EDTA, SODIUM HYDROXIDE

Principal Display Panel

Leader Sport Ultra Sunscreen Lotion SPF 50 Broad Spectrum NDC 70000-0697-1

Section 42229-5 (42229-5)

*This product is not manufactured or distributed by

Edgewell Personal Care Brands, LLC, owner of the

registered trademark Banana Boat®.



DIST. BY CAH, DUBLIN, OH 43017

www.myleader.com 1-800-200-6313

Made in China

©2026 Cardinal Health. All other marks are the

property of their respective owners.

CIN 5915178 REV. 01/26

Do Not Use (Do not use)

• on damaged or broken skin.

Active Ingredients

Avobenzone 2.7%, Homosalate 9%, Octisalate 4.5%, Octocrylene 6.5%

Questions Or Comments? (Questions or comments?)

+1-866-306-9136

You may also report serious side effects to this phone number.

Mon - Fri 9:00 a.m. - 5:00 p.m. EST

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 1-800-222-1222.


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Raw Label Data

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