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

Description

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

Purpose

Sunscreen


Medication Information

Purpose

Sunscreen

Description

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

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.

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

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

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.

Do Not Use

• on damaged or broken skin.

Other Information

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

• may stain some fabrics

Active Ingredients

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

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

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

Principal Display Panel

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

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

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.

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

Purpose

Sunscreen

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

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.

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

• may stain some fabrics

Active Ingredients

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

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

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

Principal Display Panel

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

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.


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)