LEADER SPORT ULTRA SUNSCREEN SPF 50- avobenzone, homosalate, octisalate, octocrylene lotion

Leader Sport Ultra Sunscreen SPF 50 by

Drug Labeling and Warnings

Leader Sport Ultra Sunscreen SPF 50 by is a Otc medication manufactured, distributed, or labeled by CARDINAL HEALTH 110, LLC. DBA LEADER, Medical Group Care LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients

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

Purpose

Sunscreen

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.

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

Do not use

on damaged or broken skin.

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.

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.

Inactive ingredients

Alcohol, Aloe Barbadensis Leaf Juice, Ammonium Acryloyldimethyltaurate/VP Copolymer, Cetearyl Alcohol, Dimethicone, Disodium EDTA, Ethylhexylglycerin, Menthol, Phenoxyethanol, Polysorbate 60, Propylene Glycol, Sorbitan Stearate, Styrene/Acrylates Copolymer, Tocopheryl Acetate, Water.

Other Information

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

may stain some fabrics

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

INGREDIENTS AND APPEARANCE

LEADER SPORT ULTRA SUNSCREEN SPF 50 
avobenzone, homosalate, octisalate, octocrylene lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70000-0697
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	4.5 g  in 100 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	6.5 g  in 100 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	2.7 g  in 100 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	9 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
ALOE BARBADENSIS LEAF JUICE (UNII: RUE8E6T4NB)
ALCOHOL (UNII: 3K9958V90M)
AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER (UNII: W59H9296ZG)
CETEARYL ALCOHOL (UNII: 2DMT128M1S)
DIMETHICONE (UNII: 92RU3N3Y1O)
EDTA (UNII: 9G34HU7RV0)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
MENTHOL (UNII: L7T10EIP3A)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
POLYSORBATE 60 (UNII: CAL22UVI4M)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SORBITAN STEARATE (UNII: NVZ4I0H58X)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70000-0697-1	236 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/17/2025

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	06/17/2025

Labeler - CARDINAL HEALTH 110, LLC. DBA LEADER (063997360)

Registrant - Medical Group Care LLC (085137089)