LEADER KIDS SPORT SUNSCREEN SPF 50- avobenzone, homosalate, octisalate, octocrylene spray

Leader Kids Sport Sunscreen SPF 50 by

Drug Labeling and Warnings

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

Drug Details [pdf]

Active Ingredients

Avobenzone 3.0%, Homosalate 10.0%, Octisalate 5.0%, Octocrylene 6.0%

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

avoid spraying eyes. Rinse with water to remove

do not puncture or incinerate. Contents under pressure.

do not store at temperature above 120 F

use only as directed. Intentional misure by deliberately concentrating and inhaling the contents can be harmful or fatal

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

Shake well

hold container 4 to 6 inches from the skin to apply

spray liberally and evenly by hand 15 minutes before sun exposure

do not spray directly into face. Spray on hands then apply to face

do not apply in windy conditions, use in well-ventilated area and avoid inhalation

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

Aloe Barbadensis Leaf Juice, Ascorbic Acid,
Butylparaben, Caprylyl Glycol, Cetyl
PEG/PPG-10/1 Dimethicone, Dibutyl
Adipate, Ethylhexyl Methoxycrylene,
Ethylparaben, Glycerin, Isobutane,
Isobutylparaben, Isododecane, Methyl
Dihydroabietate, Methylparaben,
Octyldodecanol, PEG-8, PEG-8 Dimethicone,
Phenoxyethanol, Phenylisopropyl
Dimethicone, Polyglyceryl-3
Stearate/Isostearate/Dimer Dilinoleate
Crosspolymer, Propylparaben, Retinyl
Palmitate, Silica, Sodium Chloride, Sodium
Citrate, Sodium Propoxyhydroxypropyl
Thiosulfate Silica, Tocopheryl Acetate, Water.

Other Information

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

may stain sime fabrics

Questions or comments?

+1-866-306-9136

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

Mon - Fri 9:00 am - 5:00 pm EST

Principal Display Panel

INGREDIENTS AND APPEARANCE

LEADER KIDS SPORT SUNSCREEN SPF 50 
avobenzone, homosalate, octisalate, octocrylene spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70000-0700
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	5 g  in 100 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	6 g  in 100 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	3 g  in 100 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	10 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
ALOE BARBADENSIS LEAF JUICE (UNII: RUE8E6T4NB)
ASCORBIC ACID (UNII: PQ6CK8PD0R)
BUTYLPARABEN (UNII: 3QPI1U3FV8)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2) (UNII: V2W71V8T0X)
DIBUTYL ADIPATE (UNII: F4K100DXP3)
ETHYLHEXYL METHOXYCRYLENE (UNII: S3KFG6Q5X8)
ETHYLPARABEN (UNII: 14255EXE39)
GLYCERIN (UNII: PDC6A3C0OX)
ISOBUTANE (UNII: BXR49TP611)
ISOBUTYLPARABEN (UNII: 0QQJ25X58G)
ISODODECANE (UNII: A8289P68Y2)
METHYL DIHYDROABIETATE (UNII: 7666FJ0J9F)
METHYLPARABEN (UNII: A2I8C7HI9T)
OCTYLDODECANOL (UNII: 461N1O614Y)
PEG-8 (UNII: B697894SGQ)
PEG-8 DIMETHICONE (UNII: GIA7T764OD)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
RETINYL PALMITATE (UNII: 1D1K0N0VVC)
SILICA (UNII: ETJ7Z6XBU4)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
SODIUM PROPOXYHYDROXYPROPYL THIOSULFATE SILICA (UNII: 208G222332)
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70000-0700-1	177 mL in 1 CAN; Type 0: Not a Combination Product	05/28/2025

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	05/28/2025

Labeler - CARDINAL HEALTH, INC (063997360)

Registrant - Medical Group Care LLC (085137089)