Active Ingredients
Avobenzone 3.0%, Homosalate 10.0%, Octisalate 5.0%, Octocrylene 6.0%
Leader Kids Sport Sunscreen Spf 50 Spray
FDA Label NDC 70000-0700
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Cardinal Health 110, Llc. Dba Leader for the product Leader Kids Sport Sunscreen Spf 50 (NDC 70000-0700). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredients, purpose, uses, warnings, do not use, when using this product, stop use and ask a doctor if, keep out of reach of children., and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
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.
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