Indications and 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.
OCTISALATE - CARDINAL HEALTH 110, LLC. DBA LEADER | Medical Group Care LLC
- Manufacturer
- CARDINAL HEALTH 110, LLC. DBA LEADER | Medical Group Care LLC
- Effective date
- 2026-08-05
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 3
- Source
- daily-update
- Hydrated at
- 2026-08-08 02:02:02
Label at a glance#
ProductLeader Kids Sport Sunscreen SPF 50
Active ingredientOCTISALATE, OCTOCRYLENE, AVOBENZONE, HOMOSALATE
Label structure9 sections
Dosage and administration
• 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 ...
Contacts and useful links#
Label contents#
Full prescribing information#
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
Water, Isobutane, Isododecane, C12-15 AlkyI
Benzoate, Cetyl PEG/PPG-10/1Dimethicone,
Phenoxyethanol, Aloe Barbadensis Leaf
Juice, Glycerin, Methylparaben,
Octyldodecanol, Retinyl Palmitate,
Tocopheryl Acetate, Ascorbic Acid, Caprylyl
Glycol, Dibutyl Adipate, Ethylhexyl
Methoxycrylene, Methyl Dihydroabietate,
PEG-8, PEG-8 Dimethicone, Phenylisopropyl
Dimethicone, Polyglyceryl-3
Stearate/lsostearate/Dimer Dilinoleate
Crosspolymer, Silica, Sodium Chloride,
Sodium Citrate, Sodium Propoxyhydroxypropyl
Thiosulfate Silica
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
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| c5cd4727-ac49-4409-82b1-5bd8006c3ec7 | Product name | 1 | 20171122 |
| d5e51f11-ad28-caa4-4b49-4143974782ad | Product name | 1 | 20150831 |
Products#
Every source-derived product name is available through these pages.
- Leader Kids Sport Sunscreen SPF 50
- Avobenzone, Homosalate, Octisalate, Octocrylene
- OCTISALATE
- OCTOCRYLENE
- AVOBENZONE
- HOMOSALATE
- ALOE BARBADENSIS LEAF JUICE
- ASCORBIC ACID
- BUTYLPARABEN
- CAPRYLYL GLYCOL
- CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2)
- DIBUTYL ADIPATE
- ETHYLHEXYL METHOXYCRYLENE
- ETHYLPARABEN
- GLYCERIN
- ISOBUTANE
- ISOBUTYLPARABEN
- ISODODECANE
- METHYL DIHYDROABIETATE
- METHYLPARABEN
- OCTYLDODECANOL
- PEG-8
- PEG-8 DIMETHICONE
- PHENOXYETHANOL
- PROPYLPARABEN
- RETINYL PALMITATE
- SILICA
- SODIUM CHLORIDE
- SODIUM CITRATE
- SODIUM PROPOXYHYDROXYPROPYL THIOSULFATE SILICA
- ALPHA-TOCOPHEROL ACETATE
- WATER
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 70000-0700 | 70000-0700-1 |
Ingredients#
Every source-derived ingredient row is available through these pages.
Source Document#
Older Hydrated Versions#
| Version | Effective date | Source | Hydrated |
|---|---|---|---|
| 2 | 2025-06-19 | full-release | 2026-06-01 01:03:28 |
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Leader Kids Sport Sunscreen SPF 50 | AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE | CARDINAL HEALTH 110, LLC. DBA LEADER | 3636693a-ba81-5d49-e063-6394a90a3006 | 2026-08-05 | Warnings | 70000-0700-1 70000-0700 70000070001 584ed565-d0b1-c8f0-e063-6394a90a17f3 3636693a-ba81-5d49-e063-6394a90a3006 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.