Leader Kids Sport Sunscreen SPF 50 Avobenzone, Homosalate, Octisalate, Octocrylene 5 g/100mL; 6 g/100mL; 3 g/100mL; 10 g/100mL Spray, 177 mL — NDC 70000-0700-01 package photo

Leader Kids Sport Sunscreen SPF 50 Avobenzone, Homosalate, Octisalate, Octocrylene 5 g/100mL; 6 g/100mL; 3 g/100mL; 10 g/100mL Spray, 177 mL

by CARDINAL HEALTH 110, LLC. DBA LEADER · 177 mL in 1 CAN (70000-0700-1)
NDC 70000-0700-01
🏷️ FDA NDC (as labeled) 70000-0700-1 billing pads the package segment with a zero
OTC On market Non-controlled
🗂️ Data synced Aug 27, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

🆔 Identity & classification

FDA NDC (as labeled) 70000-0700-1
Product NDC 70000-0700
11-digit billing NDC 70000070001
UNII 4X49Y0596W, 5A68WGF6WM, G63QQF2NOX, V06SV4M95S
Application # M020
SPL Set ID 3636693a-ba81-5d49-e063-6394a90a3006
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2025-05-28
Route TOPICAL
Dosage form SPRAY
Substance OCTISALATE; OCTOCRYLENE; AVOBENZONE; HOMOSALATE
Why two NDCs? The FDA registers this code as 70000-0700-1 — a 5-4-1 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the package segment → 70000-0700-01. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

🏭 Manufacturer & labeler

LabelerCARDINAL HEALTH 110, LLC. DBA LEADER
FDA applicationM020 (OTC MONOGRAPH DRUG)
Labeler code70000
First marketedMay 2025
Product typeHuman Otc Drug
Portfolio163 products on file
The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

🩺 Clinical

🧪 What is this product?

Leader Kids Sport Sunscreen SPF 50 is a spray-applied topical sunscreen formulated with four ultraviolet (UV) filters: avobenzone, homosalate, octisalate, and octocrylene. These ingredients are commonly used together in sunscreen products to absorb and scatter UV radiation from the sun. This is an over-the-counter monograph drug, meaning it is marketed under FDA's established rules for sunscreen products rather than as an individually reviewed application.

Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

🧪 Inactive Ingredients / Excipients

Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

  • UNII RUE8E6T4NB
    Aloe vera leaf juice is a clear gel extracted from aloe vera plant leaves. It's used in medicines as a lubricant, emollient, and preservative to soothe skin contact and help keep the product stable.
  • UNII 9E8X80D2L0
    A synthetic form of vitamin E used as an antioxidant and preservative in medications. It helps prevent the active ingredients from degrading when exposed to oxygen or light.
  • UNII PQ6CK8PD0R
    Ascorbic acid, also known as vitamin C, is a white crystalline powder. It serves as an antioxidant to prevent degradation of other ingredients and may also function as a preservative in the formulation.
  • UNII 3QPI1U3FV8
    A preservative derived from benzoic acid that prevents bacterial and fungal growth in medicines. It helps extend shelf life and maintain product safety during storage and use.
  • UNII 00YIU5438U
    Caprylyl glycol is a clear liquid derived from coconut oil. In medicines, it acts as a humectant to retain moisture, a preservative booster to prevent microbial growth, and a solvent to help dissolve or mix other ingredients.
  • UNII V2W71V8T0X
    A silicone-based compound that mixes oil and water together. Used in formulations as an emulsifier to help blend ingredients and improve texture and stability of creams, lotions, and other topical products.
  • UNII F4K100DXP3
    Dibutyl adipate is a synthetic oily liquid derived from adipic acid. It serves as a plasticizer and solvent in medicines, helping softens coatings and improves flexibility so tablets and capsules don't crack or break.
  • UNII S3KFG6Q5X8
    An organic chemical compound used as a UV filter in topical formulations. It helps protect the medicine or product from degradation caused by sunlight exposure during storage and use.
  • UNII 14255EXE39
    Ethylparaben is a preservative, a chemical that stops bacteria and mold from growing in the medicine. It keeps the product safe and effective throughout its shelf life.
  • UNII PDC6A3C0OX
    Glycerin is a clear, thick liquid derived from plant oils or fats. It acts as a humectant to retain moisture, a sweetener, and a solvent in medications.
  • UNII BXR49TP611
    Isobutane is a liquefied gas used as a propellant in aerosol inhalers and sprays. It helps push the medicine out of the container so you can breathe or spray it as directed.
  • UNII 0QQJ25X58G
    Isobutylparaben is a preservative derived from para-hydroxybenzoic acid. It prevents bacterial and fungal growth in medicines, extending shelf life and maintaining product safety during storage.
  • UNII A8289P68Y2
    Isododecane is a lightweight liquid hydrocarbon used as a solvent and spreadability agent in topical formulations. It helps dissolve active ingredients and makes the product easier to apply and absorb into the skin.
  • UNII 7666FJ0J9F
    A rosin-derived compound used as a film-coating agent and binder in tablets and capsules. It helps create a protective layer around the medication and improves tablet hardness.
  • UNII A2I8C7HI9T
    Methylparaben is a preservative derived from benzoic acid that prevents growth of bacteria, fungi, and mold in medicines. It extends the product's shelf life and maintains safety during storage.
  • UNII 461N1O614Y
    A synthetic oily liquid used as an emollient and solvent in medications. It helps dissolve active ingredients and improves how the medicine spreads or absorbs through the skin.
  • UNII B697894SGQ
    Polyethylene glycol 400 is a clear, thick liquid made from petroleum-derived polymers. It acts as a solvent and humectant in medicines, helping dissolve active ingredients and retain moisture in the formulation.
  • UNII GIA7T764OD
    A silicone-based ingredient combined with polyethylene glycol. It acts as an emulsifier and surfactant to help blend oils and water-based ingredients, and reduces foaming in liquid formulations.
  • UNII HIE492ZZ3T
    Phenoxyethanol is a synthetic preservative and antimicrobial agent used to prevent bacterial and fungal growth in medicines and cosmetic products, extending shelf life and maintaining product safety.
  • UNII Z8IX2SC1OH
    Propylparaben is a chemical preservative used to prevent bacterial and fungal growth in medicines and personal care products. It helps extend shelf life and maintain product safety during storage.
  • UNII 1D1K0N0VVC
    A fat-soluble form of vitamin A used as a colorant and nutritional fortification ingredient. It gives products a yellow or orange tint and increases vitamin A content in the formula.
  • UNII ETJ7Z6XBU4
    Silicon dioxide is a naturally occurring mineral used as a glidant and anti-caking agent. It helps powder ingredients flow smoothly and prevents clumping during manufacturing and storage.
  • UNII 451W47IQ8X
    Sodium chloride is common table salt. It's used in medicines as a buffer to maintain proper pH, as a filler to add bulk, or to adjust the osmotic balance in liquid formulations.
  • UNII 1Q73Q2JULR
    Sodium citrate is a salt derived from citric acid. It works as a buffer to maintain the medicine's pH level and may also help improve taste or act as a preservative in the formulation.
  • UNII 208G222332
    A synthetic compound that acts as a thickener and stabilizer in liquid formulations. It helps maintain consistent texture and prevents separation of ingredients in medicines.
  • UNII 059QF0KO0R
    Water is a liquid solvent that dissolves and mixes ingredients together in liquid medicines, syrups, and injections. It helps distribute the active drug evenly throughout the product.

26 inactive ingredients listed in the exact product block matched to this NDC.

The official label also statesWater, 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

Label-section wording can be broader than the structured product block and may mention additional formulation ingredients.

Where does this data come from?
Data sourced from official FDA Structured Product Labeling (SPL) via DailyMedingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

💲 Pricing

A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.

Price systemPer mLPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
ℹ️
No price is published for this exact package yet. CMS surveys NADAC per package size, so a different pack of the same drug often has one.
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Leader Kids Sport Sunscreen SPF 50 5 g/100mL; 6 g/100mL; 3 g/100mL; 10 g/100mLthis 70000-0700-01 CARDINAL 177 ml FDA listed
About this product: other versions of the same ingredient, strength and form are listed above, least expensive first, with FDA equivalence ratings where available.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

Availability & generic status

🏛️
2025
On the market since
May 2025
📍
2026
Currently FDA-listed
1 year listed
🔒
·
No generic listed yet
brand only
ℹ️No FDA-approved generic found

We did not find an FDA-approved generic match for this exact strength, form and route.

Where does this data come from?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

🔬 Reported adverse events (FAERS)

Read carefully: FAERS reports are voluntary and unverified. Counts are not incidence, do not establish causation, are subject to reporting bias, and cannot be used to compare one drug to another. Shown for signal context only. Reports for Avobenzone, Homosalate, Octisalate, Octocrylene — the ingredient across all brands.

Top reported reactions

Rash40
Skin Cancer39
Pruritus31
Erythema26
Pain26
Dyspnoea25
Fatigue25

Age at onset

Infant1
Child6
Adolescent4
Adult61
Elderly45

Reporter sex

650 reports
Male · 36%
Female · 64%

Serious outcomes

Death23
Life-threatening11
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 26 0
Most recent year is provisional (FAERS lags ~3 months).
Where does this data come from?
Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
70000-0700-01 You're viewing this 177 mL in 1 CAN (70000-0700-1) 2025-05-28 Active

🧭 About this NDC listing & data coverage

Over-the-counter (OTC) product
What data is (and isn’t) available for this NDC — tap to expand
NDC identity (package / product / labeler codes) ✓ Available
Labeler ✓ Available
Product & package description ✓ Available
Marketing category & status ✓ Available
Active ingredient / dosage form / route ✓ Available
FDA label (SPL via DailyMed) ✓ Available
Package photos ✓ Available
Inactive ingredients (structured) ✓ Available
NADAC pharmacy acquisition price (CMS) — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
Orange Book / therapeutic-equivalence data — Not published for this NDC Applies only to products approved under an NDA/ANDA; many listings are out of scope.
HCPCS J-code billing crosswalk — Not published for this NDC Most self-administered / retail products have no J-code — that is normal.
Medicaid utilization (CMS SDUD) — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold.
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Is this NDC FDA-approved?
An NDC listing does not by itself establish FDA approval — the NDC Directory records that a product is listed with FDA, not that it was reviewed and approved. This listing's marketing category is "Otc Monograph Drug". Products approved under an application carry an NDA, ANDA, or BLA number.
Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The FDA registers it as 70000-0700-1, which is what is printed on the packaging and shown on DailyMed. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero: 70000-0700-01, written without dashes as 70000070001. The Identity section at the top of this page lists every form of this code.
What do the three segments of this NDC mean?
In 70000-0700-01, the first segment (70000) is the labeler code FDA assigned to CARDINAL HEALTH 110, LLC. DBA LEADER; the middle segment (0700) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (01) identifies this exact package size and type. Together they name one specific package of one specific product.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by CARDINAL HEALTH 110, LLC. DBA LEADER. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
CARDINAL HEALTH 110, LLC. DBA LEADER is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as an over-the-counter product, so it does not require a prescription. Follow the package directions, and ask your pharmacist if you are unsure whether it is right for you.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.

📄 FDA label — Drug Facts FDA SPL

The complete FDA label for this product — the official Drug Facts labeling, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage 32 words

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.

⏱️ Dosage and Administration 148 words

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.

⚠️ Warnings 121 words

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.

🧪 Active Ingredient 10 words

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

🧪 Inactive Ingredients 50 words

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

🎯 Purpose 2 words

Purpose Sunscreen

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
For educational and professional reference only — not medical advice. Pricing reflects published NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.