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NDC 70000-0326-01 Cardinal Health Leader 30; 150; 50; 100; 60 mg/g; mg/g; mg/g; mg/g; mg/g Details
Cardinal Health Leader 30; 150; 50; 100; 60 mg/g; mg/g; mg/g; mg/g; mg/g
Cardinal Health Leader is a TOPICAL AEROSOL, SPRAY in the HUMAN OTC DRUG category. It is labeled and distributed by Cardinal Health, Inc.. The primary component is AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE.
Product Information
NDC | 70000-0326 |
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Product ID | 70000-0326_65b0fc20-7257-5319-e053-2a91aa0a3f5c |
Associated GPIs | 90920000003200 |
GCN Sequence Number | n/a |
GCN Sequence Number Description | n/a |
HIC3 | n/a |
HIC3 Description | n/a |
GCN | n/a |
HICL Sequence Number | n/a |
HICL Sequence Number Description | n/a |
Brand/Generic | n/a |
Proprietary Name | Cardinal Health Leader |
Proprietary Name Suffix | SPF 70 General Protection Sunscreen Clear Continuous |
Non-Proprietary Name | Avobenzone, Homosalate, Octisalate, Octocrylene, Oxybenzone |
Product Type | HUMAN OTC DRUG |
Dosage Form | AEROSOL, SPRAY |
Route | TOPICAL |
Active Ingredient Strength | 30; 150; 50; 100; 60 |
Active Ingredient Units | mg/g; mg/g; mg/g; mg/g; mg/g |
Substance Name | AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE |
Labeler Name | Cardinal Health, Inc. |
Pharmaceutical Class | n/a |
DEA Schedule | n/a |
Marketing Category | OTC MONOGRAPH NOT FINAL |
Application Number | part352 |
Listing Certified Through | 2024-12-31 |
Package
Package Images
NDC 70000-0326-01 (70000032601)
NDC Package Code | 70000-0326-1 |
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Billing NDC | 70000032601 |
Package | 156 g in 1 CAN (70000-0326-1) |
Marketing Start Date | 2018-02-20 |
NDC Exclude Flag | N |
Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL 65b0fc20-7267-5319-e053-2a91aa0a3f5c Details
Active ingredients
Uses
FLAMMABLE:
SPL UNCLASSIFIED SECTION
SPL UNCLASSIFIED SECTION
Directions
• spray liberally and spread evenly by hand 15 minutes before sun exposure
• hold can 4-6 inches away from skin to apply
• do not spray directly into face. Spray into hand and then apply to face.
• do not apply in windy conditions
• use in well-ventilated area
• reapply:
• after 80 minutes of swimming or sweating
• immediately after towel drying
• at least every 2 hours
• children under 6 months of age: ask a doctor
•
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 a.m. - 2 p.m.
• wear long-sleeve shirts, pants, hats, and sunglasses
Other Information
Inactive ingredients
PRINCIPAL DISPLAY PANEL
INGREDIENTS AND APPEARANCE
CARDINAL HEALTH LEADER
SPF 70 GENERAL PROTECTION SUNSCREEN CLEAR CONTINUOUS
avobenzone, homosalate, octisalate, octocrylene, oxybenzone aerosol, spray |
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Labeler - Cardinal Health, Inc. (097537435) |
Registrant - Fruit Of The Earth, Inc. (079559467) |
Establishment | |||
Name | Address | ID/FEI | Business Operations |
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Fruit Of The Earth Research Laboratories, Inc. | 008193513 | manufacture(70000-0326) |