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NDC 37205-0728-34 Leader 20; 105; 50; 20; 20 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL Details
Leader 20; 105; 50; 20; 20 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL
Leader is a TOPICAL LOTION in the HUMAN OTC DRUG category. It is labeled and distributed by Cardinal Health. The primary component is AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE.
Product Information
| NDC | 37205-0728 |
|---|---|
| Product ID | 37205-728_ea2d9a8d-9d98-70bf-e053-2a95a90a3dec |
| Associated GPIs | 90920000004100 |
| 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 | Leader |
| Proprietary Name Suffix | General Protection Sunscreen SPF 30 |
| Non-Proprietary Name | Avobenzone, Homosalate, Octisalate, Octocrylene, Oxybenzone |
| Product Type | HUMAN OTC DRUG |
| Dosage Form | LOTION |
| Route | TOPICAL |
| Active Ingredient Strength | 20; 105; 50; 20; 20 |
| Active Ingredient Units | mg/mL; mg/mL; mg/mL; mg/mL; mg/mL |
| Substance Name | AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE |
| Labeler Name | Cardinal Health |
| 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 37205-0728-34 (37205072834)
| NDC Package Code | 37205-728-34 |
|---|---|
| Billing NDC | 37205072834 |
| Package | 237 mL in 1 CAN (37205-728-34) |
| Marketing Start Date | 2012-01-15 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL a3ba66f3-6a5f-47fe-8307-bf6b111c109d Details
Active Ingredients
Uses
Keep out of reach of children.
Directions
- Apply liberally 15 minutes before sun exposure
- reapply:
- after 80 minutes 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 a.m. - 2 p.m.
- wear long sleeve shirts, pants, hats, and sunglasses
-
Children under 6 months: ask a doctor
Inactive Ingredients
water, sorbitan isostearate, sorbitol, triethanolamine, polyglyceryl-3 distearate, stearic acid, octadecene/MA copolymer, barium sulfate, benzyl alcohol, VP/eicosene copolymer, dimethicone, carbomer, methylparaben, aloe barbadensis leaf extract, simmondsia chinensis (jojoba) seed oil, tocopherol (vitamin E), cocos nucifera (coconut) oil, mineral oil, propylparaben, fragrance, disodium EDTA
Other infomation
PRINCIPAL DISPLAY PANEL
INGREDIENTS AND APPEARANCE
| LEADER
GENERAL PROTECTION SUNSCREEN SPF 30
avobenzone, homosalate, octisalate, octocrylene, oxybenzone lotion |
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| Labeler - Cardinal Health (097537435) |
Revised: 10/2022
Document Id: ea2d9a8d-9d98-70bf-e053-2a95a90a3dec
Set id: a3ba66f3-6a5f-47fe-8307-bf6b111c109d
Version: 6
Effective Time: 20221003