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NDC 70000-0545-01 Leader 45; 65 mg/mL; mg/mL Details
Leader 45; 65 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 TITANIUM DIOXIDE; ZINC OXIDE.
Product Information
NDC | 70000-0545 |
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Product ID | 70000-0545_ecb20e59-ea53-0799-e053-2a95a90aad1a |
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 | Kids Sunscreen SPF 50 |
Non-Proprietary Name | Titanium Dioxide, Zinc Oxide |
Product Type | HUMAN OTC DRUG |
Dosage Form | LOTION |
Route | TOPICAL |
Active Ingredient Strength | 45; 65 |
Active Ingredient Units | mg/mL; mg/mL |
Substance Name | TITANIUM DIOXIDE; ZINC OXIDE |
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 70000-0545-01 (70000054501)
NDC Package Code | 70000-0545-1 |
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Billing NDC | 70000054501 |
Package | 177 mL in 1 BOTTLE, PLASTIC (70000-0545-1) |
Marketing Start Date | 2019-12-11 |
NDC Exclude Flag | N |
Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL 9cbd9d67-9455-4094-9450-2eb42f6895ce Details
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
- Children under 6 months: 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 value 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 sleeved shirts, pants, hats, and sunglasses
Other infomation
Inactive Ingredients
water, caprylic/capric triglyceride, isohexadecane, butyloctyl salicylate, octyldodecyl citrate crosspolymer, cetyl PEG/PPG-10/1 dimethicone, lauryl PEG-8 dimethicone, C30-38 olefin/isopropyl maleate/MA copolymer, sodium chloride, ethylhexyl methoxycrylene, dimethicone, caprylyl glycol, PEG-8, silica, triethoxycaprylylsilane, glycerin, sodium citrate, tocopheryl acetate, benzyl alcohol, benzoic acid, sorbic acid.
INGREDIENTS AND APPEARANCE
LEADER
KIDS SUNSCREEN SPF 50
titanium dioxide, zinc oxide lotion |
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Labeler - Cardinal Health (063997360) |