Search by Drug Name or NDC

NDC 70000-0536-01 Leader 30; 100; 50; 100 mg/mL; mg/mL; mg/mL; mg/mL Details

Leader 30; 100; 50; 100 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, INC.. The primary component is AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE.

Product Information

NDC	70000-0536
Product ID	70000-0536_ecb182a4-c794-1c87-e053-2995a90a222d
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 SPF 30 Sunscreen
Non-Proprietary Name	avobenzone, homosalate, octisalate, octocrylene
Product Type	HUMAN OTC DRUG
Dosage Form	LOTION
Route	TOPICAL
Active Ingredient Strength	30; 100; 50; 100
Active Ingredient Units	mg/mL; mg/mL; mg/mL; mg/mL
Substance Name	AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE
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 70000-0536-01 (70000053601)

Pricing Information	N/A
NDC Package Code	70000-0536-1
Billing NDC	70000053601
Package	237 mL in 1 BOTTLE (70000-0536-1)
Marketing Start Date	2019-10-19
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 9544b046-055e-5886-e053-2a95a90ad09e Details

Active ingredients

Avobenzone 3.0%

Homosalate 10.0%

Octisalate 5.0%

Octocrylene 10.0%

Purpose

Sunscreen

Uses

helps prevent sunburn
if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun

Warnings

For external use only

Do not use

• on damaged or broken skin.

When using this product

• keep out of eyes. Rinse with water to remove

Stop use and ask a doctor if

• rash occurs.

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

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 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 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 information

• protect the product in this container from excessive heat and direct sun

• may stain or damage some fabrics, materials or surfaces

Inactive ingredients

water, sorbitol, ethylhexyl palmitate, polyamide-8, benzyl alcohol, diethylhexyl syringylidenemalonate, tocopherol (vitamin E), caprylic/capric triglyceride, triethanolamine, fragrance, acrylates/C10-30 alkyl acrylate crosspolymer, chlorphenesin, sodium ascorbyl phosphate, retinyl palmitate, oleth-3, disodium EDTA

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

LEADER GENERAL PROTECTION SPF 30 SUNSCREEN

avobenzone, homosalate, octisalate, octocrylene lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:70000-0536
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	30 mg in 1 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	100 mg in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	50 mg in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	100 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
SORBITOL (UNII: 506T60A25R)
TROLAMINE (UNII: 9O3K93S3TK)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
POLYAMIDE-8 (4500 MW) (UNII: 77723GV81A)
DIETHYLHEXYL SYRINGYLIDENEMALONATE (UNII: 3V5U97P248)
BENZYL ALCOHOL (UNII: LKG8494WBH)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
CARBOMER COPOLYMER TYPE A (UNII: 71DD5V995L)
CHLORPHENESIN (UNII: I670DAL4SZ)
SODIUM ASCORBYL PHOSPHATE (UNII: 836SJG51DR)
TOCOPHEROL (UNII: R0ZB2556P8)
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)
OLETH-3 (UNII: BQZ26235UC)
EDETATE DISODIUM (UNII: 7FLD91C86K)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:70000-0536-1	237 mL in 1 BOTTLE; Type 0: Not a Combination Product	10/19/2019

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part352	10/19/2019

Labeler - CARDINAL HEALTH, INC. (063997360)

Revised: 11/2022

Document Id: ecb182a4-c794-1c87-e053-2995a90a222d

Set id: 9544b046-055e-5886-e053-2a95a90ad09e

Version: 5

Effective Time: 20221104