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NDC 37205-0731-30 Leader 30; 100; 50; 20; 40 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL Details

Leader 30; 100; 50; 20; 40 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL

Leader is a TOPICAL AEROSOL, SPRAY 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	37205-0731
Product ID	37205-731_ea2db986-723c-7f1a-e053-2a95a90a7286
Associated GPIs
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
Non-Proprietary Name	Homosalate, Octisalate, Oxybenzone, Octocrylene, Avobenzone
Product Type	HUMAN OTC DRUG
Dosage Form	AEROSOL, SPRAY
Route	TOPICAL
Active Ingredient Strength	30; 100; 50; 20; 40
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 37205-0731-30 (37205073130)

Pricing Information	N/A
NDC Package Code	37205-731-30
Billing NDC	37205073130
Package	177 mL in 1 CAN (37205-731-30)
Marketing Start Date	2012-01-15
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 103bf2dc-a02f-432e-805c-71d00ac9cadf Details

Active Ingredients

Avobenzone 3.0%, Homosalate 10.0%, Octisalate 5.0%, Oxybenzone 4.0%, Octocrylene 2.0%

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

FLAMMABLE

do not use near heat, flame or while smoking
avoid long term storage above 104 deg F (40 degC)

Do not use

on damaged or broken skin

When using this product

keep out of eyes. Rinse with water to remove. Do not puncture or incinerate. Contents under pressure. Do not store at temperatures above 120 deg F.

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.

Directions

Apply liberally 15 minutes before sun exposure

Hold can 4-6 inches away form body, spray evenly to ensure complete coverage

Do not spray into face. Spray into hand and apply to face.

Use in well ventilated, but not windy areas

Reapply:

After 80 minutes of swimming or sweating

Immdiately 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 theis 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 am - 2 pm

wear long sleeve shirts, pants, hats, and sunglasses

Inactive Ingredients

Alcohol denat. (76.2% V/V), acrylates/octylacrylamide copolymer, stearoxytrimethylsilane, glycerin, diethylhexyl syringylidenemalonate, tocopherol (vitamin E), fragrance, retinyl palmitate (vitamin A palmitate), caprylic/capric triglyceride

PRINCIPAL DISPLAY PANEL

Leader General Protection SPF 30 Continuous Spray Sunscreen

Product NDC 37205-731

INGREDIENTS AND APPEARANCE

LEADER GENERAL PROTECTION SPF 30

homosalate, octisalate, oxybenzone, octocrylene, avobenzone aerosol, spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:37205-731
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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	20 mg in 1 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	40 mg in 1 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	30 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
ALCOHOL (UNII: 3K9958V90M)
STEAROXYTRIMETHYLSILANE (UNII: 9862TW94B2)
GLYCERIN (UNII: PDC6A3C0OX)
DIETHYLHEXYL SYRINGYLIDENEMALONATE (UNII: 3V5U97P248)
TOCOPHEROL (UNII: R0ZB2556P8)
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
ACRYLATE/ISOBUTYL METHACRYLATE/N-TERT-OCTYLACRYLAMIDE COPOLYMER (75000 MW) (UNII: JU3XHR8VWK)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:37205-731-30	177 mL in 1 CAN; Type 0: Not a Combination Product	01/15/2012

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part352	01/15/2012

Labeler - Cardinal Health (097537435)

Revised: 10/2022

Document Id: ea2db986-723c-7f1a-e053-2a95a90a7286

Set id: 103bf2dc-a02f-432e-805c-71d00ac9cadf

Version: 5

Effective Time: 20221003