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NDC 70000-0327-01 Cardinal Health Leader 30; 100; 50; 20; 40 mg/g; mg/g; mg/g; mg/g; mg/g Details

Cardinal Health Leader 30; 100; 50; 20; 40 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	70000-0327
Product ID	70000-0327_65ae16df-411e-213c-e053-2a91aa0ad3d2
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 30 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; 100; 50; 20; 40
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 70000-0327-01 (70000032701)

Pricing Information	N/A
NDC Package Code	70000-0327-1
Billing NDC	70000032701
Package	156 g in 1 CAN (70000-0327-1)
Marketing Start Date	2018-02-20
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 65ae16df-412e-213c-e053-2a91aa0ad3d2 Details

Active ingredients

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

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°F (40°C)

SPL UNCLASSIFIED SECTION

Do not use

on damaged or broken skin

SPL UNCLASSIFIED SECTION

When using this product • keep out of eyes. Rinse with water to remove. • keep away from face to avoid breathing it. • do not puncture or incinerate. Contents under pressure. • do not store at temperatures above 120° F.

SPL UNCLASSIFIED SECTION

Stop use and ask doctor if

rash occurs.

SPL UNCLASSIFIED SECTION

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

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

• protect this product from excessive heat and direct sun

• may stain or damage some fabrics, materials or surfaces

Inactive ingredients

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

Questions or comments?

Call toll free 1-800-527-7731

PRINCIPAL DISPLAY PANEL

Cardinal Health Leader SPF 30 General Protection Sunscreen Clear Continuous Spray

NDC: 70000-0327-1

NET WT 5.5 OZ (156 g)

INGREDIENTS AND APPEARANCE

CARDINAL HEALTH LEADER SPF 30 GENERAL PROTECTION SUNSCREEN CLEAR CONTINUOUS

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:70000-0327
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 g
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	100 mg in 1 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	50 mg in 1 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	20 mg in 1 g
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	40 mg in 1 g

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

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:70000-0327-1	156 g in 1 CAN; Type 0: Not a Combination Product	02/20/2018

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part352	02/20/2018

Labeler - Cardinal Health, Inc. (097537435)

Registrant - Fruit Of The Earth, Inc. (079559467)

Name	Address	ID/FEI	Business Operations
Establishment
Fruit Of The Earth Research Laboratories, Inc.		008193513	manufacture(70000-0327)

Revised: 2/2018

Document Id: 65ae16df-411e-213c-e053-2a91aa0ad3d2

Set id: 65ae16df-412e-213c-e053-2a91aa0ad3d2

Version: 1

Effective Time: 20180220

Search by Drug Name or NDC

NDC 70000-0327-01 Cardinal Health Leader 30; 100; 50; 20; 40 mg/g; mg/g; mg/g; mg/g; mg/g Details

Cardinal Health Leader 30; 100; 50; 20; 40 mg/g; mg/g; mg/g; mg/g; mg/g

Product Information

Package

Package Images

NDC 70000-0327-01 (70000032701)

Contents

Standard Product Labeling (SPL)/Prescribing Information SPL 65ae16df-412e-213c-e053-2a91aa0ad3d2 Details

Active ingredients

Purpose

Uses

Warnings

FLAMMABLE:

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

Directions

Other Information

Inactive ingredients

Questions or comments?

PRINCIPAL DISPLAY PANEL

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