Search by Drug Name or NDC

NDC 70000-0072-01 Cardinal Health Leader General Protection SPF 70 Sunscreen 30; 150; 50; 100 mg/g; mg/g; mg/g; mg/g Details

Cardinal Health Leader General Protection SPF 70 Sunscreen 30; 150; 50; 100 mg/g; mg/g; mg/g; mg/g

Cardinal Health Leader General Protection SPF 70 Sunscreen is a TOPICAL SPRAY 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	70000-0072
Product ID	70000-0072_e715df51-25f5-298a-e053-2a95a90a0464
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 General Protection SPF 70 Sunscreen
Proprietary Name Suffix	n/a
Non-Proprietary Name	Avobenzone, Homosalate, Octisalate, Octcrylene
Product Type	HUMAN OTC DRUG
Dosage Form	SPRAY
Route	TOPICAL
Active Ingredient Strength	30; 150; 50; 100
Active Ingredient Units	mg/g; mg/g; mg/g; mg/g
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 70000-0072-01 (70000007201)

Pricing Information	N/A
NDC Package Code	70000-0072-1
Billing NDC	70000007201
Package	156 g in 1 CAN (70000-0072-1)
Marketing Start Date	2020-12-09
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL b60cf360-7c8d-5da4-e053-2995a90a24c2 Details

Active ingredients

Avobenzone 3.0%, Homosalate 15.0%, 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

Flammable:

• do not use near heat, flame or while smoking

• avoid long term storage above 104°F (40°C)

Do not use

• on damaged or broken skin.

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.

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

• Spray liberally and spread evenly by hand 15 minutes before sun exposure

• Hold can 4-6 inches away from the skin to apply

• Do not spray directly into face. Spray into hands then apply to face

• Do not apply in windy conditions

• Use in a 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 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

SD alcohol 40-B, tridecyl salicylate, acrylates/octylacrylamide copolymer, butyloctyl salicylate, caprylic/capric triglyceride, fragrance, glycerin

Label

INGREDIENTS AND APPEARANCE

CARDINAL HEALTH LEADER GENERAL PROTECTION SPF 70 SUNSCREEN

avobenzone, homosalate, octisalate, octcrylene spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:70000-0072
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	50 mg in 1 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	100 mg in 1 g
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	150 mg in 1 g
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	30 mg in 1 g

Ingredient Name	Strength
Inactive Ingredients
ALCOHOL (UNII: 3K9958V90M)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
TRIDECYL SALICYLATE (UNII: AZQ08K38Z1)
GLYCERIN (UNII: PDC6A3C0OX)
ACRYLATE/ISOBUTYL METHACRYLATE/N-TERT-OCTYLACRYLAMIDE COPOLYMER (75000 MW) (UNII: JU3XHR8VWK)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:70000-0072-1	156 g in 1 CAN; Type 0: Not a Combination Product	12/09/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part352	12/09/2020

Labeler - CARDINAL HEALTH, INC. (063997360)

Revised: 8/2022

Document Id: e715df51-25f5-298a-e053-2a95a90a0464

Set id: b60cf360-7c8d-5da4-e053-2995a90a24c2

Version: 2

Effective Time: 20220825