FDA.reportPublic FDA data

Cardinal Health Leader

Manufacturer
Cardinal Health, Inc. | Fruit Of The Earth, Inc. | Fruit Of The Earth Research Laboratories, Inc.
Effective date
2018-02-20
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-02 01:03:08

Label at a glance#

ProductCardinal Health Leader SPF 30 General Protection Sunscreen Clear Continuous
Active ingredientAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE
Label structure14 sections

Indications and 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

Dosage and administration

• 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 doct...

Storage and handling

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

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

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

Purpose

OTC - PURPOSE SECTION

Sunscreen

Uses

INDICATIONS & USAGE SECTION

  • 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

WARNINGS SECTION

​For external use only

FLAMMABLE:

STORAGE AND HANDLING SECTION

• do not use near heat, flame or while smoking

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

OTC - DO NOT USE SECTION

​Do not use

  • ​​on damaged or broken skin

OTC - WHEN USING 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.

OTC - STOP USE SECTION

​Stop use and ask doctor if​

  • rash occurs.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

• 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

SPL UNCLASSIFIED SECTION

• protect this product from excessive heat and direct sun

• may stain or damage some fabrics, materials or surfaces

Inactive ingredients

INACTIVE INGREDIENT SECTION

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?

OTC - QUESTIONS SECTION

Call toll free 1-800-527-7731

PACKAGE LABEL.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) LabelLabel

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70000-0327-1GM - Gram70000-03270d92fd62-fddf-4c44-abde-bd75c601ffc312018-09-05

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 15 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
70000-032770000-0327-1

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 13 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALCOHOL3K9958V90MIACT
ACRYLATE/ISOBUTYL METHACRYLATE/N-TERT-OCTYLACRYLAMIDE COPOLYMER (75000 MW)JU3XHR8VWKIACT
STEAROXYTRIMETHYLSILANE9862TW94B2IACT
GLYCERINPDC6A3C0OXIACT
DIETHYLHEXYL SYRINGYLIDENEMALONATE3V5U97P248IACT
TOCOPHEROLR0ZB2556P8IACT
VITAMIN A PALMITATE1D1K0N0VVCIACT
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
AVOBENZONEG63QQF2NOXACTIB
HOMOSALATEV06SV4M95SACTIB
OCTISALATE4X49Y0596WACTIB
OCTOCRYLENE5A68WGF6WMACTIB
OXYBENZONE95OOS7VE0YACTIB

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
251892fa-ade0-70f8-e063-6394a90a0cb365ae16df-412e-213c-e053-2a91aa0ad3d22024-10-22WarningsExact identifier
spl set id: 65ae16df-412e-213c-e053-2a91aa0ad3d2

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.