FDA.reportPublic FDA data

Leader Dark Tanning SPF 4 Continuous Spray Sunscreen 6 fl oz - Drug Facts Label

Manufacturer
Cardinal Health | Fruit of the Earth
Effective date
2013-01-08
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-02 01:42:19

Label at a glance#

ProductLeader Dark Tanning SPF 4
Active ingredientOCTINOXATE, OXYBENZONE
Label structure14 sections

Indications and uses

• helps prevent sunburn

Dosage and administration

Apply liberally 15 minutes before sun exposure Hold can 4-6 inches away from 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 Immediately after towel drying At least every 2 hours

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Octinoxate 2.0%, Oxybenzone 0.5%

Purpose

OTC - PURPOSE SECTION

Sunscreen

Uses

INDICATIONS & USAGE SECTION

• helps prevent sunburn

Warnings

WARNINGS SECTION

Skin Cancer / Skin Aging Alert: Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to prevent sunburn, not skin cancer or early skin aging.

For external use only

FLAMMABLE

SAFE HANDLING WARNING SECTION

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

Do not use

OTC - DO NOT USE SECTION

on damaged or broken skin

When using this product

OTC - WHEN USING SECTION

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

Stop use and ask a doctor

OTC - STOP USE SECTION

if rash occurs.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

Apply liberally 15 minutes before sun exposure

Hold can 4-6 inches away from 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

Immediately after towel drying

At least every 2 hours

Sun Protection Measures

OTHER SAFETY INFORMATION

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 am - 2 pm

wear long sleeve shirts, pants, hats, and sunglasses

Children under 6 months: ask a doctor

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Alcohol denat., C12-15 alkyl benzoate, aloe barbadensis leaf juice, retinyl palmitate (vitamin A), ascorbic acid (vitamin C), tocopheryl acetate (vitamin E), daucus carota sativa (carrot) root extract, acrylates/octylacrylamide copolymer, fragrance

Questions or Comments?

OTC - QUESTIONS SECTION

Call toll free 1-800-200-6313

Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Image of labelImage of labelLabel8.jpg

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
OCTINOXATEACTIVE INGREDIENT4Y5P7MUD511
OXYBENZONEACTIVE INGREDIENT95OOS7VE0Y1
OCTINOXATEACTIVE MOIETY4Y5P7MUD511
OXYBENZONEACTIVE MOIETY95OOS7VE0Y1
.ALPHA.-TOCOPHEROL ACETATEINACTIVE INGREDIENT9E8X80D2L01
ALCOHOLINACTIVE INGREDIENT3K9958V90M1
ALOEINACTIVE INGREDIENTV5VD430YW91
ASCORBIC ACIDINACTIVE INGREDIENTPQ6CK8PD0R1
C12-15 ALKYL BENZOATEINACTIVE INGREDIENTA9EJ3J61HQ1
CARROT JUICEINACTIVE INGREDIENTQXF936IX431
VITAMIN A PALMITATEINACTIVE INGREDIENT1D1K0N0VVC1

Products#

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

DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
37205-72237205-722-30

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Name, UNII, Kind table
NameUNIIKind
OCTINOXATE4Y5P7MUD51ACTIB
OXYBENZONE95OOS7VE0YACTIB
ALCOHOL3K9958V90MIACT
CARROT JUICEQXF936IX43IACT
C12-15 ALKYL BENZOATEA9EJ3J61HQIACT
ASCORBIC ACIDPQ6CK8PD0RIACT
VITAMIN A PALMITATE1D1K0N0VVCIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
ALOEV5VD430YW9IACT

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 2 · 87 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
ASCORBIC ACIDASCORBIC ACIDPQ6CK8PD0RTABLET, FILM COATED / ORAL20 mgExact identifier — unii candidate
25 equally ranked IID candidates
ASCORBIC ACIDASCORBIC ACIDPQ6CK8PD0RINJECTION, SOLUTION / INTRAVENOUS4 mgExact identifier — unii candidate
25 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSOLUTION / OPHTHALMIC0.5 %w/vExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MMOUTHWASH / BUCCAL200 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MAEROSOL, SPRAY / TOPICAL561 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSUSPENSION / RECTAL0.35 %v/vExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MJELLY / VAGINALNAExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MPOWDER, FOR SOLUTION / TOPICAL40 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MAEROSOL, SPRAY / RESPIRATORY (INHALATION)35.75 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MCONCENTRATE / BUCCAL679 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSOLUTION / TRANSDERMAL49.37 %w/vExact identifier — unii candidate
59 equally ranked IID candidates
ASCORBIC ACIDASCORBIC ACIDPQ6CK8PD0RSOLUTION / RESPIRATORY (INHALATION)0.04 %w/wExact identifier — unii candidate
25 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MAEROSOL / NASAL20 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSHAMPOO / TOPICAL714 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MINJECTION / INTRAVASCULAR100 %v/vExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSOLUTION / NASAL10 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MGEL / DENTAL1.8 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSWAB / TOPICAL2250 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSPRAY / TOPICAL3633 mgExact identifier — unii candidate
59 equally ranked IID candidates
ASCORBIC ACIDASCORBIC ACIDPQ6CK8PD0RSUSPENSION, EXTENDED RELEASE / ORAL6 mgExact identifier — unii candidate
25 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MCAPSULE / ORAL882 mgExact identifier — unii candidate
59 equally ranked IID candidates
ASCORBIC ACIDASCORBIC ACIDPQ6CK8PD0RINJECTION, SOLUTION / INFILTRATION0.2 %w/vExact identifier — unii candidate
25 equally ranked IID candidates
ASCORBIC ACIDASCORBIC ACIDPQ6CK8PD0RINJECTION / INTRAVENOUS1440 mgExact identifier — unii candidate
25 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MINJECTION / INTRAMUSCULAR1491 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MGEL / TRANSDERMAL7360 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MPASTE / DENTAL1.8 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MINJECTION / SUBCUTANEOUS149 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MCAPSULE, EXTENDED RELEASE / ORAL8 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MINJECTION, SOLUTION / INTRAMUSCULAR1000 mgExact identifier — unii candidate
59 equally ranked IID candidates
ASCORBIC ACIDASCORBIC ACIDPQ6CK8PD0RTABLET / ORAL80 mgExact identifier — unii candidate
25 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSOLUTION / RESPIRATORY (INHALATION)0.08 %w/vExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSPRAY / TRANSDERMAL90 %w/vExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MINJECTION / INTRAVENOUS92 %w/vExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSPRAY / NASAL20 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MLIQUID / ORAL3563 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MTABLET, DELAYED RELEASE / ORALNAExact identifier — unii candidate
59 equally ranked IID candidates
ASCORBIC ACIDASCORBIC ACIDPQ6CK8PD0RAEROSOL, SPRAY / RESPIRATORY (INHALATION)0.11 %w/wExact identifier — unii candidate
25 equally ranked IID candidates
ASCORBIC ACIDASCORBIC ACIDPQ6CK8PD0RINJECTION / INTRAMUSCULAR192 mgExact identifier — unii candidate
25 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSOLUTION / TOPICAL2445 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSUSPENSION / ORAL681 mgExact identifier — unii candidate
59 equally ranked IID candidates
.ALPHA.-TOCOPHEROL ACETATE.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0TABLET / ORAL0.5 mgExact identifier — unii candidate
3 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MAEROSOL / TOPICAL561 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MDROPS / NASAL10 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSPRAY, METERED / SUBLINGUAL29 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSOLUTION / DENTAL12.8 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
ASCORBIC ACIDASCORBIC ACIDPQ6CK8PD0RGEL / TOPICAL7 mgExact identifier — unii candidate
25 equally ranked IID candidates
ASCORBIC ACIDASCORBIC ACIDPQ6CK8PD0RSUSPENSION / ORAL520 mgExact identifier — unii candidate
25 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MCONCENTRATE / ORAL198 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MGEL / TOPICAL9971 mgExact identifier — unii candidate
59 equally ranked IID candidates
ASCORBIC ACIDASCORBIC ACIDPQ6CK8PD0RSOLUTION / TOPICAL0.04 %w/wExact identifier — unii candidate
25 equally ranked IID candidates
ASCORBIC ACIDASCORBIC ACIDPQ6CK8PD0RSYRUP / ORAL200 mgExact identifier — unii candidate
25 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MINJECTION, SOLUTION / SUBCUTANEOUS6.1 %v/vExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSYRUP / ORAL21000 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MAEROSOL, METERED / RESPIRATORY (INHALATION)26664 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSOLUTION / INTRAVESICAL7892 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MDROPS / ORAL210 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MAEROSOL, METERED / NASAL70 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MLIQUID / INTRAMUSCULAR400 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MLOTION / TOPICAL25 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MGEL, METERED / TOPICAL541 mgExact identifier — unii candidate
59 equally ranked IID candidates

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
97d9c99a-e5d6-a191-e053-2a95a90a1842db5f842b-7ae8-40bf-89b0-d875b31e86fb2019-11-21WarningsExact identifier
spl set id: db5f842b-7ae8-40bf-89b0-d875b31e86fb

Reported adverse events (FAERS/openFDA)#

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