Eight Hour Cream Targeted Sun Defense SPF 50

Manufacturer
Elizabeth Arden, Inc
Effective date
2011-01-13
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-05-31 22:28:37

Label at a glance#

ProductEight Hour Cream Targeted Sun Defense SPF 50
Active ingredientHOMOSALATE, OCTINOXATE, OCTOCRYLENE, OXYBENZONE, AVOBENZONE
Label structure10 sections

Indications and uses

Directions: Apply liberally and evenly to targeted areas 30 minutes before sun exposure and as needed. Reapply after 40 minutes of swimming or perspiring, and after towel drying. Otherwise, reapply at least every 2 hours. Children under 6 months of age: ask a doctor.

Label contents#

Full prescribing information#

DESCRIPTION

DESCRIPTION SECTION

Target over-exposed areas such as lips, nose, earlobes, even scars to shield from the burning and aging effects of UVA and UVB rays. Eight Hour Cream hydrating benefits sooth and smooth for up to 8 hours.

Oil-free. Water-resistant. PABA-free. Non-acnegenic. Perspiration-resistant. Suitable for all skin types. Ophthalmologist, clinically and dermatologist tested.

Uses: Helps prevent sunburn. Higher SPF gives more sunburn protection. Retains SPF after 40 minutes of swimming or perspiring.

Sun Alert: Limiting sun exposure, wearing protective clothing and using sunscreens may reduce the risk of skin cancer and other harmful effects of the sun.

INDICATIONS AND USAGE

INDICATIONS & USAGE SECTION

Directions: Apply liberally and evenly to targeted areas 30 minutes before sun exposure and as needed. Reapply after 40 minutes of swimming or perspiring, and after towel drying. Otherwise, reapply at least every 2 hours. Children under 6 months of age: ask a doctor.

WARNINGS

WARNINGS SECTION

Warnings: For external use only. When using this product, keep out of eyes. Rinse with water to remove. Stop use and ask a doctor if rash or irritation develops and lasts. Keep out of reach of children. If swallowed, get medical help or contact a poison controll center right away.

OTC - ACTIVE INGREDIENT

OTC - ACTIVE INGREDIENT SECTION

Active Ingredients: Homosalate 7.5% w/w, Octinoxate 7.5% w/w, Octocrylene 5.0% w/w, Oxybenzone 4.0% w/w, Avobenzone 2.0% w/w.

INACTIVE INGREDIENT

INACTIVE INGREDIENT SECTION

Other Ingredients: Octyldodecyl Myristate, Polyethylene, Phenyl Trimethicone, Tocopheryl Acetate, Caprylyl Glycol, Parfum/Fragrance, Citral, Citronellol, Geraniol, Limonene, Linalool, Phenoxyethanol.

DOSAGE & ADMINISTRATION

DOSAGE & ADMINISTRATION SECTION

Apply evenly and liberally to targeted areas.

OTC - KEEP OUT OF REACH OF CHILDREN

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

OTC - PURPOSE

OTC - PURPOSE SECTION

Helps prevent sunburn. Higher SPF gives more sun protection.

OTC - WHEN USING

OTC - WHEN USING SECTION

Keep out of eyes.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

 Eight Hour Cream Targeted Sun Defense Stick BoxEight Hour Cream Targeted Sun Defense Stick Box

 Eight Hour Cream Targeted Sun Defense Stick TubeEight Hour Cream Targeted Sun Defense Stick Tube

 

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
67938-1130-12020-01-31C16284748780-19d75b9d0-89cb-f424-e053-dadaa90a57ceBC1130

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67938-1130-1Eight Hour Cream Targeted Sun Defense SPF 501 in 1 BOXSTICK14
67938-1130-2Eight Hour Cream Targeted Sun Defense SPF 506.8 g in 1 TUBESTICK6.84

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67938-1130EIGHT HOUR CREAM TARGETED SUN DEFENSE SPF 50 (HOMOSALATE) STICK [ELIZABETH ARDEN, INC]4Legacy NDC, 2 package rows20110718_b8bcb692-3a6c-4c57-8fd2-1298011bd245.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
AVOBENZONEACTIVE INGREDIENTG63QQF2NOX4
HOMOSALATEACTIVE INGREDIENTV06SV4M95S4
OCTINOXATEACTIVE INGREDIENT4Y5P7MUD514
OCTOCRYLENEACTIVE INGREDIENT5A68WGF6WM4
OXYBENZONEACTIVE INGREDIENT95OOS7VE0Y4
AVOBENZONEACTIVE MOIETYG63QQF2NOX4
HOMOSALATEACTIVE MOIETYV06SV4M95S4
OCTINOXATEACTIVE MOIETY4Y5P7MUD514
OCTOCRYLENEACTIVE MOIETY5A68WGF6WM4
OXYBENZONEACTIVE MOIETY95OOS7VE0Y4
CAPRYLYL GLYCOLINACTIVE INGREDIENT00YIU5438U4
OCTYLDODECYL MYRISTATEINACTIVE INGREDIENTS013N99GR84
PHENOXYETHANOLINACTIVE INGREDIENTHIE492ZZ3T4
PHENYL TRIMETHICONEINACTIVE INGREDIENTDR0K5NOJ4R4

Products#

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

DailyMed product names page 1 of 1 · 10 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
67938-113067938-1130-2, 67938-1130-1

Ingredients#

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

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

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 1 · 6 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
PHENOXYETHANOLPHENOXYETHANOLHIE492ZZ3TAEROSOL / TOPICAL1.05 %w/wExact identifier — unii candidate
6 equally ranked IID candidates
PHENOXYETHANOLPHENOXYETHANOLHIE492ZZ3TAEROSOL, FOAM / TOPICAL72 mgExact identifier — unii candidate
6 equally ranked IID candidates
PHENOXYETHANOLPHENOXYETHANOLHIE492ZZ3TLOTION / TOPICAL1 %w/wExact identifier — unii candidate
6 equally ranked IID candidates
PHENOXYETHANOLPHENOXYETHANOLHIE492ZZ3TCREAM / TOPICAL57 mgExact identifier — unii candidate
6 equally ranked IID candidates
PHENOXYETHANOLPHENOXYETHANOLHIE492ZZ3TGEL / TOPICAL14 mgExact identifier — unii candidate
6 equally ranked IID candidates
PHENOXYETHANOLPHENOXYETHANOLHIE492ZZ3TCREAM, AUGMENTED / TOPICAL10 mgExact identifier — unii candidate
6 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
fa51c66b-22fb-44cc-8a99-b4178c023739b8bcb692-3a6c-4c57-8fd2-1298011bd2452011-01-13WarningsExact identifier
spl id: fa51c66b-22fb-44cc-8a99-b4178c023739
spl set id: b8bcb692-3a6c-4c57-8fd2-1298011bd245

Reported adverse events (FAERS/openFDA)#

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