Eight Hour Cream Sun Defense for Face SPF 50 Sunscreen

Manufacturer: Elizabeth Arden, Inc
Effective date: 2011-01-14
Label type: HUMAN OTC DRUG LABEL
Version: 3
Source: full-release
Hydrated at: 2026-05-31 22:28:44

Label at a glance#

ProductEight Hour Cream Sun Defense for Face SPF 50 Sunscreen

Active ingredientZINC OXIDE, OCTINOXATE, OCTISALATE

Label structure10 sections

Indications and uses

Directions: Apply liberally and evenly to face 30 minutes before sun exposure. Reapply as needed or after towel drying, swimming, or perspiring. Children under 6 months of age: ask a doctor.

Label contents#

Full prescribing information#

DESCRIPTION

DESCRIPTION SECTION

Provides powerful SPF 50 PA+++ protection to shield against UVA/UVB rays that can cause sunburn, surface skin cell damage and premature signs of aging. Lightweight, oil-free lotion helps protect your skin from sun exposure while hydrating for up to 8 hours. PABA free.

Uses: Helps prevent sunburn. Higher SPF gives more sunburn protection.

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 face 30 minutes before sun exposure. Reapply as needed or after towel drying, swimming, or perspiring. 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 is rash or irritation develops and lasts. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

OTC - ACTIVE INGREDIENT

OTC - ACTIVE INGREDIENT SECTION

Active Ingredients: Zinc Oxide 11.62% w/w, Octinoxate 7.40% w/w, Octisalate 5.00% w/w.

INACTIVE INGREDIENT

INACTIVE INGREDIENT SECTION

Water/Aqua/Eau, C12-25 Alkyl Benzoate, Isodecyl Neopentanoate, Neopentyl Glycol Diheptanoate, Magnesium Aluminum Silicate, Glyceryl Stearate, PEG-100 Stearate, Caprlyl Glycol, Arachidyl Alcohol, Polyhydroxystearic Acid, Arachidyl Glucoside, Triethoxycaprylylsilane, Behenyl Alcohol, Xanthan Gum, BHT, Disodium EDTA, Parfum/Fragrance, Citral, Citronellol, Geraniol, Limonene, Linalool, Methylparaben, Phenoxyethanol, Sorbic Acid.

DOSAGE & ADMINISTRATION

DOSAGE & ADMINISTRATION SECTION

Apply liberally and evenly to face.

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 sunburn protection.

OTC - WHEN USING

OTC - WHEN USING SECTION

Keep out of eyes.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Eight Hour Cream Sun Defense For Face Box

Eight Hour Cream Sun Defense For Face Tube

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
67938-1094-1	2019-10-29	C162847	48780-1	960f7f55-ccaa-8e05-e053-dbdaa90a074a	BC1094

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
67938-1094-1	Eight Hour Cream Sun Defense for Face SPF 50 Sunscreen	1 in 1 BOX	LOTION	1		3
67938-1094-2	Eight Hour Cream Sun Defense for Face SPF 50 Sunscreen	53 g in 1 TUBE	LOTION	53		3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
67938-1094	EIGHT HOUR CREAM SUN DEFENSE FOR FACE SPF 50 SUNSCREEN (ZINC OXIDE) LOTION [ELIZABETH ARDEN, INC]	3	Legacy NDC, 2 package rows	20110720_d6f9e599-8516-48ac-a7ab-31c847b235be.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
OCTINOXATE	ACTIVE INGREDIENT	4Y5P7MUD51	3
OCTISALATE	ACTIVE INGREDIENT	4X49Y0596W	3
ZINC OXIDE	ACTIVE INGREDIENT	SOI2LOH54Z	3
OCTINOXATE	ACTIVE MOIETY	4Y5P7MUD51	3
OCTISALATE	ACTIVE MOIETY	4X49Y0596W	3
ZINC OXIDE	ACTIVE MOIETY	SOI2LOH54Z	3
ALKYL (C12-15) BENZOATE	INACTIVE INGREDIENT	A9EJ3J61HQ	3
ARACHIDYL ALCOHOL	INACTIVE INGREDIENT	1QR1QRA9BU	3
ARACHIDYL GLUCOSIDE	INACTIVE INGREDIENT	6JVW35JOOJ	3
BUTYLATED HYDROXYTOLUENE	INACTIVE INGREDIENT	1P9D0Z171K	3
CAPRYLYL GLYCOL	INACTIVE INGREDIENT	00YIU5438U	3
DOCOSANOL	INACTIVE INGREDIENT	9G1OE216XY	3
EDETATE DISODIUM	INACTIVE INGREDIENT	7FLD91C86K	3
GLYCERYL MONOSTEARATE	INACTIVE INGREDIENT	230OU9XXE4	3
ISODECYL NEOPENTANOATE	INACTIVE INGREDIENT	W60VYE24XC	3
MAGNESIUM ALUMINUM SILICATE	INACTIVE INGREDIENT	6M3P64V0NC	3
METHYLPARABEN	INACTIVE INGREDIENT	A2I8C7HI9T	3
NEOPENTYL GLYCOL DIHEPTANOATE	INACTIVE INGREDIENT	5LKW3C543X	3
PEG-100 STEARATE	INACTIVE INGREDIENT	YD01N1999R	3
PHENOXYETHANOL	INACTIVE INGREDIENT	HIE492ZZ3T	3
SORBIC ACID	INACTIVE INGREDIENT	X045WJ989B	3
TRIETHOXYCAPRYLYLSILANE	INACTIVE INGREDIENT	LDC331P08E	3
WATER	INACTIVE INGREDIENT	059QF0KO0R	3
XANTHAN GUM	INACTIVE INGREDIENT	TTV12P4NEE	3

Products#

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

DailyMed product names page 1 of 1 · 22 matching rows.

Eight Hour Cream Sun Defense for Face SPF 50 Sunscreen
Zinc Oxide
OCTINOXATE
OCTISALATE
WATER
ALKYL (C12-15) BENZOATE
ISODECYL NEOPENTANOATE
NEOPENTYL GLYCOL DIHEPTANOATE
MAGNESIUM ALUMINUM SILICATE
GLYCERYL MONOSTEARATE
PEG-100 STEARATE
ARACHIDYL ALCOHOL
PHENOXYETHANOL
CAPRYLYL GLYCOL
DOCOSANOL
TRIETHOXYCAPRYLYLSILANE
XANTHAN GUM
EDETATE DISODIUM
METHYLPARABEN
ARACHIDYL GLUCOSIDE
SORBIC ACID
BUTYLATED HYDROXYTOLUENE

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
67938-1094	67938-1094-2, 67938-1094-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 21 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
ZINC OXIDE	SOI2LOH54Z	ACTIB
OCTINOXATE	4Y5P7MUD51	ACTIB
OCTISALATE	4X49Y0596W	ACTIB
WATER	059QF0KO0R	IACT
ALKYL (C12-15) BENZOATE	A9EJ3J61HQ	IACT
ISODECYL NEOPENTANOATE	W60VYE24XC	IACT
NEOPENTYL GLYCOL DIHEPTANOATE	5LKW3C543X	IACT
MAGNESIUM ALUMINUM SILICATE	6M3P64V0NC	IACT
GLYCERYL MONOSTEARATE	230OU9XXE4	IACT
PEG-100 STEARATE	YD01N1999R	IACT
ARACHIDYL ALCOHOL	1QR1QRA9BU	IACT
PHENOXYETHANOL	HIE492ZZ3T	IACT
CAPRYLYL GLYCOL	00YIU5438U	IACT
DOCOSANOL	9G1OE216XY	IACT
TRIETHOXYCAPRYLYLSILANE	LDC331P08E	IACT
XANTHAN GUM	TTV12P4NEE	IACT
EDETATE DISODIUM	7FLD91C86K	IACT
METHYLPARABEN	A2I8C7HI9T	IACT
ARACHIDYL GLUCOSIDE	6JVW35JOOJ	IACT
SORBIC ACID	X045WJ989B	IACT
BUTYLATED HYDROXYTOLUENE	1P9D0Z171K	IACT

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 5 · 285 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
PHENOXYETHANOL	PHENOXYETHANOL	HIE492ZZ3T	CREAM, AUGMENTED / TOPICAL		10 mg	Exact identifier — unii candidate 6 equally ranked IID candidates
GLYCERYL MONOSTEARATE	GLYCERYL MONOSTEARATE	230OU9XXE4	CAPSULE, DELAYED RELEASE / ORAL		15 mg	Exact identifier — unii candidate 21 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	INJECTION / INTRAVENOUS	10 %w/v		Exact identifier — unii candidate 77 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	DROPS / NASAL	0.1 mg/1ml		Exact identifier — unii candidate 77 equally ranked IID candidates
BUTYLATED HYDROXYTOLUENE	BUTYLATED HYDROXYTOLUENE	1P9D0Z171K	GUM, CHEWING / BUCCAL		5 mg	Exact identifier — unii candidate 32 equally ranked IID candidates
XANTHAN GUM	XANTHAN GUM	TTV12P4NEE	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL		36 mg	Exact identifier — unii candidate 29 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	INJECTION, POWDER, FOR SOLUTION / INTRAMUSCULAR	3.6 mg		Exact identifier — unii candidate 79 equally ranked IID candidates
XANTHAN GUM	XANTHAN GUM	TTV12P4NEE	POWDER, FOR SUSPENSION / ORAL		600 mg	Exact identifier — unii candidate 29 equally ranked IID candidates
BUTYLATED HYDROXYTOLUENE	BUTYLATED HYDROXYTOLUENE	1P9D0Z171K	TABLET, EXTENDED RELEASE / ORAL		1 mg	Exact identifier — unii candidate 32 equally ranked IID candidates
MAGNESIUM ALUMINUM SILICATE	MAGNESIUM ALUMINUM SILICATE	6M3P64V0NC	SHAMPOO / TOPICAL	1.25 %w/w		Exact identifier — unii candidate 17 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	SYRUP / ORAL		40 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	CAPSULE / ORAL		5 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	TABLET, COATED / ORAL	0.8 mg		Exact identifier — unii candidate 79 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	GEL / VAGINAL		8 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
SORBIC ACID	SORBIC ACID	X045WJ989B	TABLET, COATED / ORAL		1 mg	Exact identifier — unii candidate 19 equally ranked IID candidates
MAGNESIUM ALUMINUM SILICATE	MAGNESIUM ALUMINUM SILICATE	6M3P64V0NC	SUSPENSION / RECTAL		14480 mg	Exact identifier — unii candidate 17 equally ranked IID candidates
XANTHAN GUM	XANTHAN GUM	TTV12P4NEE	ENEMA / RECTAL		150 mg	Exact identifier — unii candidate 29 equally ranked IID candidates
PHENOXYETHANOL	PHENOXYETHANOL	HIE492ZZ3T	GEL / TOPICAL		14 mg	Exact identifier — unii candidate 6 equally ranked IID candidates
GLYCERYL MONOSTEARATE	GLYCERYL MONOSTEARATE	230OU9XXE4	SUSPENSION / OPHTHALMIC	0.5 %w/v		Exact identifier — unii candidate 21 equally ranked IID candidates
BUTYLATED HYDROXYTOLUENE	BUTYLATED HYDROXYTOLUENE	1P9D0Z171K	SOLUTION / TOPICAL		3 mg	Exact identifier — unii candidate 32 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	DROPS / OPHTHALMIC	0.01 %w/w		Exact identifier — unii candidate 79 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	POWDER, FOR SOLUTION / ORAL		126 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
MAGNESIUM ALUMINUM SILICATE	MAGNESIUM ALUMINUM SILICATE	6M3P64V0NC	SYRUP / ORAL	100 mg/1ml		Exact identifier — unii candidate 17 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	INJECTION / INTRAVENOUS		95 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
MAGNESIUM ALUMINUM SILICATE	MAGNESIUM ALUMINUM SILICATE	6M3P64V0NC	OINTMENT / VAGINAL		231 mg	Exact identifier — unii candidate 17 equally ranked IID candidates
SORBIC ACID	SORBIC ACID	X045WJ989B	EMULSION / OPHTHALMIC		1 mg	Exact identifier — unii candidate 19 equally ranked IID candidates
BUTYLATED HYDROXYTOLUENE	BUTYLATED HYDROXYTOLUENE	1P9D0Z171K	CREAM, AUGMENTED / TOPICAL	0.2 %w/w		Exact identifier — unii candidate 32 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	SUSPENSION / TOPICAL	0.24 %w/v		Exact identifier — unii candidate 79 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	SOLUTION / OPHTHALMIC	0.05 %w/w		Exact identifier — unii candidate 79 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	TABLET / ORAL	1.8 mg		Exact identifier — unii candidate 79 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	INJECTION / INTRA-ARTICULAR	0.05 %w/v		Exact identifier — unii candidate 77 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	AEROSOL, FOAM / TOPICAL	0.05 %w/w		Exact identifier — unii candidate 77 equally ranked IID candidates
SORBIC ACID	SORBIC ACID	X045WJ989B	TABLET, FILM COATED / ORAL		5 mg	Exact identifier — unii candidate 19 equally ranked IID candidates
BUTYLATED HYDROXYTOLUENE	BUTYLATED HYDROXYTOLUENE	1P9D0Z171K	SUPPOSITORY / RECTAL		1 mg	Exact identifier — unii candidate 32 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	SHAMPOO / TOPICAL	0.15 %w/w		Exact identifier — unii candidate 79 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	AEROSOL, FOAM / TOPICAL	0.16 %w/w		Exact identifier — unii candidate 79 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	SYSTEM / TOPICAL		126 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
XANTHAN GUM	XANTHAN GUM	TTV12P4NEE	TABLET, CHEWABLE, EXTENDED RELEASE / ORAL		6 mg	Exact identifier — unii candidate 29 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	INJECTION / INTRAVASCULAR	0.48 mg		Exact identifier — unii candidate 77 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	INJECTION / INFILTRATION		80 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	CREAM / TOPICAL		14 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	INJECTION, SOLUTION / SUBCUTANEOUS		2 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	SOLUTION / RESPIRATORY (INHALATION)	0.03 %w/w		Exact identifier — unii candidate 79 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	ENEMA / RECTAL		60 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
BUTYLATED HYDROXYTOLUENE	BUTYLATED HYDROXYTOLUENE	1P9D0Z171K	CAPSULE / ORAL		3 mg	Exact identifier — unii candidate 32 equally ranked IID candidates
MAGNESIUM ALUMINUM SILICATE	MAGNESIUM ALUMINUM SILICATE	6M3P64V0NC	LOTION / TOPICAL	1.5 %w/w		Exact identifier — unii candidate 17 equally ranked IID candidates
BUTYLATED HYDROXYTOLUENE	BUTYLATED HYDROXYTOLUENE	1P9D0Z171K	SPRAY / TOPICAL		3 mg	Exact identifier — unii candidate 32 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	INJECTION / PERINEURAL		80 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
SORBIC ACID	SORBIC ACID	X045WJ989B	TABLET, FILM COATED, EXTENDED RELEASE / ORAL		1 mg	Exact identifier — unii candidate 19 equally ranked IID candidates
BUTYLATED HYDROXYTOLUENE	BUTYLATED HYDROXYTOLUENE	1P9D0Z171K	CAPSULE, LIQUID FILLED / ORAL	0.1 mg		Exact identifier — unii candidate 32 equally ranked IID candidates
XANTHAN GUM	XANTHAN GUM	TTV12P4NEE	SOLUTION / OPHTHALMIC	0.6 %w/v		Exact identifier — unii candidate 29 equally ranked IID candidates
GLYCERYL MONOSTEARATE	GLYCERYL MONOSTEARATE	230OU9XXE4	LIQUID / TOPICAL	1 %w/w		Exact identifier — unii candidate 21 equally ranked IID candidates
BUTYLATED HYDROXYTOLUENE	BUTYLATED HYDROXYTOLUENE	1P9D0Z171K	INJECTION, POWDER, FOR SOLUTION / INTRAVENOUS	NA		Exact identifier — unii candidate 32 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	DROPS / AURICULAR (OTIC)	0.01 %w/w		Exact identifier — unii candidate 79 equally ranked IID candidates
BUTYLATED HYDROXYTOLUENE	BUTYLATED HYDROXYTOLUENE	1P9D0Z171K	INJECTION / INTRAVENOUS	NA		Exact identifier — unii candidate 32 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	SUSPENSION/ DROPS / ORAL		4 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	TABLET, COATED / ORAL	0.21 mg		Exact identifier — unii candidate 77 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	DROPS / OPHTHALMIC	0.05 %w/v		Exact identifier — unii candidate 77 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	TABLET, ORALLY DISINTEGRATING / ORAL		3 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	GEL / VAGINAL		5 mg	Exact identifier — unii candidate 77 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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
3b8062cc-06a4-496e-8aa5-8fe2a940014d			d6f9e599-8516-48ac-a7ab-31c847b235be	2011-01-14	Warnings	Exact identifier spl id: 3b8062cc-06a4-496e-8aa5-8fe2a940014d spl set id: d6f9e599-8516-48ac-a7ab-31c847b235be

Reported adverse events (FAERS/openFDA)#

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