Eight Hour Cream Lip Protectant SPF 15

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 22:28:37

Label at a glance#

ProductEight Hour Cream Lip Protectant SPF 15

Active ingredientPETROLATUM, PADIMATE O, OXYBENZONE

Label structure10 sections

Indications and uses

Apply to lips.

Label contents#

Full prescribing information#

DESCRIPTION

DESCRIPTION SECTION

An all weather treatment stick for softer, smoother lips. Sunscreen ingredients (SPF 15) guard against the damaging effects of sun exposure. Dermatologist, clinically and allergy tested.

INDICATIONS AND USAGE

INDICATIONS & USAGE SECTION

Apply to lips.

WARNINGS

WARNINGS SECTION

Warnings: Discontinue use if signs of irritation or rash appear and see a doctor. Keep out of reach of children.

OTC - ACTIVE INGREDIENT

OTC - ACTIVE INGREDIENT SECTION

Active Ingredients: Petrolatum 30.2% w/w, Padimate O 8.0% w/w, Oxybenzone 3.0% w/w.

INACTIVE INGREDIENT

INACTIVE INGREDIENT SECTION

Other Ingredients: Ricinus Communis (Castor) Seed Oil, Ozokerite, Glyceryl Rosinate, Cetyl Lactate, Myristyl Lactate, Lanolin Oil, Cetyl Acetate, Euphorbia Cerifera (Candelilla) Wax/Candelilla Cera/Cire de Candelilla, Copernicia Cerifera (Carnauba) Wax/Cera Carnauba/Cire De Carnauba, Beeswax/Cera Alba/Cire D'Abeille, Tocopherol, Acetylated Lanolin Alcohol, Methylstyrene/Vinyltoluene Copolymer, Microcrystalline Wax/Cera Microcristallina/Cire Microcristalline, BHT, Vegetable Oil/Olus/Huille Vegetale, Zea Mays (Corn) Oil, Parfum/Fragrance, Citral, Citronellol, Geraniol, Limonene, Linalool, Butylparaben, Propylparaben, Iron Oxides.

DOSAGE & ADMINISTRATION

DOSAGE & ADMINISTRATION SECTION

Apply to lips.

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

Protects skin. Provides SPF 15 sun protection.

OTC - WHEN USING

OTC - WHEN USING SECTION

Discontinue use if signs of irritation or rash appear.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Eight Hour Cream Lip Protectant Stick Box

Eight Hour Cream Lip Protectant Stick Base Label

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
67938-0774-1	2020-01-31	C162847	48780-1	9d75b9d0-208c-f424-e053-dadaa90a57ce	BL0774

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
67938-0774-1	Eight Hour Cream Lip Protectant SPF 15	1 in 1 BOX	STICK	1		3
67938-0774-2	Eight Hour Cream Lip Protectant SPF 15	3.7 g in 1 TUBE	STICK	3.7		3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
67938-0774	EIGHT HOUR CREAM LIP PROTECTANT SPF 15 (PETROLATUM) STICK [ELIZABETH ARDEN, INC]	3	Legacy NDC, 2 package rows	20110718_aeeb3768-e03d-43c8-9cd0-7e8a8508b207.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
OXYBENZONE	ACTIVE INGREDIENT	95OOS7VE0Y	3
PADIMATE O	ACTIVE INGREDIENT	Z11006CMUZ	3
PETROLATUM	ACTIVE INGREDIENT	4T6H12BN9U	3
OXYBENZONE	ACTIVE MOIETY	95OOS7VE0Y	3
PADIMATE O	ACTIVE MOIETY	Z11006CMUZ	3
PETROLATUM	ACTIVE MOIETY	4T6H12BN9U	3
ALPHA-TOCOPHEROL	INACTIVE INGREDIENT	H4N855PNZ1	3
BUTYLATED HYDROXYTOLUENE	INACTIVE INGREDIENT	1P9D0Z171K	3
BUTYLPARABEN	INACTIVE INGREDIENT	3QPI1U3FV8	3
CANDELILLA WAX	INACTIVE INGREDIENT	WL0328HX19	3
CASTOR OIL	INACTIVE INGREDIENT	D5340Y2I9G	3
CORN OIL	INACTIVE INGREDIENT	8470G57WFM	3
MICROCRYSTALLINE WAX	INACTIVE INGREDIENT	XOF597Q3KY	3
MYRISTYL LACTATE	INACTIVE INGREDIENT	1D822OC34X	3
OXYBENZONE	INACTIVE INGREDIENT	95OOS7VE0Y	3
PROPYLPARABEN	INACTIVE INGREDIENT	Z8IX2SC1OH	3
YELLOW WAX	INACTIVE INGREDIENT	2ZA36H0S2V	3

Products#

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

DailyMed product names page 1 of 1 · 14 matching rows.

Eight Hour Cream Lip Protectant SPF 15
Petrolatum
PADIMATE O
OXYBENZONE
CASTOR OIL
MYRISTYL LACTATE
CANDELILLA WAX
YELLOW WAX
MICROCRYSTALLINE WAX
PROPYLPARABEN
BUTYLPARABEN
CORN OIL
ALPHA-TOCOPHEROL
BUTYLATED HYDROXYTOLUENE

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
67938-0774	67938-0774-2, 67938-0774-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 14 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
PETROLATUM	4T6H12BN9U	ACTIB
PADIMATE O	Z11006CMUZ	ACTIB
OXYBENZONE	95OOS7VE0Y	ACTIB
CASTOR OIL	D5340Y2I9G	IACT
MYRISTYL LACTATE	1D822OC34X	IACT
OXYBENZONE	95OOS7VE0Y	IACT
CANDELILLA WAX	WL0328HX19	IACT
YELLOW WAX	2ZA36H0S2V	IACT
MICROCRYSTALLINE WAX	XOF597Q3KY	IACT
PROPYLPARABEN	Z8IX2SC1OH	IACT
BUTYLPARABEN	3QPI1U3FV8	IACT
CORN OIL	8470G57WFM	IACT
ALPHA-TOCOPHEROL	H4N855PNZ1	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 3 · 170 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
BUTYLPARABEN	BUTYLPARABEN	3QPI1U3FV8	LOTION / TOPICAL		4 mg	Exact identifier — unii candidate 15 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	INJECTION, SOLUTION / INTRAMUSCULAR		5 mg	Exact identifier — unii candidate 68 equally ranked IID candidates
CORN OIL	CORN OIL	8470G57WFM	SUSPENSION / ORAL	2.5 ml/5ml		Exact identifier — unii candidate 11 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	INJECTION / PARENTERAL		2 mg	Exact identifier — unii candidate 68 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	INJECTION, SUSPENSION / INTRAMUSCULAR	0.02 %w/v		Exact identifier — unii candidate 68 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	INJECTION, SUSPENSION / SUBCUTANEOUS	0.02 %w/v		Exact identifier — unii candidate 68 equally ranked IID candidates
CORN OIL	CORN OIL	8470G57WFM	TABLET, CHEWABLE / ORAL	NA		Exact identifier — unii candidate 11 equally ranked IID candidates
YELLOW WAX	YELLOW WAX	2ZA36H0S2V	CREAM / TOPICAL	5 %w/w		Exact identifier — unii candidate 9 equally ranked IID candidates
BUTYLATED HYDROXYTOLUENE	BUTYLATED HYDROXYTOLUENE	1P9D0Z171K	CAPSULE, EXTENDED RELEASE / ORAL	0.03 mg		Exact identifier — unii candidate 32 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	SOLUTION / NASAL	140 mg		Exact identifier — unii candidate 68 equally ranked IID candidates
YELLOW WAX	YELLOW WAX	2ZA36H0S2V	TABLET, SUGAR COATED / ORAL	NA		Exact identifier — unii candidate 9 equally ranked IID candidates
ALPHA-TOCOPHEROL	.ALPHA.-TOCOPHEROL	H4N855PNZ1	FILM, SOLUBLE / BUCCAL	0.07 mg		Exact identifier — unii candidate 10 equally ranked IID candidates
BUTYLATED HYDROXYTOLUENE	BUTYLATED HYDROXYTOLUENE	1P9D0Z171K	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS	0.02 mg		Exact identifier — unii candidate 32 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	SUSPENSION / ORAL		64 mg	Exact identifier — unii candidate 68 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	SOLUTION / ORAL	100 mg		Exact identifier — unii candidate 68 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	INJECTION, POWDER, FOR SOLUTION / INTRAVENOUS	0.8 mg		Exact identifier — unii candidate 68 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	LIQUID / ORAL		2 mg	Exact identifier — unii candidate 68 equally ranked IID candidates
MICROCRYSTALLINE WAX	MICROCRYSTALLINE WAX	XOF597Q3KY	GEL / TOPICAL	NA		Exact identifier — unii candidate 4 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	SUPPOSITORY / VAGINAL	NA		Exact identifier — unii candidate 68 equally ranked IID candidates
BUTYLATED HYDROXYTOLUENE	BUTYLATED HYDROXYTOLUENE	1P9D0Z171K	GUM, CHEWING / BUCCAL		5 mg	Exact identifier — unii candidate 32 equally ranked IID candidates
BUTYLATED HYDROXYTOLUENE	BUTYLATED HYDROXYTOLUENE	1P9D0Z171K	AEROSOL, FOAM / TOPICAL		4 mg	Exact identifier — unii candidate 32 equally ranked IID candidates
BUTYLATED HYDROXYTOLUENE	BUTYLATED HYDROXYTOLUENE	1P9D0Z171K	GEL / TOPICAL		8 mg	Exact identifier — unii candidate 32 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	CREAM / VAGINAL		3 mg	Exact identifier — unii candidate 68 equally ranked IID candidates
BUTYLATED HYDROXYTOLUENE	BUTYLATED HYDROXYTOLUENE	1P9D0Z171K	CREAM / VAGINAL	0.05 %w/w		Exact identifier — unii candidate 32 equally ranked IID candidates
BUTYLATED HYDROXYTOLUENE	BUTYLATED HYDROXYTOLUENE	1P9D0Z171K	CREAM / TOPICAL		6 mg	Exact identifier — unii candidate 32 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	SUSPENSION / RECTAL		271 mg	Exact identifier — unii candidate 68 equally ranked IID candidates
BUTYLPARABEN	BUTYLPARABEN	3QPI1U3FV8	SOLUTION / OPHTHALMIC	0.02 %w/w		Exact identifier — unii candidate 15 equally ranked IID candidates
BUTYLPARABEN	BUTYLPARABEN	3QPI1U3FV8	SOLUTION / RECTAL	0.01 %w/v		Exact identifier — unii candidate 15 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	INJECTION / INTRA-ARTICULAR	0.03 %w/v		Exact identifier — unii candidate 68 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	SPRAY / NASAL	0.2 mg		Exact identifier — unii candidate 68 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	POWDER / ORAL	NA		Exact identifier — unii candidate 68 equally ranked IID candidates
ALPHA-TOCOPHEROL	.ALPHA.-TOCOPHEROL	H4N855PNZ1	TABLET, CHEWABLE / ORAL	0.1 mg		Exact identifier — unii candidate 10 equally ranked IID candidates
BUTYLATED HYDROXYTOLUENE	BUTYLATED HYDROXYTOLUENE	1P9D0Z171K	LOTION / TOPICAL		1000 mg	Exact identifier — unii candidate 32 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	SUSPENSION / AURICULAR (OTIC)	NA		Exact identifier — unii candidate 68 equally ranked IID candidates
BUTYLPARABEN	BUTYLPARABEN	3QPI1U3FV8	LIQUID / TOPICAL	0.02 %w/w		Exact identifier — unii candidate 15 equally ranked IID candidates
CASTOR OIL	CASTOR OIL	D5340Y2I9G	TABLET / SUBLINGUAL	1.6 mg		Exact identifier — unii candidate 16 equally ranked IID candidates
BUTYLPARABEN	BUTYLPARABEN	3QPI1U3FV8	SOLUTION / ORAL		6 mg	Exact identifier — unii candidate 15 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	SUSPENSION, EXTENDED RELEASE / ORAL		4 mg	Exact identifier — unii candidate 68 equally ranked IID candidates
CASTOR OIL	CASTOR OIL	D5340Y2I9G	CAPSULE, EXTENDED RELEASE / ORAL		47 mg	Exact identifier — unii candidate 16 equally ranked IID candidates
MICROCRYSTALLINE WAX	MICROCRYSTALLINE WAX	XOF597Q3KY	CAPSULE, EXTENDED RELEASE / ORAL	6 mg		Exact identifier — unii candidate 4 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	CAPSULE, EXTENDED RELEASE / ORAL	0.22 mg		Exact identifier — unii candidate 68 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	SOLUTION / INTRAMUSCULAR	0.02 %w/v		Exact identifier — unii candidate 68 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	GEL / VAGINAL		2 mg	Exact identifier — unii candidate 68 equally ranked IID candidates
MICROCRYSTALLINE WAX	MICROCRYSTALLINE WAX	XOF597Q3KY	OINTMENT / TOPICAL		3575 mg	Exact identifier — unii candidate 4 equally ranked IID candidates
CASTOR OIL	CASTOR OIL	D5340Y2I9G	INJECTION, SOLUTION / INTRAMUSCULAR		525 mg	Exact identifier — unii candidate 16 equally ranked IID candidates
BUTYLATED HYDROXYTOLUENE	BUTYLATED HYDROXYTOLUENE	1P9D0Z171K	CAPSULE / ORAL		3 mg	Exact identifier — unii candidate 32 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	POWDER, FOR SUSPENSION / ORAL		8 mg	Exact identifier — unii candidate 68 equally ranked IID candidates
CANDELILLA WAX	CANDELILLA WAX	WL0328HX19	TABLET, FILM COATED / ORAL	0.8 mg		Exact identifier — unii candidate 4 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	ENEMA / RECTAL	0.02 %w/w		Exact identifier — unii candidate 68 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	INJECTION / INFILTRATION	0.35 mg		Exact identifier — unii candidate 68 equally ranked IID candidates
YELLOW WAX	YELLOW WAX	2ZA36H0S2V	OINTMENT / TOPICAL	20 %w/w		Exact identifier — unii candidate 9 equally ranked IID candidates
CASTOR OIL	CASTOR OIL	D5340Y2I9G	INJECTION / INTRAMUSCULAR		885 mg	Exact identifier — unii candidate 16 equally ranked IID candidates
BUTYLPARABEN	BUTYLPARABEN	3QPI1U3FV8	TABLET / ORAL	NA		Exact identifier — unii candidate 15 equally ranked IID candidates
BUTYLATED HYDROXYTOLUENE	BUTYLATED HYDROXYTOLUENE	1P9D0Z171K	OINTMENT / TOPICAL		57 mg	Exact identifier — unii candidate 32 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	SOLUTION / TOPICAL		24 mg	Exact identifier — unii candidate 68 equally ranked IID candidates
BUTYLATED HYDROXYTOLUENE	BUTYLATED HYDROXYTOLUENE	1P9D0Z171K	SPRAY / TOPICAL		3 mg	Exact identifier — unii candidate 32 equally ranked IID candidates
ALPHA-TOCOPHEROL	.ALPHA.-TOCOPHEROL	H4N855PNZ1	TABLET, EXTENDED RELEASE / ORAL		4 mg	Exact identifier — unii candidate 10 equally ranked IID candidates
CORN OIL	CORN OIL	8470G57WFM	SUSPENSION, EXTENDED RELEASE / ORAL		10 mg	Exact identifier — unii candidate 11 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	SOLUTION / RESPIRATORY (INHALATION)	0.01 %w/w		Exact identifier — unii candidate 68 equally ranked IID candidates
BUTYLATED HYDROXYTOLUENE	BUTYLATED HYDROXYTOLUENE	1P9D0Z171K	TABLET, FOR SUSPENSION / ORAL	0.1 mg		Exact identifier — unii candidate 32 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
1eef0736-09fc-40de-b8c0-a745842f4ea6			aeeb3768-e03d-43c8-9cd0-7e8a8508b207	2011-01-14	Warnings	Exact identifier spl id: 1eef0736-09fc-40de-b8c0-a745842f4ea6 spl set id: aeeb3768-e03d-43c8-9cd0-7e8a8508b207

Reported adverse events (FAERS/openFDA)#

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