Eight Hour Cream Lip Protectant Sheer Tint SPF 15 Berry

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 Sheer Tint SPF 15 Berry

Active ingredientPETROLATUM, PADIMATE O, OXYBENZONE

Label structure10 sections

Indications and uses

To Use: Apply liberally as often as necessary.

Label contents#

Full prescribing information#

DESCRIPTION

DESCRIPTION SECTION

Moisturizes, softens and smooths lips. Provides antioxidant protection with vitamin E. SPF 15 protects against UV exposure. Provides a sheer wash of color in 6 translucent shades. Dermatologist, clinically and allergy tested.

INDICATIONS AND USAGE

INDICATIONS & USAGE SECTION

To Use: Apply liberally as often as necessary.

WARNINGS

WARNINGS SECTION

Warning: If condition worsens or does not improve within 7 days, consult a physician.

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: Ozokerite, Ricinus Communis (Castor) Seed Oil, Glyceryl Rosinate, Cetyl Lactate, Lanolin Oil, Myristyl Lactate, Cetyl Acetate, Euphorbia Cerifera (Candelilla) Wax/Candelilla Cera/Cire De Candelilla, Copernicia Cerifera (Carnauba) Wax/Cer 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/Huile Vegetale, Zea Mays (Corn) Oil, Citral Citronellol, Geraniol, Limonene, Linalool, Butylparaben, Propylparaben.

May Contain: Blue 1 Lake (CI 42090), Iron Oxides (CI 77491, CI 77499, CI 77492), Red 6 Lake (CI 15850), Red 7 Lake (CI 15850), Red 21 Lake (CI 45380), Red 27 Lake (CI 45410), Titanium Dioxide (CI 77891), Yellow 5 Lake (CI 19140), Yellow 6 Lake (CI15985).

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

SPF 15 protects against UV exposure.

OTC - WHEN USING

OTC - WHEN USING SECTION

Note condition.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Sheer Tint Box

Sheer Tint Base Label

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
67938-1472-1	2020-01-31	C162847	48780-1	9d75b9d0-2e3c-f424-e053-dadaa90a57ce	BL1472

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
67938-1472-1	Eight Hour Cream Lip Protectant Sheer Tint SPF 15 Berry	1 in 1 BOX	STICK	1		3
67938-1472-2	Eight Hour Cream Lip Protectant Sheer Tint SPF 15 Berry	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
67938-1472	EIGHT HOUR CREAM LIP PROTECTANT SHEER TINT SPF 15 BERRY (PETROLATUM) STICK [ELIZABETH ARDEN, INC]	3	Legacy NDC, 2 package rows	20110718_802a78a2-26c1-49ae-ac3b-e6b32ae93563.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
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 Sheer Tint SPF 15 Berry
Petrolatum
PADIMATE O
OXYBENZONE
CASTOR OIL
MYRISTYL LACTATE
CANDELILLA WAX
YELLOW WAX
MICROCRYSTALLINE WAX
BUTYLPARABEN
PROPYLPARABEN
BUTYLATED HYDROXYTOLUENE
ALPHA-TOCOPHEROL
CORN OIL

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
67938-1472	67938-1472-2, 67938-1472-1

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
Name	UNII	Kind
PETROLATUM	4T6H12BN9U	ACTIB
PADIMATE O	Z11006CMUZ	ACTIB
OXYBENZONE	95OOS7VE0Y	ACTIB
CASTOR OIL	D5340Y2I9G	IACT
MYRISTYL LACTATE	1D822OC34X	IACT
CANDELILLA WAX	WL0328HX19	IACT
YELLOW WAX	2ZA36H0S2V	IACT
MICROCRYSTALLINE WAX	XOF597Q3KY	IACT
BUTYLPARABEN	3QPI1U3FV8	IACT
PROPYLPARABEN	Z8IX2SC1OH	IACT
BUTYLATED HYDROXYTOLUENE	1P9D0Z171K	IACT
ALPHA-TOCOPHEROL	H4N855PNZ1	IACT
CORN OIL	8470G57WFM	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
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	ENEMA / RECTAL	0.02 %w/w		Exact identifier — unii candidate 68 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	SUPPOSITORY / VAGINAL	NA		Exact identifier — unii candidate 68 equally ranked IID candidates
MICROCRYSTALLINE WAX	MICROCRYSTALLINE WAX	XOF597Q3KY	CAPSULE, EXTENDED RELEASE / ORAL	6 mg		Exact identifier — unii candidate 4 equally ranked IID candidates
MYRISTYL LACTATE	MYRISTYL LACTATE	1D822OC34X	LOTION / TOPICAL		64 mg	Exact identifier — unii candidate
BUTYLATED HYDROXYTOLUENE	BUTYLATED HYDROXYTOLUENE	1P9D0Z171K	CAPSULE / ORAL		3 mg	Exact identifier — unii candidate 32 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	SOLUTION / RECTAL	0.02 %w/v		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
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	SHAMPOO / TOPICAL	0.03 %w/w		Exact identifier — unii candidate 68 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	CREAM / TOPICAL		6 mg	Exact identifier — unii candidate 68 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	SOLUTION / RESPIRATORY (INHALATION)	0.01 %w/w		Exact identifier — unii candidate 68 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	SUSPENSION / AURICULAR (OTIC)	NA		Exact identifier — unii candidate 68 equally ranked IID candidates
BUTYLATED HYDROXYTOLUENE	BUTYLATED HYDROXYTOLUENE	1P9D0Z171K	SOLUTION / ORAL		14 mg	Exact identifier — unii candidate 32 equally ranked IID candidates
BUTYLATED HYDROXYTOLUENE	BUTYLATED HYDROXYTOLUENE	1P9D0Z171K	SPRAY, METERED / NASAL	0.1 mg/1ml		Exact identifier — unii candidate 32 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	DROPS / OPHTHALMIC	0.01 %w/w		Exact identifier — unii candidate 68 equally ranked IID candidates
YELLOW WAX	YELLOW WAX	2ZA36H0S2V	TABLET / ORAL	3.22 mg		Exact identifier — unii candidate 9 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	AEROSOL, FOAM / TOPICAL	0.04 %w/w		Exact identifier — unii candidate 68 equally ranked IID candidates
CASTOR OIL	CASTOR OIL	D5340Y2I9G	TABLET / ORAL		17 mg	Exact identifier — unii candidate 16 equally ranked IID candidates
MICROCRYSTALLINE WAX	MICROCRYSTALLINE WAX	XOF597Q3KY	GEL / TOPICAL	NA		Exact identifier — unii candidate 4 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	INJECTION, SOLUTION / INTRAVENOUS		5 mg	Exact identifier — unii candidate 68 equally ranked IID candidates
BUTYLPARABEN	BUTYLPARABEN	3QPI1U3FV8	TABLET, COATED / ORAL	0.08 mg		Exact identifier — unii candidate 15 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	SOLUTION / OPHTHALMIC	0.02 %w/w		Exact identifier — unii candidate 68 equally ranked IID candidates
BUTYLPARABEN	BUTYLPARABEN	3QPI1U3FV8	SUSPENSION / ORAL		12 mg	Exact identifier — unii candidate 15 equally ranked IID candidates
YELLOW WAX	YELLOW WAX	2ZA36H0S2V	CAPSULE, EXTENDED RELEASE / ORAL	80.67 mg		Exact identifier — unii candidate 9 equally ranked IID candidates
MICROCRYSTALLINE WAX	MICROCRYSTALLINE WAX	XOF597Q3KY	OINTMENT / TOPICAL		3575 mg	Exact identifier — unii candidate 4 equally ranked IID candidates
YELLOW WAX	YELLOW WAX	2ZA36H0S2V	TABLET, DELAYED RELEASE / ORAL	0.1 mg		Exact identifier — unii candidate 9 equally ranked IID candidates
BUTYLATED HYDROXYTOLUENE	BUTYLATED HYDROXYTOLUENE	1P9D0Z171K	FILM, SOLUBLE / ORAL	0.06 mg		Exact identifier — unii candidate 32 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	TABLET, CHEWABLE / ORAL	0.14 mg		Exact identifier — unii candidate 68 equally ranked IID candidates
CORN OIL	CORN OIL	8470G57WFM	TABLET, EXTENDED RELEASE / ORAL	10 mg		Exact identifier — unii candidate 11 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	TABLET, EXTENDED RELEASE / ORAL	0.12 mg		Exact identifier — unii candidate 68 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	TABLET, COATED / ORAL	0.8 mg		Exact identifier — unii candidate 68 equally ranked IID candidates
CASTOR OIL	CASTOR OIL	D5340Y2I9G	CAPSULE / ORAL	1.04 mg		Exact identifier — unii candidate 16 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	SOLUTION / INTRAVENOUS	0.02 %w/v		Exact identifier — unii candidate 68 equally ranked IID candidates
CORN OIL	CORN OIL	8470G57WFM	CREAM / TOPICAL	NA		Exact identifier — unii candidate 11 equally ranked IID candidates
BUTYLPARABEN	BUTYLPARABEN	3QPI1U3FV8	CREAM / TOPICAL	0.4 %w/w		Exact identifier — unii candidate 15 equally ranked IID candidates
BUTYLPARABEN	BUTYLPARABEN	3QPI1U3FV8	LOTION / TOPICAL		4 mg	Exact identifier — unii candidate 15 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	INJECTION / INTRAMUSCULAR		6 mg	Exact identifier — unii candidate 68 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	INJECTION / INTRAVENOUS		6 mg	Exact identifier — unii candidate 68 equally ranked IID candidates
BUTYLATED HYDROXYTOLUENE	BUTYLATED HYDROXYTOLUENE	1P9D0Z171K	GEL, METERED / TOPICAL		4 mg	Exact identifier — unii candidate 32 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	EMULSION / TOPICAL	0.06 %w/w		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
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	SYRUP / ORAL		40 mg	Exact identifier — unii candidate 68 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	TABLET / ORAL	0.2 mg		Exact identifier — unii candidate 68 equally ranked IID candidates
CASTOR OIL	CASTOR OIL	D5340Y2I9G	OINTMENT / TOPICAL	14.9 %w/w		Exact identifier — unii candidate 16 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	INJECTION / INFILTRATION	0.35 mg		Exact identifier — unii candidate 68 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	POWDER, FOR SUSPENSION / ORAL		8 mg	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
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	ELIXIR / ORAL	200 mg		Exact identifier — unii candidate 68 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	INJECTION / SOFT TISSUE	0.02 %w/v		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
CASTOR OIL	CASTOR OIL	D5340Y2I9G	TABLET / SUBLINGUAL	1.6 mg		Exact identifier — unii candidate 16 equally ranked IID candidates
CORN OIL	CORN OIL	8470G57WFM	TABLET, CHEWABLE / ORAL	NA		Exact identifier — unii candidate 11 equally ranked IID candidates
BUTYLATED HYDROXYTOLUENE	BUTYLATED HYDROXYTOLUENE	1P9D0Z171K	TABLET / SUBLINGUAL	0.13 mg		Exact identifier — unii candidate 32 equally ranked IID candidates
BUTYLATED HYDROXYTOLUENE	BUTYLATED HYDROXYTOLUENE	1P9D0Z171K	SUPPOSITORY / VAGINAL	NA		Exact identifier — unii candidate 32 equally ranked IID candidates
YELLOW WAX	YELLOW WAX	2ZA36H0S2V	OINTMENT / TOPICAL	20 %w/w		Exact identifier — unii candidate 9 equally ranked IID candidates
BUTYLATED HYDROXYTOLUENE	BUTYLATED HYDROXYTOLUENE	1P9D0Z171K	INJECTION, POWDER, FOR SOLUTION / INTRAVENOUS	NA		Exact identifier — unii candidate 32 equally ranked IID candidates
BUTYLATED HYDROXYTOLUENE	BUTYLATED HYDROXYTOLUENE	1P9D0Z171K	GUM, CHEWING / BUCCAL		5 mg	Exact identifier — unii candidate 32 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	INJECTION, SUSPENSION / INTRAMUSCULAR	0.02 %w/v		Exact identifier — unii candidate 68 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
54448ac9-5df9-4b54-8ca9-edb8123f39b5			802a78a2-26c1-49ae-ac3b-e6b32ae93563	2011-01-14	Warnings	Exact identifier spl id: 54448ac9-5df9-4b54-8ca9-edb8123f39b5 spl set id: 802a78a2-26c1-49ae-ac3b-e6b32ae93563

Reported adverse events (FAERS/openFDA)#

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