Eight Hour Cream Nourishing Lip Balm SPF 20

Manufacturer: Elizabeth Arden, Inc
Effective date: 2013-05-02
Label type: HUMAN OTC DRUG LABEL
Version: 1
Source: full-release
Hydrated at: 2026-05-31 22:35:19

Label at a glance#

ProductEight Hour Cream Nourishing Lip Balm SPF 20

Active ingredientOCTINOXATE, AVOBENZONE

Label structure10 sections

Indications and uses

To use: Squeeze tube and apply liberally with self-applicator tip.

Label contents#

Full prescribing information#

DESCRIPTION

DESCRIPTION SECTION

This daily moisturizing treatment replenishes lips with eight essential vitamins, nutrients and

minerals while providing advanced broad spectrum SPF 20 sun protection against damaging

UVA/UVB rays.

INDICATIONS AND USAGE

INDICATIONS & USAGE SECTION

To use: Squeeze tube and apply liberally with self-applicator tip.

WARNINGS

WARNINGS SECTION

WARNING

FOR EXTERNAL USE ONLY. DO NOT USE

ON DAMAGED OR BROKEN SKIN. WHEN USING

THIS PRODUCT KEEP OUT OF EYES. RINSE WITH

WATER TO REMOVE. STOP USE AND ASK A

DOCTOR IF RASH OCCURS. KEEP OUT OF REACH

OF CHILDREN. IF PRODUCT IS SWALLOWED, GET

MEDICAL HELP OR CONTACT A POISON CONTROL

CENTER RIGHT AWAY.

OTC - ACTIVE INGREDIENT

OTC - ACTIVE INGREDIENT SECTION

ACTIVE INGREDIENTS: OCTINOXATE, 4.0 % W/W

AVOBENZONE, 3.0 % W/W

INACTIVE INGREDIENT

INACTIVE INGREDIENT SECTION

Inactive Ingredients

POLYBUTENE, MICROCRYSTALLINE WAX/CERA

MICROCRISTALLINA/CIRE MICROCRISTALLINE,

PETROLATUM, RICINUS COMMUNIS (CASTOR)

SEED OIL, BUTYROSPERMUM PARKII (SHEA) BUTTER,

NYLON-12, DIOCTYLDODECYL DODECANEDIOATE, C12-15

ALKYL BENZOATE, GLYCERETH-26, BUTYLOCTYL

SALICYLATE, LANOLIN, ASTROCARYUM MURUMURU

SEED BUTTER, BEESWAX/CERA ALBA/CIRE D'ABEILLE,

COPERNICIA CERIFERA (CARNAUBA) WAX/CERA

CARNAUBA/CIRE DE CARNAUBA, HELIANTHUS ANNUUS

(SUNFLOWER) SEED OIL, HONEY EXTRACT,

HYDROGENATED CASTOR OIL, LINOLEIC ACID, LINOLENIC

ACID, NASTURTIUM OFFICINALE FLOWER/LEAF EXTRACT,

RETINYL PALMITATE, TOCOPHEROL, TOCOPHERYL

ACETATE, BHT, IRON OXIDES (CI 77491, CI 77492).

DOSAGE & ADMINISTRATION

DOSAGE & ADMINISTRATION SECTION

apply liberally

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

Provides SPF 20 sun protection.

OTC - WHEN USING

OTC - WHEN USING SECTION

KEEP OUT OF EYES.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
67938-1111-1	2020-01-31	C162847	48780-1	9d75b9d0-2f6b-f424-e053-dadaa90a57ce	197107

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
67938-1111-1	Eight Hour Cream Nourishing Lip Balm SPF 20	1 in 1 BOX	SALVE	1		1
67938-1111-2	Eight Hour Cream Nourishing Lip Balm SPF 20	14.2 g in 1 TUBE	SALVE	14.2		1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
67938-1111	EIGHT HOUR CREAM NOURISHING LIP BALM SPF 20 (OCTINOXATE AND AVOBENZONE) SALVE [ELIZABETH ARDEN, INC]	1	Legacy NDC, 2 package rows	20130502_a6271ee2-39c2-445a-bb24-f87745ac69be.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
AVOBENZONE	ACTIVE INGREDIENT	G63QQF2NOX	1
OCTINOXATE	ACTIVE INGREDIENT	4Y5P7MUD51	1
AVOBENZONE	ACTIVE MOIETY	G63QQF2NOX	1
OCTINOXATE	ACTIVE MOIETY	4Y5P7MUD51	1
ASTROCARYUM MURUMURU SEED BUTTER	INACTIVE INGREDIENT	12V64UPU6R	1
BUTYLOCTYL SALICYLATE	INACTIVE INGREDIENT	2EH13UN8D3	1
DIOCTYLDODECYL DODECANEDIOATE	INACTIVE INGREDIENT	7QDB5EE79Y	1
GLYCERETH-26	INACTIVE INGREDIENT	NNE56F2N14	1
HYDROGENATED CASTOR OIL	INACTIVE INGREDIENT	ZF94AP8MEY	1
LANOLIN	INACTIVE INGREDIENT	7EV65EAW6H	1
LINOLEIC ACID	INACTIVE INGREDIENT	9KJL21T0QJ	1
LINOLENIC ACID	INACTIVE INGREDIENT	0RBV727H71	1
MICROCRYSTALLINE WAX	INACTIVE INGREDIENT	XOF597Q3KY	1
NYLON-12	INACTIVE INGREDIENT	446U8J075B	1
PETROLATUM	INACTIVE INGREDIENT	4T6H12BN9U	1
POLYBUTENE (1400 MW)	INACTIVE INGREDIENT	1NA5AO9GH7	1
TOCOPHEROL	INACTIVE INGREDIENT	R0ZB2556P8	1

Products#

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

DailyMed product names page 1 of 1 · 17 matching rows.

Eight Hour Cream Nourishing Lip Balm SPF 20
OCTINOXATE and AVOBENZONE
OCTINOXATE
AVOBENZONE
POLYBUTENE (1400 MW)
MICROCRYSTALLINE WAX
PETROLATUM
NYLON-12
DIOCTYLDODECYL DODECANEDIOATE
GLYCERETH-26
BUTYLOCTYL SALICYLATE
LANOLIN
ASTROCARYUM MURUMURU SEED BUTTER
HYDROGENATED CASTOR OIL
LINOLEIC ACID
LINOLENIC ACID
TOCOPHEROL

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
67938-1111	67938-1111-2, 67938-1111-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 15 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
OCTINOXATE	4Y5P7MUD51	ACTIB
AVOBENZONE	G63QQF2NOX	ACTIB
POLYBUTENE (1400 MW)	1NA5AO9GH7	IACT
MICROCRYSTALLINE WAX	XOF597Q3KY	IACT
PETROLATUM	4T6H12BN9U	IACT
NYLON-12	446U8J075B	IACT
DIOCTYLDODECYL DODECANEDIOATE	7QDB5EE79Y	IACT
GLYCERETH-26	NNE56F2N14	IACT
BUTYLOCTYL SALICYLATE	2EH13UN8D3	IACT
LANOLIN	7EV65EAW6H	IACT
ASTROCARYUM MURUMURU SEED BUTTER	12V64UPU6R	IACT
HYDROGENATED CASTOR OIL	ZF94AP8MEY	IACT
LINOLEIC ACID	9KJL21T0QJ	IACT
LINOLENIC ACID	0RBV727H71	IACT
TOCOPHEROL	R0ZB2556P8	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 1 · 50 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
PETROLATUM	PETROLATUM	4T6H12BN9U	CAPSULE, EXTENDED RELEASE / ORAL	0.07 mg		Exact identifier — unii candidate 18 equally ranked IID candidates
HYDROGENATED CASTOR OIL	HYDROGENATED CASTOR OIL	ZF94AP8MEY	CAPSULE / ORAL	405 mg		Exact identifier — unii candidate 12 equally ranked IID candidates
PETROLATUM	PETROLATUM	4T6H12BN9U	OINTMENT, AUGMENTED / TOPICAL	81.94 %w/w		Exact identifier — unii candidate 18 equally ranked IID candidates
PETROLATUM	PETROLATUM	4T6H12BN9U	AEROSOL, FOAM / TOPICAL	7.9 %w/w		Exact identifier — unii candidate 18 equally ranked IID candidates
MICROCRYSTALLINE WAX	MICROCRYSTALLINE WAX	XOF597Q3KY	CAPSULE, EXTENDED RELEASE / ORAL	6 mg		Exact identifier — unii candidate 4 equally ranked IID candidates
POLYBUTENE (1400 MW)	POLYBUTENE (1400 MW)	1NA5AO9GH7	FILM, EXTENDED RELEASE / TRANSDERMAL	NA		Exact identifier — unii candidate 2 equally ranked IID candidates
PETROLATUM	PETROLATUM	4T6H12BN9U	OINTMENT / TOPICAL		7275 mg	Exact identifier — unii candidate 18 equally ranked IID candidates
LANOLIN	LANOLIN	7EV65EAW6H	OINTMENT / RECTAL		105 mg	Exact identifier — unii candidate 9 equally ranked IID candidates
PETROLATUM	PETROLATUM	4T6H12BN9U	SUPPOSITORY / VAGINAL	27 mg		Exact identifier — unii candidate 18 equally ranked IID candidates
PETROLATUM	PETROLATUM	4T6H12BN9U	CREAM, AUGMENTED / TOPICAL	26 %w/w		Exact identifier — unii candidate 18 equally ranked IID candidates
PETROLATUM	PETROLATUM	4T6H12BN9U	TABLET / ORAL	3.5 mg		Exact identifier — unii candidate 18 equally ranked IID candidates
TOCOPHEROL	TOCOPHEROL	R0ZB2556P8	TABLET / ORAL	0.08 mg		Exact identifier — unii candidate 5 equally ranked IID candidates
LANOLIN	LANOLIN	7EV65EAW6H	CREAM / TOPICAL		10 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
PETROLATUM	PETROLATUM	4T6H12BN9U	CREAM / TOPICAL		4213 mg	Exact identifier — unii candidate 18 equally ranked IID candidates
PETROLATUM	PETROLATUM	4T6H12BN9U	LIQUID / RESPIRATORY (INHALATION)	NA		Exact identifier — unii candidate 18 equally ranked IID candidates
HYDROGENATED CASTOR OIL	HYDROGENATED CASTOR OIL	ZF94AP8MEY	AEROSOL, FOAM / TOPICAL	2 %w/w		Exact identifier — unii candidate 12 equally ranked IID candidates
PETROLATUM	PETROLATUM	4T6H12BN9U	SOAP / TOPICAL	0.85 %w/w		Exact identifier — unii candidate 18 equally ranked IID candidates
PETROLATUM	PETROLATUM	4T6H12BN9U	SPONGE / TOPICAL	NA		Exact identifier — unii candidate 18 equally ranked IID candidates
POLYBUTENE (1400 MW)	POLYBUTENE (1400 MW)	1NA5AO9GH7	SYSTEM / TRANSDERMAL	17.87 mg		Exact identifier — unii candidate 2 equally ranked IID candidates
PETROLATUM	PETROLATUM	4T6H12BN9U	EMULSION / TOPICAL	7.8 %w/w		Exact identifier — unii candidate 18 equally ranked IID candidates
TOCOPHEROL	TOCOPHEROL	R0ZB2556P8	CAPSULE / ORAL	NA		Exact identifier — unii candidate 5 equally ranked IID candidates
PETROLATUM	PETROLATUM	4T6H12BN9U	OINTMENT / OPHTHALMIC	88.4 %w/w		Exact identifier — unii candidate 18 equally ranked IID candidates
PETROLATUM	PETROLATUM	4T6H12BN9U	LOTION / TOPICAL	25 %w/w		Exact identifier — unii candidate 18 equally ranked IID candidates
PETROLATUM	PETROLATUM	4T6H12BN9U	CAPSULE / VAGINAL	NA		Exact identifier — unii candidate 18 equally ranked IID candidates
LANOLIN	LANOLIN	7EV65EAW6H	SHAMPOO / TOPICAL	2 %w/w		Exact identifier — unii candidate 9 equally ranked IID candidates
LANOLIN	LANOLIN	7EV65EAW6H	OINTMENT / OPHTHALMIC	3 %w/w		Exact identifier — unii candidate 9 equally ranked IID candidates
PETROLATUM	PETROLATUM	4T6H12BN9U	TABLET, EXTENDED RELEASE / ORAL	0.18 mg		Exact identifier — unii candidate 18 equally ranked IID candidates
MICROCRYSTALLINE WAX	MICROCRYSTALLINE WAX	XOF597Q3KY	CREAM / VAGINAL		23 mg	Exact identifier — unii candidate 4 equally ranked IID candidates
HYDROGENATED CASTOR OIL	HYDROGENATED CASTOR OIL	ZF94AP8MEY	LIQUID / TOPICAL	0.24 %w/w		Exact identifier — unii candidate 12 equally ranked IID candidates
MICROCRYSTALLINE WAX	MICROCRYSTALLINE WAX	XOF597Q3KY	GEL / TOPICAL	NA		Exact identifier — unii candidate 4 equally ranked IID candidates
PETROLATUM	PETROLATUM	4T6H12BN9U	OINTMENT / VAGINAL		4084 mg	Exact identifier — unii candidate 18 equally ranked IID candidates
HYDROGENATED CASTOR OIL	HYDROGENATED CASTOR OIL	ZF94AP8MEY	TABLET / SUBLINGUAL	1.6 mg		Exact identifier — unii candidate 12 equally ranked IID candidates
LANOLIN	LANOLIN	7EV65EAW6H	OINTMENT / TOPICAL	10 %w/w		Exact identifier — unii candidate 9 equally ranked IID candidates
TOCOPHEROL	TOCOPHEROL	R0ZB2556P8	CAPSULE, COATED / ORAL	0.25 mg		Exact identifier — unii candidate 5 equally ranked IID candidates
HYDROGENATED CASTOR OIL	HYDROGENATED CASTOR OIL	ZF94AP8MEY	TABLET, FOR SUSPENSION / ORAL		17 mg	Exact identifier — unii candidate 12 equally ranked IID candidates
HYDROGENATED CASTOR OIL	HYDROGENATED CASTOR OIL	ZF94AP8MEY	CAPSULE, DELAYED RELEASE / ORAL	3.1 mg		Exact identifier — unii candidate 12 equally ranked IID candidates
HYDROGENATED CASTOR OIL	HYDROGENATED CASTOR OIL	ZF94AP8MEY	TABLET / ORAL		232 mg	Exact identifier — unii candidate 12 equally ranked IID candidates
PETROLATUM	PETROLATUM	4T6H12BN9U	OINTMENT / AURICULAR (OTIC)	NA		Exact identifier — unii candidate 18 equally ranked IID candidates
TOCOPHEROL	TOCOPHEROL	R0ZB2556P8	INJECTION, EMULSION / INTRAVENOUS	0.02 %w/v		Exact identifier — unii candidate 5 equally ranked IID candidates
HYDROGENATED CASTOR OIL	HYDROGENATED CASTOR OIL	ZF94AP8MEY	TABLET, DELAYED RELEASE / ORAL		1337 mg	Exact identifier — unii candidate 12 equally ranked IID candidates
HYDROGENATED CASTOR OIL	HYDROGENATED CASTOR OIL	ZF94AP8MEY	TABLET, EXTENDED RELEASE / ORAL		393 mg	Exact identifier — unii candidate 12 equally ranked IID candidates
LANOLIN	LANOLIN	7EV65EAW6H	EMULSION / TOPICAL	0.25 %w/w		Exact identifier — unii candidate 9 equally ranked IID candidates
HYDROGENATED CASTOR OIL	HYDROGENATED CASTOR OIL	ZF94AP8MEY	CAPSULE, EXTENDED RELEASE / ORAL	410.82 mg		Exact identifier — unii candidate 12 equally ranked IID candidates
TOCOPHEROL	TOCOPHEROL	R0ZB2556P8	CREAM / TOPICAL	NA		Exact identifier — unii candidate 5 equally ranked IID candidates
HYDROGENATED CASTOR OIL	HYDROGENATED CASTOR OIL	ZF94AP8MEY	SUSPENSION / TOPICAL		286 mg	Exact identifier — unii candidate 12 equally ranked IID candidates
LANOLIN	LANOLIN	7EV65EAW6H	SPRAY / NASAL	NA		Exact identifier — unii candidate 9 equally ranked IID candidates
LANOLIN	LANOLIN	7EV65EAW6H	LOTION / TOPICAL	1.5 %w/w		Exact identifier — unii candidate 9 equally ranked IID candidates
LANOLIN	LANOLIN	7EV65EAW6H	CREAM / VAGINAL	2 %w/w		Exact identifier — unii candidate 9 equally ranked IID candidates
HYDROGENATED CASTOR OIL	HYDROGENATED CASTOR OIL	ZF94AP8MEY	TABLET, FILM COATED / ORAL		17 mg	Exact identifier — unii candidate 12 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
97dab94c-6a46-48c9-9427-68be6eb6e103			a6271ee2-39c2-445a-bb24-f87745ac69be	2013-05-02	Warnings	Exact identifier spl id: 97dab94c-6a46-48c9-9427-68be6eb6e103 spl set id: a6271ee2-39c2-445a-bb24-f87745ac69be

Reported adverse events (FAERS/openFDA)#

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