EIGHT HOUR CREAM SKIN PROTECTANT NIGHTTIME MIRACLE MOISTURIZER

Manufacturer: Elizabeth Arden, Inc
Effective date: 2013-07-29
Label type: HUMAN OTC DRUG LABEL
Version: 1
Source: full-release
Hydrated at: 2026-05-31 22:36:22

Label at a glance#

ProductEIGHT HOUR CREAM SKIN PROTECTANT NIGHTTIME MIRACLE MOISTURIZER

Active ingredientDIMETHICONE

Label structure10 sections

Indications and uses

To use: Incorporate as the last step in your nighttime skincare ritual. 1) Dip fingertips into moisturizer, 2) gently warming between your hands. 3) Breathe in the soothing scent of lavender as you 4) lightly massage onto face with small circular motions. Apply generously to other dryness-prone areas such as hands, elbows and legs.

Dosage and administration

Massage onto face.

Label contents#

Full prescribing information#

DESCRIPTION

DESCRIPTION SECTION

The whisper-light formula is instantly absorbed, replenishing and sealing in moisture for up to 8 hours. Lavender essence gently lulls your senses. Awaken to supple, radiant and revitalized skin.

INDICATIONS AND USAGE

INDICATIONS & USAGE SECTION

WARNINGS

WARNINGS SECTION

For external use only

OTC - ACTIVE INGREDIENT

OTC - ACTIVE INGREDIENT SECTION

Dimethicone 2.0%...................................... Skin Protectant

INACTIVE INGREDIENT

INACTIVE INGREDIENT SECTION

Inactive Ingredients

Petrolatum, Microcrystalline Wax / Cera Microcristallina /Cire Microcristalline, Lanolin, Isononyl Isononanoate, Hydrogenated Polyisobutene, Isopropyl Myristate, Isopropyl Palmitate, Butyrospermum Parkii (Shea) Butter, Polybutene, Triisostearin, Oleyl Erucate, Polypropylene, Mineral Oil / Paraffinum Liquidum / Huile Minerale, Synthetic Wax, Cyclopentasiloxane, Ricinus Communis (Castor) Seed Oil, Glyceryl Behenate / Eicosadioate, Hydrogenated Lecithin, Dimethiconol, Glyceryl Citrate / Lactate / Linoleate / Oleate, Parfum /Fragrance, Salicylic Acid, Tocopherol, Tocopheryl Acetate, Vegetable Oil / Olus / Huile Vegetale, Alpha-isomethyl Ionone, Benzyl Salicylate, Citronellol, Geraniol, Limonene, Linalool, Yellow 6 Lake (CI 15985).

DOSAGE AND ADMINISTRATION

DOSAGE & ADMINISTRATION SECTION

Massage onto 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

Skin Protection

OTC - WHEN USING

OTC - WHEN USING SECTION

Avoid contact with eyes Do not apply over puncture wounds, infections or lacerations

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
244642	dimethicone 2 % Topical Cream	PSN	1
244642	dimethicone 20 MG/ML Topical Cream	SCD	1
244642	dimethicone 2 % Topical Cream	SY	1

DailyMed Pharmacologic Classes#

Class, Version, Type table
Class	Version	Type	Effective
DIMETHICONE Pharmacologic Class Indexing	3	Indexing - Pharmacologic Class	20180813

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
67938-2001-1	2020-01-31	C162847	48780-1	9d75b9d0-ef08-f424-e053-dadaa90a57ce	242214

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
67938-2001-1	EIGHT HOUR CREAM SKIN PROTECTANT NIGHTTIME MIRACLE MOISTURIZER	1 in 1 BOX	CREAM	1		1
67938-2001-2	EIGHT HOUR CREAM SKIN PROTECTANT NIGHTTIME MIRACLE MOISTURIZER	45 g in 1 JAR	CREAM	45		1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
67938-2001	EIGHT HOUR CREAM SKIN PROTECTANT NIGHTTIME MIRACLE MOISTURIZER (DIMETHICONE) CREAM [ELIZABETH ARDEN, INC]	1	Legacy NDC, 2 package rows	20130730_b03c3248-aeea-47fc-b354-f73a93a8d1e6.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
DIMETHICONE	ACTIVE INGREDIENT	92RU3N3Y1O	1
DIMETHICONE	ACTIVE MOIETY	92RU3N3Y1O	1
BENZYL SALICYLATE	INACTIVE INGREDIENT	WAO5MNK9TU	1
CITRONELLOL ACETATE, (R)-	INACTIVE INGREDIENT	9X45FJL446	1
DIMETHICONOL (40 CST)	INACTIVE INGREDIENT	343C7U75XW	1
GERANIOL	INACTIVE INGREDIENT	L837108USY	1
GLYCERYL BEHENATE/EICOSADIOATE	INACTIVE INGREDIENT	73CJJ317SR	1
GLYCERYL CITRATE	INACTIVE INGREDIENT	4987GT719I	1
ISONONYL ISONONANOATE	INACTIVE INGREDIENT	S4V5BS6GCX	1
ISOPROPYL MYRISTATE	INACTIVE INGREDIENT	0RE8K4LNJS	1
ISOPROPYL PALMITATE	INACTIVE INGREDIENT	8CRQ2TH63M	1
LANOLIN	INACTIVE INGREDIENT	7EV65EAW6H	1
MICROCRYSTALLINE WAX	INACTIVE INGREDIENT	XOF597Q3KY	1
MINERAL OIL	INACTIVE INGREDIENT	T5L8T28FGP	1
OLEYL ERUCATE	INACTIVE INGREDIENT	753W099NQ6	1
PETROLATUM	INACTIVE INGREDIENT	4T6H12BN9U	1
POLYBUTENE (1400 MW)	INACTIVE INGREDIENT	1NA5AO9GH7	1
SALICYLIC ACID	INACTIVE INGREDIENT	O414PZ4LPZ	1
SYNTHETIC WAX (1200 MW)	INACTIVE INGREDIENT	Q3Z4BCH099	1
TOCOPHEROL	INACTIVE INGREDIENT	R0ZB2556P8	1
TRIISOSTEARIN	INACTIVE INGREDIENT	71503RH8KG	1

Products#

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

DailyMed product names page 1 of 1 · 21 matching rows.

EIGHT HOUR CREAM SKIN PROTECTANT NIGHTTIME MIRACLE MOISTURIZER
DIMETHICONE
PETROLATUM
MICROCRYSTALLINE WAX
LANOLIN
ISONONYL ISONONANOATE
ISOPROPYL MYRISTATE
ISOPROPYL PALMITATE
POLYBUTENE (1400 MW)
TRIISOSTEARIN
OLEYL ERUCATE
MINERAL OIL
SYNTHETIC WAX (1200 MW)
GLYCERYL BEHENATE/EICOSADIOATE
DIMETHICONOL (40 CST)
GLYCERYL CITRATE
SALICYLIC ACID
TOCOPHEROL
BENZYL SALICYLATE
CITRONELLOL ACETATE, (R)-
GERANIOL

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
67938-2001	67938-2001-2, 67938-2001-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 20 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
DIMETHICONE	92RU3N3Y1O	ACTIB
PETROLATUM	4T6H12BN9U	IACT
MICROCRYSTALLINE WAX	XOF597Q3KY	IACT
LANOLIN	7EV65EAW6H	IACT
ISONONYL ISONONANOATE	S4V5BS6GCX	IACT
ISOPROPYL MYRISTATE	0RE8K4LNJS	IACT
ISOPROPYL PALMITATE	8CRQ2TH63M	IACT
POLYBUTENE (1400 MW)	1NA5AO9GH7	IACT
TRIISOSTEARIN	71503RH8KG	IACT
OLEYL ERUCATE	753W099NQ6	IACT
MINERAL OIL	T5L8T28FGP	IACT
SYNTHETIC WAX (1200 MW)	Q3Z4BCH099	IACT
GLYCERYL BEHENATE/EICOSADIOATE	73CJJ317SR	IACT
DIMETHICONOL (40 CST)	343C7U75XW	IACT
GLYCERYL CITRATE	4987GT719I	IACT
SALICYLIC ACID	O414PZ4LPZ	IACT
TOCOPHEROL	R0ZB2556P8	IACT
BENZYL SALICYLATE	WAO5MNK9TU	IACT
CITRONELLOL ACETATE, (R)-	9X45FJL446	IACT
GERANIOL	L837108USY	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 2 · 94 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
MICROCRYSTALLINE WAX	MICROCRYSTALLINE WAX	XOF597Q3KY	GEL / TOPICAL	NA		Exact identifier — unii candidate 4 equally ranked IID candidates
MICROCRYSTALLINE WAX	MICROCRYSTALLINE WAX	XOF597Q3KY	OINTMENT / TOPICAL		3575 mg	Exact identifier — unii candidate 4 equally ranked IID candidates
ISOPROPYL PALMITATE	ISOPROPYL PALMITATE	8CRQ2TH63M	FILM / TRANSDERMAL		2 mg	Exact identifier — unii candidate 8 equally ranked IID candidates
MINERAL OIL	MINERAL OIL	T5L8T28FGP	SUPPOSITORY / VAGINAL	30 mg		Exact identifier — unii candidate 30 equally ranked IID candidates
TOCOPHEROL	TOCOPHEROL	R0ZB2556P8	CAPSULE, COATED / ORAL	0.25 mg		Exact identifier — unii candidate 5 equally ranked IID candidates
MINERAL OIL	MINERAL OIL	T5L8T28FGP	OINTMENT / OPHTHALMIC	59.5 %w/w		Exact identifier — unii candidate 30 equally ranked IID candidates
PETROLATUM	PETROLATUM	4T6H12BN9U	EMULSION / TOPICAL	7.8 %w/w		Exact identifier — unii candidate 18 equally ranked IID candidates
ISOPROPYL MYRISTATE	ISOPROPYL MYRISTATE	0RE8K4LNJS	OIL / AURICULAR (OTIC)		36 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	OINTMENT, AUGMENTED / TOPICAL	81.94 %w/w		Exact identifier — unii candidate 18 equally ranked IID candidates
MINERAL OIL	MINERAL OIL	T5L8T28FGP	CREAM / VAGINAL		402 mg	Exact identifier — unii candidate 30 equally ranked IID candidates
PETROLATUM	PETROLATUM	4T6H12BN9U	CAPSULE, EXTENDED RELEASE / ORAL	0.07 mg		Exact identifier — unii candidate 18 equally ranked IID candidates
MINERAL OIL	MINERAL OIL	T5L8T28FGP	SUSPENSION / AURICULAR (OTIC)	0.5 %w/v		Exact identifier — unii candidate 30 equally ranked IID candidates
LANOLIN	LANOLIN	7EV65EAW6H	SHAMPOO / TOPICAL	2 %w/w		Exact identifier — unii candidate 9 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
ISOPROPYL MYRISTATE	ISOPROPYL MYRISTATE	0RE8K4LNJS	FILM / TRANSDERMAL	58.08 mg		Exact identifier — unii candidate 18 equally ranked IID candidates
MINERAL OIL	MINERAL OIL	T5L8T28FGP	TABLET, CHEWABLE / ORAL		6 mg	Exact identifier — unii candidate 30 equally ranked IID candidates
MINERAL OIL	MINERAL OIL	T5L8T28FGP	CAPSULE, EXTENDED RELEASE / ORAL		120 mg	Exact identifier — unii candidate 30 equally ranked IID candidates
LANOLIN	LANOLIN	7EV65EAW6H	OINTMENT / TOPICAL	10 %w/w		Exact identifier — unii candidate 9 equally ranked IID candidates
PETROLATUM	PETROLATUM	4T6H12BN9U	LIQUID / RESPIRATORY (INHALATION)	NA		Exact identifier — unii candidate 18 equally ranked IID candidates
ISOPROPYL PALMITATE	ISOPROPYL PALMITATE	8CRQ2TH63M	AEROSOL / TOPICAL		397 mg	Exact identifier — unii candidate 8 equally ranked IID candidates
ISOPROPYL MYRISTATE	ISOPROPYL MYRISTATE	0RE8K4LNJS	OINTMENT / TOPICAL	35 %w/w		Exact identifier — unii candidate 18 equally ranked IID candidates
MINERAL OIL	MINERAL OIL	T5L8T28FGP	SUSPENSION / OPHTHALMIC	0.1 %w/w		Exact identifier — unii candidate 30 equally ranked IID candidates
MINERAL OIL	MINERAL OIL	T5L8T28FGP	GEL / TOPICAL	2.5 %w/w		Exact identifier — unii candidate 30 equally ranked IID candidates
ISOPROPYL MYRISTATE	ISOPROPYL MYRISTATE	0RE8K4LNJS	CREAM / TOPICAL		65000 mg	Exact identifier — unii candidate 18 equally ranked IID candidates
MINERAL OIL	MINERAL OIL	T5L8T28FGP	OINTMENT / TOPICAL		9938 mg	Exact identifier — unii candidate 30 equally ranked IID candidates
ISOPROPYL MYRISTATE	ISOPROPYL MYRISTATE	0RE8K4LNJS	AEROSOL / TOPICAL	9.3 %w/w		Exact identifier — unii candidate 18 equally ranked IID candidates
ISOPROPYL MYRISTATE	ISOPROPYL MYRISTATE	0RE8K4LNJS	SYSTEM / TOPICAL		7 mg	Exact identifier — unii candidate 18 equally ranked IID candidates
ISOPROPYL PALMITATE	ISOPROPYL PALMITATE	8CRQ2TH63M	LOTION / TOPICAL	5 %w/w		Exact identifier — unii candidate 8 equally ranked IID candidates
MINERAL OIL	MINERAL OIL	T5L8T28FGP	SPRAY / TOPICAL		1379 mg	Exact identifier — unii candidate 30 equally ranked IID candidates
ISOPROPYL PALMITATE	ISOPROPYL PALMITATE	8CRQ2TH63M	GEL / TOPICAL	NA		Exact identifier — unii candidate 8 equally ranked IID candidates
PETROLATUM	PETROLATUM	4T6H12BN9U	LOTION / TOPICAL	25 %w/w		Exact identifier — unii candidate 18 equally ranked IID candidates
ISOPROPYL MYRISTATE	ISOPROPYL MYRISTATE	0RE8K4LNJS	SUSPENSION / AURICULAR (OTIC)	0.02 %w/w		Exact identifier — unii candidate 18 equally ranked IID candidates
MINERAL OIL	MINERAL OIL	T5L8T28FGP	SUSPENSION / TOPICAL	82 %w/w		Exact identifier — unii candidate 30 equally ranked IID candidates
ISOPROPYL MYRISTATE	ISOPROPYL MYRISTATE	0RE8K4LNJS	LOTION / TOPICAL		50 mg	Exact identifier — unii candidate 18 equally ranked IID candidates
PETROLATUM	PETROLATUM	4T6H12BN9U	CREAM / TOPICAL		4213 mg	Exact identifier — unii candidate 18 equally ranked IID candidates
MINERAL OIL	MINERAL OIL	T5L8T28FGP	CAPSULE / ORAL		120 mg	Exact identifier — unii candidate 30 equally ranked IID candidates
MINERAL OIL	MINERAL OIL	T5L8T28FGP	TABLET / ORAL	113.75 mg		Exact identifier — unii candidate 30 equally ranked IID candidates
ISOPROPYL MYRISTATE	ISOPROPYL MYRISTATE	0RE8K4LNJS	AEROSOL, FOAM / TOPICAL		144 mg	Exact identifier — unii candidate 18 equally ranked IID candidates
MINERAL OIL	MINERAL OIL	T5L8T28FGP	DROPS / ORAL	NA		Exact identifier — unii candidate 30 equally ranked IID candidates
ISOPROPYL MYRISTATE	ISOPROPYL MYRISTATE	0RE8K4LNJS	SPRAY / TOPICAL		3665 mg	Exact identifier — unii candidate 18 equally ranked IID candidates
MINERAL OIL	MINERAL OIL	T5L8T28FGP	CREAM / TOPICAL		2772 mg	Exact identifier — unii candidate 30 equally ranked IID candidates
ISOPROPYL MYRISTATE	ISOPROPYL MYRISTATE	0RE8K4LNJS	GEL / TRANSDERMAL		85 mg	Exact identifier — unii candidate 18 equally ranked IID candidates
MINERAL OIL	MINERAL OIL	T5L8T28FGP	TABLET, DELAYED RELEASE / ORAL	5.67 mg		Exact identifier — unii candidate 30 equally ranked IID candidates
ISOPROPYL MYRISTATE	ISOPROPYL MYRISTATE	0RE8K4LNJS	FILM, EXTENDED RELEASE / TRANSDERMAL	20.4 mg		Exact identifier — unii candidate 18 equally ranked IID candidates
PETROLATUM	PETROLATUM	4T6H12BN9U	SUPPOSITORY / VAGINAL	27 mg		Exact identifier — unii candidate 18 equally ranked IID candidates
MINERAL OIL	MINERAL OIL	T5L8T28FGP	SYSTEM / TRANSDERMAL	6.09 mg		Exact identifier — unii candidate 30 equally ranked IID candidates
MINERAL OIL	MINERAL OIL	T5L8T28FGP	TABLET, COATED / ORAL	1.5 mg		Exact identifier — unii candidate 30 equally ranked IID candidates
TOCOPHEROL	TOCOPHEROL	R0ZB2556P8	CREAM / TOPICAL	NA		Exact identifier — unii candidate 5 equally ranked IID candidates
PETROLATUM	PETROLATUM	4T6H12BN9U	AEROSOL, FOAM / TOPICAL	7.9 %w/w		Exact identifier — unii candidate 18 equally ranked IID candidates
MINERAL OIL	MINERAL OIL	T5L8T28FGP	TABLET, FILM COATED / ORAL	NA		Exact identifier — unii candidate 30 equally ranked IID candidates
ISOPROPYL MYRISTATE	ISOPROPYL MYRISTATE	0RE8K4LNJS	CREAM / VAGINAL		50 mg	Exact identifier — unii candidate 18 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	OINTMENT / OPHTHALMIC	3 %w/w		Exact identifier — unii candidate 9 equally ranked IID candidates
PETROLATUM	PETROLATUM	4T6H12BN9U	OINTMENT / VAGINAL		4084 mg	Exact identifier — unii candidate 18 equally ranked IID candidates
MINERAL OIL	MINERAL OIL	T5L8T28FGP	SYSTEM / TOPICAL	654.36 mg		Exact identifier — unii candidate 30 equally ranked IID candidates
ISOPROPYL PALMITATE	ISOPROPYL PALMITATE	8CRQ2TH63M	FILM, EXTENDED RELEASE / TRANSDERMAL	187.5 mg		Exact identifier — unii candidate 8 equally ranked IID candidates
MINERAL OIL	MINERAL OIL	T5L8T28FGP	SOAP / TOPICAL	0.82 %w/w		Exact identifier — unii candidate 30 equally ranked IID candidates
MINERAL OIL	MINERAL OIL	T5L8T28FGP	FILM / TRANSDERMAL	11.42 mg		Exact identifier — unii candidate 30 equally ranked IID candidates
LANOLIN	LANOLIN	7EV65EAW6H	SPRAY / NASAL	NA		Exact identifier — unii candidate 9 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
6c9bc32a-a84d-4cfb-b56a-80977727a280			b03c3248-aeea-47fc-b354-f73a93a8d1e6	2013-07-29	Warnings	Exact identifier spl id: 6c9bc32a-a84d-4cfb-b56a-80977727a280 spl set id: b03c3248-aeea-47fc-b354-f73a93a8d1e6

Reported adverse events (FAERS/openFDA)#

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