EIGHT HOUR CREAM SKIN PROTECTANT NIGHTTIME MIRACLE MOISTURIZER- dimethicone cream

EIGHT HOUR CREAM SKIN PROTECTANT NIGHTTIME MIRACLE MOISTURIZER by

Drug Labeling and Warnings

EIGHT HOUR CREAM SKIN PROTECTANT NIGHTTIME MIRACLE MOISTURIZER by is a Otc medication manufactured, distributed, or labeled by Elizabeth Arden, Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

DESCRIPTION

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

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.

WARNINGS

For external use only

OTC - ACTIVE INGREDIENT

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

INACTIVE INGREDIENT

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

Massage onto face.

OTC - KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children

OTC - PURPOSE

Skin Protection

OTC - WHEN USING

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

EIGHT HOUR CREAM SKIN PROTECTANT NIGHTTIME MIRACLE MOISTURIZER 
dimethicone cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 67938-2001
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O)	DIMETHICONE	0.9 g  in 45 g

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 67938-2001-1	1 in 1 BOX
1	NDC: 67938-2001-2	45 g in 1 JAR

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part310.545	05/07/2013

Labeler - Elizabeth Arden, Inc (849222187)