EIGHT HOUR CREAM SKIN PROTECTANT NIGHTTIME MIRACLE MOISTURIZER- dimethicone cream 
Elizabeth Arden, Inc

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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242214

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

242214 - 8HR NIGHTTIME MOIST
EIGHT HOUR CREAM SKIN PROTECTANT NIGHTTIME MIRACLE MOISTURIZER 
dimethicone cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67938-2001
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE0.9 g  in 45 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:67938-2001-11 in 1 BOX
1NDC:67938-2001-245 g in 1 JAR
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart310.54505/07/2013
Labeler - Elizabeth Arden, Inc (849222187)

Revised: 7/2013
Document Id: 6c9bc32a-a84d-4cfb-b56a-80977727a280
Set id: b03c3248-aeea-47fc-b354-f73a93a8d1e6
Version: 1
Effective Time: 20130729
 
Elizabeth Arden, Inc