CERAMIDE TIME COMPLEX MOISTURE CREAM SPF 15- octinoxate 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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BC0732

DESCRIPTION

The continuous-release super-moisturizer that helps combat visible signs of aging, as it protects skin from damaging sun exposure: Boosts skin's hydration level over 450% after one hour. Helps provide all-day (up to 15 hours) skin-essential moisture. Relieves dryness. Softens the appearance of fine lines and wrinkles. Exclusively formulated with: Skin-identical Ceramides to help reinforce skin's protective barrier and prevent vital moisture loss. An effective combination of age-fighting ingredients including HCA, our advanced alpha-hydroxy complex.

INDICATIONS & USAGE

To Use: Smooth on to cleansed face and throat before sun exposure.

WARNINGS

Warning: For external use only. Avoid contact with eyes. Discontinue use if signs of irritation or rash appear. If irritation or rash persists, consult a doctor. Keep out of reach of children.

OTC - ACTIVE INGREDIENT

Active Ingredient: Octinoxate 6% w/w.

INACTIVE INGREDIENT

Other Ingredients: Water/Aqua/Eau, Cyclopentasiloxane, Cetyl Ethylhexanoate, Sodium Chloride, Butylene Glycol, Glycerin, Squalene, Aluminum Distearate, Cetyl Dimethicone Urea, Ceramide 1, Ceramide 3, Algae Extract, Hydrolyzed Oat Flour, Yeast Extract/Faex/Extrait de Levure, Sodium Hyaluronate, Hydroxycaprylic Acid, Sodium Lactate, Ascorbyl Plamitate, Tocopheryl Acetate, Glycine, Serine, Propylene Glycol, Sodium PCA, Cetyl PEG/PPG-10/1 Dimethicone, Beta-Glucan, Disodium Edta, Aluminum Citrate, Cyclohexasiloxane, Dimethicone Copolyol, Parfum/Fragrance, Alpha-Isomethyl Ionone, Benzyl Benzoate, Betylpheny Methylpropional, Citral Citronellol, Geraniol, Hexyl Cinnamal, Hydroxyisohexyl 3-Cyclohexen, Carboxaldehyde, Limonene, Linalool, Methylparaben, Propylparaben.

DOSAGE & ADMINISTRATION

Smooth on to face and throat.

OTC - KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children.

OTC - PURPOSE

Provides SPF 15 sun protection.

OTC - WHEN USING

Avoid contact with eyes.

Ceramide Time Complex Moisture Cream Box

 Ceramide Time Complex Moisture Cream Tube


CERAMIDE TIME COMPLEX MOISTURE CREAM SPF 15 
octinoxate cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67938-0732
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE3 g  in 50 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
CETYL ETHYLHEXANOATE (UNII: 134647WMX4)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
GLYCERIN (UNII: PDC6A3C0OX)  
SQUALENE (UNII: 7QWM220FJH)  
ALUMINUM DISTEARATE (UNII: 7P1HP1B9UI)  
UREA (UNII: 8W8T17847W)  
SODIUM LACTATE (UNII: TU7HW0W0QT)  
GLYCINE (UNII: TE7660XO1C)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
CERAMIDE 3 (UNII: 4370DF050B)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
CYCLOMETHICONE 6 (UNII: XHK3U310BA)  
ASCORBYL PALMITATE (UNII: QN83US2B0N)  
SERINE (UNII: 452VLY9402)  
OAT BRAN (UNII: KQX236OK4U)  
HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:67938-0732-11 in 1 BOX
1NDC:67938-0732-250 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35203/27/2007
Labeler - Elizabeth Arden, Inc (849222187)

Revised: 6/2011
Document Id: 0f754894-4e0b-453b-b1fa-6af0e7e8db5a
Set id: cd2ce861-4e8e-409a-8a74-dd5a70d4b1dd
Version: 2
Effective Time: 20110601
 
Elizabeth Arden, Inc