CERAMIDE TIME COMPLEX MOISTURE CREAM SPF 15- octinoxate cream

Ceramide Time Complex Moisture Cream SPF 15 by

Drug Labeling and Warnings

Ceramide Time Complex Moisture Cream SPF 15 by is a Otc medication manufactured, distributed, or labeled by Elizabeth Arden, Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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.

PRINCIPAL DISPLAY PANEL

 

INGREDIENTS AND APPEARANCE

CERAMIDE TIME COMPLEX MOISTURE CREAM SPF 15 
octinoxate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 67938-0732
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	3 g  in 50 g

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 67938-0732-1	1 in 1 BOX
1	NDC: 67938-0732-2	50 g in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	03/27/2007

Labeler - Elizabeth Arden, Inc (849222187)