CERAMIDE PREMIER INTENSE MOISTURE AND RENEWAL ACTIVATION BROAD SPECTRUM SPF 30- octinoxate, octisalate, oxybenzone, octocrylene, and avobenzone cream

Ceramide Premier Intense Moisture and Renewal Activation Broad Spectrum SPF 30 by

Drug Labeling and Warnings

Ceramide Premier Intense Moisture and Renewal Activation Broad Spectrum SPF 30 by is a Otc medication manufactured, distributed, or labeled by Elizabeth Arden, Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

DESCRIPTION

This rich, replenishing moisture cream with skin identical Ceramide Triple Complex hydrates deeply to restore skin's natural protective barrier and ease the look of fine lines and wrinkles. Nutrient rich sea minerals including calcium help support skin’s natural processes to fortify thin, fragile looking skin. Our patented retinyl complex is clinically proven to optimize surface cell turnover to improve the appearance of age spots, discolorations and overall radiance.

DOSAGE AND ADMINISTRATION

To Use: Apply to cleansed face and throat.

Directions For Sunscreen Use:Apply liberally 15 minutes before sun exposure. Reapply at least every 2 hours.

Sun Protection Measures:Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease mthis risk, regularly use a sunscreen with a broad spectrum SPF of 15 or higher and other sun protection measures including: Limit time in the sun, especially from 10 a.m. – 2 p.m. Wear long-sleeve shirts, pants, hats, and sunglasses

Children under 6 months: Ask a doctor.

 

OTC - ACTIVE INGREDIENT

Active Ingredients: Octinoxate 7.5%, Octisalate 5.0%, Oxybenzone 4.0%, Octocrylene 3.0%, Avobenzone 2.0%.

INACTIVE INGREDIENT

Inactive Ingredients: Water/Aqua/Eau, Dimethicone, Glycerin, Hydrogenated Polyisobutene, Petrolatum, Glyceryl Stearate, Butylene Glycol, Butyloctly Salicylate, Caprylic/Capric Triglyceride, Cetearyl Alochol, PEG-100 Stearate, Butyrospermum Parkii (Shea Butter), Hydrogenated Lecithin, Dimethylcapramide, Ceramide 1, Ceramide 3, Ceramide 6 II, Fucus Serratus Extract, Yeast Extract/Faex/Extrait de Levure, Retinyl Lonoleate, Tocopheryl Acetate, Cetearyl Dimethicone Crosspolymer, PEG-40 Hydrogenated Castor Oil, Soy Amino Acids, 3-Aminopropane Sulfonic Acid, Calcium Hydroxymethionine, Hydrolyzed Soy Protein, Methyl Methacrylate Crosspolymer, Phytosphingosine, Ammonium Acryloyldimethyltaurate/VP Copolymer, Cholesterol, Sodium Lauroyl Lactylate, PEG-8 Laurate, Polysorbate 20, Sodium Dodecylbenzenesulfonate, Styrene/Acrylates Copolymer, Behenyl Alcohol, Pentylene Glycol, Carbomer, Hydroxyethylcellulose, Polyethylene, Xanthan Gum, EDTA, Sodium Hydroxide, BHT, Disodium EDTA, Mica, Tin Oxide, Aminopropyl Dimethicone, Fragrance/Parfum, Alpha-Isomethyl Ionone, Butylpheyl Methylpropional, Citronellol, Hydroxycitronellal, Ethylparaben, Methylparaben, Phenoxyethanol, Potassium Sorbate, Propylparaben, Sodium Benzoate, Titanium Dioxide (CI 77891).

INDICATIONS AND USAGE

Apply to face and throat.

OTC - KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.

OTC - PURPOSE

Provides SPF 30 Sun Protection.

OTC - WHEN USING

Keep out of eyes.

WARNINGS

Warnings:

For external use only.

Do not use on damaged or broken skin.

When using this product keep out of eyes. Rinse with water to remove.

Stop use and ask a doctor if rash occurs.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

CERAMIDE PREMIER INTENSE MOISTURE AND RENEWAL ACTIVATION BROAD SPECTRUM SPF 30 
octinoxate, octisalate, oxybenzone, octocrylene, and avobenzone cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 67938-1145
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	3.68 g  in 49 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	2.45 g  in 49 g
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	1.96 g  in 49 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	1.47 g  in 49 g
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	0.98 g  in 49 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
DIMETHICONE (UNII: 92RU3N3Y1O)
GLYCERIN (UNII: PDC6A3C0OX)
PETROLATUM (UNII: 4T6H12BN9U)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
PEG-100 STEARATE (UNII: YD01N1999R)
SHEA BUTTER (UNII: K49155WL9Y)
HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N)
DIMETHYL CAPRAMIDE (UNII: O29Y6X2JEZ)
CERAMIDE 1 (UNII: 5THT33P7X7)
CERAMIDE 3 (UNII: 4370DF050B)
CERAMIDE 6 II (UNII: F1X8L2B00J)
FUCUS SERRATUS (UNII: V8K40WNW5B)
YEAST (UNII: 3NY3SM6B8U)
RETINYL LINOLEATE (UNII: 61911N8D6W)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)
TRAMIPROSATE (UNII: 5K8EAX0G53)
PHYTOSPHINGOSINE (UNII: GIN46U9Q2Q)
AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER (UNII: W59H9296ZG)
CHOLESTEROL (UNII: 97C5T2UQ7J)
SODIUM LAUROYL LACTYLATE (UNII: 7243K85WFO)
PEG-8 LAURATE (UNII: 762O8IWA10)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
SODIUM DODECYLBENZENESULFONATE (UNII: 554127163Y)
DOCOSANOL (UNII: 9G1OE216XY)
PENTYLENE GLYCOL (UNII: 50C1307PZG)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
XANTHAN GUM (UNII: TTV12P4NEE)
EDETIC ACID (UNII: 9G34HU7RV0)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
EDETATE DISODIUM (UNII: 7FLD91C86K)
MICA (UNII: V8A1AW0880)
STANNIC OXIDE (UNII: KM7N50LOS6)
ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)
BUTYLPHENYL METHYLPROPIONAL (UNII: T7540GJV69)
HYDROXYCITRONELLAL (UNII: 8SQ0VA4YUR)
ETHYLPARABEN (UNII: 14255EXE39)
METHYLPARABEN (UNII: A2I8C7HI9T)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
SODIUM BENZOATE (UNII: OJ245FE5EU)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 67938-1145-1	1 in 1 JAR
1	NDC: 67938-1145-2	49 g in 1 CARTON

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	12/22/2011

Labeler - Elizabeth Arden, Inc (849222187)