CERAMIDE LIFT AND FIRM MAKEUP BROAD SPRECTRUM SUNSCREEN SPF 15 SANDSTONE- octinoxate and titanium dioxide cream

Ceramide Lift And Firm Makeup Broad Sprectrum Sunscreen SPF 15 Sandstone by

Drug Labeling and Warnings

Ceramide Lift And Firm Makeup Broad Sprectrum Sunscreen SPF 15 Sandstone by is a Otc medication manufactured, distributed, or labeled by Elizabeth Arden, Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

DESCRIPTION

- For normal to dry skin.

- Medium to full coverage. Luminous finish.

Makeup goes ultra to smooth, lift, and firm the look of skin. This moisturizing cream foundation with CPT technology, Ceramides, and Advanced Moisture Complex diminished the appearance of fine lines, perfects skin tone, and creates a luminous finish that lasts all day. Provides Broad Spectrum Sunscreen SPF 15 protection.

INDICATIONS AND USAGE

To Use: Smooth onto face.

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 this 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.

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.

OTC - ACTIVE INGREDIENT

Active Ingredients: Octinoxate 4.0%, Titanium Dioxide 3.0%.

INACTIVE INGREDIENT

Other Ingredients: Water/Aqua/Eau, Cyclopentasiloxane, Dimethicone, Isohexadecane, Mica, Glycerin, Sorbitan, Isostearate, Dimethicone Crosspolymer, Alumina, Caprylyl Dimethicone Ethoxy Glucoside, Aluminum/Magnesium Hydroxide Stearate, Ceramide 1, Ceramide 3, Ceramide 6 II, Alpinia Speciosa Leaf Extract, Hibiscus Abelmoschus Seed Extract, Trifolium Pratense (Clover) Flower Extract, Sodium Hyaluronate, Ascorbyl Palmitate, Retinyl palmitate, Tocopherol, Alanine, Aspartic Acide, Glumatic Acid, Silica Silyate, Acetyl Octatpeptide-3, Mannitol, Sodium PCA, Sorbitol, Trehalose, Urea, Lecithin, PCA Dimethicone, Phytosphingosine, Polyperfluoroethoxymethoxy Difluororethyl PEG Phostphate, Fructose, Glucose, Sucrose, Cholesterol, Sodium Lauroyl Lactylate, Polyquaternium-51, Dextrin, Butylene Glycol, Hexylene Glycol, Carbomer, Xanthan Gum, BHT, Sodium Choloride, Zinc Stearate, Benzoic Acid, Butylparaben, Ethylparaben, Isobutylparaben, Methylparaben, Phenoxyethanol, Pottasium Sorbate, Propylparaben, Chlorphenesin, Iron Oxides (CI 77481, CI 77482), Titanium Dioxide (CI 77891).

DOSAGE & ADMINISTRATION

Smooth on to face.

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 15 sun protection.

OTC - WHEN USING

Keep out of eyes.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

CERAMIDE LIFT AND FIRM MAKEUP BROAD SPRECTRUM SUNSCREEN SPF 15 SANDSTONE 
octinoxate and titanium dioxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 67938-0939
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	1.28 g  in 32 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	0.96 g  in 32 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
DIMETHICONE (UNII: 92RU3N3Y1O)
ISOHEXADECANE (UNII: 918X1OUF1E)
MICA (UNII: V8A1AW0880)
GLYCERIN (UNII: PDC6A3C0OX)
CERAMIDE 3 (UNII: 4370DF050B)
TRIFOLIUM PRATENSE FLOWER (UNII: 4JS0838828)
ASCORBYL PALMITATE (UNII: QN83US2B0N)
ALANINE (UNII: OF5P57N2ZX)
ASPARTIC ACID (UNII: 30KYC7MIAI)
GLUTAMIC ACID (UNII: 3KX376GY7L)
MANNITOL (UNII: 3OWL53L36A)
SORBITOL (UNII: 506T60A25R)
TREHALOSE (UNII: B8WCK70T7I)
UREA (UNII: 8W8T17847W)
FRUCTOSE (UNII: 6YSS42VSEV)
SUCROSE (UNII: C151H8M554)
CHOLESTEROL (UNII: 97C5T2UQ7J)
SODIUM LAUROYL LACTYLATE (UNII: 7243K85WFO)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
HEXYLENE GLYCOL (UNII: KEH0A3F75J)
XANTHAN GUM (UNII: TTV12P4NEE)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
ZINC STEARATE (UNII: H92E6QA4FV)
BENZOIC ACID (UNII: 8SKN0B0MIM)
BUTYLPARABEN (UNII: 3QPI1U3FV8)
ETHYLPARABEN (UNII: 14255EXE39)
ISOBUTYLPARABEN (UNII: 0QQJ25X58G)
METHYLPARABEN (UNII: A2I8C7HI9T)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
CHLORPHENESIN (UNII: I670DAL4SZ)

Product Characteristics
Color	BROWN (Sandstone)	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 67938-0939-1	1 in 1 BOX
1	NDC: 67938-0939-2	32 g in 1 JAR

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	08/05/2010

Labeler - Elizabeth Arden, Inc (849222187)