PREVAGE ANTI AGING MOISTURE BROAD SPECTRUM SUNSCREEN SPF 30- octinoxate, octisalate, oxybenzone, octocrylene, and avobenzone cream

Prevage Anti Aging Moisture Broad Spectrum Sunscreen SPF 30 by

Drug Labeling and Warnings

Prevage Anti Aging Moisture Broad Spectrum Sunscreen 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

PREVAGE® Anti-aging Skincare helps protect and correct skin’s appearance from environmental threats, a leading cause of visible aging signs, for younger-looking, more beautiful skin. This multi-defense, concentrated moisturizing cream for dry to very dry skin helps nourish skin’s natural moisture defenses and reverse dryness. Diminishes the appearance of aging signs and existing sun damage – fine lines, wrinkles and discolorations. Advanced Idebenone technology provides powerful environmental protection while broad spectrum UVA/UVB sunscreens help shield from the sun. Skin feels ultra soft and smooth, looks healthy, radiant - younger than ever.

INDICATIONS AND USAGE

To Use: Massage onto cleansed face and neck daily after PREVAGE Anti-aging Daily Serum.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 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.

Children under 6 months: Ask a doctor.

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 7.50%, Octisalate 5.00%, Oxybenzone 5.00%, Octocrylene 2.20%, Avobenzone 2.00%

INACTIVE INGREDIENT

Inactive Ingredients: Water/Aqua/Eau, Dimethicone, C12-15 Alkyl Benzoate, Butylene Glycol, Cyclopentasiloxane, Isostearyl Neopentanoate, Dimethicone/Vinyl Dimethicone Crosspolymer, Butyrospermum Parii (Shea Butter) Extract, Theobroma Cacao (Cocoa) Seed Butter, Propylene Glycol, PPG-2 Isoceteth-20 Acetate, Glycerin, Caprylic/Capric Triglyceride, Ergothioneine, Hydroxydecyl Ubiquinoyl Dipalmitoyl Glycerate, Hibiscus Abelmoschus Seed Extract, Sodium Hyaluronate, Retinyl Linoleate, Cetearyl Dimethicone Crosspolymer, Isohexadecane, Sodium PCA, Trehalose, Urea, Hydrogenated Lecithin, Phospholipids, Polyphosphorylcholine Glycol Acrylate, Sucrose, Cetearyl Alcohol, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Polysorbate 60, Trideceth-6, Acrylamide/Sodium Acrylate Copolymer, Polyquaternium-51, PEG-8, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Xanthan Gum, Sodium Hydroxide, BHT, Mica, Mineral Oil/Paraffinum Liquidum/Huile Minerale, Dimethiconol, Phenyl Trimethicone, Parfum/Fragrance, Alpha-Isomethyl Ionone, Linalool, Benzoic Acid, Butylparaben, Ethylparaben, Isobutylparaben, Methylparaben, Phenoxyethanol, Propylparaben, Chlorphenesin, Iron Oxides (CI 77492), Red 4 (CI 14700), Titanium Dioxide (CI 77891), Yellow 5 (CI 19140).

DOSAGE AND ADMINISTRATION

Massage onto face and neck.

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.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

PREVAGE ANTI AGING MOISTURE BROAD SPECTRUM SUNSCREEN SPF 30 
octinoxate, octisalate, oxybenzone, octocrylene, and avobenzone cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 67938-9144
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	3.75 g  in 50 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	2.5 g  in 50 g
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	2.5 g  in 50 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	1.1 g  in 50 g
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	1 g  in 50 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
DIMETHICONE (UNII: 92RU3N3Y1O)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
ISOSTEARYL NEOPENTANOATE (UNII: 411THY156Q)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
PPG-2 ISOCETETH-20 ACETATE (UNII: BI6C7YO419)
GLYCERIN (UNII: PDC6A3C0OX)
ERGOTHIONEINE (UNII: BDZ3DQM98W)
ISOHEXADECANE (UNII: 918X1OUF1E)
TREHALOSE (UNII: B8WCK70T7I)
SUCROSE (UNII: C151H8M554)
POLYSORBATE 60 (UNII: CAL22UVI4M)
TRIDECETH-6 (UNII: 3T5PCR2H0C)
XANTHAN GUM (UNII: TTV12P4NEE)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
MICA (UNII: V8A1AW0880)
MINERAL OIL (UNII: T5L8T28FGP)
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)
BENZOIC ACID (UNII: 8SKN0B0MIM)
BUTYLPARABEN (UNII: 3QPI1U3FV8)
ETHYLPARABEN (UNII: 14255EXE39)
ISOBUTYLPARABEN (UNII: 0QQJ25X58G)
METHYLPARABEN (UNII: A2I8C7HI9T)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
CHLORPHENESIN (UNII: I670DAL4SZ)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 67938-9144-1	1 in 1 BOX
1	NDC: 67938-9144-2	50 g in 1 JAR

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	06/22/2011

Labeler - Elizabeth Arden, Inc (849222187)