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

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 high performance multi-defense moisturizer with advanced Idebenone technology, a powerful environmental protectant, and broad spectrum UVA/UVB sunscreens, helps protect against the visible signs of aging as it minimizes the appearance of existing sun damage – fine lines, wrinkles and discolorations. Locks in moisture to enhance the benefits of PREVAGE Anti-aging Daily Serum.

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

Other Ingredients: Water/Aqua/Eau, Glycerin, Dimethicone, Cetearyl Alcohol, C12-15 Alkyl Benzoate, Propylene Glycol, PEG-40 Hydrogenated Castor Oil, Potassium Cetyl Phosphate, Glyceryl Polyacrylate, Glyceryl Stearate, Butyrospermum Parkii (Shea Butter), Ergothioneine, Hydroxydecyl Ubiquinoyl Dipalmitoyl Glycerate, Sodium Hyaluronate, Hydrogenated Palm Glycerides, Sodium PCA, Trehalose, Urea, Polyquaternium-51, Carbomer, Sodium Hydroxide, Mica, Cylcohexasiloxane, Cyclopentasiloxane, Parfum/Fragrance, Alpha-Isomethyl Ionone, Linaloo, Benzoic Acid, Methylparaben, Phenoxyethanol, Chlorphenesin, Iron Oxisdes (CI 77492), Red 4 (CI 14700), Titanium Dioxide (CI 77891), Yellow 5 (CI 19140).

DOSAGE & ADMINISTRATION

Massage on to 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 lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 67938-0904
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	35 mg  in 50 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	25 mg  in 50 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	25 mg  in 50 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	11 mg  in 50 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	10 mg  in 50 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
DIMETHICONE (UNII: 92RU3N3Y1O)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)
POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
CYCLOMETHICONE 6 (UNII: XHK3U310BA)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
METHYLPARABEN (UNII: A2I8C7HI9T)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
MICA (UNII: V8A1AW0880)
SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)
UREA (UNII: 8W8T17847W)
CHLORPHENESIN (UNII: I670DAL4SZ)
BENZOIC ACID (UNII: 8SKN0B0MIM)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
TREHALOSE (UNII: B8WCK70T7I)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 67938-0904-1	1 in 1 BOX
1	NDC: 67938-0904-2	50 mL in 1 BOTTLE, PUMP

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	06/04/2009

Labeler - Elizabeth Arden, Inc (849222187)