PREVENTAGE FIRMING DEFENSE NORMAL/OILY BROAD SPECTRUM SPF 15 MERLE NORMAN- avobenzone, octocrylene cream

Preventage Firming Defense Normal/Oily Broad Spectrum SPF 15 by

Drug Labeling and Warnings

Preventage Firming Defense Normal/Oily Broad Spectrum SPF 15 by is a Otc medication manufactured, distributed, or labeled by Merle Norman Cosmetics, Inc , Merle Norman Cosmetics, Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredients Purpose

Avobenzone 1.9% Sunscreen

Octocrylene 9.4% Sunscreen

PURPOSE

Uses

-Helps prevent sunburn

-If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun.

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.

INDICATIONS & USAGE

Stop use and ask a doctor if rash occurs.

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.

DOSAGE & ADMINISTRATION

Directions For sunscreen use:

Apply liberally 15 minutes before sun exposure.

Use a water resistant sunscreen if swimming or sweating.

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 value 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-sleeved shirts, pants, hats, and sunglasses.

Children under 6 months: Ask a doctor.

INACTIVE INGREDIENT

Inactive ingredients: Water(Aqua), Butylene Glycol, Cyclopentasiloxane, Cyclohexasiloxane, Hamamelis Virginiana (Witch Hazel) Water, Glyceryl Polymethacrylate, Propylene Glycol, Biosaccharide Gum-1, Sorbitan Stearate, Palmitoyl Oligopeptide, Dipalmitoyl Hydroxyproline, Hydrolyzed Elastin, Collagen Amino Acids, Hydrolyzed Rice Protein, Hydrolyzed Malt Extract, Ilex Aquifolium (Holly) Leaf Extract, Calluna Vulgaris Flower Extract, Cucumis Sativus (Cucumber) Fruit Extract, Ruscus Aculeatus Root Extract, Ginkgo Biloba Leaf Extract, Camellia Sinensis Leaf Extract, Euphrasia Officinalis Extract, Echinacea Angustifolia Extract, Bisabolol, Glycyrrhetinic Acid, Hyaluronic Acid, Tocopheryl Acetate, Ascorbyl Palmitate, Retinyl Palmitate, Lecithin, Dimethicone, Phenyl Trimethicone, Bis-Ethylhexyl Hydroxydimethoxy Benzylmalonate, PPG-20 Methyl Glucose Ether, Octyldodecyl Neopentanoate, Glycerin, Myristyl Lactate, Sorbitol, Phospholipids, Stearic Acid, Stearyl Alcohol, PEG-100 Stearate, Polysorbate 60, Triethanolamine, Alcohol, Caprylyl Glycol, Polyquaternium-24, Sodium Oleanolate, Sodium Ursolate, PEG-7M, PEG-8, Carbomer, Silica, PVP, Phenoxyethanol, Chlorphenesin, Methylisothiazolinone, Disodium EDTA, Trisodium EDTA

PRINCIPAL DISPLAY PANEL

Merle Norman Preventage Defense Cream Normal Oily SPF 15

Merle Norman

Established in Los Angeles in 1931

56 g Net Wt 2 oz

INGREDIENTS AND APPEARANCE

PREVENTAGE FIRMING DEFENSE NORMAL/OILY BROAD SPECTRUM SPF 15  MERLE NORMAN
avobenzone, octocrylene cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 57627-119
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	1.064 g  in 56 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	5.264 g  in 56 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
CYCLOMETHICONE 6 (UNII: XHK3U310BA)
HAMAMELIS VIRGINIANA TOP WATER (UNII: NT00Y05A2V)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
BIOSACCHARIDE GUM-1 (UNII: BB4PU4V09H)
SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X)
PALMITOYL OLIGOPEPTIDE (UNII: HO4ZT5S86C)
DIPALMITOYL HYDROXYPROLINE (UNII: E6AHA53N1H)
HYDROLYZED ELASTIN, BOVINE, ALKALINE (1000 MW) (UNII: ZR28QKN0WT)
ILEX AQUIFOLIUM LEAF (UNII: 9Z32IEA9F7)
CALLUNA VULGARIS FLOWERING TOP (UNII: D9PC510CQV)
CUCUMBER (UNII: YY7C30VXJT)
RUSCUS ACULEATUS ROOT (UNII: ZW12V95I1Q)
GINKGO (UNII: 19FUJ2C58T)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
EUPHRASIA STRICTA (UNII: C9642I91WL)
ECHINACEA ANGUSTIFOLIA (UNII: VB06AV5US8)
LEVOMENOL (UNII: 24WE03BX2T)
ENOXOLONE (UNII: P540XA09DR)
HYALURONIC ACID (UNII: S270N0TRQY)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
ASCORBYL PALMITATE (UNII: QN83US2B0N)
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)
DIMETHICONE (UNII: 92RU3N3Y1O)
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)
BIS-ETHYLHEXYL HYDROXYDIMETHOXY BENZYLMALONATE (UNII: 7D4Q5YJ8NV)
PPG-20 METHYL GLUCOSE ETHER (UNII: 3WV1T97D3K)
OCTYLDODECYL NEOPENTANOATE (UNII: X8725R883T)
GLYCERIN (UNII: PDC6A3C0OX)
MYRISTYL LACTATE (UNII: 1D822OC34X)
SORBITOL (UNII: 506T60A25R)
STEARIC ACID (UNII: 4ELV7Z65AP)
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)
PEG-100 STEARATE (UNII: YD01N1999R)
POLYSORBATE 60 (UNII: CAL22UVI4M)
TROLAMINE (UNII: 9O3K93S3TK)
ALCOHOL (UNII: 3K9958V90M)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
SODIUM OLEANOLATE (UNII: LVB19G8AUT)
SODIUM URSOLATE (UNII: NV5D25VL1O)
POLYETHYLENE GLYCOL 300000 (UNII: 4QIB4U4CQR)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
CHLORPHENESIN (UNII: I670DAL4SZ)
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)
EDETATE DISODIUM (UNII: 7FLD91C86K)
EDETATE TRISODIUM (UNII: 420IP921MB)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 57627-119-01	56 g in 1 JAR; Type 0: Not a Combination Product	08/15/2012

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	08/15/2012

Labeler - Merle Norman Cosmetics, Inc (008479388)

Registrant - Merle Norman Cosmetics, Inc (008479388)

Establishment
Name	Address	ID/FEI	Business Operations
Merle Norman Cosmetics, Inc		008479388	manufacture(57627-119)