PREVENTAGE FIRMING DEFENSE CREME NORMAL/DRY MERLE NORMAN- avobenzone, octocrylene cream

Preventage Firming Defense Creme Normal/Dry by

Drug Labeling and Warnings

Preventage Firming Defense Creme Normal/Dry by is a Otc medication manufactured, distributed, or labeled by 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

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. If product is swallowed, get medical help or contact a Poison Control Center right away.

Stop use and ask a doctor if rash occurs.

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.

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 sin 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 Ingredients: Water (Aqua), Glycerin, Butyloctyl Salicylate, Diethylhexyl Maleate, Jojoba Esters, Cyclopentasiloxane, C10-30 Cholesterol/Lanosterol Esters, Phenyl Trimethicone, Stearic Acid, Stearyl Alcohol, GlycerylPolymethacrylate, Propylene Glycol, Biosaccharide Gum-1, Sorbitan Stearate, PalmitoylOligopeptide, DipalmitoylHydroxylproline, Hydrolyzed Elastin, Collagen Amino Acids, Hydrolyzed Malt Extract, Hydrolyzed Rice Protein, Ilex Aquifolium (Holly) Leaf Extract, Calluna Vulgaris Flower Extract, CucumisSativus (Cucumber) Fruit Extract, Ginkgo Biloba Leaf Extract, RuscusAculeatus Root Extract, Echinacea Angustifolia Extract, Camellia Sinensis Leaf Extract, Glycyrrhetinic Acid, HamamelisVirginiana (Witch Hazel) Bark/Leaf/Twig Extract, Hyaluronic Acid, EuphrasiaOfficinalis Extract, Bisabolol, Tocopheryl Acetate, AscorbylPalmitate, RetinylPalmitate, Lecithin, Dimethicone, Dimethicone/Vinyl DimethiconeCrosspolymer, CetearylMethicone, Bis-EthylhexylHydroxydimethoxyBenzylmalonate, PPG-20 Methyl Glucose Ether, PEG-100 Stearate, Polysorbate 60, Sorbitol, Triethanolamine, Alcohol, Caprylyl Glycol, Butylene Glycol, Polyquaternium-24, Sodium Oleanolate, Sodium Ursolate, Phospholipids, PEG-7M, PEG-8, Carbomer, Silica, PVP, Phenoxyethanol, Chlorphenesin, Methylisothiazolinone, Diazolidinyl Urea, Imidazolidinyl Urea, Methylparaben, Disodium EDTA, Trisodium EDTA, Yellow 5, Red 4

PRINCIPAL DISPLAY PANEL

Preventage Firming Defense creme

Broad Spectrum SPF 15

Merle Norman established in Los Angeles since 1931

56 g Net Wt. 2 Oz

INGREDIENTS AND APPEARANCE

PREVENTAGE FIRMING DEFENSE CREME NORMAL/DRY  MERLE NORMAN
avobenzone, octocrylene cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 57627-121
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)
GLYCERIN (UNII: PDC6A3C0OX)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
DIETHYLHEXYL MALEATE (UNII: C2F7JHI12L)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
C10-30 CHOLESTEROL/LANOSTEROL ESTERS (UNII: 137SL7IL0Y)
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)
STEARIC ACID (UNII: 4ELV7Z65AP)
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)
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)
GINKGO (UNII: 19FUJ2C58T)
RUSCUS ACULEATUS ROOT (UNII: ZW12V95I1Q)
ECHINACEA ANGUSTIFOLIA ROOT (UNII: D982V7VT3P)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
ENOXOLONE (UNII: P540XA09DR)
HYALURONIC ACID (UNII: S270N0TRQY)
EUPHRASIA STRICTA (UNII: C9642I91WL)
LEVOMENOL (UNII: 24WE03BX2T)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
ASCORBYL PALMITATE (UNII: QN83US2B0N)
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)
DIMETHICONE (UNII: 92RU3N3Y1O)
BIS-ETHYLHEXYL HYDROXYDIMETHOXY BENZYLMALONATE (UNII: 7D4Q5YJ8NV)
PPG-20 METHYL GLUCOSE ETHER (UNII: 3WV1T97D3K)
PEG-100 STEARATE (UNII: YD01N1999R)
POLYSORBATE 60 (UNII: CAL22UVI4M)
SORBITOL (UNII: 506T60A25R)
TROLAMINE (UNII: 9O3K93S3TK)
ALCOHOL (UNII: 3K9958V90M)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
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)
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)
IMIDUREA (UNII: M629807ATL)
METHYLPARABEN (UNII: A2I8C7HI9T)
EDETATE DISODIUM (UNII: 7FLD91C86K)
EDETATE TRISODIUM (UNII: 420IP921MB)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
FD&C RED NO. 4 (UNII: X3W0AM1JLX)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 57627-121-02	1 in 1 BOX	08/17/2012
1	NDC: 57627-121-01	56 g in 1 JAR; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	08/17/2012

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(57627-121)