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

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

----------

Merle Norman Preventage Defense Cream Normal Oily SPF 15

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 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 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

Merle Norman Preventage Defense Cream Normal Oily SPF 15

Merle Norman

Established in Los Angeles in 1931

56 g Net Wt 2 oz

carton

Jar

PREVENTAGE FIRMING DEFENSE NORMAL/OILY BROAD SPECTRUM SPF 15  MERLE NORMAN
avobenzone, octocrylene cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:57627-119
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE1.064 g  in 56 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE5.264 g  in 56 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:57627-119-0156 g in 1 JAR; Type 0: Not a Combination Product08/15/2012
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35208/15/2012
Labeler - Merle Norman Cosmetics, Inc (008479388)
Registrant - Merle Norman Cosmetics, Inc (008479388)
Establishment
NameAddressID/FEIBusiness Operations
Merle Norman Cosmetics, Inc008479388manufacture(57627-119)

Revised: 1/2020
Document Id: 352ebafe-245a-4cf5-9a2a-bbfa51765ab1
Set id: 27ced99b-59a5-473f-90c5-f72b7e48ebdc
Version: 8
Effective Time: 20200127
 
Merle Norman Cosmetics, Inc