PREVENTAGE FIRMING DEFENSE CREME NORMAL/DRY BROAD SPECTRUM SPF 15- 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.

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Preventage Firming Defense Creme Normal/Dry Broad Spectrum SPF 15

Active Ingredients (w/w): Purpose

Avobenzone 1.9% .........Sunscreen

Octocrylene 9.4% ......... Sunscreen

Uses

Stop use and ask a doctor if rash occurs.

Directions

For sunscreen use:
apply liberally and evenly 15 minutes before sun exposure
use a water resistant sunscreen if swimming or sweating
reapply at least every 2 hours
children under 6 months: Ask a doctor
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
Apply to cleansed and toned skin prior to sun exposure

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.

Inactive (non-medicinal) ingredients: Aqua/Water/Eau, Glycerin, Butyloctyl Salicylate, Diethylhexyl Maleate, Jojoba Esters, Cyclopentasiloxane, C10-30 Cholesterol/Lanosterol Esters, Phenyl Trimethicone, Stearic Acid, Stearyl Alcohol, Glyceryl Polymethacrylate, Biosaccharide Gum-1, Sorbitan Stearate, Propylene Glycol, Dimethicone, Dipalmitoyl Hydroxyproline, PEG-100 Stearate, Polysorbate 60, PPG-20 Methyl Glucose Ether, Hydrolyzed Malt Extract, Tocopheryl Acetate, Phenoxyethanol, Bis-Ethylhexyl Hydroxydimethoxy Benzylmalonate, Bisabolol, Cetearyl Methicone, Hydrolyzed Elastin, Hamamelis Virginiana (Witch Hazel) Bark/Leaf/Twig Extract, PEG-8, Alcohol, Triethanolamine, Sorbital, Lecithin, Caprylyl Glycol, Collagen Amino Acids, PEG-7M, Carbomer, Dimethicone/Vinyl Dimethicone Crosspolymer, Ethylhexylglycerin, Phospholipids, Silica, Calluna Vulgaris Flower Extract, Glycyrrhethic Acid, Glycyrrhetinic Acid, Hexylene Glycol, Butylene Glycol, Tetrasodium EDTA, Hydrolyzed Rice Protein, Disodium EDTA, Camellia Sinensis Leaf Extract, PVP, Cucumis Sativus (Cucumber) Fruit Extract, Ginkgo Biloba Leaf Extract, Ruscus Aculeatus Root Extract, Echinacea angustifolia extract, Chlorphenesin, Hyaluronic Acid, Polyquaternium-24, Ilex Aquifolium (Holly) Leaf Extract, Sodium Oleanolate, Sodium Ursolate, Ascorbyl Palmitate, Euphrasia Officinalis Extract, Retinyl Palmitate, Diazolidinyl Urea, Yellow 5 (CI 19140), Imidazolidinyl Urea, Palmitoyl Hexapeptide-12, Methylparaben, Red 4 (CI 14700)

Other Information

Prev Firm Normal-Dry

PFDC Normal-Dry

PREVENTAGE FIRMING DEFENSE CREME NORMAL/DRY BROAD SPECTRUM SPF 15 
avobenzone, octocrylene cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:57627-203
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE1.9 g  in 100 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE9.4 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
SORBITOL (UNII: 506T60A25R)  
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X)  
HEXYLENE GLYCOL (UNII: KEH0A3F75J)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
SODIUM URSOLATE (UNII: NV5D25VL1O)  
CHLORPHENESIN (UNII: I670DAL4SZ)  
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (HARD PARTICLE) (UNII: H895X08VNQ)  
CUCUMBER (UNII: YY7C30VXJT)  
TROLAMINE (UNII: 9O3K93S3TK)  
GINKGO (UNII: 19FUJ2C58T)  
ENOXOLONE (UNII: P540XA09DR)  
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
AMINO ACIDS (UNII: 0O72R8RF8A)  
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
POVIDONE (UNII: FZ989GH94E)  
HYALURONIC ACID (UNII: S270N0TRQY)  
SODIUM OLEANOLATE (UNII: LVB19G8AUT)  
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
FD&C RED NO. 4 (UNII: X3W0AM1JLX)  
WATER (UNII: 059QF0KO0R)  
DIETHYLHEXYL MALEATE (UNII: C2F7JHI12L)  
C10-30 CHOLESTEROL/LANOSTEROL ESTERS (UNII: 137SL7IL0Y)  
BIOSACCHARIDE GUM-1 (UNII: BB4PU4V09H)  
POLYSORBATE 60 (UNII: CAL22UVI4M)  
HYDROLYZED BOVINE ELASTIN (BASE; 1000 MW) (UNII: ZR28QKN0WT)  
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
PPG-20 METHYL GLUCOSE ETHER (UNII: 3WV1T97D3K)  
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
LEVOMENOL (UNII: 24WE03BX2T)  
CETEARYL METHICONE (15000 MW) (UNII: VY9RTR7MSY)  
DIPALMITOYL HYDROXYPROLINE (UNII: E6AHA53N1H)  
PEG-100 STEARATE (UNII: YD01N1999R)  
CALLUNA VULGARIS FLOWERING TOP (UNII: D9PC510CQV)  
EDETATE SODIUM (UNII: MP1J8420LU)  
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
BASIC YELLOW 5 (UNII: 07BP340B4T)  
IMIDUREA (UNII: M629807ATL)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
GLYCERIN (UNII: PDC6A3C0OX)  
BIS-ETHYLHEXYL HYDROXYDIMETHOXY BENZYLMALONATE (UNII: 7D4Q5YJ8NV)  
HAMAMELIS VIRGINIANA TOP (UNII: UDA30A2JJY)  
POLYETHYLENE OXIDE 300000 (UNII: 4QIB4U4CQR)  
EUPHRASIA STRICTA (UNII: C9642I91WL)  
PALMITOYL HEXAPEPTIDE-12 (UNII: HO4ZT5S86C)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
ILEX AQUIFOLIUM LEAF (UNII: 9Z32IEA9F7)  
ASCORBYL PALMITATE (UNII: QN83US2B0N)  
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
ALCOHOL (UNII: 3K9958V90M)  
RUSCUS ACULEATUS ROOT (UNII: ZW12V95I1Q)  
ECHINACEA ANGUSTIFOLIA (UNII: VB06AV5US8)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:57627-203-0156 g in 1 JAR; Type 0: Not a Combination Product11/15/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35211/15/2021
Labeler - Merle Norman Cosmetics, Inc. (008479388)
Establishment
NameAddressID/FEIBusiness Operations
Merle Norman Cosmetics, Inc.008479388manufacture(57627-203)

Revised: 11/2021
Document Id: d0dc5744-82d2-2f51-e053-2a95a90a3972
Set id: d0dc5744-82d1-2f51-e053-2a95a90a3972
Version: 1
Effective Time: 20211115
 
Merle Norman Cosmetics, Inc.