Label: PREVENTAGE FIRMING DEFENSE CREME NORMAL/DRY BROAD SPECTRUM SPF 15- avobenzone, octocrylene cream

  • NDC Code(s): 57627-203-01
  • Packager: Merle Norman Cosmetics, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

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.

Drug Label Information

Updated November 15, 2021

If you are a consumer or patient please visit this version.

  • ACTIVE INGREDIENT

    Active Ingredients (w/w): 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
  • INDICATIONS & USAGE

    Stop use and ask a doctor if rash occurs.

  • DOSAGE & ADMINISTRATION

    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

    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 INGREDIENT

    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)

  • STORAGE AND HANDLING

    Other Information

    • protect the product from excessive heat and direct sun
  • PRINCIPAL DISPLAY PANEL

    Prev Firm Normal-Dry

    PFDC Normal-Dry

  • INGREDIENTS AND APPEARANCE
    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)