Label: MEDERMA- avobenzone, octocrylene, and oxybenzone cream

  • NDC Code(s): 0259-3192-05, 0259-3192-20, 0259-3192-50
  • Packager: Merz Pharmaceuticals, LLC
  • 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 February 22, 2022

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  • DOSAGE & ADMINISTRATION

    Mederma® Cream should be evenly applied and gently rubbed into the scar 3 times daily for 8 weeks on new scars, and 3 times daily for 3–6 months on existing scars. Also apply Mederma® Cream to the scar before sun exposure.

    Children under 6 months of age: ask a doctor.

  • Active Ingredients

    AVOBENZONE 3%, OCTOCRYLENE 10%, OXYBENZONE 6%

  • Inactive Ingredients

    WATER, ALLIUM CEPA (ONION) BULB EXTRACT, C12-15 ALKYL BENZOATE, DICAPRYLYL CARBONATE, HYDROGENATED LECITHIN, CAPRYLIC/CAPRIC TRIGLYCERIDE, PANTHENOL, PENTYLENE GLYCOL, PHENOXYETHANOL, BUTYROSPERMUM PARKII (SHEA BUTTER), GLYCERIN, AMMONIUM ACRYLOYL-DIMETHYLTAURATE/VP COPOLYMER, FRAGRANCE, SQUALANE, METHYLPARABEN, XANTHAN GUM, DISODIUM EDTA, CERAMIDE 3, SODIUM HYALURONATE, BUTYLPARABEN, ETHYLPARABEN, PROPYLPARABEN, ISOBUTYLPARABEN.

  • Warnings

    For external use only.

    When using this product keep out of eyes. Rinse with water to remove.

    Stop use and ask a doctor if rash or irritation develops and lasts.

    Do not use on open wounds.

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

  • STORAGE AND HANDLING

    Store at room temperature.

  • QUESTIONS

    For more information call 1-888-925-8989 or visit www.mederma.com

  • SPL UNCLASSIFIED SECTION

    Manufactured for Merz Pharmaceuticals, Greensboro, NC 27410
    Made in Germany © 2007 Merz Pharmaceuticals

  • PRINCIPAL DISPLAY PANEL - 20 g Tube Carton

    SKIN CARE FOR SCARS™
    MEDERMA®
    +SPF 30
    SCAR
    CREAM

    NET WT. 0.70 OZ. (20g)
    MERZ

    PRINCIPAL DISPLAY PANEL - 20 g Tube Carton
  • INGREDIENTS AND APPEARANCE
    MEDERMA 
    avobenzone, octocrylene, and oxybenzone cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0259-3192
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE30 mg  in 1 g
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE100 mg  in 1 g
    OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE60 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    ONION (UNII: 492225Q21H)  
    ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
    DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)  
    HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    PANTHENOL (UNII: WV9CM0O67Z)  
    PENTYLENE GLYCOL (UNII: 50C1307PZG)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER (UNII: W59H9296ZG)  
    SQUALANE (UNII: GW89575KF9)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    CERAMIDE NP (UNII: 4370DF050B)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    BUTYLPARABEN (UNII: 3QPI1U3FV8)  
    ETHYLPARABEN (UNII: 14255EXE39)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    ISOBUTYLPARABEN (UNII: 0QQJ25X58G)  
    C12-15 ALCOHOLS (UNII: 2C8M6XLB5C)  
    ALCOHOL (UNII: 3K9958V90M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0259-3192-050.5 g in 1 PACKET; Type 0: Not a Combination Product12/01/200708/31/2023
    2NDC:0259-3192-201 in 1 CARTON12/01/200708/31/2023
    220 g in 1 TUBE; Type 0: Not a Combination Product
    3NDC:0259-3192-501 in 1 CARTON12/01/200708/31/2023
    350 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35212/01/200708/31/2023
    Labeler - Merz Pharmaceuticals, LLC (126209282)
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