Label: PHOTOBLOCK- avobenzone, bis-ethylhexyl hydroxydimethoxy benzylmalonate gel

  • NDC Code(s): 82160-344-01
  • Packager: Pella Pharmaceuticals Co. Ltd
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not 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 24, 2021

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  • Forms and Presentation

    Gel: Tube of 75 g.

  • Active ingredients

    Avobenzone

    Bis-Ethylhexyl Hydroxydimethoxy Benzylmalonate

  • Inactive Ingredients

    Aqua, Alcohol, Glycerin, Isopropyl Myristate, Ceteareth-25, Carbomer, Methylparaben, Triethanolamine, Propylparaben and Disodium EDT A.

  • Purpose

    Sunscreen

  • Properties

    Photoblock ® Gel is a gel sunscreen with a protection factor SPF 50. The Photoblock ® Gel sunscreen is distinguished by its special formula; it is suitable for oily and acne-prone skin, Photoblock ® Gel provides long-term protection during times of peak temperatures during the day.

  • Indications

    Photoblock ® Gel with its protection SPF 50 is recommended for oily and acne-prone skin.

  • Precautions

    Keep out of reach of children

  • Warnings

    • For external use only
    • Avoid contact with eyes
  • Contraindications

    Hypersensitivity to any of the components.

  • Side effects

    Photoblock ® Gel has no known side effects, its use is harmless.

  • Dosage and administration

    Apply Photoblock ® Gel before sun exposure and on dry skin, apply a sufficient amount of Photoblock ® Gel and spread it well on the whole area.
    Reapply every 2 hours or after swimming or sports.

  • Storage conditions

    Store at a temperature below 30 ° C.

  • Primary Package

    Primary Package

  • Secondary Package

    Secondary Package

  • INGREDIENTS AND APPEARANCE
    PHOTOBLOCK 
    avobenzone, bis-ethylhexyl hydroxydimethoxy benzylmalonate gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:82160-344
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BIS-ETHYLHEXYL HYDROXYDIMETHOXY BENZYLMALONATE (UNII: 7D4Q5YJ8NV) (BIS-ETHYLHEXYL HYDROXYDIMETHOXY BENZYLMALONATE - UNII:7D4Q5YJ8NV) BIS-ETHYLHEXYL HYDROXYDIMETHOXY BENZYLMALONATE3.75 mg  in 75 g
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE30 mg  in 75 g
    Inactive Ingredients
    Ingredient NameStrength
    EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
    ALCOHOL (UNII: 3K9958V90M)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    CETEARETH-25 (UNII: 8FA93U5T67)  
    WATER (UNII: 059QF0KO0R)  
    CARBOMER 940 (UNII: 4Q93RCW27E)  
    Product Characteristics
    ColorwhiteScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:82160-344-011 in 1 CARTON07/07/2011
    175 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35207/07/2011
    Labeler - Pella Pharmaceuticals Co. Ltd (562370925)
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