Label: SOLVADERM DERMAXSOL DERMAL DEFENSE MOISTURIZER SPF-30- octocrylene, zinc oxide cream

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated March 21, 2024

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  • DRUG FACTS

  • ACTIVE INGREDIENTS:

    Octocrylene 10.0% 
    Zinc Oxide 7.0%

    PURPOSE

    Sunscreen

  • USES:

    Helps prevent sunburn.

  • 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.

    Stop use and ask a doctor if

    rash occurs.

    Keep out of reach of children.

    If product is swallowed, get medical help or contact a Poison Control Center right away.

  • DIRECTIONS:

    Apply to all skin exposed to the sun.

    *Apply liberally and evenly 15 minutes before sun exposure.

    *Reapply at least every 2 hours.

    *Use a water-resistant sunscreen if swimming or sweating.

    *If pregnant or breast-feeding, ask a health care professional before use.

    *For children under 6 months of age: Ask a doctor.

  • INACTIVE INGREDIENTS:

    Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Aluminum Starch Octenyl succinate, Aqua (Deionized Water), Beeswax, Calendula Officinalis Extract, Camellia Sinensis (Green Tea) Extract, Chamomilla Matricaria Extract, Cetearyl Alcohol, Cyclopentasiloxane, Diisopropyl Adipate, Dimethicone, Dimethiconol, Ethylhexylglycerin, Glycerin, Glyceryl Laurate, Glyceryl Stearate, Hyaluronic Acid, C13-14 Isoparaffin, Laureth-7, Parfum (Fragrance)., PEG-100 Stearate, Phenoxyethanol, Polyacrylamide, Sorbitan Stearate, Stearyl Alcohol, Tocopheryl Acetate (Vitamin E).

  • OTHER INFORMATION:

    Protect the product in this container from excessive heat and direct sun.

  • Package Labeling:

    Bottle

  • INGREDIENTS AND APPEARANCE
    SOLVADERM DERMAXSOL DERMAL DEFENSE MOISTURIZER SPF-30 
    octocrylene, zinc oxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:84197-467
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE100 mg  in 1 g
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION70 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    ALUMINUM STARCH OCTENYLSUCCINATE (UNII: I9PJ0O6294)  
    WATER (UNII: 059QF0KO0R)  
    YELLOW WAX (UNII: 2ZA36H0S2V)  
    CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)  
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    DIISOPROPYL ADIPATE (UNII: P7E6YFV72X)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    GLYCERYL LAURATE (UNII: Y98611C087)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    HYALURONIC ACID (UNII: S270N0TRQY)  
    C13-14 ISOPARAFFIN (UNII: E4F12ROE70)  
    LAURETH-7 (UNII: Z95S6G8201)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X)  
    STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:84197-467-001 in 1 BOX03/04/2024
    150 g in 1 JAR; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02003/04/2024
    Labeler - SOLVADERM LLC (093262409)
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