Label: ONCODERM RX MINERAL SUNSCREEN SPF-30- titanium dioxide, zinc oxide cream

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

Drug Label Information

Updated November 11, 2023

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

  • Drug Facts

  • Active Ingredient

    Titanium Dioxide 6.00%

    Zinc Oxide 6.00%

    Purpose

    Sunscreen

  • Uses:

    • Helps prevent sunburn

    • Higher SPF gives more sunburn protection

    • If used as directed with other sun protection measures ( ), decreases the risk of skin cancer and early skin aging caused by the sun. see Directions

  • 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 consult physician if irritation or rash develops and lasts.

    KEEP OUT OF REACH OF CHILDREN.

    If product is swallowed, get medical attention or contact poison control center immediately.

  • Directions:

    Apply liberally 15-minutes before sun exposure. Reapply: ■ After swimming or sweating. ■ Immediately after towel drying. ■ At least every 2 hours.



    Spending time in the sun increases your risk of skin cancer, early skin aging and other harmful effects of the sun to skin on those undergoing oncology therapies. To help decrease this risk, regularly use sunscreen with broad spectrum protection and an SPF rating of 15 or higher, along with other sun protection measures including: ■ Limit time in the sun, especially between 10am and 2pm. ■ Wear protective clothing: long sleeve shirts, pants, hats and sunglasses. ■ For children under 6-months, consult a physician. SUN PROTECTION MEASURES.


  • Inactive Ingredients:

    Aloe barbadensis leaf (aloe vera gel) juice, aqua (deionized water), camellia sinensis (green tea) extract, daucus carota sativa (carrot) extract, ethylhexylglycerin, ethylhexyl palmitate, glycerin, glycine soja (soybean) oil, helianthus annuus (sunflower) oil, lecithin, phenoxyethanol, prunus amygdalus dulcis (sweet almond) oil, sesamum indicum (sesame) seed oil, sodium laurylglucosides hydroxypropylsulfonate, theobroma cacao (cocoa) butter, tocopherol (vitamin E), xanthan gum.

  • Other Information

    ■ Do not store in excessive heat or direct sunlight.

  • QUESTIONS

    Questions or comments? (833) 662-6376 (M-F) (9-5pm EST)

  • ​Package Labeling:

    Label

  • INGREDIENTS AND APPEARANCE
    ONCODERM RX MINERAL SUNSCREEN SPF-30 
    titanium dioxide, zinc oxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:75087-074
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE60 mg  in 1 mL
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION60 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    WATER (UNII: 059QF0KO0R)  
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    CARROT (UNII: L56Z1JK48B)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    ETHYLHEXYL PALMITATE (UNII: 2865993309)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    SOYBEAN OIL (UNII: 241ATL177A)  
    SUNFLOWER OIL (UNII: 3W1JG795YI)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    ALMOND OIL (UNII: 66YXD4DKO9)  
    SESAME OIL (UNII: QX10HYY4QV)  
    COCOA BUTTER (UNII: 512OYT1CRR)  
    .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:75087-074-04118 mL in 1 TUBE; Type 0: Not a Combination Product04/17/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02004/17/2020
    Labeler - Oncoderm, LLC (117473289)