FDA Label for Oncoderm Rx Mineral Sunscreen Spf-30

View Indications, Usage & Precautions

Oncoderm Rx Mineral Sunscreen Spf-30 Product Label

The following document was submitted to the FDA by the labeler of this product Oncoderm, Llc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

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 ( see Directions), decreases the risk of skin cancer and early skin aging caused by the sun.


Warnings:



  • ​​​For external use only.

Otc - Do Not Use



• Do not use on damaged or broken skin.


Otc - When Using



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

Otc - Stop Use



  • 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.

SUN PROTECTION MEASURES. 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.


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.


Otc - Questions



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


​Package Labeling:




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