Oncoderm Rx Mineral Sunscreen Spf-30 Cream
FDA Label NDC 75087-074

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Oncoderm, Llc for the product Oncoderm Rx Mineral Sunscreen Spf-30 (NDC 75087-074). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding active ingredient, purpose, uses:, warnings:, otc - do not use, otc - when using, otc - stop use, keep out of reach of children., and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

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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