Active Ingredient
Titanium Dioxide 5.81%
Cover Creme Cream
FDA Label NDC 84203-005
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Baxter Of California for the product Cover Creme (NDC 84203-005). 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, do not use, when using this product, stop use and ask a doctor, keep out of reach of children, directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Sunscreen
Uses
helps prevent sunburn. 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.
Do Not Use
Do not use on damaged or broken skin.
When Using This Product
When using this product keep out of eyes. Rinse with water to remove.
Stop Use And Ask A Doctor
Stop use and ask a doctor if rash occurs.
Keep Out Of Reach Of Children
If swallowed, get medical help or contact a Poison Control Cneter right away.
Directions
For sunscreen use, apply liberally 15 minutes before sun exposure; reapply at least every 2 hours; use a water resistant sunscreen if swimming or sweating.
Sun Protection Measures
Spending time n the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrun SPF value of 15 or higher and other sun protection measures including; limit time in the sun, especially from 10a.m.-2p.m.; wear long-sleeve shirts, pants, hats and sunglasses. Children under 6 months of age. Ask a doctor.
Other Information
Protect the product in this container from excessive heat and direct sun
Inactive Ingredients
Inactive ingredients
mineral oil (paraffinum liquidum), zea mays (corn) starch, synthetic beeswax, kaolin, barium sulfate, isopropyl plamitate, magnesium carbonate, copernicia cerifera (carnauba) wax, aluminum hydroxide, microcrystalline wax (cera microcristallina), stearic acid, phenoxyethanol, triethoxycaprylylsilane, caprylyl glycol, lauroyl lysine, allantoin, silica silylate, tocopherol. may contain: iron oxides, titanium dioxide
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