The following Structured Product Label (SPL) was submitted to the FDA by Cp Skin Health Group, Inc for the product Eltamd Uv Restore (NDC 72043-2631). 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 warnings, indication, directions, keep out of reach of children, active ingredients, purpose, inactive ingredients, other information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
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 physician if rash occurs. If product is swallowed get medical help or contact a Poison Control Center right away.
Helps prevent sunburn. If used as directed with other sun protection measure (See Directions), decreases the risk of skin cancer and early skin aging caused by the sun.
Apply liberally 15 minutes before sun exposure. Use a water-resistant sunscreen if swimming or sweating. Reapply at least every 2 hours. Sun Protection Measures: Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a broad-spectrum SPF of 15 or higher and other sun protection measures including: limit time in the sun, especially from 10 am to 2 pm. Wear long-sleeve shirts, pants, hats, and sunglasses. Children under 6 months: ask a physician.
Keep out of reach of children
Titanium Dioxide 2.0%
Zinc Oxide 15.0%
Sunscreen
water, coco-caprylate/caprate, butyloctyl salicylate, caprylic/capric triglyceride, octyldodecyl neopentanoate, methyl glucose sequistearate, silica, glyceryl stearate, PEG-100 stearate, PEG-20 methyl glucose sequistearate, Phenoxyethanol, triethocycaprylylsilane, polyhydroxysteric acid, glycerin, glyceryl behenate, saccharide isomerate, xanthan gum, zingber officinale (Ginger) root extract, hydroxyethyl acrylate/sodium acryloyldimethyl taurate copolymer, squalane, dimethicone, ethylhexylglycerin, tetrahexyldocyl ascorbate, tocopheryl aceteate, sclerothum gum, lecithin, pullulan, polysorate 60, tocopherol, mica
protect this product from excessive heat and direct sun
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