The following Structured Product Label (SPL) was submitted to the FDA by Cp Skin Health Group, Inc for the product Eltamd Uv Restore Tinted (NDC 72043-2641). 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, indications and uses, purpose, active ingredients, directions, keep out of reach of children, inactive ingredients, other infomration, 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.
Sunscreen
Titanium Dioxide 2.0%
Zinc Oxide 15.0%
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
water, coco-caprylate/caprate, butyloctyl salicylate, caprylic/capric triglyceride, octyldodecyl neopentanoate, methyl glycose sesquistearate, silica, glyceryl stearate, PEG-100 stearate, PEG-20 methyl glycose sesquistearate, phenoxyethanol, triethoxycaprylylsilane, polyhydroxystearic acid, glycerin, glyceryl behenate, saccharide isomerate, xanthan gum, zingiber officinale (Ginger) root extract, hydroxyethyl acrylate/sodium acryloyldimethyl taurate copoylmer, squalane, diemthicone, ethylhexylglycerin, tetrahexyldecyl ascorbate, tocopheryl acetate, sclerotium gum, lecithin, pullulan, polysorbate 60, tocopherol, mica, iron oxides
Protect this product from excessive heat and direct sun.
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