The following Structured Product Label (SPL) was submitted to the FDA by Yoderm, Inc. for the product Apostrophe Screen Spf43 (NDC 81780-007). 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, active ingredients, uses, keep out of reach of children, directions, other information, inactive ingredients, tube labeling, 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.
Zinc Oxide 7.5% Sunscreen
Octinoxate 7.5% Sunscreen
Octisalate 2.5% Sunscreen
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.
KEEP OUT OF REACH OF CHILDREN
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.
Protect this product from excessive heat and direct sun.
purified water, isopropyl palmitate, ethylhexyl stearate, ethylhexyl isononanoate, cyclopentasiloxane, dimethicone, cetearyl glucoside, glycereth-26, phenoxyethanol, oleth-3 phosphate, hydroxyethyl acrylate/sodium acryloyldimethyl taurate copolymer, allantoin, polyisobutene, polyether-1, panthenol, butylene glycol, PEG-7 trimethylolpropane coconut ether, sodium hyaluronate, tocopheryl acetate, iodopropynyl butylcarbamate, ascorbyl palmitate, triethoxycaprylylsilane
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