The following Structured Product Label (SPL) was submitted to the FDA by Swiss-american Cdmo, Llc for the product Private Label Moisturizing Oil Free Paraben Free Spf43 (NDC 60232-0007). 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, uses, active ingredients, keep out of reach of children, directions, other ingredients, 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. Stope use and ask doctor if rash occurs. When using the product keep out of eyes; rinse with water to remove. Keep out of reach of children. If swallowed, get medical help or contact poison control immediately. Protect this product from excessive heat and direct sun.
Helps prevent sunbrun an dphoto damage caused by UVA/UVB exposure. 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.
Zinc Oxide 7.50%
Octinoxate 7.50%
Octisalate 2.50%
Keep out of reach of children.
Apply liberally 15 minutes before exposure to the sun. Use a water resistant sunscreen if swimming or sweating. Reapply at least every 2 hours. Children under 6 months of age, ask physician. 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 value of 15 or higher and other sun protection measures including: limit time in the sun, especially from 10 a.m. to 2 p.m. Wear long-sleeved shirts, pants, hats and sunglasses.
Water, Isopropyl Palmitate, Octyl Stearate, Ethylhexyl Isononanoate, Cylcopentasiloxane, Cetearyl Glucoside, Dimethicone, Glycerth-26, Sodium Hyaluronate, Panthenol, Allantoin, Tocopheryl Acetate, Ascorbyl Palmitate, Oleth-3 Phosphate, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Polyisobutene, PEG-7 Trimethylopropane Coconut Ether, Polyether-1, Phenoxyethanol, Butylene Glycol, Iodopropynyl Butylcarbamate, Triethoxycaprylysilane
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