The following Structured Product Label (SPL) was submitted to the FDA by Swiss-american Cdmo, Llc for the product Private Label Spf45 Water Resistant Paraben Free Sunscreen (NDC 60232-0006). 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, directions, keep out of reach of children, active ingredients, inactive ingredients, label, 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 physician if rash occurs. Keep out of reach of children. 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 measures (See Directions), decrease the risk of skin cancer and early skin aging caused by the sun
Apply liberally 15 minutes before sun exposure. Reapply: after 80 minutes of swimming or sweating, immediately after towel drying and 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 a.m. – 2 p.m., wear long-sleeve shirts, pants, hats and sunglasses. Before use on children under 6 months, ask a physician.
Keep Out of Reach of Children
Zinc Oxide 8.0%, Octinoxate 7.5%, Octisalate 3.0%
Ascorbyl Palmitate, Butylene Glycol, Cylcopentasiloxane, Dimethicone, Dimethicone/PEG-10/15 Crosspolymer, Dimethicone/Vinyl Dimethicone Crosspolymer, Ethylhexyl Isonnonanoate, Iodopropynyl Butylcarbamate, Lauryl PEG-9 Polymethylsiloxyethyl Dimethicone, Phenoxyethanol, Purified Water, Retinyl Palmitate, Sodium Chloride, Triethyoxycaprylylsilane
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