The following Structured Product Label (SPL) was submitted to the FDA by Swiss-american Cdmo, Llc for the product Private Label Super Light Oil-free Spf45 (NDC 60232-0008). 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, use and directions, keep out of reach of children, active ingredients, inactive 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. 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), decreases the risk of skin cancer and early skin aging caused by the sun.
Apply liberally 15 minutes before sun exposure. Reapply at least every 2 hours. Use a water resistant sunscreen if swimming or sweating. 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 10a.m. to 2p.m. Wear long sleeve shirts, pants, hats and sunglasses. Children under 6 months: ask a doctor.
Keep out of reach of children
Octinoxate 7.50%
Octisalate 2.75%
Zinc Oxide 8.00%
Ascorbyl Palmitate, Butylene Glycol, Citric Acid, Cyclopentasiloxane, Sodium Hyaluronate, Hydroxyethyl Acrylate/Sodium Acrylouldimethyl Taurate Copolymer, Idodopropynyl Butylcarbamate, Octyldodecyl neopentanoate, Oleth-3 Phosphate, PEG-7 Triethylolpropane Coconut Ether, Phenoxyethanol, Polyisobutene, Purified Water, Retinyl Palmitate, Triethocycaprylysilane
* Please review the disclaimer below.
