Chemical Sunscreen Spf50 With Antipollution Lotion
FDA Label NDC 60232-4400

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Swiss-american Cdmo, Llc for the product Chemical Sunscreen Spf50 With Antipollution (NDC 60232-4400). 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, keep out of reach of children, directions, other information:, inactive ingredients, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Warnings

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.

Indications And Uses

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.

Purpose

Sunscreen

Active Ingredients

Homosalate 15.0% Sunscreen
Octocrylene 10.0% Sunscreen
Avobenzone 3.0% Sunscreen
Octisalate 5.0% Sunscreen

Keep Out Of Reach Of Children

Keep out of reach of children

Directions

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.

Other Information:

Protect this product from excessive heat and direct sun.

Inactive Ingredients

Water, C15-19 Alkane, Triheptanoin C13-16 Isoalkane, Dicaprylyl Carbonate, Butyloctyl Salicylate, Glycerin, Ethylhexyl Methoxycrylene, Cetearyl alcohol, Coco-Glucoside, Glucose, Argania Spinosa Kernel Oil, Phenoxyethanol, Ethylhexylglycerin, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Isohexadecane, Polysorbate 60, Sorbitan Isostearate, Triacontanyl PVP, Biosaccharide Gum-4, 1,2-Hexanediol

Questions

Call toll free 1-866-416-2366

* Please review the disclaimer below.