Fair And Square
FDA Label NDC 58443-0152
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Prime Enterprises, Inc. for the product Fair And Square (NDC 58443-0152). 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 principal display panel - 237 ml bottle label, active ingredients, purpose, uses, warnings, otc - when using, otc - stop use, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Active Ingredients
Avobenzone 1.5%, Homosalate 15%, Octisalate 5%, Octocrylene 1.25%, and Oxybenzone 6%
Purpose
Sunscreen
Uses
- 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.
Warnings
Otc - When Using
When using this product keep out of eyes. Rinse with water to remove.
Otc - Stop Use
Stop use and ask a doctor if rash occurs.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Directions: Apply Liberally 15 Minutes Before Sun Exposure
reapply:
- after 80 minutes of swimming or sweating
- Immediately after towel drying
- at least every 2 hours
- limit time in the sun, especially from 10 a.m. – 2 p.m.
- wear long-sleeve shirts, pants, hats, and sunglasses
Sun Protection Measures: Spending time in the sun increases your risk of skin cancer & early skin aging. To decrease this risk, regularly use a sunscreen with a broad spectrum SPF of 15 or higher & other sun protection measures including:
Children under 6 months: Ask a doctor
Inactive Ingredients
Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Aloe Barbadensis Leaf Juice, Butylphthalimide, C12-15 Alkyl Benzoate, Carbomer, Disodium EDTA, Fragrance (Parfum), Hydroxypropyl Methylcellulose, Isopropylphthalimide, Methylisothiazolinone, Methylparaben, Polyethylene, Polysorbate 20, Propylene Glycol, Propylparaben, Sorbitan Oleate, Theobroma Cacao (Cocoa) Seed Butter, Tocopheryl Acetate, Triethanolamine, Water (Aqua)
Other Information
- protect from excesive heat & direct sunlight
* Please review the disclaimer below.