Active Ingredients
Octinoxate 7.5%
Zinc Oxide 9%
Traci Lynn Skin
FDA Label NDC 58443-0296
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Prime Enterprises for the product Traci Lynn Skin (NDC 58443-0296). 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 active ingredients, purpose, uses:, warnings, otc - do not use, otc - when using, otc - ask doctor, 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
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
For external use only
Do not use on damaged or broken skin
When using this product keeo out of the eyes.
Rinse with water to remove.
Stop use and ask a doctor if arash occurs
Kep out of reach of children if product is walloed, get medical help or contact a Poison Control Center right away
Otc - Do Not Use
Do not use on damaged or broken skin
Otc - When Using
When using this product keep out of eyes. Rinse with water to remove.
Otc - Ask Doctor
Stop use and ask a doctor if rash occurs.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. If product is 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.
- 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 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.
- Children under 6 months: Ask a doctor.
Inactive Ingredients
Butylene Glycol, Cyclopentasiloxane, Ethylhexyl Stearate, Ethylhexylglycerin, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Iron Oxides (CI 77491), Iron Oxides (CI 77492), Iron Oxides (CI 77499), Isopropyl Palmitate, Niacinamide, Octyldodecyl Neopentanoate, Oleth-3 Phosphate, PEG-7 Trimethylolpropane Coconut Ether, Phenoxyethanol, Polyisobutene, Sodium Hyaluronate, Tocopheryl Acetate, Triethoxycaprylylsilane, Water
Other Information
- Protect this product from excessive heat and direct sun.
Questions Or Comments?
Mafactured for TRACI LYNN BEAUTY, LLC
954.717.4448 / www.tracilynnbeauty.com
Traci Lynn Skin Illuminator Sunscreen Broad Spectrum Spf 50
Principal Display Label (58443 0296 3)
* Please review the disclaimer below.
