Drug Facts
Active Ingredient
Zinc Oxide 19.5%
Tinted Lip Balm Spf30 Wild Peony Stick
FDA Label NDC 51514-0357
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Autumn Harp for the product Tinted Lip Balm Spf30 Wild Peony (NDC 51514-0357). 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 drug facts, purpose, uses, warnings, directions, otc - keep out of reach of children, other information, inactive ingredients, 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 keep out of eyes. Rinse with water to remove.
Stop use and ask a doctor if rash occurs.
Directions
- For sunscreen use
- 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 a.m. - 2 p.m.
- wear long-sleeve shirts, pants, hats and sunglasses.
Otc - Keep Out Of Reach Of Children
- children under 6 months: Ask a doctor
Other Information
Protect this product from excessive heat and direct sun.
Inactive Ingredients
Isoamyl Laurate, Sesamum Indicum (Sesame) Seed Oil, Oleic/Linoleic/Linolenic Polyglycerides, Prunus Amygdalus Dulcis (Sweet Almond) Oil, Simmondsia Chinensis (Jojoba) Seed Oil, Triticum Vulgare (Wheat) Germ Oil, Olea Europaea (Olive) Fruit Oil, Ricinus Communis (Castor) Seed Oil, Glycerin, Helianthus Annuus (Sunflower) Seed Wax, Beeswax, Flavor*, Glyceryl Behenate, Glyceryl Stearate, Hydrogenated Castor Oil, Polyglyceryl-2 Dipolyhydroxystearate, Dioctyldecyl Dimer Dilinoleate, Tocopheryl Acetate, Argania Spinosa Kernel Oil, Polyglyceryl-3 Diisostearate, Helianthus Annuus (Sunflower) Seed Oil, Butyrospermum Parkii (Shea) Butter, Theobroma Grandiflorum Seed Butter, Glyceryl Caprylate, Propanediol, Tocopherol, Bisabolol, Glyceryl Undecylenate, Glycine Soja (Soybean) Oil, Ammonium Glycyrrhizate, Mica, Carmine, Titanium dioxide, Iron Oxides.
* Natural Flavor
Questions?
1-800-849-7112 or www.burtsbees.com
Package Label.Principal Display Panel
image components
* Please review the disclaimer below.
