Otc - Active Ingredient
Zinc Oxide 19%
Lather Daily Defense Mineral Spf 45 Facial Sunscreen Lotion
FDA Label NDC 77394-204
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Lather, Inc. for the product Lather Daily Defense Mineral Spf 45 Facial Sunscreen (NDC 77394-204). 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 otc - active ingredient, otc - purpose, indications & usage, warnings, otc - keep out of reach of children, dosage & administration, inactive ingredient, package label.principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Sunscreen
Indications & Usage
Helps prevent sunburn. If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging cause by the sun.
Warnings
For external use only
Do not use on damaged or broken sin
When using this product keep out of eyes. Rinse with water to remove.
Stop use and ask a doctor if rash occurs
Otc - Keep Out Of Reach Of Children
If product is swallowed, get medical help or contact a Poison Control Center right away.
Dosage & Administration
Apply liberally 15 minutes before sun exposure. Reapply after 80 minutes of swimming or sweating, immediately after towel drying, and 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
- children under 6 months: ask a doctor
Inactive Ingredient
Water (Aqua), Aloe Barbadensis leaf Juice*, Coco-Caprylate/Caprate, Isoamyl Laurate, Glycerin, Polyglyceryl-3 Oleate, Propanediol, Polyhydroxystearic Acid, Diisostearoyl Polyceryl-3 Dime Dilinoleate, Mica, Caprylic/Capric Triglycride, Magnesium Sulfate, Squalane**, Camellia Sineis (Green Tea) Leaf Extract*, Olea Europa (Olive) Leaf Extract*, Curcuma Longa (Turmeeric) Root Extract*, Jojoba Esters, Helianthus Annuus (Sunflower) Seed Oil, Alaria Esculenta (Wakame Seaweed) Extract, Ocimum Tenuiflorum (Tulsi) Leaf Extract*, Ethyl Lauroyl Arginate HCl, Mixed Tocopherols, Sodium Stearoyl Glutamate, Tetrasodium Glutamate Diacetate, Silica, Xanthan Gum, Iron Oxides (CI 77492, CI 44791, CI 77499), *Organic Ingredient **Olive
Package Label.Principal Display Panel
Carton (Daily Defense Mineral Spf45 2oz Box Ol Registration)
* Please review the disclaimer below.
