Otc - Active Ingredient
Active IngredientsNon-Nano Zinc Oxide 12%
PurposeSunscreen
Terra Lotus Spf 50 Organic Tallow Sunscreen Cream
FDA Label NDC 87761-006
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Moes Group Llc for the product Terra Lotus Spf 50 Organic Tallow Sunscreen (NDC 87761-006). 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 - keep out of reach of children, otc - purpose, warnings, dosage & administration, inactive ingredient, indications & usage, 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 - Keep Out Of Reach Of Children
Keep out of reach of children.If swallowed, get medical help or contact a PoisonControl Center right away
Otc - Purpose
Uses . helps prevent sunburn
Warnings
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 doctor if
rash occurs
Dosage & Administration
shake well prior to useapply liberally 15 minutes before sun exposurechildren under 6 months of age: Ask a doctor
reapply:after 80 minutes of swimming or sweatingimmediately after towel dryingat least every 2 hours
Inactive Ingredient
Inactive ingredients
100% Grass-Fed Beef Tallow,Organic Jojoba Oil, OrganicBeeswax, Vanilla planifolia(Vanilla) oil, Tocopherol
(Vitamin E).
Indications & Usage
Sun Protection Measures.Spending time inthe sun increases your risk of skin cancer and earlyskin aging. To decrease this risk, regularly use asunscreen with a Broad Spectrum SPF value of 15or higher and other sun protecting measuresincluding · limit time in the sun, especiallyfrom 10 a.m. - 2 p.m. · wear long-sleevedshirts, pants, hats, and sunglasses
Package Label.Principal Display Panel
Labeling (87761 006 01terralotus Sunscreen Box)
* Please review the disclaimer below.
