Otc - Active Ingredient
Zinc Oxide 12%
Purpose Sunscreen
Terra Lotus Spf 50 Organic Tallow Sunscreen Spray
FDA Label NDC 87761-001
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 87761-001). 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, otc - keep out of reach of children, warnings, inactive ingredient, dosage & administration, 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 - Purpose
Uses . helps prevent sunburn
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
Warnings
WarningsFor external use only
Inactive Ingredient
100% Grass-Fed Beef Tallow,Organic Jojoba Oil, OrganicBeeswax, Vanilla planifolia(Vanilla) oil, Tocopherol(Vitamin E)
Dosage & Administration
shake well prior to use
apply liberally 15 minutes before sun exposure
Indications & Usage
Directions·shake well prior to useapply liberally 15 minutes before sun exposure.children under 6 months of age: Ask a doctor
reapply:.after 80 minutes of swimming or sweating
immediately after towel dryingat least every 2 hoursSun 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 001 01terralotus Sunscreen Box)
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