Otc - Active Ingredient
Non-Nano Zinc Oxide 25%
Tallow Sunscreen Cream
FDA Label NDC 85739-001
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Foundation Commerce Inc for the product Tallow Sunscreen (NDC 85739-001). 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, indications & usage, warnings, otc - do not use, otc - when using, otc - stop use, 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
Otc - Purpose
Sunscreen
Indications & Usage
- Helps prevent sunburn
- If used as directed with othersun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun
Warnings
For external use only
Otc - Do Not Use
on damaged or broken skin
Otc - When Using
Keep out of eyes. Rinse with water to remowe.
Otc - Stop Use
Ask a doctor if rash occurs.
Otc - Keep Out Of Reach Of Children
lf product is swallowed, get medical help or contact a Poison Control Center right away.
Dosage & Administration
- Apply liberally 15 minutes belore 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 sunincreases your risk of skin cancer and eariy skin aging. Todecrease this risk, regularly use a sunscreen wiih a BroadSpectrum SPF value ot 15 or higher and other sunprotection measures including:
- limit time in the sun,especially from 10 a.m.-2 p.m.
- wear long-sleeved shirts,pants, hats and sunglasses
- children under 6 months ofage: Ask a doclor
Other Safety Information
Protect the product in this container from excessive heat and direct sun
Inactive Ingredient
Water, Beef Tallow, Beeswax, Butyrospermum Parkii {Shea)Butter, Vitamin E, Simmondsia Chinensis (Jojoba) seed oll, OleaEuropaea (Olive) Fruit Oil, Lecithin,C12-15 Alkyl Benzoate, Silica,Squalane, Xanthan Gum, Dimethicone, Glyceryl Stearate,Cetearyl Alcohol, lsononyi lsononanoate, Disodium EDTA, RadishRoot Ferment Filtrate, Saururus Chinensis Leaf/root Extract,Taraxacum Offcinale (Dandelion) Leaf Extract
Otc - Questions
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Package Label.Principal Display Panel
Sunscreen (Sunscreen)
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