Otc - Active Ingredient
Non-Nano Zinc Oxide 19%
Tallow Sunscreen Spf 30 Cream
FDA Label NDC 85739-004
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 Spf 30 (NDC 85739-004). 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 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
Otc - Do Not Use
Do not use on damaged or broken skin
Otc - When Using
When using this product keep out of eyes. Rinse with water to remove.
Otc - Stop Use
Stop use and ask a doctor if rash occurs
Otc - Keep Out Of Reach Of Children
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 - 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 value 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-sleeved shirts, pants, hats and sunglasses - children under 6 months of age: Ask a doctor
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 oil, Olea Europaea (Olive) Fruit Oil, Lecithin, C12-15 Alkyl Benzoate, Silica, Squalane, Xanthan Gum, Dimethicone, Glyceryl Stearate, Cetearyl Alcohol, Isononyl Isononanoate, Radish Root Ferment Filtrate, Saururus Chinensis Leaf/root Extract, Taraxacum Officinale (Dandelion) Leaf Extract
Otc - Questions
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