Otc - Active Ingredient
Zinc Oxide
Beef Tallow Sunscreen Cream
FDA Label NDC 84763-004
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Yunqi Cosmetics (shenzhen) Co., Ltd for the product Beef Tallow Sunscreen (NDC 84763-004). 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
Uses.Halps prevent sunburnm lf usedas directed with oter sun protectionmeasures (see Directions)decreasesthe risk of skin cancer and early skinaging caused by the sun.
Warnings
For exteral use onby
Otc - Do Not Use
Do not use on damaged or brokenskin. Stop use and ask a doctor if rash occurs
Otc - When Using
When using thls preduct keep outof eves. 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 or reach of chlldren. lfproduct is swallowed, get medicalhelp ar contact a Poison ContolCenter night away
Dosage & Administration
Directions .For full protection,applyliberally(2mg/cm of skin) to allexposed skin 15 minutes before sunexposure.Reapply:After 80 minutesof swlmming or sweating.lmmedlatelyafter towel drying .At least every 2hours Sun Protection Measures:Spending time in the sun increasesyour risk of skin cancer and early skinaging .To decrease this risk, regularlyuse a sunscreen with a broad spectumSPF value of 15 or higher and cther sunprotection measures including
Lmit tma In the sun,especlally tom 10em 2pm
Wesr lon aleeved chirtss, pants, hats, and runglaeses
For chilcren under b manths of aoet aek a cloctor
Inactive Ingredient
Beef Tallow
Olea Europaea (Olive)Fruit Oil
Cera Alba
Butyrospermum Parkii (Shea) Butter
Jojoba Oil/Macadamia Seed Oil Esters
Propolis Wax
Package Label.Principal Display Panel
Label2 (Label2)
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