Active Ingredient
Non-Nano Zinc Oxide 25%
Tallow Sunscreen Cream
FDA Label NDC 85646-001
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Glowvera for the product Tallow Sunscreen (NDC 85646-001). 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 active ingredient, use, warning, directions, inactive ingredients, none, questions?, purpose, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Use
.helps prevent sunburn
.if used as directed with other sun protectionmeasures(see Directions),decreases therisk of skin cancer and early skin agingcaused by the sun
Warning
.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 a doctorif rash occurs.
.Keep out of reach of children.lf product isswallowed, get medical help or contact aPoison Control Center right away.
Directions
.apply liberally 15 minutes before sun exposure.
.reapply: after 80 minutes of swimming or sweating immediately after towel drying at least every 2 hours
children after 6 months of age: ask a doctor
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 of 15 or higher and other sun protection.
measures including:
-limit time in the sun, especially from10am-2pm
-wear long-sleeve shirts, pants, hats, and sunglasses
Sun alert: Limiting sun exposure, wearing protective clothing, and using sunscreens may reduce the risks of skin aging, skin cancer, and other harmful effects of the sun.
Inactive Ingredients
Water, Tallow, Tocopherol(vitamin E),Centella Asiatica extract, Camellia Sinensisleaf extract, Rosmarinus Officinalis leafextract,Jojoba Esters, Lecithin, CeraAlba(beeswax),Glycerin,Titanium Dioxide.Cetyl Alcohol, Dioctyl Carbonate, Silica,Polyglycerol-10 Decaoleate.
None
none
none
none
none
none
Questions?
Purpose
Sunscreen
Package Label.Principal Display Panel
Label (Label)
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