Tallow Sunscreen SPF 30
Initial Drug Listing - Vigority Tallow Sunscreen SPF30
3b410ed7-c629-e39c-e063-6294a90a12f6
HUMAN OTC DRUG LABEL
Jul 31, 2025
FOUNDATION COMMERCE INC
DUNS: 096404242
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Non-Nano Zinc Oxide 19%
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
Product Classification
Product Specifications
INGREDIENTS (20)
Drug Labeling Information
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
INDICATIONS & USAGE SECTION
- 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
OTC - ACTIVE INGREDIENT SECTION
Non-Nano Zinc Oxide 19%
OTC - PURPOSE SECTION
Sunscreen
WARNINGS SECTION
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 doctor if rash occurs
Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.
DOSAGE & ADMINISTRATION SECTION
- 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 SECTION
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 SECTION
service@vigority.com