TALLOW SUNSCREEN SPF 30- non-nano zinc oxide 19% cream

Tallow Sunscreen SPF 30 by

Drug Labeling and Warnings

Tallow Sunscreen SPF 30 by is a Otc medication manufactured, distributed, or labeled by FOUNDATION COMMERCE INC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Non-Nano Zinc Oxide 19%

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

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

• 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

QUESTIONS

service@vigority.com

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

TALLOW SUNSCREEN SPF 30 
non-nano zinc oxide 19% cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 85739-004
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	19 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
XANTHAN GUM (UNII: TTV12P4NEE)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
ISONONYL ISONONANOATE (UNII: S4V5BS6GCX)
BEEF TALLOW (UNII: 98HPY76U4W)
BUTYROSPERMUM PARKII (SHEA) BUTTER (UNII: K49155WL9Y)
SAURURUS CHINENSIS WHOLE (UNII: 6DRV3D37XS)
BEESWAX (UNII: 2ZA36H0S2V)
LEUCONOSTOC/RADISH ROOT FERMENT FILTRATE (UNII: D2QHA03458)
C12-15 ALKYL BENZOATE (UNII: A9EJ3J61HQ)
SILICA (UNII: ETJ7Z6XBU4)
GLYCERYL STEARATE (UNII: 230OU9XXE4)
CETEARYL ALCOHOL (UNII: 2DMT128M1S)
TARAXACUM OFFICINALE LEAF (UNII: 0022LFJ74Y)
SQUALANE (UNII: GW89575KF9)
DIMETHICONE (UNII: 92RU3N3Y1O)
SIMMONDSIA CHINENSIS (JOJOBA) SEED OIL (UNII: 724GKU717M)
TOCOPHEROL (UNII: R0ZB2556P8)
OLEA EUROPAEA (OLIVE) FRUIT OIL (UNII: 6UYK2W1W1E)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 85739-004-01	100 mL in 1 CARTON; Type 0: Not a Combination Product	08/25/2025

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	08/25/2025

Labeler - FOUNDATION COMMERCE INC (096404242)