FDA.reportPublic FDA data

Tallow Sunscreen SPF 30

Manufacturer
FOUNDATION COMMERCE INC
Effective date
2025-07-31
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 01:11:35

Label at a glance#

ProductTallow Sunscreen SPF 30
Active ingredientZINC OXIDE
Label structure9 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Non-Nano Zinc Oxide 19%

OTC - PURPOSE SECTION

Sunscreen

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

WARNINGS SECTION

For external use only

OTC - DO NOT USE SECTION

Do not use on damaged or broken skin

OTC - WHEN USING SECTION

When using this product keep out of eyes. Rinse with water to remove.

OTC - STOP USE SECTION

Stop use and ask a doctor if rash occurs

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

tallow sunscreen 30tallow sunscreen 30

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
85739-004-01Tallow Sunscreen SPF 30100 mL in 1 CARTONCREAM1001

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 22 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
85739-00485739-004-01

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 20 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
XANTHAN GUMTTV12P4NEEIACT
LECITHIN, SOYBEAN1DI56QDM62IACT
ISONONYL ISONONANOATES4V5BS6GCXIACT
BEEF TALLOW98HPY76U4WIACT
BUTYROSPERMUM PARKII (SHEA) BUTTERK49155WL9YIACT
SAURURUS CHINENSIS WHOLE6DRV3D37XSIACT
BEESWAX2ZA36H0S2VIACT
LEUCONOSTOC/RADISH ROOT FERMENT FILTRATED2QHA03458IACT
C12-15 ALKYL BENZOATEA9EJ3J61HQIACT
SILICAETJ7Z6XBU4IACT
GLYCERYL STEARATE230OU9XXE4IACT
CETEARYL ALCOHOL2DMT128M1SIACT
TARAXACUM OFFICINALE LEAF0022LFJ74YIACT
ZINC OXIDESOI2LOH54ZACTIB
SQUALANEGW89575KF9IACT
DIMETHICONE92RU3N3Y1OIACT
SIMMONDSIA CHINENSIS (JOJOBA) SEED OIL724GKU717MIACT
TOCOPHEROLR0ZB2556P8IACT
OLEA EUROPAEA (OLIVE) FRUIT OIL6UYK2W1W1EIACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Tallow Sunscreen SPF 30NON-NANO ZINC OXIDE 19%FOUNDATION COMMERCE INC3b410ed7-c629-e39c-e063-6294a90a12f62025-07-31WarningsExact identifier
ndc (package): 85739-004-01
ndc (product): 85739-004
ndc11 (package): 85739000401
spl id: 3b410ed7-c62a-e39c-e063-6294a90a12f6
spl set id: 3b410ed7-c629-e39c-e063-6294a90a12f6

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.