FDA.reportPublic FDA data

TALLOW SUNSCREEN

Manufacturer
FOUNDATION COMMERCE INC | Guangzhou Haishi Biological Technology Co., Ltd
Effective date
2025-05-28
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 01:03:18

Label at a glance#

ProductTALLOW SUNSCREEN
Active ingredientZINC OXIDE
Label structure9 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Non-Nano Zinc Oxide 25%

OTC - PURPOSE SECTION

Sunscreen

INDICATIONS & USAGE SECTION

  • Helps prevent sunburn
  • If used as directed with othersun 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

on damaged or broken skin

OTC - WHEN USING SECTION

Keep out of eyes. Rinse with water to remowe.

OTC - STOP USE SECTION

Ask a doctor if rash occurs.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

lf product is swallowed, get medical help or contact a Poison Control Center right away.

DOSAGE & ADMINISTRATION SECTION

  • Apply liberally 15 minutes belore 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 sunincreases your risk of skin cancer and eariy skin aging. Todecrease this risk, regularly use a sunscreen wiih a BroadSpectrum SPF value ot 15 or higher and other sunprotection 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 ofage: Ask a doclor

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 oll, OleaEuropaea (Olive) Fruit Oil, Lecithin,C12-15 Alkyl Benzoate, Silica,Squalane, Xanthan Gum, Dimethicone, Glyceryl Stearate,Cetearyl Alcohol, lsononyi lsononanoate, Disodium EDTA, RadishRoot Ferment Filtrate, Saururus Chinensis Leaf/root Extract,Taraxacum Offcinale (Dandelion) Leaf Extract

OTC - QUESTIONS SECTION

servicegvigority.com

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

SunscreenSunscreen

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
85739-001-01TALLOW SUNSCREEN100 mL in 1 CARTONCREAM1001

Products#

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

DailyMed product names page 1 of 1 · 23 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
85739-00185739-001-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 21 matching rows.

Name, UNII, Kind table
NameUNIIKind
TARAXACUM OFFICINALE (DANDELION) ROOT9DE5YCO0RUIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
XANTHAN GUMTTV12P4NEEIACT
DIMETHICONE 1000MCU2324216IACT
LECITHIN, SOYBEAN1DI56QDM62IACT
ISONONYL ISONONANOATES4V5BS6GCXIACT
WATER059QF0KO0RIACT
OLEA EUROPAEA (OLIVE) FRUIT OIL6UYK2W1W1EIACT
C12-15 ALKYL BENZOATEA9EJ3J61HQIACT
CETEARYL ALCOHOL2DMT128M1SIACT
CALCIUM DISODIUM EDTA8U5D034955IACT
SQUALANEGW89575KF9IACT
SAURURUS CHINENSIS WHOLE6DRV3D37XSIACT
ZINC OXIDESOI2LOH54ZACTIB
BEEF TALLOW98HPY76U4WIACT
BEESWAX2ZA36H0S2VIACT
BUTYROSPERMUM PARKII (SHEA) BUTTERK49155WL9YIACT
VITAMIN E POLYETHYLENE GLYCOL SUCCINATEO03S90U1F2IACT
SIMMONDSIA CHINENSIS (JOJOBA) SEED OIL724GKU717MIACT
LEUCONOSTOC/RADISH ROOT FERMENT FILTRATED2QHA03458IACT
GLYCERYL STEARATE230OU9XXE4IACT

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 SUNSCREENNON-NANO ZINC OXIDEFOUNDATION COMMERCE INC363e38bf-b4b4-dcc4-e063-6294a90a5d2f2025-05-28WarningsExact identifier
ndc (package): 85739-001-01
ndc (product): 85739-001
ndc11 (package): 85739000101
spl id: 363e38bf-b4b5-dcc4-e063-6294a90a5d2f
spl set id: 363e38bf-b4b4-dcc4-e063-6294a90a5d2f

Reported adverse events (FAERS/openFDA)#

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