TALLOW SUNSCREEN- non-nano zinc oxide cream

TALLOW SUNSCREEN by

Drug Labeling and Warnings

TALLOW SUNSCREEN by is a Otc medication manufactured, distributed, or labeled by FOUNDATION COMMERCE INC, Guangzhou Haishi Biological Technology Co., Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Non-Nano Zinc Oxide 25%

PURPOSE

Sunscreen

INDICATIONS & USAGE

• 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

For external use only

on damaged or broken skin

Keep out of eyes. Rinse with water to remowe.

Ask a doctor if rash occurs.

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

DOSAGE & ADMINISTRATION

• 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

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

QUESTIONS

servicegvigority.com

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

TALLOW SUNSCREEN 
non-nano zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 85739-001
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	25 mg  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
TARAXACUM OFFICINALE (DANDELION) ROOT (UNII: 9DE5YCO0RU)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
XANTHAN GUM (UNII: TTV12P4NEE)
DIMETHICONE 1000 (UNII: MCU2324216)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
ISONONYL ISONONANOATE (UNII: S4V5BS6GCX)
WATER (UNII: 059QF0KO0R)
OLEA EUROPAEA (OLIVE) FRUIT OIL (UNII: 6UYK2W1W1E)
C12-15 ALKYL BENZOATE (UNII: A9EJ3J61HQ)
CETEARYL ALCOHOL (UNII: 2DMT128M1S)
CALCIUM DISODIUM EDTA (UNII: 8U5D034955)
SQUALANE (UNII: GW89575KF9)
SAURURUS CHINENSIS WHOLE (UNII: 6DRV3D37XS)
BEEF TALLOW (UNII: 98HPY76U4W)
BEESWAX (UNII: 2ZA36H0S2V)
BUTYROSPERMUM PARKII (SHEA) BUTTER (UNII: K49155WL9Y)
VITAMIN E POLYETHYLENE GLYCOL SUCCINATE (UNII: O03S90U1F2)
SIMMONDSIA CHINENSIS (JOJOBA) SEED OIL (UNII: 724GKU717M)
LEUCONOSTOC/RADISH ROOT FERMENT FILTRATE (UNII: D2QHA03458)
GLYCERYL STEARATE (UNII: 230OU9XXE4)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 85739-001-01	100 mL in 1 CARTON; Type 0: Not a Combination Product	06/19/2025

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	06/19/2025

Labeler - FOUNDATION COMMERCE INC (096404242)

Establishment
Name	Address	ID/FEI	Business Operations
Guangzhou Haishi Biological Technology Co., Ltd		421262738	manufacture(85739-001) , label(85739-001)