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 GLOWVERA. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

Non-Nano Zinc Oxide 25%

use

.helps prevent sunburn

.if used as directed with other sun protectionmeasures(see Directions),decreases therisk of skin cancer and early skin agingcaused by the sun

Warning

.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 doctorif rash occurs.

.Keep out of reach of children.lf product isswallowed, get medical help or contact aPoison Control Center right away.

Directions

.apply liberally 15 minutes before sun exposure.

.reapply: after 80 minutes of swimming or sweating immediately after towel drying at least every 2 hours

children after 6 months of age: ask a doctor

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 of 15 or higher and other sun protection.

measures including:

-limit time in the sun, especially from10am-2pm

-wear long-sleeve shirts, pants, hats, and sunglasses

Sun alert: Limiting sun exposure, wearing protective clothing, and using sunscreens may reduce the risks of skin aging, skin cancer, and other harmful effects of the sun.

Inactive ingredients

Water, Tallow, Tocopherol(vitamin E),Centella Asiatica extract, Camellia Sinensisleaf extract, Rosmarinus Officinalis leafextract,Jojoba Esters, Lecithin, CeraAlba(beeswax),Glycerin,Titanium Dioxide.Cetyl Alcohol, Dioctyl Carbonate, Silica,Polyglycerol-10 Decaoleate.

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Questions?

support@jardients.com

Purpose

Sunscreen

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

TALLOW SUNSCREEN 
non-nano zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 85646-002
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 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
SORBITAN OLEATE (UNII: 06XEA2VD56)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
BUTYROSPERMUM PARKII (SHEA) OIL (UNII: O88E196QRF)
POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)
WATER (UNII: 059QF0KO0R)
ETHYLHEXYL METHOXYCINNAMATE (UNII: 4Y5P7MUD51)
C13-14 ISOPARAFFIN (UNII: E4F12ROE70)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
STEARETH-20 (UNII: L0Q8IK9E08)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
DIMETHICONE (UNII: 92RU3N3Y1O)
EDETATE DISODIUM (UNII: 7FLD91C86K)
XANTHAN GUM (UNII: TTV12P4NEE)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
LAURETH-7 (UNII: Z95S6G8201)
GLYCERIN (UNII: PDC6A3C0OX)
CETEARYL ALCOHOL (UNII: 2DMT128M1S)
POLYACRYLAMIDE (1500 MW) (UNII: 5D6TC4BRWV)
PANTHENOL (UNII: WV9CM0O67Z)
OCTISALATE (UNII: 4X49Y0596W)
STEARETH-2 (UNII: V56DFE46J5)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
PARAFFINUM LIQUIDUM (UNII: T5L8T28FGP)
SODIUM ACRYLATE/SODIUM ACRYLOYLDIMETHYLTAURATE COPOLYMER (4000000 MW) (UNII: 1DXE3F3OZX)
SILICA (UNII: ETJ7Z6XBU4)
C12-15 ALKYL BENZOATE (UNII: A9EJ3J61HQ)
ISOHEXADECANE (UNII: 918X1OUF1E)
TOCOPHEROL (UNII: R0ZB2556P8)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 85646-002-01	1 in 1 BOX	05/07/2025
1		85 g in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	05/07/2025

Labeler - GLOWVERA (696716376)

Establishment
Name	Address	ID/FEI	Business Operations
GLOWVERA		696716376	manufacture(85646-002)