TALLOW AND SOLSUNSCREEN SPF50- non-nano zinc oxide 25% cream

Drug Labeling and Warnings

Drug Details [pdf]

DOSAGE & ADMINISTRATION

shake well before useapply liberally 15 minutes before sun exposurereapply: * after 60 minutes of swimming or sweating immediately after towel drying* at least every 2 hours

INACTIVE INGREDIENT

Water, Tallow, Jojoba oil, Jojoba esters, Lecithin fromsunflower, Beeswax, Coconut oil, Kaith bark extractBabassu starch, Astaxanthin, Radish root

ACTIVE INGREDIENT

Non-Nano Zinc Oxide 25%(25g/100g)

PURPOSE

helps prevent sunbum

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children. If product is swallowed,get medical help or contact a Poison Control Centerright away.

WARNINGS

children under 1 year old, consult your 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

INDICATIONS & USAGE

helps prevent sunbum

if used as directed with other sun protection measures(see Directions), decreases the risk of skin cancer andearly skin aging caused by the sun

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

TALLOW AND SOLSUNSCREEN SPF50 
non-nano zinc oxide 25% cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 87092-004
Route of Administration	CUTANEOUS

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
COCOS NUCIFERA (COCONUT) OIL (UNII: Q9L0O73W7L)	1 g  in 100 g
ATTALEA SPECIOSA WHOLE (UNII: 86U1G8MUQ3)	0.6 g  in 100 g
ASTAXANTHIN (UNII: 8XPW32PR7I)	0.3 g  in 100 g
HYDROLYZED JOJOBA ESTERS (UNII: UDR641JW8W)	2.2 g  in 100 g
TALLOW (UNII: 98HPY76U4W)	4 g  in 100 g
AQUA (UNII: 059QF0KO0R)	60 g  in 100 g
LEUCONOSTOC/RADISH ROOT FERMENT FILTRATE (UNII: D2QHA03458)	0.2 g  in 100 g
BEESWAX (UNII: 2ZA36H0S2V)	1.2 g  in 100 g
LECITHIN, SUNFLOWER (UNII: 834K0WOS5G)	1.8 g  in 100 g
LIMONIA ACIDISSIMA BARK (UNII: 68SJ7W9Y65)	0.7 g  in 100 g
SIMMONDSIA CHINENSIS (JOJOBA) SEED OIL (UNII: 724GKU717M)	3 g  in 100 g

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 87092-004-02	1 in 1 BOX	05/28/2026
1	NDC: 87092-004-01	1 g in 1 TUBE; 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	05/28/2026

Labeler - Guangzhou Shengyanghui Industrial Trading Co., Ltd (455836784)

Establishment
Name	Address	ID/FEI	Business Operations
Guangzhou Shengyanghui Industrial Trading Co., Ltd		455836784	label(87092-004) , manufacture(87092-004)