CANCER COUNCIL MINERAL FLUID SPF50- zinc oxide lotion

Cancer Council Mineral Fluid SPF50 by

Drug Labeling and Warnings

Cancer Council Mineral Fluid SPF50 by is a Otc medication manufactured, distributed, or labeled by Vitality US Co.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active Ingredients

Zinc Oxide 15%

Purpose

Sunscreen

Uses

• 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

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 doctor

if rash occurs

Keep out of reach of children.

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

Directions

• apply liberally 15 minutes before sun exposure
• apply to all skin exposed to the sun
• 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 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-sleeve shirts, pants, hats, and sunglasses
• children under 6 months: Ask a doctor

Inactive ingredients

Adansonia Digitata (Baobab) Oil, Allantoin, Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Ascorbic Acid (Vitamin C), Betaglucan, Butyloctyl Salicylate, Calendula Officinalis Extract, Camellia Sinensis (Green Tea) Leaf Extract, Caprylic/Capric Triglyceride, Citric Acid, Cocos Nucifera (Coconut) Oil, Decyl Glucoside, Dodecane, Glycerin, Glyceryl Caprylate, Glyceryl Stearate SE, Glyceryl Undecylenate, Iron Oxides (Black, Red, Yellow), Magnesium Aluminum Silicate, Methyl Dihydroabietate, Niacinamide, Polysorbate 20, Propanediol, Punica Granatum (Pomegranate) Fruit Extract, Saccharide Isomerate, Simmondsia Chinensis (Jojoba) Seed Oil, Sodium Citrate, Sodium Hyaluronate, Squalane, Tocopheryl Acetate (Vitamin E), Tridecyl Salicylate, Water (Aqua), Xanthan Gum

Other information

• protect this product from excessive heat and direct sun

Questions or comments?

info@vitalityusco.com

Product Packaging

INGREDIENTS AND APPEARANCE

CANCER COUNCIL MINERAL FLUID SPF50 
zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 84258-006
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	150 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
DECYL GLUCOSIDE (UNII: Z17H97EA6Y)
GLYCERYL STEARATE SE (UNII: FCZ5MH785I)
SACCHARIDE ISOMERATE (UNII: W8K377W98I)
SQUALANE (UNII: GW89575KF9)
YEAST .BETA.-D-GLUCAN (UNII: 44FQ49X6UN)
PROPANEDIOL (UNII: 5965N8W85T)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
ADANSONIA DIGITATA SEED OIL (UNII: 77MKL7AR5I)
ALLANTOIN (UNII: 344S277G0Z)
DODECANE (UNII: 11A386X1QH)
POMEGRANATE (UNII: 56687D1Z4D)
SODIUM HYALURONATE (UNII: YSE9PPT4TH)
ASCORBIC ACID (UNII: PQ6CK8PD0R)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
WATER (UNII: 059QF0KO0R)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
COCONUT OIL (UNII: Q9L0O73W7L)
GLYCERYL CAPRYLATE (UNII: TM2TZD4G4A)
GLYCERYL 1-UNDECYLENATE (UNII: B68LJT9544)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)
NIACINAMIDE (UNII: 25X51I8RD4)
XANTHAN GUM (UNII: TTV12P4NEE)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
JOJOBA OIL (UNII: 724GKU717M)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
TRIDECYL SALICYLATE (UNII: AZQ08K38Z1)
GLYCERIN (UNII: PDC6A3C0OX)
SODIUM CITRATE MONOHYDRATE (UNII: X6JU3FX5UU)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 84258-006-01	1 in 1 CARTON	09/30/2024
1		50 mL 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	09/30/2024

Labeler - Vitality US Co. (119152224)