FUSION MINERAL BODY- zinc oxide lotion

Fusion Mineral Body by

Drug Labeling and Warnings

Fusion Mineral Body by is a Otc medication manufactured, distributed, or labeled by ISDIN Corp.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredient

Zinc Oxide 12%

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 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

• Shake well before use
• apply liberally 15 minutes before sun exposure
• Reapply:
  • use a water-resistant sunscreen if swimming or sweating
  • at least every 2 hours.
• Children under 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 broad spectrum SPF value of 15 or higher and other sun protection measures including:
  • limit your time in the sun, especially from 10 a.m.- 2 p.m.
  • wear long-sleeved shirts, pants, hats, and sunglasses.

Other Information

• Protect the product in this container from excessive heat and direct sun.

Inactive Ingredients

Allantoin, Aloe Barbadensis Leaf Juice Powder, Bisabolol, Butyloctyl Salicylate, Caprylic/Capric Triglyceride, Caprylyl Glycol, Ceteth-20, Cetyl Alcohol, Ethylhexylglycerin, Glycerin, Glyceryl Stearate, Hexylene Glycol, Isoamyl Laurate, Jojoba Esters, Lecithin, Lysolecithin, Methylpropanediol, PEG-75 Stearate, Phenoxyethanol, Phenylpropanol, Polyglyceryl-2 Dipolyhydroxystearate, Pullulan, Pyrus Malus (Apple) Fruit Extract, Sclerotium Gum, Silica, Sodium Hydroxide, Squalane, Steareth-20, Tetrasodium Glutamate Diacetate, Tocopherol, Water, Xanthan Gum

Questions or comments?

Call (862) 242-8129 Monday – Friday (9 a.m. to 5 p.m. EST) or visit www.isdin.com

PRINCIPAL DISPLAY PANEL - 100 mL Tube Label

ISDIN
PHOTO

Fusion Mineral
BODY

BROAD SPECTRUM SPF 40

Ultralight protection and
hydration for all skin types

100% MINERAL
SUNSCREEN

3.4 FL OZ (100 mL)

INGREDIENTS AND APPEARANCE

FUSION MINERAL BODY 
zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69494-014
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z)	Zinc Oxide	120 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE (UNII: 9229XJ4V12)
Hydrolyzed Jojoba Esters (Acid Form) (UNII: UDR641JW8W)
Methylpropanediol (UNII: N8F53B3R4R)
Caprylyl Glycol (UNII: 00YIU5438U)
Phenylpropanol (UNII: 0F897O3O4M)
Xanthan Gum (UNII: TTV12P4NEE)
Isoamyl Laurate (UNII: M1SLX00M3M)
Hexylene Glycol (UNII: KEH0A3F75J)
Tocopherol (UNII: R0ZB2556P8)
Cetyl Alcohol (UNII: 936JST6JCN)
Ethylhexylglycerin (UNII: 147D247K3P)
Glycerin (UNII: PDC6A3C0OX)
Silicon Dioxide (UNII: ETJ7Z6XBU4)
Water (UNII: 059QF0KO0R)
.ALPHA.-BISABOLOL, (+)- (UNII: 105S6I733Z)
Butyloctyl Salicylate (UNII: 2EH13UN8D3)
Ceteth-20 (UNII: I835H2IHHX)
Pullulan (UNII: 8ZQ0AYU1TT)
Squalane (UNII: GW89575KF9)
Steareth-20 (UNII: L0Q8IK9E08)
Cyclodextrins (UNII: 7E6SK9QDT8)

Product Characteristics
Color	WHITE	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69494-014-02	100 mL in 1 TUBE; Type 0: Not a Combination Product	10/13/2023
2	NDC: 69494-014-01	250 mL in 1 TUBE; Type 0: Not a Combination Product	10/13/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph drug	M020	10/13/2023

Labeler - ISDIN Corp. (079609155)