Label: FUSION MINERAL BODY- zinc oxide lotion

  • NDC Code(s): 69494-014-01, 69494-014-02
  • Packager: ISDIN Corp.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated October 5, 2023

If you are a consumer or patient please visit this version.

View All Sections
  • 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)

    PRINCIPAL DISPLAY PANEL - 100 mL Tube Label
  • INGREDIENTS AND APPEARANCE
    FUSION MINERAL BODY 
    zinc oxide lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69494-014
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide120 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    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
    ColorWHITEScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69494-014-02100 mL in 1 TUBE; Type 0: Not a Combination Product10/13/2023
    2NDC:69494-014-01250 mL in 1 TUBE; Type 0: Not a Combination Product10/13/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph drugM02010/13/2023
    Labeler - ISDIN Corp. (079609155)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!