Label: ISA SUNGUARD SPF 30- zinc oxide, titanium dioxide cream

  • NDC Code(s): 76187-850-03
  • Packager: Isagenix International, LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 12, 2023

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  • ACTIVE INGREDIENT

    Active Ingredients                                        Purpose Zinc Oxide 6.0%.......................................Sunscreen Titanium Dioxide 2.3%..............................Sunscreen

  • PURPOSE

    Uses   Helps prevent sunburn   Higher SPF gives more sunburn protection

  • Uses

    Helps prevent sunburn

    Higher SPF gives more sunburn protection

  • WARNINGS

    Warnings  For External use only

  • DO NOT USE

    Do not use on irritated or broken skin

  • STOP USE

    Stop use and ask a physician if rash, irritation or sensitivity develops and lasts.

  • WHEN USING

    When using this product do not ger into eyes. If contact occurs, rinse eyes thoroughly with water.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.

  • OTHER SAFETY INFORMATION

    In case of accidental ingestion, get medical help or contact a Poison Control Center right away.

  • DOSAGE & ADMINISTRATION

    Directions  -  Apply liberally before sun exposure to the sun.  -  Reapply after excessive perspiration or swimming.  -  Ask a doctor before use on children under 3 years of age.

  • PRECAUTIONS

    Other information  Sun alert:  Limiting sun exposure, wearing protective clothing, and using sunscreen may reduce the risk of skin aging, skin cancer, and other harmful effects of the sun.

  • INACTIVE INGREDIENT

    Inactive Ingredients  Water (Aqua/Eau), Ethylhexyl Palmitate, Cyclomethicone, Dimethicone, Glyceryl Stearate, PEG-100 Stearate, C12-15 Alkyl Benzoate, Polysorbate 80, Caprylyl Methicone, Sodium Acrylate/ Sodium Acryloyldimethyl Taurate Copolymer, Isohexadecane, Cetyl Alcohol, Propylene Glycol, Polyglyceryl-6 Isostearate, Diethylhexyl Carbonate, Triethoxycaprylylsilane, Aloe Barbadensis Leaf Juice, Panthenol, Allantoin, Disodium EDTA, Lauryl PEG-9 Polydimethylsiloxyethyl Dimethicone, Triethoxysilyllethyl Polydimethylsiloxyethyl Hexyl Dimethicone, Glycerin, Butylene Glycol, Chamomilla Recutita (Matricaria) Flower Extract, Camellia Sinensis (Green Tea) Leaf Extract, Glycyrrhiza Glabra (Licorice) Root Extract, Algae Extract, Alumina, Polyhydroxystearic Acid, Phenoxyethanol, Caprylyl Glycol, Chlorophenesin

  • DESCRIPTION

    Rich in Aloe vera gel, green tea and chamomile, this long-lasting, water-resistant facial moisturizer provides optimal broad-spectrum protection from UVA and UVB rays.  Manufactured for Isagenix International LLC,  Distributed by Isagenix International LLC AZ 85286 USA.  Isagenix International ULC, Mississauga, Ontario L4W 1G4 Canada  3900949.000-00  Item #40040

  • PRINCIPAL DISPLAY PANEL

    Reveal a New You  REJUVITY   REJUVITY  ISAGENIX

  • PRINCIPAL DISPLAY PANEL

    Isa SunGuard All-natural  SPF 30 Featuring Zinc Oxide and Titanium Dioxide  3.4 OZ (100 ml)

  • PRINCIPAL DISPLAY PANEL

    REJUVITY  ISAGENIX  Isa SunGuard  All-natural  SPF 30 Featuring Zinc Oxide and Titanium Dioxide  3.4 OZ (100 ml)   Rich in Aloe vera gel, green tea and chamomile, this long-lasting, water-resistant facial moisturizer provides optimal broad-spectrum protection from UVA and UVB rays.   Manufactured for Isagenix International LLC,  Distributed by Isagenix International LLC AZ 85286 USA.  Isagenix International ULC, Mississauga, Ontario L4W 1G4 Canada  3901021.000-00

  • PRINCIPAL DISPLAY PANEL

    Isa 1

  • PRINCIPAL DISPLAY PANEL

    Isa 2

  • PRINCIPAL DISPLAY PANEL

    Isa 3

  • INGREDIENTS AND APPEARANCE
    ISA SUNGUARD SPF 30 
    zinc oxide, titanium dioxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76187-850
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE60 mg  in 1 mL
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE23 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ETHYLHEXYL PALMITATE (UNII: 2865993309)  
    CYCLOMETHICONE (UNII: NMQ347994Z)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    ISOHEXADECANE (UNII: 918X1OUF1E)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    DIETHYLHEXYL CARBONATE (UNII: YCD50O0Z6L)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    PANTHENOL (UNII: WV9CM0O67Z)  
    ALLANTOIN (UNII: 344S277G0Z)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    CHAMOMILE (UNII: FGL3685T2X)  
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    GLYCYRRHIZA GLABRA (UNII: 2788Z9758H)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:76187-850-031 in 1 PACKAGE12/19/2017
    1100 mL in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02005/26/2011
    Labeler - Isagenix International, LLC (144798480)
    Establishment
    NameAddressID/FEIBusiness Operations
    Englewood Lab, Inc.172198223manufacture(76187-850)
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