ZERMAT SKIN SPF 50 BROAD SPECTRUM (AVOBENZONE, HOMOSALATE, OCTINOXATE, OCTISALATE) CREAM [ZERMAT INTERNACIONAL S.A. DE C.V.]

ZERMAT SKIN SPF 50 BROAD SPECTRUM (AVOBENZONE, HOMOSALATE, OCTINOXATE, OCTISALATE) CREAM [ZERMAT INTERNACIONAL S.A. DE C.V.]
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NDC 15828-737-01
Set ID 6d74028a-550d-4ddd-a7ff-9f7cf96162e8
Category HUMAN OTC DRUG LABEL
Packager Zermat Internacional S.A. de C.V.
Generic Name
Product Class
Product Number
Application Number PART352
  • Drug Facts

  • Active Ingredients:

    Avobenzone..........3.00%

    Homosalate..........10.00%

    Octinoxate............7.50%

    Octisalate..............5.00%

    Sunscreen

  • Uses:

    • Helps prevent sunburn,
    • If used as directed with other sun protection measure (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 consult physician

    If irritation

    • or rash develops.

    Keep out of reach of children.

    If product is swallowed, get medical attention or contact poison control center immediately.

  • Directions:

    • Apply liberally 15-minutes before sun exposure. Reapply:
    • At least, every two-hours.
    • Immediately after swimming, sweating or towel drying.

    Sun Protection Measures: Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use sunscreen with broad spectrum protection and an SPF rating of 15 or higher, along with other sun protection measures including:

    • Limit time in the sun, especially between 10am and 2pm.
    • Wear long sleeve shirts, pants, hats and sunglasses.
    • For children under 6 months, consult a physician.
  • Inactive Ingredients:

    Aloe Barbadensis (Aloe Vera Gel) Juice, Aqua (Deionized Water), Ascorbic Acid (Vitamin C), Butyrospermum Parkii (Shea) Butter, C13-14 Isoparaffin, Camellia Sinensis (Green Tea) Leaf Extract, Cetearyl Alcohol, Cetearyl Olivate, Cocamidopropyl Betaine, Cucumis Sativus
    (Cucumber) Fruit Extract, Cyclotetrasiloxane, Cyclopentasiloxane, Ethylhexylglycerin, Glycerin, Glyceryl Stearate, Glyceryl Stearate SE, Helianthus Annuus (Sunflower) Seed Oil, Isopropyl Myristate, Laureth-7, Mangifera Indica (Mango) Seed Butter, Parfum (Fragrance), PEG-100 Stearate, Phenoxyethanol, Polyacrylamide, Polysorbate-20, Punica Granatum (Pomegranate) Extract, Soluble Collagen, Sorbitan
    Olivate, Tocopheryl Acetate (Vitamin E), Zemea Propanediol.

  • Package Labeling:

    Label

  • INGREDIENTS AND APPEARANCE
    ZERMAT SKIN SPF 50 BROAD SPECTRUM 
    avobenzone, homosalate, octinoxate, octisalate cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:15828-737
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE30 mg  in 1 g
    HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE100 mg  in 1 g
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE75 mg  in 1 g
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE50 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    WATER (UNII: 059QF0KO0R)  
    ASCORBIC ACID (UNII: PQ6CK8PD0R)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    C13-14 ISOPARAFFIN (UNII: E4F12ROE70)  
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    CETEARYL OLIVATE (UNII: 58B69Q84JO)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    CUCUMBER (UNII: YY7C30VXJT)  
    CYCLOMETHICONE 4 (UNII: CZ227117JE)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    GLYCERYL STEARATE SE (UNII: FCZ5MH785I)  
    SUNFLOWER OIL (UNII: 3W1JG795YI)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    LAURETH-7 (UNII: Z95S6G8201)  
    MANGIFERA INDICA SEED BUTTER (UNII: 4OXD9M35X2)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    PUNICA GRANATUM ROOT BARK (UNII: CLV24I3T1D)  
    SORBITAN OLIVATE (UNII: MDL271E3GR)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:15828-737-011 in 1 BOX04/15/2016
    148 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35204/15/2016
    Labeler - Zermat Internacional S.A. de C.V. (812820712)

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