SUNSCREEN 30 SPF (OCTINOXATE, OXYBENZONE) LOTION [AZTEX ENTERPRISES]

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SUNSCREEN 30 SPF (OCTINOXATE, OXYBENZONE) LOTION [AZTEX ENTERPRISES]
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NDC 75887-003-01, 75887-003-02, 75887-003-03, 75887-003-04
Set ID 1bf464b3-f9ac-4c7e-9ec9-7a9b7e97f2e9
Category HUMAN OTC DRUG LABEL
Packager Aztex Enterprises
Generic Name
Product Class
Product Number
Application Number PART352
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  • ACTIVE INGREDIENT

    Drug Facts 30ml/1oz.
    Active Ingredient Purpose
    Octinoxate (7.3%) sunscreen
    Oxybenzone (5.2%) sunscreen
  • PURPOSE

    Uses
    Provides moderate protection against sunburn
    For skin that burns easily
  • WARNINGS

    Warnings
    For external use only.
    When using this produce
    Keep out of eyes, rinse with water to remove
    Discontinue use of irritation and redness develop
    Keep out of reach of children
    If swallowed, get medical help or contact a Poison Control Center right away
    If pregnant or breastfeeding, ask a health care professional before use
  • INDICATIONS & USAGE

    Directions
    Apply generously and evenly before sun exposure
    Reapply as needed or after swimming or perspiring
  • INACTIVE INGREDIENT

    Inactive Ingredients
    Acrylate/C10-30 Alkylacrylate Crosspolymer
    BHT
    C12-15 Alkyl Benzoate
    Carbomer polymers
    Diazolydinyl Urea
    Disodium EDTA
    Hexyl Laurate
    Methylparaben, Propylparaben
    PEG-8, Sorbitan Oleate, Tocopheryl Acetate
    Propylene Glycol, Triethanolamine, VP/Eicosene copolymer
  • PRINCIPAL DISPLAY PANEL

    Label Image
    AZX SPORT
    30 SPF
    Sunscreen
    1 oz. / 30 ml.
    Made in Canada
  • INGREDIENTS AND APPEARANCE
    SUNSCREEN  30 SPF
    octinoxate, oxybenzone lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:75887-003
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE22 mL  in 30 mL
    OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE16 mL  in 30 mL
    Inactive Ingredients
    Ingredient NameStrength
    CARBOMER INTERPOLYMER TYPE A (55000 CPS) (UNII: 59TL3WG5CO)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
    CARBOMER 1342 (UNII: 809Y72KV36)  
    UREA (UNII: 8W8T17847W)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    HEXYL LAURATE (UNII: 4CG9F9W01Q)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    SORBITAN MONOOLEATE (UNII: 06XEA2VD56)  
    .ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:75887-003-0130 mL in 1 BOTTLE
    2NDC:75887-003-0260 mL in 1 BOTTLE
    3NDC:75887-003-03118 mL in 1 BOTTLE
    4NDC:75887-003-04236 mL in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35201/18/2011
    Labeler - Aztex Enterprises (253232326)
    Registrant - Aztex Enterprises (253232326)
    Establishment
    NameAddressID/FEIBusiness Operations
    Aztex Enterprises253232326manufacture
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