Label: I-MAX EXCELLENCE- avobenzone octinoxate oxybenzone lotion

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated November 7, 2018

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  • ACTIVE INGREDIENT

    ACTIVE INGREDIENTS:

    AVOBENZONE 2.5%

    OCTINOXATE 7.5%

    OXYBENZONE 5%

  • PURPOSE

    PURPOSE:

    SUNSCREEN

  • INDICATIONS & USAGE

    USES:

    HELPS PREVENT SUNBURNS. HIGHER SPF GIVES MORE SUNBURN PROTECTION.

  • WARNINGS

    WARNINGS:

    FOR EXTERNAL USE ONLY.

  • KEEP OUT OF REACH OF CHILDREN

    KEEP OUT OF REACH OF CHILDREN.

  • WHEN USING

    WHEN USING THIS PRODUCT

    KEEP OUT OF EYES. RINSE WITH WATER TO REMOVE.

  • STOP USE

    STOP USE AND ASK A DOCTOR IF

    A RASH OR IRRITATION DEVELOPS AND LASTS. IF SWALLOWED, GET

    MEDICAL HELP OR CONTACT A POISON CONTROL CENTER RIGHT AWAY.

  • DOSAGE & ADMINISTRATION

    DIRECTIONS

    APPLY TO CLEAN SKIN 15 MINUTES BEFORE SUN EXPOSURE. REAPPLY

    AFTER SWIMMING, EXCERCISING OR PERSPIRATION IN THE SUNLIGHT.

    CHILDREN UNDER 6 MONTHS OF AGE: ASK A DOCTOR.

  • INACTIVE INGREDIENT

    INACTIVE INGREDIENTS:

    ALKYL BENZOATE, ACRYLATES/C10-30 ALKYL ACRYLATES CROSSPOLYMER, C12-15 GLYCERYL STEARATE, CETEARYL PHOSPHATE, ETHYLHEXYLGLYCERIN, MAGNESIUM ALUMINUM SILICATE, PHENOXYETHANOL, PROPYLENE GLYCOL, SODIUM HYDROXIDE, STEARETH-20, STEARYL ALCOHOL, TETRAHEXYLDECYL ASCORBATE, TOCOPHERYL ACETATE, WATER (AQUA).

  • QUESTIONS

    QUESTIONS? 1-323-733-7033

  • PRINCIPAL DISPLAY PANEL

    30_SPF Lotion_Label_2012-03-15

    30_SPF Lotion_Label_2012-05-23

  • INGREDIENTS AND APPEARANCE
    I-MAX EXCELLENCE 
    avobenzone octinoxate oxybenzone lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:42952-101
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE2.5 g  in 100 mL
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE7.5 g  in 100 mL
    OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE5 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
    CARBOMER INTERPOLYMER TYPE A (55000 CPS) (UNII: 59TL3WG5CO)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    CETYL PHOSPHATE (UNII: VT07D6X67O)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    STEARETH-20 (UNII: L0Q8IK9E08)  
    STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
    TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)  
    ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:42952-101-1259 mL in 1 BOTTLE; Type 0: Not a Combination Product03/15/2012
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35203/15/2012
    Labeler - MAXLIFE USA, INC. (785111431)
    Registrant - MAXLIFE USA, INC. (785111431)
    Establishment
    NameAddressID/FEIBusiness Operations
    CUSTOM RESEARCH LABS INC028611598manufacture(42952-101)
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