I-MAX EXCELLENCE (AVOBENZONE OCTINOXATE OXYBENZONE) LOTION [MAXLIFE USA, INC.]

I-MAX EXCELLENCE (AVOBENZONE OCTINOXATE OXYBENZONE) LOTION [MAXLIFE USA, INC.]
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NDC 42952-101-12
Set ID 0a654c5f-32c0-4599-91c3-1f17877aa8cb
Category HUMAN OTC DRUG LABEL
Packager MAXLIFE USA, INC.
Generic Name
Product Class
Product Number
Application Number PART352
  • ACTIVE INGREDIENT

    ACTIVE INGREDIENTS:

    AVOBENZONE 2.5%

    OCTINOXATE 7.5%

    OXYBENZONE 5%

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  • PURPOSE

    PURPOSE:

    SUNSCREEN

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  • INDICATIONS & USAGE

    USES:

    HELPS PREVENT SUNBURNS. HIGHER SPF GIVES MORE SUNBURN PROTECTION.

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  • WARNINGS

    WARNINGS:

    FOR EXTERNAL USE ONLY.

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  • KEEP OUT OF REACH OF CHILDREN

    KEEP OUT OF REACH OF CHILDREN.

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  • WHEN USING

    WHEN USING THIS PRODUCT

    KEEP OUT OF EYES. RINSE WITH WATER TO REMOVE.

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  • 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.

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  • 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.

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  • 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).

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  • QUESTIONS

    QUESTIONS? 1-323-733-7033

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  • INGREDIENTS AND APPEARANCE
    I-MAX EXCELLENCE 
    avobenzone octinoxate oxybenzone lotion
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:42952-101
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 2.5 g  in 100 mL
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 7.5 g  in 100 mL
    OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE 5 g  in 100 mL
    Inactive Ingredients
    Ingredient Name Strength
    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 Code Package Description Marketing Start Date Marketing End Date
    1 NDC:42952-101-12 59 mL in 1 BOTTLE; Type 0: Not a Combination Product 03/15/2012
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part352 03/15/2012
    Labeler - MAXLIFE USA, INC. (785111431)
    Registrant - MAXLIFE USA, INC. (785111431)
    Establishment
    Name Address ID/FEI Business Operations
    CUSTOM RESEARCH LABS INC 028611598 manufacture(42952-101)
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