Label: MIRACLE WORKER SPF 55- avobenzone, homosalate, octisalate, octocrylene and oxybenzone cream

  • 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 January 24, 2011

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  • ACTIVE INGREDIENT

    AVOBENZONE (3.00%)........SUNSCREEN

    HOMOSALATE (10.00%)......SUNSCREEN

    OCTISALATE (5.00%)...........SUNSCREEN

    OCTOCRYLENE (2.00%).......SUNSCREEN

    OXYBENZONE (6.00%).........SUNSCREEN

  • PURPOSE

    HELPS PREVENT SUNBURN

    HIGHER SPF GIVES MORE PROTECTION

  • WARNINGS

    FOR EXTERNAL USE ONLY

  • WHEN USING

    KEEP OUT OF EYES. RINSE WITH WATER TO REMOVE.

  • ASK DOCTOR

    STOP USE AND ASK A DOCTOR IF RASH OR IRRITATION DEVELOPS AND LASTS.

  • KEEP OUT OF REACH OF CHILDREN

    KEEP OUT OF REACH OF CHILDREN.  IF SWALLOWED GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER RIGHT AWAY.

  • INDICATIONS & USAGE

    APPLY LIBERALLY TO CLEAN, DRY FACE IN THE MORNING BEFORE SUN EXPOSURE AND AS NEEDED.  CHILDREN UNDER 6 MONTHS OF AGE: ASK A DOCTOR.

  • INACTIVE INGREDIENT

    WATER (AQUA), BUTYLENE GLYCOL, PEG-8, POLYETHYLENE, DIMETHICONE, TETRAPEPTIDE-21, HEXYLDECANOL, PICEA EXCELSA WOOD EXTRACT, BRASSICA CAMPESTRIS (RAPESEED) STEROLS, ALOE BARBADENSIS LEAF JUICE, SODIUM ASCORBYL PHOSPHATE, CETYLHYDROXYPROLINE PALMITAMIDE, TRITICUM VULGARE (WHEAT) GERM EXTRACT, GLYCERIN, BISABOLOL, TOCOPHEROL, RETINYL PALMITATE, TOCOPHERYL ACETATE, SODIUM POLYACRYLATE, ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER, LAURYL GLUCOSIDE, TITANIUM DIOXIDE, BENTONITE, STEARIC ACID, DISODIUM EDTA, ETHYLHEXYLGLYCERIN, PHENOXYETHANOL, CHLORPHENESIN.

  • PRINCIPAL DISPLAY PANEL

    MM1Enter section text here

  • INGREDIENTS AND APPEARANCE
    MIRACLE WORKER SPF 55 
    avobenzone, homosalate, octisalate, octocrylene and oxybenzone cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50184-6500
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE1.5 mL  in 50 mL
    HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE5 mL  in 50 mL
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE2.5 mL  in 50 mL
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE1 mL  in 50 mL
    OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE3 mL  in 50 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    POLYETHYLENE GLYCOL (UNII: 3WJQ0SDW1A)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    HEXYLDECANOL (UNII: 151Z7P1317)  
    BRASSICA RAPA VAR. RAPA (UNII: AIV6895O8B)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    SODIUM ASCORBYL PHOSPHATE (UNII: 836SJG51DR)  
    WHEAT GERM (UNII: YR3G369F5A)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    LEVOMENOL (UNII: 24WE03BX2T)  
    ALPHA-TOCOPHEROL (UNII: H4N855PNZ1)  
    VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
    .ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N)  
    CARBOMER INTERPOLYMER TYPE A (55000 CPS) (UNII: 59TL3WG5CO)  
    LAURYL GLUCOSIDE (UNII: 76LN7P7UCU)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    BENTONITE (UNII: A3N5ZCN45C)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    TETRAPEPTIDE-21 (UNII: 179JUC43HU)  
    PICEA ABIES WOOD (UNII: 72GZ8K8996)  
    CETYLHYDROXYPROLINE PALMITAMIDE (UNII: 74ONU0S62G)  
    SODIUM POLYACRYLATE (8000 MW) (UNII: 285CYO341L)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50184-6500-150 mL in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35211/19/2010
    Labeler - Philosophy, Inc (948102256)
    Establishment
    NameAddressID/FEIBusiness Operations
    AMCOL Health and Beauty Solutions, Inc.148997310manufacture
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