MIRACLE WORKER SPF 55 - avobenzone, homosalate, octisalate, octocrylene and oxybenzone cream 
Philosophy, Inc

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.

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DRUG FACTS

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

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

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

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

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

HELPS PREVENT SUNBURN

HIGHER SPF GIVES MORE PROTECTION

FOR EXTERNAL USE ONLY

KEEP OUT OF EYES. RINSE WITH WATER TO REMOVE.

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

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

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

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.

MM1Enter section text here

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

Revised: 1/2011
Document Id: 46163b03-b532-4d5d-99f1-c9d024800086
Set id: be86026f-50ec-4f87-92a8-f62513816b73
Version: 3
Effective Time: 20110124
 
Philosophy, Inc