HOPE IN A TINTED MOISTURIZER - octinoxate, 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

ACTIVE INGREDIENTS:



OCTINOXATE (7.5%)

OXYBENXONE (3.5%)

INACTIVE INGREDIENTS:



WATER/AQUA/EAU        

HYDROGENATED VEGETABLE OIL 

CYCLOPENTASILOXANE  

DIMETHICONE                 

C14-22 ALCOHOLS         

STEARYL ALCOHOL        

BEHENYL ALCOHOL       

GLYCERIN                       

PHENOXYETHNOL          

CAPRYLIC/CAPRIC TRIGLYCERIDES  

CAPRYLYL GLYCOL        

MANGIFERA INDICA (MANGO) SEED OIL UNSAPONIFIABLES  

HELIANTHUS ANNUUS (SUNFLOWER) SEED OIL UNSAPONIFIABLES  

CAPROOYL TETRAPEPTIDE-3     

PALMITOYL TRIPEPTIDE-8          

LAVANDULA ANGUSTIFOLIA (LAVENDER) OIL  

SALICORNIA HERBACEA EXTRACT 

BUTYLENE GLYCOL     

ALLANTOIN   

PHYTOSTEROLS     

TOCOPHEROL     

SODIUM HYALURONATE    

TOCOPHERYL ACETATE 

CARNOSINE     

LAURYL POLYGLYCERYL-3 POLYDIMETHYLSILOXYETHYL DIMETHICONE  

HYDROGENATED LECITHIN  

GLYCERYL STEARATE    

C30-45 ALKYL CETEARYL DIMETHICONE CROSSPOLYMER  

ETHYLHEXYLGLYCERIN     

PEG-40 CASTOR OIL     

CETYL ALCOHOL     

CYCLOHEXASILOXANE     

CAPRYLYL/CAPRYL GLUCOSIDE 

POLYISOBUTENE    

ASCROBYL PALMITATE  

PEG-20 SOY STEROL  

c12-20 ALKYL GLUCOSIDE  

SORBITAN OLEATE  

DEXTRAN  

CAPRYLHYDROXAMIC ACID  

SODIUM ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPLOYMER 

MAGNESIUM SULFATE 

TRIETHOXYCAPRYLYLSILANE  

DISODIUM EDTA  

XANTHAN GUM     

MICA 

TITANIUM DIOXIDE (CI 77891)  

IRON OXIDES (CI 77491, 77492, 77499)  

BISMUTH OXYCHLORIDE (CI 77163)   



HELPS PROTECT AGAINST SUNBURN.

FOR EXTERNAL USE ONLY

WHEN USING THIS PRODUCT KEEP OUT OF EYES. RINSE WITH WARM WATER TO REMOVE.

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

KEEP OUT OF REACH OF CHILDREN.

MM1Enter section text here

HOPE IN A TINTED MOISTURIZER 
octinoxate, oxybenzone cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50184-6300
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE3.75 mL  in 50 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE1.75 mL  in 50 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
DOCOSANOL (UNII: 9G1OE216XY)  
GLYCERIN (UNII: PDC6A3C0OX)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
MANGO (UNII: I629I3NR86)  
SUNFLOWER OIL (UNII: 3W1JG795YI)  
ENGLISH LAVENDER OIL (UNII: ZBP1YXW0H8)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
ALLANTOIN (UNII: 344S277G0Z)  
.BETA.-SITOSTEROL (UNII: S347WMO6M4)  
ALPHA-TOCOPHEROL (UNII: H4N855PNZ1)  
HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
.ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N)  
CARNOSINE (UNII: 8HO6PVN24W)  
HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
POLYOXYL 40 CASTOR OIL (UNII: 4ERD2076EF)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
CYCLOMETHICONE 6 (UNII: XHK3U310BA)  
ASCORBYL PALMITATE (UNII: QN83US2B0N)  
PPG-5-CETETH-20 (UNII: 4AAN25P8P4)  
SORBITAN MONOOLEATE (UNII: 06XEA2VD56)  
DEXTRAN 1 (UNII: I8LHQ0D645)  
CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W)  
MAGNESIUM SULFATE, UNSPECIFIED (UNII: DE08037SAB)  
OCTYLTRIETHOXYSILANE (UNII: LDC331P08E)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
XANTHAN GUM (UNII: TTV12P4NEE)  
MICA (UNII: V8A1AW0880)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
BISMUTH OXYCHLORIDE (UNII: 4ZR792I587)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:50184-6300-150 mL in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35208/25/2010
Labeler - Philosophy, Inc. (948102256)
Establishment
NameAddressID/FEIBusiness Operations
Philosopy Inc for BioTech Research Labs948102256manufacture

Revised: 8/2010
Document Id: 6f514ddf-08f3-40f1-af01-5b92a430fef7
Set id: 9b290d0b-8755-4efe-8b0e-b51956642875
Version: 1
Effective Time: 20100825
 
Philosophy, Inc.