HOPE OIL FREE MOISTURIZER SPF 30 - octinoxate and octisalate and oxybenzone and zinc oxide 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%)

OCTISALATE (5.0%)

OXYBENZONE (4.0%)

ZINC OXIDE (4.5%)


INACTIVE INGREDIENTS:



WATER

C12-15 ALKYL BENZOATE

DIBUTYL ADIPATE

NEOPENTYL GLYCOL DIHEPTANOATE

GLYCERIN

POTASSIUM CETYL PHOSPHATE

BEHENYL ALCOHOL

BUTYLOCTYL SALICYLATE

ALUMINUM STARCH OCTENYLSUCCINATE

ARACHIDYL ALCOHOL

HYDROGENATED PALM GLYCERIDES

DIMETHICONE

BEHENOXY DIMETHICONE

SODIUM STEAROYL GLUTAMATE

HYDROGENATED LECITHIN

RUBUS FRUTICOSUS (BLACKBERRY) LEAF EXTRACT

ARGININE

DIPOTASSIUM GLYCYRRHIZINATE

POLYHYDROXYSTEARIC ACID

BETA-GLUCAN

TOCOPHERYL ACETATE

CAMELLIA SINENSIS LEAF POWDER

ARACHIDYL GLUCOSIDE

MALTODEXTRIN

BEHENYL ALCOHOL

XANTHAN GUM

DISODIUM EDTA

CITRIC ACID

TRIETHOXYCAPRYLYLSILANE

ETHYLHEXYLGLYCERIN

PHENOXYETHANOL

CHLORPHENESIN


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

WARNINGS: FOR EXTERNAL USE ONLY

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

KEEP OUT OF REACH OF CHILDREN.  CHILDREN UNDER 6 MONTHS OF AGE - ASK A DOCTOR.

IF SWALLOWED, GET MEDICAL HELP OR CONTACT A POISON CENTER RIGHT AWAY.

HELPS PREVENT SUNBURN

HIGHER SPF GIVES MORE SUNBURN PROTECTION.

DIRECTIONS:

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

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HOPE OIL FREE MOISTURIZER SPF 30 
octinoxate and octisalate and oxybenzone and zinc oxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50184-6100
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate75 mg  in 1 g
Octisalate (UNII: 4X49Y0596W) (Octisalate - UNII:4X49Y0596W) Octisalate50 mg  in 1 g
Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y) Oxybenzone40 mg  in 1 g
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Cation - UNII:13S1S8SF37) Zinc Oxide45 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
NEOPENTYL GLYCOL DIHEPTANOATE (UNII: 5LKW3C543X)  
GLYCERIN (UNII: PDC6A3C0OX)  
POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)  
DOCOSANOL (UNII: 9G1OE216XY)  
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
ALUMINUM STARCH OCTENYLSUCCINATE (UNII: I9PJ0O6294)  
ARACHIDYL ALCOHOL (UNII: 1QR1QRA9BU)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
MONOSODIUM GLUTAMATE ANHYDROUS (UNII: C3C196L9FG)  
HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N)  
RUBUS FRUTICOSUS LEAF (UNII: YQ2S06L8S9)  
ARGININE (UNII: 94ZLA3W45F)  
.ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N)  
GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
MALTODEXTRIN (UNII: 7CVR7L4A2D)  
BENZYL ALCOHOL (UNII: LKG8494WBH)  
XANTHAN GUM (UNII: TTV12P4NEE)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
OCTYLTRIETHOXYSILANE (UNII: LDC331P08E)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
CHLORPHENESIN (UNII: I670DAL4SZ)  
GLYCYRRHIZINATE DIPOTASSIUM (UNII: CA2Y0FE3FX)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:50184-6100-21 in 1 BOX
1NDC:50184-6100-156 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35204/01/2010
Labeler - Philosophy, Inc. (948102256)
Establishment
NameAddressID/FEIBusiness Operations
Philosophy Inc for BioTech Research Labs948102256manufacture

Revised: 4/2010
Document Id: 9cca60d6-7b77-4601-bfc1-d9800406e5a3
Set id: 71a06d13-99e1-4cdd-9bc8-e9aae1745786
Version: 2
Effective Time: 20100405
 
Philosophy, Inc.