HOPE IN A JAR FOR DRY SKIN SPF - avobenzone, octinoxate 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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Avobenzone (2.0%)......Sunscreen

Octinoxate (7.0%)........Sunscreen

Ozybenzone (2.5%)......Sunscreen

Helps prevent sunburn.  higher spf gives more sunburn protection.

FOR EXTERNAL USE ONLY.

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

WHEN USING THIS PRODUCT 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.

QUESTIONS?  CALL 1-800-568-3151

DIRECTIONS:  APPLY LIBERALLY BEFORE SUN EXPOSURE AND AS NEEDED.  CHILDREN UNDER 6 MONTHS OF AGE: ASK A DOCTOR.

WATER (AQUA), BUTYLOCTYL SALICYLATE, BEHENOXY DIMETHICONE, GLYCERYL STEARATE SE, BEHENIC ACID, GLYCERIN, C12-15 ALKYL BENZOATE, BEHENYL ALCOHOL, BENZYL ALCOHOL, CYCLOPENTASILOXANE, CYCLOHEXASILOXANE, STEARIC ACID, LAVANDULA ANGUSTIFOLIA (LAVENDER) OIL, BUTYLENE GLYCOL, CARBOMER, POLYSORBATE 20, PALMITOYL PENTAPEPTIDE-4, BETA-GLUCAN, ARGININE, SODIUM STEAROYL LACTYLATE TRIETHANOLAMINE, ACRYLATE/C10-30 ALKYL ACRYLATE CROSSPOLYMER, POTASSIUM ASCORBYL TOCOPHERYL PHOSPHATE, HAEMATOCOCCUS PLUVIALIS EXTRACT, CARTHAMUS TINCTORIUS (SAFFLOWER) SEED OIL, PHYTOSTEROLS, TOCOPHEROL, TOCOTRIENOLS, SQUALENE, ORYZA SATIVA (RICE) BRAN WAX, METHYLDIBROMO GLUTARONITRILE, PHENOXYETHANOL.

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HOPE IN A JAR FOR DRY SKIN SPF 
avobenzone, octinoxate, and oxybenzone cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50184-6400
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Avobenzone (Avobenzone) Avobenzone1.2 mL  in 60 mL
Octinoxate (Octinoxate) Octinoxate4.2 mL  in 60 mL
Oxybenzone (Oxybenzone) Oxybenzone1.5 mL  in 60 mL
Inactive Ingredients
Ingredient NameStrength
WATER 
BUTYLOCTYL SALICYLATE  
DIMETHICONE 
GLYCERYL MONOSTEARATE 
DOCOSANOIC ACID  
GLYCERIN 
C12-15 ALKYL BENZOATE 
DOCOSANOL 
BENZYL ALCOHOL 
CYCLOMETHICONE 6 
CYCLOMETHICONE 5 
STEARIC ACID 
ENGLISH LAVENDER OIL 
BUTYLENE GLYCOL  
CARBOMER 934 
POLYSORBATE 20 
ARGININE 
SODIUM STEAROYL LACTYLATE 
TROLAMINE 
CARBOMER COPOLYMER TYPE A  
SAFFLOWER OIL 
ALPHA-TOCOPHEROL 
SQUALENE 
RICE BRAN 
METHYLDIBROMO GLUTARONITRILE 
PHENOXYETHANOL 
Packaging
#Item CodePackage Description
1NDC:50184-6400-160 mL in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35210/22/2010
Labeler - Philosophy, Inc. (948102256)
Establishment
NameAddressID/FEIBusiness Operations
Philosophy Inc for BioTech Research Labs948102256manufacture

Revised: 10/2010
Document Id: 5b34c2bb-9364-4b64-9316-472429129185
Set id: 01714934-ebd7-4f2c-9e08-161e047fd29a
Version: 1
Effective Time: 20101022
 
Philosophy, Inc.