HOPE IN A JAR FOR DRY SKIN SPF  BROAD SPECTRUM SPF 20 SUNSCREEN AND EXTRA-RICH MOISTURIZER FOR NORMAL TO DRY SKIN- 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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DRUG FACTS

Active Ingredients

Avobenzone (2.0%)......Sunscreen

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

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


Purpose

Sunscreen

Uses

Warnings

For external use only.

Do not use on damaged or broken skin.

When using this product keep our of eyes.

Rinse with water to remove.

Stop use and ask a doctor if a rash occurs.

Directions

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Other Information

Questions or Comments?

Call toll-free 1-800-568-3151 from 6 a.m.-5 p.m. MST (Monday-Friday)

Inactive Ingredients

Water (aqua), butyloctyl salicylate, behenoxy dimethicone, glycerin, behinic acid, c12-c14 alkyl benzoate, glyceryl distearate, blyceryl stearate se, 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, helianthus annus (sunflower) seed oil, tocopherol, tocotrienols, trilein, trilinolein, sodium lactate, potassium stearate, bht, mthyldibromo glutaronitrile, phenoxyethanol.

Outer Packaging

HOPE IN A JAR FOR DRY SKIN SPF   BROAD SPECTRUM SPF 20 SUNSCREEN AND EXTRA-RICH MOISTURIZER FOR NORMAL TO DRY SKIN
avobenzone, octinoxate, and oxybenzone cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50184-6400
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Avobenzone (UNII: G63QQF2NOX) (Avobenzone - UNII:G63QQF2NOX) Avobenzone1.392 g  in 60 mL
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate4.242 g  in 60 mL
Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y) Oxybenzone1.98 g  in 60 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
DOCOSANOIC ACID (UNII: H390488X0A)  
GLYCERIN (UNII: PDC6A3C0OX)  
C12-15 ALKYL BENZOATE (UNII: A9EJ3J61HQ)  
DOCOSANOL (UNII: 9G1OE216XY)  
BENZYL ALCOHOL (UNII: LKG8494WBH)  
CYCLOMETHICONE 6 (UNII: XHK3U310BA)  
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
ENGLISH LAVENDER OIL (UNII: ZBP1YXW0H8)  
1,3-BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
CARBOMER 934 (UNII: Z135WT9208)  
POLYSORBATE 20 (UNII: 7T1F30V5YH)  
ARGININE (UNII: 94ZLA3W45F)  
SODIUM STEAROYL LACTYLATE (UNII: IN99IT31LN)  
TROLAMINE (UNII: 9O3K93S3TK)  
CARBOMER COPOLYMER TYPE A (UNII: 71DD5V995L)  
SAFFLOWER OIL (UNII: 65UEH262IS)  
ALPHA-TOCOPHEROL (UNII: H4N855PNZ1)  
SQUALENE (UNII: 7QWM220FJH)  
RICE BRAN (UNII: R60QEP13IC)  
METHYLDIBROMO GLUTARONITRILE (UNII: YX089CPS05)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:50184-6400-21 in 1 BOX
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(50184-6400)

Revised: 7/2013
Document Id: 5de3d011-a893-498f-b8ad-1c528e3c897b
Set id: 01714934-ebd7-4f2c-9e08-161e047fd29a
Version: 2
Effective Time: 20130708
 
Philosophy, Inc.