AGE RENEWAL FIRMING AND HYDRATING MOISTURIZER - octinoxate, octisalate, oxybenzone, zinc oxide cream 
Woonsocket Prescription Center, Incorporated

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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age renewal firming and hydrating moisturizer

Active Ingredients:  Octinoxate 7.5%, Octisalate 5%, Oxybenzone 4%, Zinc Oxide 2%

FP104front

Caution:  For external use only.  Avoid getting into eyes.  If product gets into eyes, rinse thoroughly with water.  In the beginning you may experience mild tingling, warming, flaking and/or redness.  This is a sign that the product is working.  If discomfort occurs reduce use to every other day until your skin adjusts.  Discontinue use if irritation occurs.

Discontinue use if irritation occurs.

AGE RENEWAL FIRMING AND HYDRATING MOISTURIZER 
octinoxate, octisalate, oxybenzone, zinc oxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59779-301
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate0.075 g  in 1 g
Octisalate (UNII: 4X49Y0596W) (Octisalate - UNII:4X49Y0596W) Octisalate0.05 g  in 1 g
Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y) Oxybenzone0.04 g  in 1 g
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide0.02 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
water (UNII: 059QF0KO0R)  
glycerin (UNII: PDC6A3C0OX)  
glyceryl monostearate (UNII: 230OU9XXE4)  
isopropyl myristate (UNII: 0RE8K4LNJS)  
cetostearyl alcohol (UNII: 2DMT128M1S)  
squalane (UNII: GW89575KF9)  
phenoxyethanol (UNII: HIE492ZZ3T)  
retinol (UNII: G2SH0XKK91)  
polysorbate 20 (UNII: 7T1F30V5YH)  
arginine (UNII: 94ZLA3W45F)  
soybean (UNII: L7HT8F1ZOD)  
.alpha.-tocopherol acetate, DL- (UNII: WR1WPI7EW8)  
Picea abies wood (UNII: 72GZ8K8996)  
SODIUM POLYACRYLATE (8000 MW) (UNII: 285CYO341L)  
cetearyl glucoside (UNII: 09FUA47KNA)  
bentonite (UNII: A3N5ZCN45C)  
xanthan gum (UNII: TTV12P4NEE)  
sorbitol (UNII: 506T60A25R)  
sodium borate (UNII: 91MBZ8H3QO)  
sodium hydroxide (UNII: 55X04QC32I)  
methylparaben (UNII: A2I8C7HI9T)  
ethylhexylglycerin (UNII: 147D247K3P)  
butylated hydroxytoluene (UNII: 1P9D0Z171K)  
ascorbic acid (UNII: PQ6CK8PD0R)  
edetate disodium (UNII: 7FLD91C86K)  
panthenol (UNII: WV9CM0O67Z)  
titanium dioxide (UNII: 15FIX9V2JP)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:59779-301-011 in 1 CARTON
151 g in 1 BOTTLE, GLASS
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35212/22/2009
Labeler - Woonsocket Prescription Center, Incorporated (062312574)
Registrant - AMCOL Health & Beauty Solutions, Incorporated (872684803)
Establishment
NameAddressID/FEIBusiness Operations
AMCOL Health & Beauty Solutions, Incorporated872684803manufacture

Revised: 11/2011
Document Id: 16c5d17c-4ff4-445a-9472-d236e3fdc648
Set id: 4ed84d6b-e9d0-4539-89d6-5fb8a7ef50d0
Version: 1
Effective Time: 20111111
 
Woonsocket Prescription Center, Incorporated