AGE RENEWAL FIRMING AND HYDRATING MOISTURIZER - octinoxate, octisalate, oxybenzone, zinc oxide cream 
AMCOL Health and Beauty Solutions, 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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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:68634-0031
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
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:68634-0031-21 in 1 CARTON
1NDC:68634-0031-151 g in 1 BOTTLE, GLASS
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35212/22/2009
Labeler - AMCOL Health and Beauty Solutions, Inc. (164589371)
Registrant - AMCOL Health and Beauty Solutions, Inc. (164589371)
Establishment
NameAddressID/FEIBusiness Operations
AMCOL Health and Beauty Soltuions, Inc.164589371manufacture, label, pack

Revised: 2/2010
Document Id: 3d6d5909-5da6-4436-a39a-e7a3a2a3986e
Set id: 7c1c1c4b-c91f-4c03-9026-feffa00ece33
Version: 1
Effective Time: 20100215
 
AMCOL Health and Beauty Solutions, Inc.