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Name:Age Renewal Firming And Hydrating Moisturizer
Manufacturer:Amcol Health And Beauty Solutions, Inc.
Category:Over-the-counter (OTC) Marketed Drugs


age renewal firming and hydrating moisturizer

AGE RENEWAL FIRMING AND HYDRATING MOISTURIZER  - octinoxate, octisalate, oxybenzone and 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 Type HUMAN OTC DRUG Item Code (Source) NDC:68634-0031
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Octinoxate (Octinoxate) Octinoxate 0.075 g  in 1 g
Octisalate (Octisalate) Octisalate 0.05 g  in 1 g
Oxybenzone (Oxybenzone) Oxybenzone 0.04 g  in 1 g
Zinc Oxide (Zinc Oxide) Zinc Oxide 0.02 g  in 1 g
Product Characteristics
Color      Score     
Shape Size
Flavor Imprint Code
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:68634-0031-2 1 BOTTLE, GLASS ( BOTTLE) in 1 CARTON contains a BOTTLE, GLASS (68634-0031-1)
1 NDC:68634-0031-1 51 g in 1 BOTTLE, GLASS This package is contained within the CARTON (68634-0031-2)

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part352 12/22/2009

Labeler - AMCOL Health and Beauty Solutions, Inc. (164589371)
Registrant - AMCOL Health and Beauty Solutions, Inc. (164589371)
Establishment
Name Address ID/FEI Operations
AMCOL Health and Beauty Soltuions, Inc. 164589371 manufacture, label, pack

Revised: 02/2010 AMCOL Health and Beauty Solutions, Inc.



Source: http://dailymed.nlm.nih.gov
Reproduced with permission of U.S. National Library of Medicine


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