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Glycolic Day Cream SPF 30

Dosage form: cream
Ingredients: Homosalate 0.1mL in 1mL, Octisalate 0.05mL in 1mL, Octocrylene 0.02mL in 1mL, Oxybenzone 0.05mL in 1mL, Avobenzone 0.03mL in 1mL
Labeler: AMCOL Health and Beauty Solutions, Inc.
NDC Code: 68634-0032

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.

Glycolic Day Cream SPF 30

Active ingredients

Active ingredients           Purpose

Homosalate 10.0% . . . . . Sunscreen

Octisalate 5.0% . . . . . . .  Sunscreen

Oxybenzone  5.0% . . . . .Sunscreen

Avobenzone  3.0% . . . .Sunscreen

Octocrylene  2.0% . . . . Sunscreen

Keep out of reach of children.  Do not swallow.  If swallowed, get medical help or contact a Posion Control Center right away.

GLYCOLIC DAY CREAM SPF 30 
homosalate, octisalate, octocrylene, oxybenzone, avobenzone cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68634-0032
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Homosalate (Homosalate) Homosalate0.1 mL  in 1 mL
Octisalate (Octisalate) Octisalate0.05 mL  in 1 mL
Octocrylene (Octocrylene) Octocrylene0.02 mL  in 1 mL
Oxybenzone (Oxybenzone) Oxybenzone0.05 mL  in 1 mL
Avobenzone (Avobenzone) Avobenzone0.03 mL  in 1 mL
Packaging
#Item CodePackage Description
1NDC:68634-0032-21 JAR (JAR) in 1 BOX
1NDC:68634-0032-130 mL in 1 JAR
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35201/04/2010
Labeler - AMCOL Health and Beauty Solutions, Inc. (164589371)
Registrant - AMCOL Health and Beauty Solutions, Inc. (164589371)
Establishment
NameAddressID/FEIOperations
AMCOL Health and Beauty Solutions, Inc.164589371manufacture, label
Establishment
NameAddressID/FEIOperations
JKA Incorporated621539352pack

Revised: 02/2010
Document Id: e8bc0518-5921-4505-99fc-b8c4f30b58c6
Set id: cf473fce-9831-4e48-bfc4-e8f8bdd6663b
Version: 1
Effective Time: 20100204
 
AMCOL Health and Beauty Solutions, Inc.

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

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