GLYCOLIC DAY CREAM SPF 30 - homosalate, octisalate, octocrylene, oxybenzone, avobenzone 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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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.

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GLYCOLIC DAY CREAM SPF 30
homosalate, octisalate, octocrylene, oxybenzone, avobenzone cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:68634-0032
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Homosalate (UNII: V06SV4M95S) (Homosalate - UNII:V06SV4M95S)	Homosalate	0.1 mL in 1 mL
Octisalate (UNII: 4X49Y0596W) (Octisalate - UNII:4X49Y0596W)	Octisalate	0.05 mL in 1 mL
Octocrylene (UNII: 5A68WGF6WM) (Octocrylene - UNII:5A68WGF6WM)	Octocrylene	0.02 mL in 1 mL
Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y)	Oxybenzone	0.05 mL in 1 mL
Avobenzone (UNII: G63QQF2NOX) (Avobenzone - UNII:G63QQF2NOX)	Avobenzone	0.03 mL in 1 mL

#	Item Code	Package Description
Packaging
1	NDC:68634-0032-2	1 in 1 BOX
1	NDC:68634-0032-1	30 mL in 1 JAR

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part352	01/04/2010

Labeler - AMCOL Health and Beauty Solutions, Inc. (164589371)

Registrant - AMCOL Health and Beauty Solutions, Inc. (164589371)

Name	Address	ID/FEI	Business Operations
Establishment
AMCOL Health and Beauty Solutions, Inc.		164589371	manufacture, label

Name	Address	ID/FEI	Business Operations
Establishment
JKA Incorporated		621539352	pack