ISAKNOX AGELESS SERUM BLEMISH BALM - titanium dioxide, octyltriethoxysilane, aluminum hydroxide, octinoxate, atractyloides japonica root oil cream 
LG Household and Healthcare, 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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Drug Fact

Active Ingredients

Enter section text here

Warning and Precautions

For external use only.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children. Is swallowed, get medical help or contact a Poison Control Center right away.

WHEN USING

Keep out of eyes. Rinse with water to remove.

Package Label

Isaknox

Ageless

Blemish Balm

Ageless BB Cream

ISAKNOX AGELESS SERUM BLEMISH BALM 
titanium dioxide, octyltriethoxysilane, aluminum hydroxide, octinoxate, atractyloides japonica root oil cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53208-475
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE5.76 mL  in 100 mL
OCTYLTRIETHOXYSILANE (UNII: LDC331P08E) (OCTYLTRIETHOXYSILANE - UNII:LDC331P08E) OCTYLTRIETHOXYSILANE0.12 mL  in 100 mL
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) (ALUMINUM HYDROXIDE - UNII:5QB0T2IUN0) ALUMINUM HYDROXIDE0.12 mL  in 100 mL
ATRACTYLODES JAPONICA ROOT (UNII: 58N5X5H9XU) (ATRACTYLODES JAPONICA ROOT - UNII:58N5X5H9XU) ATRACTYLODES JAPONICA ROOT 0.05 mL  in 100 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE5 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
ETHYLHEXYL PALMITATE (UNII: 2865993309)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
GLYCERIN (UNII: PDC6A3C0OX)  
PARAFFIN (UNII: I9O0E3H2ZE)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
MAGNESIUM SULFATE, UNSPECIFIED (UNII: DE08037SAB)  
SORBITAN OLIVATE (UNII: MDL271E3GR)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
ETHYLPARABEN (UNII: 14255EXE39)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:53208-475-021 in 1 BOX
1NDC:53208-475-0150 mL in 1 CONTAINER
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35208/24/2010
Labeler - LG Household and Healthcare, Inc. (688276187)
Registrant - LG Household and Healthcare, Inc. (688276187)
Establishment
NameAddressID/FEIBusiness Operations
LG Household and Healthcare, Inc. 688276187manufacture

Revised: 5/2012
Document Id: 67a7c69f-83e8-4e31-a1a2-a310de75dac4
Set id: 33d43f13-3793-45b6-a360-4c9a41568bd4
Version: 4
Effective Time: 20120515
 
LG Household and Healthcare, Inc.