FOR THE GARDENER LIP BALM  SPF 30- octinoxate, octocrylene, octisalate, and oxybenzone stick 
GANZ U.S.A., LLC

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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time & again®
LIP BALM

Active ingredients

Octinoxate 7.5%, Octocrylene 7.0%, Octisalate 5.0%, Oxybenzone 5.0%

Purposes

Sunscreens

Use

Warnings

  • Stop use if skin rash occurs

Inactive ingredients

petrolatum, isopropyl myristate, paraffin, candelilla wax, synthetic beeswax, polyethylene, cetyl alcohol, lanolin, isopropyl lanolate, oleyl alcohol, octyldodecanol, phenyl trimethicone, flavor, tocopheryl acetate, aloe barbadensis leaf extract, glycine soja (soybean) oil, titanium dioxide, methylparaben, propylparaben, silica, saccharin, DEA-oleth-3-phosphate

Other information

You may report serious adverse reaction to this product to: Ganz U.S.A., LLC #043, 60 Industrial Parkway, Cheektowaga, New York, 14227-9903

MANUFACTURED FOR:
GANZ, Cheektowaga, N.Y. 14227-9903

PRINCIPAL DISPLAY PANEL - 4 g Carton

time & again®

LIP BALM

SPF 30
ALOE & VITAMIN E

UVA/UVB SUNSCREEN PROTECTION

Principal Display Panel - 4 g Carton
FOR THE GARDENER LIP BALM   SPF 30
octinoxate, octocrylene, octisalate, and oxybenzone stick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:75862-018
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE7.5 g  in 100 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE7 g  in 100 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE5 g  in 100 g
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE5 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
PETROLATUM (UNII: 4T6H12BN9U)  
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
PARAFFIN (UNII: I9O0E3H2ZE)  
CANDELILLA WAX (UNII: WL0328HX19)  
LOW DENSITY POLYETHYLENE (UNII: J245LN42AI)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
LANOLIN (UNII: 7EV65EAW6H)  
OLEYL ALCOHOL (UNII: 172F2WN8DV)  
OCTYLDODECANOL (UNII: 461N1O614Y)  
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)  
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
SOYBEAN OIL (UNII: 241ATL177A)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
SACCHARIN (UNII: FST467XS7D)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:75862-018-501 in 1 BOX
14 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart35208/10/2011
Labeler - GANZ U.S.A., LLC (798785242)

Revised: 8/2011
Document Id: 8eeb92ef-bf4c-436e-a70c-2538df88cb72
Set id: f0d3c419-a743-4ed6-b9cf-b50812bec8f2
Version: 1
Effective Time: 20110816
 
GANZ U.S.A., LLC