SUN-KISSED LIP BALM  LEMON LIME SPF30- octinoxate, octocrylene, octisalate, and oxybenzone stick 
KISS AND SHIELD LIP BALM  LEMON LIME SPF 30- octinoxate, octocrylene, octisalate, and oxybenzone stick 
INSPIRED BY COLOR  LEMON LIME 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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Lemon-Lime
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

PRINCIPAL DISPLAY PANEL - 4 g Box

time & again®

SPF30
UVA/UVB SUNSCREEN PROTECTION

LIP BALM

Net wt 4 g (0.14 Oz)

Principal Display Panel - 4 g Box

PRINCIPAL DISPLAY PANEL - 4 g Box

time & again®

SPF30
UVA/UVB SUNSCREEN PROTECTION

LIP BALM

Net wt 4 g (0.14 Oz)

Principal Display Panel - 4 g Box

PRINCIPAL DISPLAY PANEL - 4 g Box

LIP BALM
with SPF30

UVA/UVB Sunscreen Protection

Lemon Lime

Principal Display Panel - 4 g Box
SUN-KISSED LIP BALM   LEMON LIME SPF30
octinoxate, octocrylene, octisalate, and oxybenzone stick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:75862-015
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:75862-015-501 in 1 BOX
14 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart35201/01/2011
KISS AND SHIELD LIP BALM   LEMON LIME SPF 30
octinoxate, octocrylene, octisalate, and oxybenzone stick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:75862-016
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:75862-016-501 in 1 BOX
14 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart35201/01/2011
INSPIRED BY COLOR   LEMON LIME SPF 30
octinoxate, octocrylene, octisalate, and oxybenzone stick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:75862-017
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:75862-017-501 in 1 BOX
14 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart35201/01/2011
Labeler - GANZ U.S.A., LLC (798785242)

Revised: 4/2011
Document Id: 7520e137-ca8e-4dcd-af38-79a2f74a6175
Set id: ff3d2e5a-95ae-4e15-99d4-9ddbd0a72e53
Version: 1
Effective Time: 20110425
 
GANZ U.S.A., LLC