FOR THE GARDENER LIP BALM- octinoxate, octocrylene, octisalate, and oxybenzone stick

FOR THE GARDENER LIP BALM by

Drug Labeling and Warnings

FOR THE GARDENER LIP BALM by is a Otc medication manufactured, distributed, or labeled by GANZ U.S.A., LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients

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

Purposes

Sunscreens

Use

• helps prevent sunburn

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

SPL UNCLASSIFIED SECTION

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

INGREDIENTS AND APPEARANCE

FOR THE GARDENER LIP BALM   SPF 30
octinoxate, octocrylene, octisalate, and oxybenzone stick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 75862-018
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	7.5 g  in 100 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	7 g  in 100 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	5 g  in 100 g
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	5 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 75862-018-50	1 in 1 BOX
1		4 g in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part352	08/10/2011

Labeler - GANZ U.S.A., LLC (798785242)