BIRDS GARDEN LIP BALM- octinoxate, octocrylene, octisalate, and oxybenzone stick

BIRDS GARDEN LIP BALM by

Drug Labeling and Warnings

BIRDS GARDEN 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]

INGREDIENTS

MEDICINAL INGREDIENTS (W/W)

Octinoxate 7.5%, Octocrylene 7.0%, Octyl Salicylate 5.0%, Oxybenzone 5.0%.

NON-MEDICINAL INGREDIENTS

Petrolatum, Isopropyl Myristate, Paraffin, Candelilla Cera, 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.

CONTAINS

Soy

STORAGE AND HANDLING

Store between 15°C and 30°C

PRECAUTIONS

Avoid eye contact. For external use only.

Keep out of reach of children.

PRINCIPAL DISPLAY PANEL - 4 g Carton

LIP BALM

ALOE & VITAMIN E
UVA / UVB PROTECTION

SPF 30

INGREDIENTS AND APPEARANCE

BIRDS GARDEN LIP BALM   WESTERN TANAGER - SPF 30
octinoxate, octocrylene, octisalate, and oxybenzone stick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 75862-010
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: 75862-010-50	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	01/01/2011

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