Label: BIRDS GARDEN LIP BALM- octinoxate, octocrylene, octisalate, and oxybenzone stick
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Contains inactivated NDC Code(s)
NDC Code(s): 75862-009-50 - Packager: GANZ U.S.A., LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
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.
Drug Label Information
Updated December 20, 2010
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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
- STORAGE AND HANDLING
- PRECAUTIONS
- PRINCIPAL DISPLAY PANEL - 4 g Carton
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INGREDIENTS AND APPEARANCE
BIRDS GARDEN LIP BALM CERULEAN WARBLER SPF 30
octinoxate, octocrylene, octisalate, and oxybenzone stickProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:75862-009 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:75862-009-50 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)