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Name:Birds Garden Lip Balm Western Tanager - Spf 30
Manufacturer:Norwood Packaging Ltd.
Category:Over-the-counter (OTC) Marketed Drugs


LIP BALM ALOE & VITAMIN E UVA / UVB PROTECTION SPF 30

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

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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LIP BALM
ALOE & VITAMIN E
UVA / UVB PROTECTION
SPF 30

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

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

Principal Display Panel - 4 g Carton

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:55143-010
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OCTINOXATE (OCTINOXATE) OCTINOXATE 7.5 g  in 100 g
OCTOCRYLENE (OCTOCRYLENE) OCTOCRYLENE 7 g  in 100 g
OCTISALATE (OCTISALATE) OCTISALATE 5 g  in 100 g
OXYBENZONE (OXYBENZONE) OXYBENZONE 5 g  in 100 g
Inactive Ingredients
Ingredient Name Strength
PETROLATUM  
ISOPROPYL MYRISTATE  
PARAFFIN  
CANDELILLA WAX  
LOW DENSITY POLYETHYLENE  
CETYL ALCOHOL  
LANOLIN  
OLEYL ALCOHOL  
OCTYLDODECANOL  
PHENYL TRIMETHICONE  
ALPHA-TOCOPHEROL ACETATE  
ALOE VERA LEAF  
SOYBEAN OIL  
TITANIUM DIOXIDE  
METHYLPARABEN  
PROPYLPARABEN  
SILICON DIOXIDE  
SACCHARIN  
Product Characteristics
Color      Score     
Shape Size
Flavor Imprint Code
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:55143-010-50 4 g in 1 TUBE None

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part352 01/01/2011

Labeler - Norwood Packaging Ltd. (243693926)

Revised: 03/2011 Norwood Packaging Ltd.



Source: http://dailymed.nlm.nih.gov
Reproduced with permission of U.S. National Library of Medicine


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