SUN SHADES LIP BALM  POMEGRANATE SPF 15- octinoxate and oxybenzone stick 
Melaleuca, Inc.

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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Drug Facts

Active Ingredients:  Octinoxate 7.5% w/w, Oxybenzone 3% w/w.

Uses:  Helps protect against sunburn.

Warnings:  Keep out of eyes.  Stop use if skin rash/irritation occurs.  Keep out of reach of children.

Directions:  Apply to the lips prior to sun exposure or as needed.

Inactive Ingredients:  Petrolatum USP, Jojoba Oil, Beeswax, Cetyl Esters, Ozokerite, Cocoa Butter, Stearyl Dimethicone, Flavor, Tocopheryl Acetate (Vitamin E USP), Monoammonium Glycyrrhizinate, Ethylene/VA Copolymer.

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SUN SHADES LIP BALM   POMEGRANATE SPF 15
octinoxate and oxybenzone stick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54473-168
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate75 mg  in 1 g
Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y) Oxybenzone30 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
Petrolatum (UNII: 4T6H12BN9U)  
Jojoba Oil (UNII: 724GKU717M)  
Yellow Wax (UNII: 2ZA36H0S2V)  
Cetyl Esters Wax (UNII: D072FFP9GU)  
Ceresin (UNII: Q1LS2UJO3A)  
Cocoa Butter (UNII: 512OYT1CRR)  
Vitamin E Acetate (UNII: 9E8X80D2L0)  
Glycyrrhizin, Ammoniated (UNII: 3VRD35U26C)  
ETHYLENE-VINYL ACETATE COPOLYMER (40% VINYL ACETATE) (UNII: L5F16ZG4ZU)  
Product Characteristics
Color    Score    
ShapeSize
FlavorPOMEGRANATE (Pomegranate) Imprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:54473-168-014.2 g in 1 APPLICATOR
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35210/01/2010
Labeler - Melaleuca, Inc. (139760102)
Establishment
NameAddressID/FEIBusiness Operations
Melaleuca, Inc.139760102manufacture

Revised: 12/2010
Document Id: 967dad22-e802-4c24-86ea-a24a0297a4a7
Set id: 5bc60cf9-675e-4cfe-b96e-40a349705af8
Version: 2
Effective Time: 20101215
 
Melaleuca, Inc.