SUN SHADES 15 LIP BALM LEMON GUM DROP- 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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SUN SHADES Lemon Gum Drop Label Information

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

Caution:  For external use only.  Keep out of reach of children.  If irritation develops, discontinue use.  Avoid contact with the eyes.

Active Ingredients:  Octinoxate 7.5% w/w.  Oxybenzone 3.0% w/w.

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

image of label

SUN SHADES  15 LIP BALM LEMON GUM DROP
octinoxate and oxybenzone stick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54473-162
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
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)  
ETHYLENE-VINYL ACETATE COPOLYMER (40% VINYL ACETATE) (UNII: L5F16ZG4ZU)  
Glycyrrhizin, Ammoniated (UNII: 3VRD35U26C)  
Petrolatum (UNII: 4T6H12BN9U)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:54473-162-014.2 g in 1 APPLICATOR
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35210/01/2007
Labeler - Melaleuca, Inc. (139760102)
Establishment
NameAddressID/FEIBusiness Operations
Melaleuca, Inc.139760102manufacture

Revised: 12/2010
Document Id: 0887440f-3c85-49c0-a2b4-acd9840fd322
Set id: 84b1b21e-f710-4673-98c6-63bc147db3bf
Version: 1
Effective Time: 20101230
 
Melaleuca, Inc.