SunShades 15 Lip Balm Harvest Berry

Dosage form: stick
Ingredients: Octinoxate 75mg in 1g, Oxybenzone 30mg in 1g
Labeler: Melaleuca, Inc.
NDC Code: 54473-137

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.

SUN SHADES Harvest Berry 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 or rash 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.

SUNSHADES  15 LIP BALM HARVEST BERRY
octinoxate and oxybenzone stick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54473-137
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Octinoxate (Octinoxate) Octinoxate75 mg  in 1 g
Oxybenzone (Oxybenzone) Oxybenzone30 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
Jojoba Oil 
Yellow Wax 
Cetyl Esters Wax 
Ceresin 
Cocoa Butter 
VITAMIN E ACETATE 
ETHYLENE-VINYL ACETATE COPOLYMER (40% VINYL ACETATE) 
Glycyrrhizin, Ammoniated 
Petrolatum 
Packaging
#Item CodePackage Description
1NDC:54473-137-014.2 g in 1 APPLICATOR
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35210/01/2006
Labeler - Melaleuca, Inc. (139760102)
Establishment
NameAddressID/FEIOperations
Melaleuca, Inc.139760102manufacture

Revised: 12/2010
 
Melaleuca, Inc.

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

Hide
(web4)