GLY-MIRACLE LIP BALM by DIVERSIFIED MANUFACTURING CORP

GLY-MIRACLE LIP BALM by

Drug Labeling and Warnings

GLY-MIRACLE LIP BALM by is a Otc medication manufactured, distributed, or labeled by DIVERSIFIED MANUFACTURING CORP. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

GLY-MIRACLE LIP BALM- octinoxate, oxybenzone, octisalate lipstick 
DIVERSIFIED MANUFACTURING CORP

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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USES

PREVENTS SUNBURN

01b LBL_Lip Balm

GLY-MIRACLE LIP BALM 
octinoxate, oxybenzone, octisalate lipstick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 62172-701
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE7.3 g  in 100 g
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE5.8 g  in 100 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE5 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
METHYL SALICYLATE (UNII: LAV5U5022Y) 5.4 g  in 100 g
COCONUT OIL (UNII: Q9L0O73W7L)  
YELLOW WAX (UNII: 2ZA36H0S2V)  
CANDELILLA WAX (UNII: WL0328HX19)  
LANOLIN (UNII: 7EV65EAW6H)  
ALOE VERA WHOLE (UNII: KIZ4X2EHYX)  
SHEA BUTTER (UNII: K49155WL9Y)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 62172-701-124.25 g in 1 TUBE; Type 0: Not a Combination Product12/11/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35212/11/2019
Labeler - DIVERSIFIED MANUFACTURING CORP (185073996)
Establishment
NameAddressID/FEIBusiness Operations
DIVERSIFIED MANUFACTURING CORP185073996manufacture(62172-701)

Revised: 12/2019
Document Id: 7a7dfb60-592f-432b-9173-f72b91850896
Set id: d8fca738-188b-4d7e-9b0e-06829634cea5
Version: 2
Effective Time: 20191211