GLY-MIRACLE LIP BALM SPF 30- octinoxate, oxybenzone, octisalate lipstick

GLY-MIRACLE LIP BALM by

Drug Labeling and Warnings

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

Drug Details [pdf]

ACTIVE INGREDIENTS

OCTYL METHOXYCINNAMATE 7.3%, BENZOPHENONE-3 5.8%, OCTYL SALICYLATE 5.0%, HOMOMETHYL SALICYLATE 5.4%

PURPOSE

SUNSCREEN

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

GLY-MIRACLE LIP BALM  SPF 30
octinoxate, oxybenzone, octisalate lipstick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 73537-701
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	7.3 g  in 100 g
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	5.8 g  in 100 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	5 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 73537-701-12	4.25 g in 1 TUBE; Type 0: Not a Combination Product	12/11/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	12/11/2019

Labeler - DSG INNOVATIONS INC (203900654)

Establishment
Name	Address	ID/FEI	Business Operations
DIVERSIFIED MANUFACTURING CORP		185073996	manufacture(73537-701)