GLY-MIRACLE LIP BALM SPF 30- octinoxate, oxybenzone, octisalate lipstick
DSG INNOVATIONS 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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ACTIVE INGREDIENTS

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

PURPOSE

SUNSCREEN

01b LBL_Lip Balm

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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:73537-701-12	4.25 g in 1 TUBE; Type 0: Not a Combination Product	12/11/2019

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

Labeler - DSG INNOVATIONS INC (203900654)

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