Label: GLY-MIRACLE LIP BALM SPF 30- octinoxate, oxybenzone, octisalate lipstick
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Contains inactivated NDC Code(s)
NDC Code(s): 73537-701-12 - Packager: DSG INNOVATIONS INC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
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.
Drug Label Information
Updated December 30, 2019
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- ACTIVE INGREDIENTS
- PURPOSE
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
GLY-MIRACLE LIP BALM SPF 30
octinoxate, oxybenzone, octisalate lipstickProduct 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)
