HEMP LIP BALM- octisalate, oxybenzone lipstick
Nemadji Management LLC

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

OCTISALATE 7.3%

OXYBENZONE 4.7%

PURPOSE

SUNSCREEN

WARNINGS

EXTERNAL USE ONLY

KEEP OUT OF REACH OF CHILDREN.

USES

PREVENTS SUNBURN

DIRECTIONS

APPLY TO AFFECTED AREA AS DESIRED.

INACTIVE INGREDIENTS

Hemp flower oil, Coconut oil, Beeswax, Patrolatum, Candelilla wax, Dimethicone, Aloe oil, Flavor, Tocopherol Acetate.

01b LBL_Hemp Lip Balm

HEMP LIP BALM
octisalate, oxybenzone lipstick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:73278-201
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	7.3 g in 100 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	0.4 g in 100 mL

Ingredient Name	Strength
Inactive Ingredients
CANNABIS SATIVA SUBSP. SATIVA FLOWERING TOP (UNII: 8X454SZ22D)
COCONUT OIL (UNII: Q9L0O73W7L)
YELLOW WAX (UNII: 2ZA36H0S2V)
PETROLATUM (UNII: 4T6H12BN9U)
CANDELILLA WAX (UNII: WL0328HX19)
DIMETHICONE (UNII: 92RU3N3Y1O)
ALOE VERA WHOLE (UNII: KIZ4X2EHYX)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:73278-201-11	10 mL in 1 BOTTLE; Type 0: Not a Combination Product	08/07/2019

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part352	08/07/2019

Labeler - Nemadji Management LLC (100279564)

Name	Address	ID/FEI	Business Operations
Establishment
DIVERSIFIED MANUFACTURING CORP		185073996	manufacture(73278-201)