HEMP LIP BALM- octisalate, oxybenzone lipstick

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

OCTISALATE  7.3%, OXYBENZONE  4.7%

Available from:

Nemadji Management LLC

Administration route:

TOPICAL

Prescription type:

OTC DRUG

Therapeutic indications:

SUNSCREEN PREVENTS SUNBURN

Authorization status:

OTC monograph not final

Summary of Product characteristics

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._
----------
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.
HEMP LIP BALM
octisalate, oxybenzone lipstick
PRODUCT INFORMATION
PRODUCT T YPE
HUMAN OTC DRUG
ITE M CODE (SOURCE )
NDC:73278 -20 1
ROUTE OF ADMINISTRATION
TOPICAL
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF STRENGTH
STRE NG TH
O CTISALATE (UNII: 4X49 Y0 59 6 W) (OCTISALATE - UNII:4X49 Y0 59 6 W)
OCTISALATE
7.3 g in 10 0 mL
O XYBENZO NE (UNII: 9 5OOS7VE0 Y) (OXYBENZONE - UNII:9 5OOS7VE0 Y)
OXYBENZONE
0 .4 g in 10 0 mL
INACTIVE INGREDIENTS
INGREDIENT NAME
STRE NG TH
CANNABIS SATIVA SUBSP. SATIVA FLO WERING TO P (UNII: 8 X454SZ22D)
Nemadji Management LLC
CO CO NUT O IL (UNII: Q9 L0 O73W7L)
YELLO W WAX (UNII: 2ZA36 H0 S2V)
PETRO LATUM (UNII: 4T6 H12BN9 U)
CANDELILLA WAX (UNII: WL0 328 HX19 )
DIMETHICO NE (UNII: 9 2RU3N3Y1O)
ALO E VERA WHO LE (UNII: KIZ4X2EHYX)
.ALPHA.-TO CO PHERO L ACETATE (UNII: 9 E8 X8 0 D2L0 )
PACKAG ING
#
ITEM CODE
PACKAGE DESCRIPTION
MARKETING START DATE
MARKETING END DATE
1
NDC:73278 -20 1-11
10 mL in 1 BOTTLE; Type 0 : No t a Co mbinatio n Pro duct
0 8 /0 7/20 19
MARKETING INFORMATION
MARKE TING CATE GORY
APPLICATION NUMBE R OR MONOGRAPH CITATION
MARKE TING START DATE
MARKE TING END DATE
OTC mo no graph no t final
pa rt352
0 8 /0 7/20 19
LABELER -
Nemadji Management LLC (100279564)
ESTABLISHMENT
NAME
AD D RE S S
ID/FEI
BUSINE SS OPE RATIONS
DIVERSIFIED MANUFACTURING CORP
18 50 739 9 6
ma nufa c ture (73278 -20 1)
Revised: 8/2019