HEMP LIP BALM- octisalate, oxybenzone lipstick

United States - English - NLM (National Library of Medicine)

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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
Authorization number:
73278-201-11

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.

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

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