BIORLX LIP BALM HEMP- avobenzone, mineral oil, octinoxate, petrolatum,zinc oxide stick

BIORLX LIP BALM HEMP by

Drug Labeling and Warnings

BIORLX LIP BALM HEMP by is a Otc medication manufactured, distributed, or labeled by LOTUSA LLC, FRENCH MALIHOME PERSONAL PRODUCTS LIMITED. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

This is a hand sanitizer manufactured according to the Temporary Policy for Preparation of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (CoViD-19); Guidance for Industry.

The hand sanitizer is manufactured using only the following United States Pharmacopoeia (USP) grade ingredients in the preparation of the product (percentage in final product formulation) consistent with World Health Organization (WHO) recommendations:

a. Avobenzone 1.0%w/w

b. Mineral Oil 30.0%w/w

c. Octinoxate 6.0% w/w

d. Petrolatum 30.0% w/w

e. Zinc Oxide 6.0% w/w

f. Aloe Barbadensis (Alove Vera) Leaf Juice

g. Beeswax

h. Butyrpsoermum (Shea) Parkii Butter

i.Cannabis Sativa (Hemp) Seed Oil

j. Caprylic/ Capric Triglyceride

k. Ceresin

l. Microcrystalline Wax

m. Potassium Sorbate

n. Tocopherol

The firm does not add other active or inactive ingredients. Different or additional ingredients may impact the quality and potency of the product.

Active Ingredient(s)

Avobenzone 1.0% w/w Sunscreen
Mineral Oil 30.0% w/w Skin protectant
Octinoxate 6.0% w/w Sunscreen
Petrolatum 30.0% w/w Skin protectant
Zinc Oxide 6.0% w/w Sunscreen

Purpose

Sunscreen, Skin protectant, Lip Balm

Use

Helps prevent sunburn if use as directed with other sun protection measures.
provides moderate protection against sunburn
Helps temporarily protect chapped and cracked lips.

Warnings

For external use only.

Do not use

• in children less than 6 months of age
• on damaged or broken skin
  if you are allergic to any ingredients

WHEN USING

When using this product do not get into eyes. In case of contact, rinse eyes thoroughly with water.

Stop use and ask a doctor if rash or irritation develops and lasts.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

STOP USE

Stop use and ask a doctor if rash or irritation develops and lasts.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

• Apply as needed. Apply liberally 15 minutes before sun exposure. Reapply after 60 minutes of swimming or sweatig, immediately after towel drying at leaft every 2 hours. For best results use daily.

Other information

Spending time in the sun increases your risk of skin cancer and early aging. To decrease the risk, regularly use a sunscreen with a broad spectrum SPF of 15 or higher and other longsleeve shirts, pants or hats and sunglassess.
Store at room temperature

Inactive ingredients

Aloe Barbadensis (Alove Vera) Leaf Juice, Beeswax, Butyrpsoermum (Shea) Parkii Butter, Cannabis Sativa (Hemp) Seed Oil, Caprylic/ Capric Triglyceride, Ceresin, Microcrystalline Wax, Potassium Sorbate, Tocopherol

Package Label - Principal Display Panel

3.5g x 12 NDC: 80554-001-01

INGREDIENTS AND APPEARANCE

BIORLX LIP BALM HEMP 
avobenzone, mineral oil, octinoxate, petrolatum,zinc oxide stick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 80554-001
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	6 g  in 100 g
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	6 g  in 100 g
PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U)	PETROLATUM	30 g  in 100 g
MINERAL OIL (UNII: T5L8T28FGP) (MINERAL OIL - UNII:T5L8T28FGP)	MINERAL OIL	30 g  in 100 g
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	1 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
TOCOPHEROL (UNII: R0ZB2556P8)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
WHITE WAX (UNII: 7G1J5DA97F)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
CERESIN (UNII: Q1LS2UJO3A)
BUTYROSPERMUM PARKII (SHEA) BUTTER UNSAPONIFIABLES (UNII: 0C9AC7D6XU)
CANNABIS SATIVA SEED OIL (UNII: 69VJ1LPN1S)
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 80554-001-02	12 in 1 BOX	09/01/2020
1	NDC: 80554-001-01	3.5 g in 1 APPLICATOR; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	03/30/2020

Labeler - LOTUSA LLC (122415153)

Registrant - LOTUSA LLC (122415153)

Establishment
Name	Address	ID/FEI	Business Operations
FRENCH MALIHOME PERSONAL PRODUCTS LIMITED		664283791	manufacture(80554-001)