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

----------

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

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 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.

Directions

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

3.5 g

BIORLX LIP BALM HEMP 
avobenzone, mineral oil, octinoxate, petrolatum,zinc oxide stick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:80554-001
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE6 g  in 100 g
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE6 g  in 100 g
PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U) PETROLATUM30 g  in 100 g
MINERAL OIL (UNII: T5L8T28FGP) (MINERAL OIL - UNII:T5L8T28FGP) MINERAL OIL30 g  in 100 g
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE1 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:80554-001-0212 in 1 BOX09/01/2020
1NDC:80554-001-013.5 g in 1 APPLICATOR; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35203/30/2020
Labeler - LOTUSA LLC (122415153)
Registrant - LOTUSA LLC (122415153)
Establishment
NameAddressID/FEIBusiness Operations
FRENCH MALIHOME PERSONAL PRODUCTS LIMITED664283791manufacture(80554-001)

Revised: 9/2020
Document Id: af786d13-df27-6075-e053-2995a90a5115
Set id: af78a54c-ff15-d9e1-e053-2a95a90aec14
Version: 1
Effective Time: 20200916
 
LOTUSA LLC