BIORLX LIP BALM GINSENG- 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.

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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. Butyrospermum (Shea) Parkii Butter

i.Curcuma Longa (Turmeric) Root Extract

j. Caprylic/ Capric Triglyceride

k. Ceresin

l. Microcrystalline Wax

m. Potassium Sorbate

n. Tocopherol

o. Panax Ginseng (Ginseng ) Root Extract

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

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

Inactive ingredients

Aloe Barbadensis (Alove Vera) Leaf Juice, Beeswax, Butyrpsoermum (Shea) Parkii Butter, Caprylic/ Capric Triglyceride, Ceresin, Curcuma Longa (Turmeric) Root Etract, Microcrystalline Wax, Panax Ginseng (Ginseng ) Root Extract, Potassium Sorbate, Tocopherol

Package Label - Principal Display Panel

12x3.5 g NDC: 80554-003-01

ginseng

BIORLX LIP BALM GINSENG 
avobenzone, mineral oil, octinoxate, petrolatum, zinc oxide stick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:80554-003
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE1 g  in 100 g
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE6 g  in 100 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE6 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
Inactive Ingredients
Ingredient NameStrength
BUTYROSPERMUM PARKII (SHEA) BUTTER UNSAPONIFIABLES (UNII: 0C9AC7D6XU)  
WHITE WAX (UNII: 7G1J5DA97F)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
CERESIN (UNII: Q1LS2UJO3A)  
CURCUMA LONGA LEAF (UNII: H2HC4RY52C)  
PANAX GINSENG ROOT OIL (UNII: P9T4K47OM0)  
TOCOPHEROL (UNII: R0ZB2556P8)  
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:80554-003-0212 in 1 BOX09/01/2020
1NDC:80554-003-013.5 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(80554-003)

Revised: 9/2020
Document Id: af9b4ace-650c-dd55-e053-2a95a90a965f
Set id: af9b5a30-be5e-3918-e053-2995a90ae69c
Version: 1
Effective Time: 20200918
 
LOTUSA LLC.