BIORLX LIP BALM HEMP

Manufacturer
LOTUSA LLC | FRENCH MALIHOME PERSONAL PRODUCTS LIMITED
Effective date
2020-09-16
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:29:44

Label at a glance#

ProductBIORLX LIP BALM HEMP
Active ingredientZINC OXIDE, OCTINOXATE, PETROLATUM, MINERAL OIL, AVOBENZONE
Label structure13 sections

Dosage and administration

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.

Storage and handling

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

Label contents#

Full prescribing information#

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)

OTC - ACTIVE INGREDIENT SECTION

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

OTC - PURPOSE SECTION

Sunscreen, Skin protectant, Lip Balm

Use

INDICATIONS & USAGE SECTION

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

WARNINGS SECTION

For external use only.

Do not use

OTC - DO NOT USE SECTION

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

OTC - WHEN USING SECTION

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.

OTC - STOP USE SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

  • 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

STORAGE AND HANDLING SECTION

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

INACTIVE INGREDIENT SECTION

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

3.5g x 12 NDC: 80554-001-01

3.5 g3.5 g

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
80554-001-022022-01-28C16284748780-1d6a99b39-7bba-a426-e053-dadaa90af4c2af78a54c-ff15-d9e1-e053-2a95a90aec14

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
80554-001-01BIORLX LIP BALM HEMP3.5 g in 1 APPLICATORSTICK3.51
80554-001-02BIORLX LIP BALM HEMP12 in 1 BOXSTICK121

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80554-001BIORLX LIP BALM HEMP (AVOBENZONE, MINERAL OIL, OCTINOXATE, PETROLATUM,ZINC OXIDE) STICK [LOTUSA LLC]1Legacy NDC, 2 package rows20200919_af78a54c-ff15-d9e1-e053-2a95a90aec14.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 16 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
80554-00180554-001-01, 80554-001-02

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 14 matching rows.

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
af786d13-df27-6075-e053-2995a90a5115af78a54c-ff15-d9e1-e053-2a95a90aec142020-09-16WarningsExact identifier
spl id: af786d13-df27-6075-e053-2995a90a5115
spl set id: af78a54c-ff15-d9e1-e053-2a95a90aec14

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.