Biorlx Lip Balm Ginseng
FDA Label NDC 80554-003

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Lotusa Llc. for the product Biorlx Lip Balm Ginseng (NDC 80554-003). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding other, active ingredient(s), purpose, use, warnings, do not use, otc - when using, otc - stop use, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

→ Other

→ Active Ingredient(s)

→ Purpose

→ Use

→ Warnings

→ Do Not Use

→ Otc - When Using

→ Otc - Stop Use

→ Otc - Keep Out Of Reach Of Children

→ Directions

→ Other Information

→ Inactive Ingredients

→ Package Label - Principal Display Panel

Other

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

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

Otc - 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.

Otc - Stop Use

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

Otc - 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, 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

* Please review the disclaimer below.

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