Intense Therapy Lip Balm SPF25, Shea Butter and Vitamin E

LIP BALM SPF25 TOPICAL HUMAN OTC DRUG

Intense Therapy Lip Balm SPF25, Shea Butter and Vitamin E is an FDA drug label for the active ingredient LIP BALM SPF25 manufactured by Jack Black, LLC administered by TOPICAL. This page reproduces the FDA-approved indications and usage, dosage, contraindications, warnings, and adverse reactions exactly as published in the drug label. Data source: openFDA (U.S. FDA), label effective 20260908.

Generic name
LIP BALM SPF25
Manufacturer
Jack Black, LLC
Product type
HUMAN OTC DRUG
Route
TOPICAL
Dosage form
N/A
NDC
66738-030
Application
M020
Label effective
20260908

About this product

Intense Therapy Lip Balm SPF25, Shea Butter and Vitamin E is an FDA-registered drug product whose active ingredient is LIP BALM SPF25. It is labelled by Jack Black, LLC taken by topical and marketed as a human otc drug product. Identifiers on file: NDC 66738-030, application M020, label effective 20260908. This page reproduces the FDA-approved label text so you can check what a product is, who makes it and how it is supplied before discussing it with a pharmacist or prescriber.

Active ingredients

Active Ingredients Avobenzone 3.0% Sunscreen Octinoxate 7.5% Sunscreen Petrolatum 40.2% Skin Protectant

Dosage & Administration

Directions Apply liberally 15 minutes before sun exposure and as needed. Children under 6 monhts: ask a doctor.

Warnings

Warning Stop use if skin rash occurs

Frequently asked questions

What is Intense Therapy Lip Balm SPF25, Shea Butter and Vitamin E used for?
No indications section is present in the FDA label on file for this product. Consult the prescribing information supplied with the medicine or ask a pharmacist.

Who makes Intense Therapy Lip Balm SPF25, Shea Butter and Vitamin E?
Jack Black, LLC is the labeler of record for Intense Therapy Lip Balm SPF25, Shea Butter and Vitamin E.

What form does Intense Therapy Lip Balm SPF25, Shea Butter and Vitamin E come in?
administered by topical. Strengths and pack sizes vary by label, so compare the NDC on your pack with the identifier listed on this page.

Is Intense Therapy Lip Balm SPF25, Shea Butter and Vitamin E prescription or over-the-counter?
The FDA label for this product is recorded as human otc drug. Marketing status can differ between strengths and countries, so check the dispensing rules where you live.

Has Intense Therapy Lip Balm SPF25, Shea Butter and Vitamin E been recalled?
No FDA recall record in our database matches this product name or manufacturer. Recall data is updated periodically, so a very recent notice may not appear here yet.

Where does this information come from?
All content is reproduced from FDA Structured Product Labelling data via openFDA. It is provided for identification and reference only and is not medical advice.

This page reproduces FDA Structured Product Labelling data for identification and reference. It is not medical advice, does not diagnose or treat any condition, and does not sell or price any medicine.