Carmex Sun and Soothe Moisturizing Lip Balm SPF 30

AVOBENZONE, OCTISALATE, OCTOCRYLENE HUMAN OTC DRUG

Carmex Sun and Soothe Moisturizing Lip Balm SPF 30 is an FDA drug label for the active ingredient AVOBENZONE, OCTISALATE, OCTOCRYLENE manufactured by Carma Laboratories, Inc.. 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 20260505.

Generic name
AVOBENZONE, OCTISALATE, OCTOCRYLENE
Manufacturer
Carma Laboratories, Inc.
Product type
HUMAN OTC DRUG
Route
N/A
Dosage form
N/A
NDC
10210-0099
Application
M020
Label effective
20260505

About this product

Carmex Sun and Soothe Moisturizing Lip Balm SPF 30 is an FDA-registered drug product whose active ingredient is AVOBENZONE, OCTISALATE, OCTOCRYLENE. It is labelled by Carma Laboratories, Inc. and marketed as a human otc drug product. Identifiers on file: NDC 10210-0099, application M020, label effective 20260505. It is one of 17 FDA drug label records sharing the active ingredient AVOBENZONE, OCTISALATE, OCTOCRYLENE. 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.

What it is used for

Across FDA labelling, products containing AVOBENZONE, OCTISALATE, OCTOCRYLENE are most often described in connection with: helps protect, against sunburn, chapped lips. Wording differs between labels, and the full indications section on this page takes precedence when it is present.

Active ingredients

Active ingredients Avobenzone (3.0%) Octisalate (5.0%) Octocrylene (10.0%) Purpose Sunscreen

Indications & Usage

Uses helps protect against sunburn and chapped lips

Dosage & Administration

Directions Sun Protection Measures: Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with Broad Spectrum SPF value of 15 or higher and other sun protection measures including: • limit time in the sun, especially from 10 a.m. – 2 p.m. • wear long-sleeved shirts, pants, hats and sunglasses

Warnings

Warnings Do not use on damaged or broken skin Stop use and ask a doctor if: rash occurs Keep out of reach of children Keep out of reach of children

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AVOBENZONE, OCTISALATE, OCTOCRYLENE

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How products containing AVOBENZONE, OCTISALATE, OCTOCRYLENE compare

FDA lists 17 drug label records with AVOBENZONE, OCTISALATE, OCTOCRYLENE as the active ingredient. The most common dosage forms and the manufacturers with the most records are summarised below; strengths, pack sizes and inactive ingredients can still differ between apparently similar products.

Dosage formProductsManufacturerProducts
— — Access Business Group LLC 4
— — CALMANGO, INC 2
— — Frase Skin PTY LTD 2
— — SUNPLUS SKIN CARE LLC 2
— — AMBI Enterprises LLC 1

Frequently asked questions

What is Carmex Sun and Soothe Moisturizing Lip Balm SPF 30 used for?
Uses helps protect against sunburn and chapped lips

Who makes Carmex Sun and Soothe Moisturizing Lip Balm SPF 30?
Carma Laboratories, Inc. is the labeler of record for Carmex Sun and Soothe Moisturizing Lip Balm SPF 30. 17 FDA label records share the active ingredient AVOBENZONE, OCTISALATE, OCTOCRYLENE, so generic and branded versions may come from different companies; the manufacturer named on your pack is the one that matters for any enquiry.

Is Carmex Sun and Soothe Moisturizing Lip Balm SPF 30 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.

Are there other products containing AVOBENZONE, OCTISALATE, OCTOCRYLENE?
Yes. 17 FDA drug label records list AVOBENZONE, OCTISALATE, OCTOCRYLENE as the active ingredient. Products with the same active ingredient can usually be substituted only when a prescriber or pharmacist confirms it is appropriate.

Has Carmex Sun and Soothe Moisturizing Lip Balm SPF 30 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.