Luxe Gloss Hydrating Lip Gloss SPF 35-NAKED HONEY

OCTOCRYLENE 8%, OCTISALATE 5%, TITANIUM DIOXIDE 6%, ZINC OXIDE 8% TOPICAL HUMAN OTC DRUG

Luxe Gloss Hydrating Lip Gloss SPF 35-NAKED HONEY is an FDA drug label for the active ingredient OCTOCRYLENE 8%, OCTISALATE 5%, TITANIUM DIOXIDE 6%, ZINC OXIDE 8% manufactured by Lale Cosmetics 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 20260803.

Generic name
OCTOCRYLENE 8%, OCTISALATE 5%, TITANIUM DIOXIDE 6%, ZINC OXIDE 8%
Manufacturer
Lale Cosmetics LLC
Product type
HUMAN OTC DRUG
Route
TOPICAL
Dosage form
N/A
NDC
87911-001
Application
M020
Label effective
20260803

About this product

Luxe Gloss Hydrating Lip Gloss SPF 35-NAKED HONEY is an FDA-registered drug product whose active ingredient is OCTOCRYLENE 8%, OCTISALATE 5%, TITANIUM DIOXIDE 6%, ZINC OXIDE 8%. It is labelled by Lale Cosmetics LLC taken by topical and marketed as a human otc drug product. Identifiers on file: NDC 87911-001, application M020, label effective 20260803. 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 OCTOCRYLENE 8%, OCTISALATE 5%, TITANIUM DIOXIDE 6%, ZINC OXIDE 8% are most often described in connection with: helps prevent, sun protection, measures seedirections, risk ofskin, early skin. Wording differs between labels, and the full indications section on this page takes precedence when it is present.

Active ingredients

Octocrylene 8% Octisalate 5% Titanium Dioxide 6% Zinc Oxide 8%

Indications & Usage

helps prevent sunbum. if used as directed with other sun protection measures (seeDirections), decreases the risk ofskin cancer and early skin agingcaused by the sun.

Dosage & Administration

apply liberally 15 minutes before sun exposure. reapply at least every 2 hours or after eating, drinking, or sun exposure.

Warnings

For external use only.

Frequently asked questions

What is Luxe Gloss Hydrating Lip Gloss SPF 35-NAKED HONEY used for?
helps prevent sunbum. if used as directed with other sun protection measures (seeDirections), decreases the risk ofskin cancer and early skin agingcaused by the sun.

Who makes Luxe Gloss Hydrating Lip Gloss SPF 35-NAKED HONEY?
Lale Cosmetics LLC is the labeler of record for Luxe Gloss Hydrating Lip Gloss SPF 35-NAKED HONEY.

What form does Luxe Gloss Hydrating Lip Gloss SPF 35-NAKED HONEY 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 Luxe Gloss Hydrating Lip Gloss SPF 35-NAKED HONEY 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 Luxe Gloss Hydrating Lip Gloss SPF 35-NAKED HONEY 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.