Home › NDC Lookup › Ingredients › Octocrylene 8%, Octisalate 5%, Titanium... › 87911-0003-01
Luxe Gloss Hydrating Lip Gloss SPF 35-ICED OUT Octocrylene 8%, Octisalate 5%, Titanium Dioxide 6%, Zinc Oxide 8% .08 g/mL; .05 g/mL; .08 g/mL; .06 g/mL Cream — NDC 87911-0003-01 package photo

Luxe Gloss Hydrating Lip Gloss SPF 35-ICED OUT Octocrylene 8%, Octisalate 5%, Titanium Dioxide 6%, Zinc Oxide 8% .08 g/mL; .05 g/mL; .08 g/mL; .06 g/mL Cream

by Lale Cosmetics LLC · 1 BOTTLE in 1 BOX (87911-003-01) / 5 mL in 1 BOTTLE
NDC 87911-0003-01
🏷️ FDA NDC (as labeled) 87911-003-01 billing pads the product segment with a zero
OTC On market Non-controlled
🗂️ Data synced Sep 17, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

🆔 Identity & classification

FDA NDC (as labeled) 87911-003-01
Product NDC 87911-003
11-digit billing NDC 87911000301
UNII 4X49Y0596W, SOI2LOH54Z, 15FIX9V2JP, 5A68WGF6WM
UPC 0860015898111, 0860015898128, 0860015898135
Application # M020
SPL Set ID 581fb0cd-c55d-d562-e063-6394a90a7f11
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2026-08-03
Route TOPICAL
Dosage form CREAM
Substance OCTOCRYLENE; OCTISALATE; ZINC OXIDE; TITANIUM DIOXIDE
Why two NDCs? The FDA registers this code as 87911-003-01 — a 5-3-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the product segment → 87911-0003-01. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

🏭 Manufacturer & labeler

LabelerLale Cosmetics LLC
FDA applicationM020 (OTC MONOGRAPH DRUG)
Labeler code87911
First marketedAug 2026
Product typeHuman Otc Drug
Portfolio3 products on file
The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

🩺 Clinical

🧪 What is this product?

Luxe Gloss Hydrating Lip Gloss SPF 35 is a topical lip cream marketed as an over-the-counter sunscreen product under the FDA's OTC monograph rules. It contains four active sunscreen ingredients: octocrylene, octisalate, zinc oxide, and titanium dioxide, which are typically used together to absorb and reflect ultraviolet light. This product is intended to be applied to the lips to provide sun protection. The gloss formulation also contains hydrating ingredients meant to condition the lips.

Supplement & herbal interactions

🌿 Drug–supplement interaction checker →
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

🧪 Inactive Ingredients / Excipients

Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

  • UNII 7LL6SY9YFV
    A synthetic polymer made from acrylic compounds. It forms a protective film coating on tablets or capsules to control how fast the medicine dissolves and releases in the digestive tract.
  • UNII 5QB0T2IUN0
    Aluminum hydroxide is a white powder mineral compound used as an antacid ingredient in some formulations. It works as a buffer and pH regulator to help neutralize stomach acid in the medicine.
  • UNII 24WE03BX2T
    Levomenol is a naturally derived alcohol compound used as a skin-conditioning and anti-inflammatory agent in topical formulations. It helps soothe and protect the skin while improving product texture and absorption.
  • UNII A9EJ3J61HQ
    A synthetic liquid derived from benzoic acid and long-chain alcohols. It functions as a solvent and penetration enhancer in topical formulations, helping active ingredients dissolve and absorb into the skin.
  • UNII 481744AI4O
    A synthetic red dye used to color medicines and products. It helps make tablets, capsules, and liquids visually distinct so patients can easily identify their medication.
  • UNII H77VEI93A8
    A synthetic yellow dye used to color medications. It helps identify the drug and make it visually distinctive, with no effect on how the medicine works.
  • UNII 1K09F3G675
    Ferric oxide red is an inorganic iron compound used as a colorant in medicines. It gives tablets, capsules, or other dosage forms a red or reddish tint for identification and appearance.
  • UNII EX438O2MRT
    Ferric oxide yellow is a naturally occurring iron compound used as a colorant in medications. It gives tablets, capsules, and other forms a yellow or golden hue for identification and appearance.
  • UNII 7D1YQ9Y5EZ
    Hydrogenated polybutene is a thick, wax-like ingredient made by chemically processing petroleum. It acts as a binder and lubricant, helping hold tablet ingredients together and allowing pills to slide smoothly during manufacturing and packaging.
  • UNII V8A1AW0880
    Mica is a naturally occurring mineral that's ground into fine powder. It's used in medicines as a colorant and anti-caking agent to improve appearance and prevent clumping in tablets or powders.
  • UNII XOF597Q3KY
    A refined form of wax made from petroleum, microcrystalline wax is used in medicines as a coating agent, binder, and hardening ingredient. It helps give tablets and capsules their shape and protective outer layer.
  • UNII 1NA5AO9GH7
    A synthetic polymer derived from petroleum, polybutene is used as a binder and lubricant in solid medications to help hold ingredients together and improve the tablet or capsule's flow during manufacturing.
  • UNII EU2PSP0G0W
    Silica dimethyl silylate is a silicon-based powder that acts as a glidant and anti-caking agent. It reduces friction between particles and helps powders flow smoothly during manufacturing and tablet compression.
  • UNII R0ZB2556P8
    Tocopherol is a form of vitamin E derived from plant oils. It acts as an antioxidant in medicines to prevent oils and fats from breaking down and spoiling during storage.
  • UNII LDC331P08E
    A silicone-based compound that acts as a glidant and flow agent in solid medications. It reduces friction between powder particles, helping the medicine flow smoothly during manufacturing and tablet compression.
  • UNII 5041RX63GN
    A synthetic silicon-based polymer used as a glidant and anti-caking agent. It helps powder particles flow smoothly and prevents clumping during manufacturing and storage.

16 inactive ingredients listed in the exact product block matched to this NDC.

The official label also statesHydrogenated Polyisobutene, Polybutene, C12-15 Alkyl Benzoate, Microcrystalline Wax, Acrylates/Octylacrylamide Copolymer, Trimethylsiloxysilicate, Silica Dimethyl Silylate, CI 77491, CI15850, CI77492, CI77499, Tocopherol, Bisabolol, Fragrance, Aluminum Hydroxide, Triethoxycaprylylsilane Hydrogenated Polyisobutene, Polybutene, C12-15 Alkyl Benzoate, Microcrystalline Wax, Acrylates/Octylacrylamide Copolymer, Trimethylsiloxysili- cate, Silica Dimethyl Silylate, Tridecyl Trimellitate, CI 16035, Tocopherol, CI 15850, Bisabolol, Fragrance, CI 77499, CI77491,CI77492 Hydrogenated Polyisobutene, Polybutene, C12-15 Alkyl Benzoate, Microcrystalline Wax, Acrylates/Octylacrylamide Copolymer, Trimethylsiloxysilicate, Silica Dimethyl Silylate, CI 77491, CI 15850, CI 77492, Tocopherol, Bisabolol, Fragrance, CI 15985, Aluminum Hydroxide, Triethoxycaprylylsilane, Mica

Label-section wording can be broader than the structured product block and may mention additional formulation ingredients.

Where does this data come from?
Data sourced from official FDA Structured Product Labeling (SPL) via DailyMed — ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

💲 Pricing

A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.

Price systemPer gPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
ℹ️
No price is published for this exact package yet. CMS surveys NADAC per package size, so a different pack of the same drug often has one.
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Luxe Gloss Hydrating Lip Gloss SPF 35-GUILTY PLEASURE .08 g/mL; .05 g/mL; .08 g/mL; .06 g/mL 87911-0002-01 Lale 1 bottle — — FDA listed —
Luxe Gloss Hydrating Lip Gloss SPF 35-ICED OUT .08 g/mL; .05 g/mL; .08 g/mL; .06 g/mLthis 87911-0003-01 Lale 1 bottle — — FDA listed —
About this product: other versions of the same ingredient, strength and form are listed above, least expensive first, with FDA equivalence ratings where available.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

⏳ Availability & generic status

🏛️
2026
On the market since
Aug 2026
📍
2026
Currently FDA-listed
listed with the FDA
🔒
·
No generic listed yet
brand only
ℹ️No FDA-approved generic found

We did not find an FDA-approved generic match for this exact strength, form and route.

Where does this data come from?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
87911-0003-01 You're viewing this 1 BOTTLE in 1 BOX (87911-003-01) / 5 mL in 1 BOTTLE 2026-08-03 Active

🧭 About this NDC listing & data coverage

Over-the-counter (OTC) product
What data is (and isn’t) available for this NDC — tap to expand
NDC identity (package / product / labeler codes) ✓ Available
Labeler ✓ Available
Product & package description ✓ Available
Marketing category & status ✓ Available
Active ingredient / dosage form / route ✓ Available
FDA label (SPL via DailyMed) ✓ Available
Package photos ✓ Available
Inactive ingredients (structured) ✓ Available
NADAC pharmacy acquisition price (CMS) — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
Orange Book / therapeutic-equivalence data — Not published for this NDC Applies only to products approved under an NDA/ANDA; many listings are out of scope.
HCPCS J-code billing crosswalk — Not published for this NDC Most self-administered / retail products have no J-code — that is normal.
Medicaid utilization (CMS SDUD) — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold.
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Is this NDC FDA-approved?
An NDC listing does not by itself establish FDA approval — the NDC Directory records that a product is listed with FDA, not that it was reviewed and approved. This listing's marketing category is "Otc Monograph Drug". Products approved under an application carry an NDA, ANDA, or BLA number.
Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The FDA registers it as 87911-003-01, which is what is printed on the packaging and shown on DailyMed. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero: 87911-0003-01, written without dashes as 87911000301. The Identity section at the top of this page lists every form of this code.
What do the three segments of this NDC mean?
In 87911-0003-01, the first segment (87911) is the labeler code FDA assigned to Lale Cosmetics LLC; the middle segment (0003) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (01) identifies this exact package size and type. Together they name one specific package of one specific product.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by Lale Cosmetics LLC. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Lale Cosmetics LLC is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as an over-the-counter product, so it does not require a prescription. Follow the package directions, and ask your pharmacist if you are unsure whether it is right for you.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.

📄 FDA label — Drug Facts FDA SPL

The complete FDA label for this product — the official Drug Facts labeling, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration ⚠️ Warnings 🧪 Active Ingredient 🧪 Inactive Ingredients 🎯 Purpose
🎯 Indications and Usage 25 words ▾

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 and Administration 20 words ▾

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

⚠️ Warnings 4 words ▾

For external use only.

🧪 Active Ingredient 10 words ▾

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

🧪 Inactive Ingredients 81 words ▾

Hydrogenated Polyisobutene, Polybutene, C12-15 Alkyl Benzoate, Microcrystalline Wax, Acrylates/Octylacrylamide Copolymer, Trimethylsiloxysilicate, Silica Dimethyl Silylate, CI 77491, CI15850, CI77492, CI77499, Tocopherol, Bisabolol, Fragrance, Aluminum Hydroxide, Triethoxycaprylylsilane

Hydrogenated Polyisobutene, Polybutene, C12-15 Alkyl Benzoate, Microcrystalline Wax, Acrylates/Octylacrylamide Copolymer, Trimethylsiloxysili- cate, Silica Dimethyl Silylate, Tridecyl Trimellitate, CI 16035, Tocopherol, CI 15850, Bisabolol, Fragrance, CI 77499, CI77491,CI77492

Hydrogenated Polyisobutene, Polybutene, C12-15 Alkyl Benzoate, Microcrystalline Wax, Acrylates/Octylacrylamide Copolymer, Trimethylsiloxysilicate, Silica Dimethyl Silylate, CI 77491, CI 15850, CI 77492, Tocopherol, Bisabolol, Fragrance, CI 15985, Aluminum Hydroxide, Triethoxycaprylylsilane, Mica

🎯 Purpose 1 words ▾

Sunscreen

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 87911-0002-01 · Lale 87912-0001-01 · Locsanity →
For educational and professional reference only — not medical advice. Pricing reflects published NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.