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Almost powder Makeup Broad Spectrum Spf 18 Octinoxate and Titanium Dioxide 2 g/100g; 1.2 g/100g Powder — NDC 49527-0060-01 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Almost powder Makeup Broad Spectrum Spf 18 Octinoxate and Titanium Dioxide 2 g/100g; 1.2 g/100g Powder — NDC 49527-060-01 (Billing 49527-0060-01)

by CLINIQUE LABORATORIES LLC · 1 JAR in 1 CARTON / 10 g in 1 JAR

This is a package of Almost powder Makeup Broad Spectrum Spf 18 Octinoxate and Titanium Dioxide 2 g/100g; 1.2 g/100g Powder from CLINIQUE LABORATORIES LLC, marketed since Mar 2018 and currently FDA-listed. It is this product's only package size.

NDC 49527-0060-01
🏷️ FDA NDC (as labeled) 49527-060-01 billing pads the product segment with a zero
OTC On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Jul 24, 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

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 49527-060-01
Product NDC 49527-060
11-digit billing NDC 49527006001
UNII 4Y5P7MUD51, 15FIX9V2JP
Application # M020
SPL Set ID 402add6d-a81e-4c9e-aee1-4abeb480894f
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2018-03-01
Route TOPICAL
Dosage form POWDER
Substance OCTINOXATE; TITANIUM DIOXIDE
Why two NDCs? The FDA registers this code as 49527-060-01 — 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 → 49527-0060-01. 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.

Clinical

🧪 What is this product?

This is a powder makeup product applied to the skin that contains two active ingredients commonly used as ultraviolet (UV) filters in sunscreen products. Octinoxate and titanium dioxide function as physical and chemical sun-protective agents, typically included in cosmetics to help protect skin from UV radiation exposure. As an over-the-counter monograph drug, this product is marketed under the FDA's established rules for sunscreen-containing cosmetics rather than through individual product approval.

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.

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.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
49527-0060-01 You're viewing this Main listing 1 JAR in 1 CARTON / 10 g in 1 JAR 2018-03-01 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
ALMOST powder MAKEUP BROAD SPECTRUM SPF 18 2 g/100g; 1.2 g/100gthis 49527-0060-01 CLINIQUE 1 jar — — 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

🏛️
2018
On the market since
Mar 2018
📍
2026
Currently FDA-listed
8 years listed
🔒
·
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.

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 TR046Y3K1G
    A liquid alcohol derived from petroleum or plant sources. It acts as a solvent and humectant in medicines, helping dissolve active ingredients and retain moisture in the formulation.
  • 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 LMI26O6933
    Alumina is a white powder form of aluminum oxide. It's used as a filler to add bulk to tablets and capsules, and sometimes as a thickening or anti-caking agent in powdered formulations.
  • UNII 47143LT58A
    A synthetic form of vitamin C that acts as an antioxidant. It prevents other ingredients in the medicine from breaking down or discoloring when exposed to air or light.
  • UNII 2U4T60A6YD
    Boron nitride is a synthetic mineral compound. It acts as a glidant and anti-caking agent to improve powder flow and prevent clumping in tablets and capsules.
  • UNII 134647WMX4
    Cetyl ethylhexanoate is a synthetic oil used as an emollient and texture enhancer in medications. It helps soften the skin, improve spreadability, and provides a smooth feel to topical formulations.
  • UNII QBS8A3XZGQ
    A synthetic oil made from diisostearyl alcohol and malic acid. It serves as an emollient and solvent in formulations, helping to dissolve and deliver active ingredients while improving texture and spreadability.
  • UNII 92RU3N3Y1O
    Dimethicone is a silicone-based oil that acts as an anti-foaming agent and lubricant in medicines. It reduces gas bubbles in liquid formulations and helps coat and protect the stomach lining when ingested.
  • 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 XM0M87F357
    A dark iron oxide compound that gives medicines their black or dark color. It's used as a colorant in tablets and capsules to help identify the product and make it visually distinctive.
  • UNII PDC6A3C0OX
    Glycerin is a clear, thick liquid derived from plant oils or fats. It acts as a humectant to retain moisture, a sweetener, and a solvent in medications.
  • UNII YSE9PPT4TH
    Hyaluronate sodium is a natural carbohydrate that holds moisture. It's used in medicines as a lubricant, thickener, and moisture-retaining agent to improve texture and delivery of the active ingredient.
  • UNII Y6O7T4G8P9
    Hydrated silica is a fine powder form of silicon dioxide with absorbed water. It works as an anti-caking agent and absorbent in medicines, helping powders stay free-flowing and preventing clumping.
  • UNII DH37YM1F48
    A synthetic compound combining magnesium, a fatty acid, and an amino acid. Used as a glidant and flow agent to help powder particles move smoothly during tablet manufacturing and filling.
  • UNII 6777U11MKT
    A silicone-based lubricant and anti-foaming agent used to reduce surface tension and prevent foam formation during manufacturing and storage of the medication.
  • 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 446U8J075B
    Nylon-12 is a synthetic plastic polymer used as a coating or film-forming agent in medicines. It helps create a protective barrier around tablets or capsules to control how and when the medicine is released in the body.
  • UNII 2V16EO95H1
    Palmitic acid is a saturated fatty acid derived from plant and animal sources. It serves as an emulsifier and lubricant in medicines, helping ingredients mix smoothly and preventing sticking during manufacturing.
  • UNII I49727TDYF
    Palmitoyl proline is an amino acid derivative created by attaching a fatty acid chain to proline, a naturally occurring amino acid. In medicines, it acts as an emulsifier and skin-conditioning agent, helping to stabilize mixtures and improve how the product spreads or absorbs.
  • UNII 8N725H4EFN
    A plant-derived oily substance made from plant sterols and fatty acids. It acts as an emollient and thickener to improve the texture and spreadability of the medication formulation.
  • UNII ETJ7Z6XBU4
    Silicon dioxide is a naturally occurring mineral used as a glidant and anti-caking agent. It helps powder ingredients flow smoothly and prevents clumping during manufacturing and storage.
  • UNII 8W46YN971G
    Sodium dehydroacetate is a salt derived from dehydroacetic acid, a compound used as a preservative. It helps prevent mold, bacteria, and yeast growth in medicines, extending shelf life and maintaining product safety.
  • UNII 7297LY09YF
    Sodium palmitoyl sarcosinate is a mild, plant-derived detergent used as a surfactant and cleansing agent in topical products. It helps distribute active ingredients evenly and improves the product's ability to penetrate the skin.
  • UNII GW89575KF9
    Squalane is a lightweight oil derived from plant sources or synthesized. It acts as an emollient and lubricant in formulations, helping ingredients blend smoothly and improving product texture and spreadability.
  • UNII KM7N50LOS6
    Tin oxide is an inorganic mineral compound used in medicines as a colorant and opacifying agent. It provides white or off-white color to tablets, capsules, and coatings while helping make formulations less transparent.
  • UNII 7SEV7J4R1U
    A powder made from a naturally occurring mineral. In medicines, talc works as a glidant and anti-caking agent, helping tablets and capsules flow smoothly during manufacturing and preventing clumping.
  • 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 9NH1UDD2RR
    A synthetic silicone polymer that forms a smooth, water-resistant film. Used in topical formulations as a skin protectant coating and to improve product texture and spreadability on the skin.

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

The official label also statestalc•dimethicone•nylon-12•silica•squalane•boron nitride•vinyl dimethicone/methicone silsesquioxane crosspolymer•cetyl ethylhexanoate•diisostearyl malate•phytosteryl/isostearyl/cetyl/stearyl/behenyl dimer dilinoleate•methicone•glycerin•sodium hyaluronate•magnesium palmitoyl glutamate•sodium palmitoyl sarcosinate•palmitoyl proline•alumina•tocopherol•palmitic acid•1,2-hexanediol•hydrated silica•ascorbyl tetraisopalmitate•aluminum hydroxide•tin oxide•sodium dehydroacetate•[+/- mica•iron oxides (ci 77491)•iron oxides (ci 77492)•iron oxides (ci 77499)•titanium dioxide (ci 77891)] [iln45192]

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.

Manufacturer & labeler

LabelerCLINIQUE LABORATORIES LLC
FDA applicationM020 (OTC MONOGRAPH DRUG)
Labeler code49527
First marketedMar 2018
Product typeHuman Otc Drug
Portfolio61 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.

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 📦 Storage and Handling 🧪 Active Ingredient 🧪 Inactive Ingredients 🎯 Purpose 📄 Do Not Use 📄 When Using This Product 📄 Stop Use and Ask a Doctor If 📄 Keep Out of Reach of Children 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 4 words ▾

Use helps prevent sunburn

⏱️ Dosage and Administration 96 words ▾

Directions For sunscreen use: apply liberally 15 minutes before sun exposure reapply at least every two hours use a water resistant sunscreen if swimming or sweating 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 a 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 children under 6 months of age: ask a doctor

⚠️ Warnings 56 words ▾

Warnings For external use only Do not use on damaged or broken skin When using this product keep out of eyes. Rinse with water to remove. Stop use and ask a doctor if rash occurs Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.

📦 Storage and Handling 14 words ▾

Other information protect the product in this container from excessive heat and direct sun

🧪 Active Ingredient 7 words ▾

Active ingredients Octinoxate 2.0% Titanium Dioxide 1.2%

🧪 Inactive Ingredients 37 words ▾

Inactive ingredients talc•dimethicone•nylon-12•silica•squalane•boron nitride•vinyl dimethicone/methicone silsesquioxane crosspolymer•cetyl ethylhexanoate•diisostearyl malate•phytosteryl/isostearyl/cetyl/stearyl/behenyl dimer dilinoleate•methicone•glycerin•sodium hyaluronate•magnesium palmitoyl glutamate•sodium palmitoyl sarcosinate•palmitoyl proline•alumina•tocopherol•palmitic acid•1,2-hexanediol•hydrated silica•ascorbyl tetraisopalmitate•aluminum hydroxide•tin oxide•sodium dehydroacetate•[+/- mica•iron oxides (ci 77491)•iron oxides (ci 77492)•iron oxides (ci 77499)•titanium dioxide (ci 77891)] [iln45192]

🎯 Purpose 2 words ▾

Purpose Sunscreen

📄 Do Not Use 8 words ▾

Do not use on damaged or broken skin

📄 When Using This Product 13 words ▾

When using this product keep out of eyes. Rinse with water to remove.

📄 Stop Use and Ask a Doctor If 9 words ▾

Stop use and ask a doctor if rash occurs

📄 Keep Out of Reach of Children 21 words ▾

Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.

📄 Package Label / Principal Display Panel 35 words ▾

PRINCIPAL DISPLAY PANEL - 10 g Jar Carton 02 neutral fair (VF/MF) CLINIQUE almost powder makeup broad spectrum SPF 18 POIDS NET WT. .35 OZ./10 g e PRINCIPAL DISPLAY PANEL - 10 g Jar Carton

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗

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 form printed on the packaging and shown on DailyMed is the one the FDA registered. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero and the dashes are dropped. The Identity section at the top of this page lists each form of this code.
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 CLINIQUE LABORATORIES LLC. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
CLINIQUE LABORATORIES 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.
← 49527-0056-01 · CLINIQUE 49527-0061-01 · CLINIQUE →
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.