Home › NDC Lookup › Ingredients › Octinoxate, Octisalate, Titanium Dioxide... › 10345-0910-15
ERBORIAN - CC CREME HIGH DEFINITION SPF 25 OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE, ZINC OXIDE 20 mg/mL; 60 mg/mL; 49.7 mg/mL; 19.2 mg/mL Cream — NDC 10345-0910-15 package photo

ERBORIAN - CC CREME HIGH DEFINITION SPF 25 OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE, ZINC OXIDE 20 mg/mL; 60 mg/mL; 49.7 mg/mL; 19.2 mg/mL Cream

by LABORATOIRES M&L · 1 TUBE in 1 BOX (10345-910-15) / 15 mL in 1 TUBE
NDC 10345-0910-15
🏷️ FDA NDC (as labeled) 10345-910-15 billing pads the product segment with a zero
This package
Contains15 mL in 1 tube Pack sizes4 compare ↓
Also comes in: 5 mL 10345-0910-05 45 mL 10345-0910-45 1.5 ml 10345-0910-01
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) 10345-910-15
Product NDC 10345-910
11-digit billing NDC 10345091015
UNII 4X49Y0596W, 4Y5P7MUD51, 15FIX9V2JP, SOI2LOH54Z
UPC 8809255783940
Application # M020
SPL Set ID 41b3cf18-dc11-4e1d-802e-5ba25bd87adb
Established class (EPC) Copper Absorption Inhibitor
Physiologic effect Decreased Copper Ion Absorption
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2015-02-06
Route TOPICAL
Dosage form CREAM
Substance OCTISALATE; OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE
Why two NDCs? The FDA registers this code as 10345-910-15 — 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 → 10345-0910-15. 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

LabelerLABORATOIRES M&L
FDA applicationM020 (OTC MONOGRAPH DRUG)
Labeler code10345
First marketedFeb 2015
Product typeHuman Otc Drug
Portfolio15 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?

This is a topical cream marketed as an OTC monograph sunscreen product with SPF 25. The active ingredients are four mineral UV filters (octinoxate, octisalate, titanium dioxide, and zinc oxide) that work together to reflect and absorb ultraviolet radiation from the sun. Products containing these ingredients are typically used to help protect skin from sunburn and UV exposure when applied to exposed areas before sun exposure. The cream also contains other ingredients common to cosmetic foundations and tinted moisturizers.

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.

From the label’s inactive-ingredient sectionAqua/water - cyclomethicone - dipropylene glycol - glycerin - peg-10 dimethicone - methyl trimethicone - C12-15 alkyl benzoate - dimethicone - CI 77492/iron oxides - disteardimonium hectorite - magnesium sulfate - vinyl dimethicone /methicone silsesquioxane crosspolymer - centella asiatica extract - mel/honey extract - mica - talc - trihydroxystearin - butylene glycol - polyester-1 - aluminum hydroxide - silica dimethyl silylate - palmitic acid - stearic acid - tocopheryl acetate - ethylhexylglycerin - phenoxyethanol - methicone - dimethicone/vinyl imethicone crosspolymer - parfum/fragrance - hexyl cinnamal - alpha-isomethyl ionone - linalool - citronellol - geraniol - eugenol - limonene - CI 77491/iron oxides - CI 77499/iron oxides qua/water - cyclomethicone - dipropylene glycol - glycerin - peg-10 dimethicone - methyl trimethicone - C12-15 alkyl benzoate - dimethicone - disteardimonium hectorite - magnesium sulfate - vinyl dimethicone/methicone silsesquiocane crosspolymer - centella asiatica extract - mel/honey extract - talc - dimethicone/vinyl dimethicone crosspolymer - phenoxyethanol - ethylhexylglycerin - trihydroxystearn - butylene glycol - mica - aluminum hydroxide - palmitic acid - stearicacid - polyester-1 - silica dimethyl silyate - tocopheryl acetate - methicone - tocopherol - parfum/fragrance - hexyl cinnamal - alpha-isomethyl ionone - linalool - citronellol - geraniol - eugenol - limonene - CI 77492/iron oxides - CI 77491/Iron oxides - CI77499/iron oxides

This is label-wide narrative text, not a normalized exact-product ingredient list. A label can cover multiple strengths or packages.

Where does this data come from?
Source: official FDA Structured Product Labeling (SPL) via DailyMed and the openFDA label index. Structured IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.

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.
Try another pack size: 5 mL 45 mL 1.5 ml
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
Erborian - Cc Creme High Definition Spf 25 20 mg/mL; 60 mg/mL; 49.7 mg/mL; 19.2 mg/mLthis 10345-0910-15 LABORATOIRES 1 tube — — 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

🏛️
2015
On the market since
Feb 2015
📍
2026
Currently FDA-listed
11 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.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
10345-0910-01 1.5 mL in 1 PACKET (10345-910-01) 2017-12-03 Active
10345-0910-05 1 TUBE in 1 BOX (10345-910-05) / 5 mL in 1 TUBE 2018-07-01 Active
10345-0910-15 You're viewing this 1 TUBE in 1 BOX (10345-910-15) / 15 mL in 1 TUBE 2015-02-06 Active
10345-0910-45 1 TUBE in 1 BOX (10345-910-45) / 45 mL in 1 TUBE 2015-02-06 Active

Pack size FAQ

What quantity is in NDC 10345-0910-15?
NDC 10345-0910-15 is listed by the FDA — 1 tube in 1 box / 15 ml in 1 tube.
What NDC number is used to bill for this package of ERBORIAN - CC CREME HIGH DEFINITION SPF 25 OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE, ZINC OXIDE 20 mg/mL; 60 mg/mL; 49.7 mg/mL; 19.2 mg/mL Cream?
Bill NDC 10345-0910-15 — the 11-digit billing format is 10345091015. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

🧭 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 10345-910-15, 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: 10345-0910-15, written without dashes as 10345091015. 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 10345-0910-15, the first segment (10345) is the labeler code FDA assigned to LABORATOIRES M&L; the middle segment (0910) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (15) 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 LABORATOIRES M&L. Listing status can change — the directory data on this page refreshes weekly.
Does this product come in other package sizes?
Yes — the FDA directory lists 3 other package presentations of this same product, including 1 tube (10345-0910-05), 1 tube (10345-0910-45), 1.5 ml (10345-0910-01). Each has its own NDC and its own page — see the package list near the top of this page.
Who lists this product with the FDA?
LABORATOIRES M&L 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 59 words ▾

Uses Helps prevent sunburn If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun

​Uses Helps prevent sunburn if used as directed with other sun protection measures [ see ​Directions ​], decreases the risk of skin cancer andearly skin aging caused by the sun

⏱️ Dosage and Administration 179 words ▾

Directions For sunscreen use: Apply liberally 15 minutes before sun exposure Reapply at least every 2 hours Use a water resistant sunscreen if swimming or sweating SunProtectionMeasures. Spending time in the sun increases your riskofskincancerandearlyskinaging. Todecreasethisrisk, 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

​Directions For sunscreen use: Apply liberally 15 minutes before sun exposure. Reapply at least every 2 hours Use a water resistant sunscreen if swimming or sweating Sun Protection Meausres. Spending time in the sun incerases 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 108 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 swallowed, get medical help or contact a Poison Control Center right away

​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 swallowed, get medical help or contact a Poison Control Center right away.

🧪 Active Ingredient 40 words ▾

Active ingredients Ethylhexyl methoxycinnamate / Octinoxate 6.00% Ethylhexyl salicylate / Octisalate 2.00% Titanium dioxide 4.97% Zinc oxide 1.92% Purpose Sunscreen

​Active ingredients Ethylhexyl methoxycinnamate / Octinoxte 6.00% Ethylhexyl salicylate / Octisalate 2.00% Titanium Dioxide 4.33% Zinc oxide 1.92% ​Purpose Sunscreen

🧪 Inactive Ingredients 215 words ▾

Inactive ingredients Aqua/water - cyclomethicone - dipropylene glycol - glycerin - peg-10 dimethicone - methyl trimethicone - C12-15 alkyl benzoate - dimethicone - CI 77492/iron oxides - disteardimonium hectorite - magnesium sulfate - vinyl dimethicone /methicone silsesquioxane crosspolymer - centella asiatica extract - mel/honey extract - mica - talc - trihydroxystearin - butylene glycol - polyester-1 - aluminum hydroxide - silica dimethyl silylate - palmitic acid - stearic acid - tocopheryl acetate - ethylhexylglycerin - phenoxyethanol - methicone - dimethicone/vinyl imethicone crosspolymer - parfum/fragrance - hexyl cinnamal - alpha-isomethyl ionone - linalool - citronellol - geraniol - eugenol - limonene - CI 77491/iron oxides - CI 77499/iron oxides

​Inactive ingredients qua/water - cyclomethicone - dipropylene glycol - glycerin - peg-10 dimethicone - methyl trimethicone - C12-15 alkyl benzoate - dimethicone - disteardimonium hectorite - magnesium sulfate - vinyl dimethicone/methicone silsesquiocane crosspolymer - centella asiatica extract - mel/honey extract - talc - dimethicone/vinyl dimethicone crosspolymer - phenoxyethanol - ethylhexylglycerin - trihydroxystearn - butylene glycol - mica - aluminum hydroxide - palmitic acid - stearicacid - polyester-1 - silica dimethyl silyate - tocopheryl acetate - methicone - tocopherol - parfum/fragrance - hexyl cinnamal - alpha-isomethyl ionone - linalool - citronellol - geraniol - eugenol - limonene - CI 77492/iron oxides - CI 77491/Iron oxides - CI77499/iron oxides

🎯 Purpose 4 words ▾

Purpose Sunscreen

​Purpose Sunscreen

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 10345-0904-45 · LABORATOIRES 10345-0911-01 · LABORATOIRES →
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.