Dynamic Resurfacing SPF 30 AVOBENZONE, OCTINOXATE, and OCTOCRYLENE 10 mg/g; 10 mg/g; 5 mg/g Cream — NDC 65912-0002-50 package photo

Dynamic Resurfacing SPF 30 AVOBENZONE, OCTINOXATE, and OCTOCRYLENE 10 mg/g; 10 mg/g; 5 mg/g Cream

by ELEMIS Limited · 1 JAR in 1 CARTON (65912-002-50) / 50 g in 1 JAR
NDC 65912-0002-50
🏷️ FDA NDC (as labeled) 65912-002-50 billing pads the product segment with a zero
This package
Contains50 g in 1 jar Pack sizes3 compare ↓
OTC On market Non-controlled
🗂️ Data synced Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

🆔 Identity & classification

FDA NDC (as labeled) 65912-002-50
Product NDC 65912-002
11-digit billing NDC 65912000250
UNII G63QQF2NOX, 4Y5P7MUD51, 5A68WGF6WM
Application # M020
SPL Set ID fc64720c-060c-4f33-8c76-96456fac270d
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2018-03-05
Route TOPICAL
Dosage form CREAM
Substance AVOBENZONE; OCTINOXATE; OCTOCRYLENE
Why two NDCs? The FDA registers this code as 65912-002-50 — 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 → 65912-0002-50. 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

LabelerELEMIS Limited
FDA applicationM020 (OTC MONOGRAPH DRUG)
Labeler code65912
First marketedMar 2018
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?

This is a topical cream sunscreen product marketed as an over-the-counter monograph drug. It contains three active ingredients that function as ultraviolet light filters: avobenzone, octinoxate, and octocrylene. These chemical sunscreen agents are typically used to help protect skin from UVA and UVB radiation when applied to exposed skin.

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.

💊 What it looks like

Color white
One label can cover several strengths, so colors may be combined — always confirm a loose pill against the dispensed prescription label or a pharmacist.
Where does this data come from?
Physical description (imprint, shape, color, scoring, coating) from this product’s FDA Structured Product Labeling (SPL), mirrored from DailyMed / openFDA.

🧪 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 9E8X80D2L0
    A synthetic form of vitamin E used as an antioxidant and preservative in medications. It helps prevent the active ingredients from degrading when exposed to oxygen or light.
  • UNII BB4PU4V09H
    A plant-derived gum that acts as a thickener and stabilizer in medications. It helps maintain consistent texture and prevents ingredient separation in liquid or semi-solid formulations.
  • UNII F8XAG1755S
    A plant-derived oil from borage seeds, rich in fatty acids. It's used in formulations as an emollient and skin-conditioning agent to help maintain moisture and improve texture.
  • UNII 3XUS85K0RA
    Butylene glycol is a clear liquid derived from petroleum or plants that acts as a humectant, solvent, and preservative booster in medicines. It helps keep formulations stable, dissolve active ingredients, and maintain moisture in topical products.
  • UNII 936JST6JCN
    Cetyl alcohol is a waxy, fatty substance derived from plant or animal sources. It acts as an emulsifier and thickener in medicines, helping blend oil and water components and giving products a smooth, creamy texture.
  • UNII I670DAL4SZ
    A preservative that fights bacteria and fungi. It keeps medicines and topical products stable and safe from microbial contamination during storage and use.
  • UNII 2968PHW8QP
    A weak organic acid derived from citrus fruits or made through fermentation. It works as a buffer to control pH, a preservative to extend shelf life, and a flavoring agent in medications.
  • UNII 5K6H1IMT3D
    A natural oil extracted from bitter orange (Seville orange) leaf twigs, used as a fragrance and flavoring agent to improve the taste and aroma of oral medicines.
  • UNII 4828G836N6
    A plant-derived oil mixture from coconut that acts as an emollient and solvent. It helps dissolve or carry active ingredients and improves how the medicine spreads or absorbs in topical formulations.
  • UNII B8B45BRU87
    A seaweed-derived ingredient used as a thickener and binder in medicines. It helps create the proper texture and consistency of liquid or semi-solid formulations.
  • UNII 9G1OE216XY
    Docosanol is a waxy, fatty alcohol derived from plant sources. It acts as an emollient and thickener in topical medicines, helping to soften the skin and improve product texture and stability.
  • UNII UXX2N5V39P
    Ecklonia cava is a brown seaweed extract used in medicines as a natural thickening and gelling agent. It helps create the proper texture and consistency in formulations.
  • UNII 7FLD91C86K
    Edetate disodium is a chemical compound that binds and removes certain metal ions. In medicines, it acts as a preservative and stabilizer by preventing metals like calcium from interfering with the product's shelf life and consistency.
  • UNII 7Z8S9VYZ4B
    Ethylcellulose is a plant-derived thickener and film-former made by chemically modifying cellulose. It's used as a binder to hold tablet ingredients together, a coating to control how quickly medicine is released, or a thickener in liquid formulations.
  • UNII C9642I91WL
    Euphrasia stricta is a plant extract, also known as eyebright. It's used in formulations as a natural flavoring agent and to provide mild botanical properties to the medicine.
  • UNII XH37TWY5O4
    Fu Ling is a natural fungal substance used in traditional medicine. In pharmaceuticals, it typically acts as a filler and binder to hold tablet ingredients together and add bulk to the formulation.
  • UNII 37LBZ0E1UE
    A red seaweed extract used as a natural thickener and gelling agent in medicines. It helps create the desired texture and consistency of liquid or semi-solid formulations.
  • 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 ZF94AP8MEY
    Hydrogenated castor oil is a processed plant oil made by adding hydrogen to castor oil. It's used as a binder to help hold tablet ingredients together and as a lubricant to prevent sticking during manufacturing.
  • UNII Q613OCQ44Y
    Isostearyl alcohol is a fatty alcohol derived from plant or petroleum sources. It acts as an emollient and thickener in formulations, helping to soften the product and improve texture and stability.
  • UNII 1DI56QDM62
    A natural fatty substance from soybeans that helps mix oil and water-based ingredients together. It acts as an emulsifier and lubricant in medicines to improve texture and help the product break down properly in your body.
  • UNII C9H2L21V7U
    A fat derived from coconut or palm oil containing shorter fatty acid chains. It serves as a solvent and carrier to help dissolve or suspend active ingredients, improving absorption and stability in liquid formulations.
  • UNII 50D2ZE9219
    A plant extract from lemon balm leaves, used as a flavoring and aromatic ingredient to improve the taste and smell of the medicine.
  • UNII 515MQE449I
    A natural plant extract from mimosa tenuiflora bark, used as a binder or thickening agent to help hold tablet or capsule ingredients together and improve product consistency.
  • UNII U20N87188F
    A plant extract from myrtle leaves used as a natural flavoring agent and preservative in medications. It adds taste and helps protect the medicine from spoilage.
  • UNII A236A06Y32
    Papain is an enzyme derived from papaya fruit. In medicines, it works as a proteolytic agent to help break down proteins and improve the dissolving or absorption of active ingredients in the formulation.
  • UNII HIE492ZZ3T
    Phenoxyethanol is a synthetic preservative and antimicrobial agent used to prevent bacterial and fungal growth in medicines and cosmetic products, extending shelf life and maintaining product safety.
  • UNII 1VPU26JZZ4
    Potassium sorbate is a salt derived from sorbic acid, a naturally occurring preservative. It prevents growth of mold, yeast, and some bacteria, extending the medicine's shelf life.
  • UNII 6DC9Q167V3
    Propylene glycol is a clear liquid derived from petroleum or vegetable sources. It acts as a solvent, humectant, and preservative in medicines, helping dissolve active ingredients and maintain product stability.
  • UNII 9S8867952A
    A plant-derived oil from raspberry seeds used as an emollient and skin-conditioning agent in topical formulations. It helps soften the product texture and improve skin feel.
  • UNII X436TJ4A11
    A seaweed extract used as a thickener and gelling agent. It helps give medicines a smooth texture and can stabilize liquid or semi-solid formulations.
  • UNII K49155WL9Y
    Shea butter is a fat extracted from shea tree nuts. It's used in medicines as an emollient and lubricant to soften the product, improve texture, and help ingredients blend smoothly together.
  • UNII OJ245FE5EU
    Sodium benzoate is a salt derived from benzoic acid, a preservative. It's added to medicines to prevent growth of bacteria, fungi, and other microorganisms that could spoil the product.
  • 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 55X04QC32I
    A strong alkaline chemical used to adjust and maintain the pH balance of liquid medicines. It helps keep the medicine stable and ensures it stays effective during storage.
  • UNII 65A9F4P024
    A synthetic compound derived from the amino acid glutamate and stearic acid. It acts as an emulsifier and surfactant to help mix oil and water-based ingredients, keeping the medicine uniform throughout.
  • UNII 2KR89I4H1Y
    Stearyl alcohol is a waxy, fatty substance derived from natural oils or made synthetically. It acts as an emulsifier and thickener in medicines, helping mix ingredients together and give the product the right texture.
  • UNII 0ZP13EBC5Y
    Subtilisin is a protein enzyme derived from bacteria. It's used in some medicines as a proteolytic agent to help break down proteins and improve ingredient mixing or absorption in the formulation.
  • 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 059QF0KO0R
    Water is a liquid solvent that dissolves and mixes ingredients together in liquid medicines, syrups, and injections. It helps distribute the active drug evenly throughout the product.
  • UNII TTV12P4NEE
    Xanthan gum is a thickening and stabilizing ingredient made from fermented corn or other sugars. It's added to medicines to improve texture, prevent separation of liquids and solids, and help the product stay consistent.

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

The official label also statesWater, Coco-Caprylate, Glycerin, Caprylic/Capric Triglyceride, Cetyl Alcohol, Isostearyl Alcohol, Butylene Glycol, Butylene Glycol Cocoate, Rubus Idaeus (Raspberry) Seed Oil, Phenoxyethanol, Tocopheryl Acetate, Carbomer, Chlorphenesin, Melissa Officinalis Leaf Extract, Propylene Glycol, Sodium Stearoyl Glutamate, Behenyl Alcohol, Ethylcellulose, Lecithin, Xanthan Gum, Butyrospermum Parkii (Shea) Butter, Tocopherol, Papain, Borago Officinalis Seed Oil, Fragrance, Disodium EDTA, Sodium Hydroxide, Sodium Dehydroacetate, Hydrogenated Castor Oil, Stearyl Alcohol, Euphrasia Officinalis Extract, Mimosa Tenuiflora Bark Extract, Protease, Biosaccharide Gum-1, Citric Acid, Codium Tomentosum Extract, Ecklonia Cava Extract, Gelidium Cartilagineum Extract, Hizikia Fusiforme Extract, Myrtus Communis Leaf Extract, Potassium Sorbate, Sodium Benzoate, Subtilisin, Poria Cocos Extract, Citrus Aurantium Amara (Bitter Orange) Leaf/Twig Oil.

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 DailyMedingredient 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.
Try another pack size: 50 g 50 g
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
Pro-Collagen Marine Broad Spectrum SPF 30 10 mg/g; 10 mg/g; 5 mg/g 65912-0001-10 ELEMIS 1 jar FDA listed
Dynamic Resurfacing SPF 30 10 mg/g; 10 mg/g; 5 mg/gthis 65912-0002-50 ELEMIS 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.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
65912-0002-50 You're viewing this 1 JAR in 1 CARTON (65912-002-50) / 50 g in 1 JAR 2018-03-05 Active
65912-0002-51 50 g in 1 JAR (65912-002-51) 2018-03-05 Active
65912-0002-52 50 g in 1 JAR (65912-002-52) 2018-03-05 Active

Pack size FAQ

What quantity is in NDC 65912-0002-50?
NDC 65912-0002-50 is listed by the FDA — 1 jar in 1 carton / 50 g in 1 jar.
What NDC number is used to bill for this package of Dynamic Resurfacing SPF 30 AVOBENZONE, OCTINOXATE, and OCTOCRYLENE 10 mg/g; 10 mg/g; 5 mg/g Cream?
Bill NDC 65912-0002-50 — the 11-digit billing format is 65912000250. 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 65912-002-50, 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: 65912-0002-50, written without dashes as 65912000250. 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 65912-0002-50, the first segment (65912) is the labeler code FDA assigned to ELEMIS Limited; the middle segment (0002) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (50) 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 ELEMIS Limited. 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 2 other package presentations of this same product, including 50 g (65912-0002-51), 50 g (65912-0002-52). 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?
ELEMIS Limited 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 10 words

Uses helps prevent sunburn higher SPF gives more sunburn protection

⏱️ Dosage and Administration 98 words

Directions apply liberally and evenly 15 minutes before sun exposure and as needed children under 6 months of age: Ask a doctor Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin ageing. 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 reapply at least every 2 hours use a water resistant sunscreen if swimming or sweating

⚠️ Warnings 54 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.

📦 Storage and Handling 14 words

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

🧪 Active Ingredient 11 words

Active ingredients Avobenzone 1.0% } Octinoxate 1.0% } Octocrylene 0.5% }

🧪 Inactive Ingredients 106 words

Inactive ingredients Water, Coco-Caprylate, Glycerin, Caprylic/Capric Triglyceride, Cetyl Alcohol, Isostearyl Alcohol, Butylene Glycol, Butylene Glycol Cocoate, Rubus Idaeus (Raspberry) Seed Oil, Phenoxyethanol, Tocopheryl Acetate, Carbomer, Chlorphenesin, Melissa Officinalis Leaf Extract, Propylene Glycol, Sodium Stearoyl Glutamate, Behenyl Alcohol, Ethylcellulose, Lecithin, Xanthan Gum, Butyrospermum Parkii (Shea) Butter, Tocopherol, Papain, Borago Officinalis Seed Oil, Fragrance, Disodium EDTA, Sodium Hydroxide, Sodium Dehydroacetate, Hydrogenated Castor Oil, Stearyl Alcohol, Euphrasia Officinalis Extract, Mimosa Tenuiflora Bark Extract, Protease, Biosaccharide Gum-1, Citric Acid, Codium Tomentosum Extract, Ecklonia Cava Extract, Gelidium Cartilagineum Extract, Hizikia Fusiforme Extract, Myrtus Communis Leaf Extract, Potassium Sorbate, Sodium Benzoate, Subtilisin, Poria Cocos Extract, Citrus Aurantium Amara (Bitter Orange) Leaf/Twig Oil.

🎯 Purpose 2 words

Purpose Sunscreen

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