AGE20S SIGNATURE ESSENCE PACT INTENSE COVER 21N Octinoxate, Octocrylene, Titanium Dioxide .42 g/14g; .7186 g/14g; .91 g/14g Cream — NDC 67225-5218-03 package photo

AGE20S SIGNATURE ESSENCE PACT INTENSE COVER 21N Octinoxate, Octocrylene, Titanium Dioxide .42 g/14g; .7186 g/14g; .91 g/14g Cream

by Aekyung Industrial Co., Ltd. · 2 CASE in 1 BOX (67225-5218-3) / 14 g in 1 CASE (67225-5218-1)
NDC 67225-5218-03
🏷️ FDA NDC (as labeled) 67225-5218-3 billing pads the package segment with a zero
This package
Contains14 g in 1 case Pack sizes2 compare ↓
Also comes in: 14 g 67225-5218-02
OTC On market Non-controlled
🗂️ Data synced Aug 27, 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) 67225-5218-3
Product NDC 67225-5218
11-digit billing NDC 67225521803
UNII 5A68WGF6WM, 15FIX9V2JP, 4Y5P7MUD51
Application # M020
SPL Set ID ebcc2c6c-a039-48d5-8c1c-5b347254c4c2
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2025-08-13
Route TOPICAL
Dosage form CREAM
Substance OCTOCRYLENE; TITANIUM DIOXIDE; OCTINOXATE
Why two NDCs? The FDA registers this code as 67225-5218-3 — a 5-4-1 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 package segment → 67225-5218-03. 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

LabelerAekyung Industrial Co., Ltd.
FDA applicationM020 (OTC MONOGRAPH DRUG)
Labeler code67225
First marketedAug 2025
Product typeHuman Otc Drug
Portfolio64 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 an over-the-counter topical cream marketed as a cosmetic product with sun protection. The three active ingredients, octinoxate, octocrylene, and titanium dioxide, are ultraviolet (UV) filters commonly used in sunscreens and tinted cosmetics to help protect skin from sun exposure. Octinoxate and octocrylene are chemical UV absorbers, while titanium dioxide is a mineral UV reflectant. This product is an OTC monograph drug, meaning it follows FDA's established rules for sunscreen ingredients rather than undergoing individual product approval.

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 A7E6112E4N
    A form of vitamin E used as an antioxidant in medicines. It prevents oils and fats in the product from breaking down, helping maintain stability and shelf life.
  • 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 K72T3FS567
    Adenosine is a naturally occurring nucleoside compound. In medicines, it functions as an active pharmaceutical ingredient in some formulations, though when listed as an excipient it may serve as a buffering or stabilizing agent to maintain product stability and pH.
  • UNII ZY81Z83H0X
    Aloe vera leaf is a plant extract derived from the aloe plant. It is used in medicines as a natural moisturizer and skin-soothing agent in topical formulations.
  • 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 8XPW32PR7I
    Astaxanthin is a reddish pigment from algae and other organisms, used in medicines as a colorant and antioxidant to maintain product stability and appearance during storage.
  • UNII ZF70YKN0YO
    A natural plant extract from birch bark used in formulations as a binder and thickening agent. It helps hold ingredients together and improve the texture and consistency of the medicine.
  • UNII 1B33PG6N4K
    A plant resin derived from Japanese white birch bark. It acts as a binder and film-former in tablets and capsules, helping hold ingredients together and create protective coatings on medication surfaces.
  • UNII 1P9D0Z171K
    BHT is a synthetic antioxidant that prevents fats and oils in medicines from breaking down and becoming rancid. It helps keep the product stable and effective during storage.
  • 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 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 NFX970DSI2
    A silicone-based lubricant made from long-chain alkyl groups attached to silicone. It reduces friction and helps the medicine flow smoothly during manufacturing and tablet compression.
  • UNII 6DWD51M0O8
    A synthetic oil made from long-chain hydrocarbons derived from petroleum. It acts as a lubricant and glidant to help powder particles flow smoothly during tablet manufacturing and packaging.
  • UNII 4370DF050B
    Ceramide NP is a waxy, lipid-based substance that mimics natural skin oils. It's used in topical formulations as an emollient and skin-conditioning agent to help soften, smooth, and protect the skin barrier.
  • UNII V2W71V8T0X
    A silicone-based compound that mixes oil and water together. Used in formulations as an emulsifier to help blend ingredients and improve texture and stability of creams, lotions, and other topical products.
  • 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 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 21AS8B1BSS
    A silicone-based ingredient that combines dimethicone (silicone oil) with polyethylene glycol. It works as a skin-conditioning agent and texture enhancer, helping smooth the product's feel and improve how it spreads on skin.
  • UNII E107L85C40
    Dipropylene glycol is a clear liquid made from propylene glycol. It acts as a solvent and humectant in medicines, helping dissolve active ingredients and retain moisture in the formulation.
  • UNII WL0328HX19
    A natural plant-based wax derived from candelilla shrub leaves. It acts as a coating agent, hardener, and texture modifier to control how quickly the medicine releases and to improve the tablet or capsule's appearance and stability.
  • 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 TM2TZD4G4A
    A plant-derived oily substance used as an emulsifier and solubilizer in medicines. It helps blend water and oil-based ingredients together and improves how the body absorbs certain active drugs.
  • UNII 31T0FF0472
    A red microalgae used as a natural colorant and source of astaxanthin pigment in medications and supplements. It adds color to tablets and capsules.
  • UNII S270N0TRQY
    Hyaluronic acid is a naturally occurring substance found in skin and joints. In medicines, it acts as a moisturizer and thickening agent to improve texture and help the product spread smoothly.
  • UNII P0TX083987
    A synthetic oil made from hydrogenated plant-derived hydrocarbons, used as a lubricant and glidant to help powder particles flow smoothly during tablet or capsule manufacturing and to prevent sticking.
  • UNII W60VYE24XC
    A synthetic oily compound used as an emollient and solvent in topical medicines. It helps soften the skin, improve product spreadability, and dissolve active ingredients for better absorption through the skin.
  • UNII A8289P68Y2
    Isododecane is a lightweight liquid hydrocarbon used as a solvent and spreadability agent in topical formulations. It helps dissolve active ingredients and makes the product easier to apply and absorb into the skin.
  • UNII BQX4W45LG8
    A beneficial bacterium used as a probiotic ingredient. It helps maintain the medicine's stability and viability during storage and may support the product's intended health benefits through fermentation.
  • UNII 9KJL21T0QJ
    Linoleic acid is an omega-6 fatty acid derived from plant oils. It serves as an emulsifier and skin conditioning agent in topical formulations, helping ingredients mix smoothly and improving product texture.
  • UNII EG97988M5Q
    A synthetic plastic polymer that forms a three-dimensional network. It's used as a coating on tablets and capsules to control how fast the medicine releases into the body, or as a binder to hold pill ingredients together.
  • UNII 25X51I8RD4
    Niacinamide is a form of vitamin B3, a water-soluble nutrient. In medicines, it may be added as a nutritional supplement or to support skin health, though its primary role here is as an active ingredient rather than a traditional inactive filler.
  • UNII 4SB6Y7DMM3
    P-anisic acid is an organic compound derived from anise or synthesized chemically. It functions as a preservative and pH buffer in medicines, helping maintain product stability and prevent microbial growth.
  • UNII WV9CM0O67Z
    Panthenol is a humectant and skin-conditioning agent derived from pantothenic acid. It's added to medicines to help retain moisture and soothe skin irritation.
  • UNII 255PIF62MS
    A synthetic antioxidant compound used to prevent oils and fats in medications from breaking down or becoming rancid during storage. It helps maintain the medicine's stability and shelf life.
  • UNII DR0K5NOJ4R
    Phenyl trimethicone is a silicone-based lubricant and glidant. It helps powder particles flow smoothly and reduces friction during tablet or capsule manufacturing and filling.
  • UNII YXH47AOU0F
    A synthetic fatty acid used as a thickener and stabilizer in medicines. It helps create the right texture and prevents separation of ingredients in liquid or semi-solid formulations.
  • UNII Z570VEV8XK
    A synthetic silicone polymer used as a glidant and anti-caking agent. It reduces friction between particles so the medicine flows smoothly during manufacturing and remains free-flowing in the bottle.
  • UNII 5965N8W85T
    Propanediol is a clear liquid organic compound derived from vegetable sources or synthesized chemically. It acts as a humectant to retain moisture, a solvent to dissolve active ingredients, and a preservative booster in liquid medications and supplements.
  • 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 1Q73Q2JULR
    Sodium citrate is a salt derived from citric acid. It works as a buffer to maintain the medicine's pH level and may also help improve taste or act as a preservative in the formulation.
  • UNII W81N5U6R6U
    Sodium glutamate is a salt form of glutamic acid, a naturally occurring amino acid. It serves as a flavor enhancer and pH buffer in medications, helping to improve taste and maintain chemical stability.
  • 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 4ELV7Z65AP
    Stearic acid is a fatty acid derived from plant or animal sources. It acts as a binder and lubricant in tablets and capsules, helping them hold together and flow smoothly during manufacturing.
  • UNII 2M4UGL1NCN
    Stearyl heptanoate is a waxy ester made by combining stearyl alcohol and heptanoic acid. It's used in medicines as a lubricant and thickening agent to improve texture and help the product flow smoothly during manufacturing.
  • 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 71503RH8KG
    Triisostearin is a waxy fat derived from stearic acid. It acts as a binder and hardening agent in tablets and capsules, helping hold ingredients together and control how quickly the medicine dissolves.
  • UNII KFR5QEN0N9
    A synthetic plastic polymer that helps form a protective film coating on the medicine. It's used as a binder and film-former to hold the tablet or capsule together and control how quickly the drug dissolves.
  • 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.

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

The official label also statesWATER (AQUA), ETHYLHEXYL METHOXYCINNAMATE, TITANIUM DIOXIDE (NANO), BETULA PLATYPHYLLA JAPONICA JUICE, DIPROPYLENE GLYCOL PENTAERYTHRITYL STEARATE/CAPRATE/CAPRYLATE/ADIPATE, HYDROGENATED POLY(C6-14 OLEFIN), OCTOCRYLENE, PHENYL TRIMETHICONE NIACINAMIDE, EUPHORBIA CERIFERA (CANDELILLA) WAX, DIMETHICONE, BUTYLENE GLYCOL, ALOE BARBADENSIS LEAF EXTRACT, TRIISOSTEARIN, 1,2-HEXANEDIOL, DISODODECANE, POLYMETHYLSILSESQUIOXANE, ISODECYL NEOPENTANOATE, PROPANEDIOL, VP/HEXADECENE COPOLYMER, ALUMINUM HYDROXIDE, CETYL PEG/PPG-10/1 DIMETHICONE, SODIUM GLUTAMATE, C30-45 ALKYL METHICONE, STEARIC ACID, P-ANISIC ACID, DIMETHICONE/PEG-10/15 CROSSPOLYMER, C30-45 OLEFIN, GLYCERYL CAPRYLATE, BETULA PLATYPHYLLA JAPONICA BARK EXTRACT, GLYCERIN, TRIETHOXYCAPRYLYLSILANE, PANTHENOL, TOCOPHERYL ACETATE, CERAMIDE NP, METHYL METHACRYLATE CROSSPOLYMER, STEARYL HEPTANOATE, ADENOSINE, SILICA, HYDROLYZED HYALURONIC ACID, POLYHYDROXYSTEARIC ACID, SODIUM HYALURONATE, LACTOBACILLUS FERMENT LYSATE, HAEMATOCOCCUS PLUVIALIS EXTRACT, LINOLEIC ACID, BHT, SODIUM CITRATE, BORON NITRIDE, ASTAXANTHIN, PENTAERYTHRITYL TETRA-DI-T-BUTYL, YDROXYHYDROCINNAMATE, TOCOPHEROL, APHANOTHECE SACRUM POLYSACCHARIDE, FRAGRANCE (PARFUM), Titanium Dioxide(CI 77891), IRON OXIDES (CI 77492), IRON OXIDES (CI 77491), IRON OXIDES (CI 77499)

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: 14 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
Age20S Signature Essence Pact Intense Cover 21W .42 g/14g; .7186 g/14g; .91 g/14g 67225-5202-02 Aekyung 14 g FDA listed
Age20S Signature Essence Pact Intense Cover 31N .42 g/14g; .7186 g/14g; .91 g/14g 67225-5214-02 Aekyung 14 g FDA listed
Age20S Signature Essence Pact Intense Cover 25N .42 g/14g; .7186 g/14g; .91 g/14g 67225-5217-02 Aekyung 14 g FDA listed
Age20S Signature Essence Pact Intense Cover 41N .42 g/14g; .7186 g/14g; .91 g/14g 67225-5209-02 Aekyung 14 g FDA listed
Age20S Signature Essence Pact Intense Cover 19C .42 g/14g; .7186 g/14g; .91 g/14g 67225-5220-02 Aekyung 14 g FDA listed
Age20S Signature Essence Pact Intense Cover 15C .42 g/14g; .7186 g/14g; .91 g/14g 67225-5203-02 Aekyung 14 g FDA listed
Age20S Signature Essence Pact Intense Cover 29W .42 g/14g; .7186 g/14g; .91 g/14g 67225-5208-02 Aekyung 14 g FDA listed
Age20S Signature Essence Pact Intense Cover 35N .42 g/14g; .7186 g/14g; .91 g/14g 67225-5210-02 Aekyung 14 g FDA listed
Age20S Signature Essence Pact Intense Cover 23W .42 g/14g; .7186 g/14g; .91 g/14g 67225-5219-02 Aekyung 14 g FDA listed
Age20S Signature Essence Pact Intense Cover 13C .42 g/14g; .7186 g/14g; .91 g/14g 67225-5221-02 Aekyung 14 g FDA listed
Age20S Signature Essence Pact Intense Cover 47N .42 g/14g; .7186 g/14g; .91 g/14g 67225-5212-02 Aekyung 14 g FDA listed
Age20S Signature Essence Pact Intense Cover 33W .42 g/14g; .7186 g/14g; .91 g/14g 67225-5213-02 Aekyung 14 g FDA listed
Age20S Signature Essence Pact Intense Cover 27W .42 g/14g; .7186 g/14g; .91 g/14g 67225-5215-02 Aekyung 14 g FDA listed
Age20S Signature Essence Pact Intense Cover 27C .42 g/14g; .7186 g/14g; .91 g/14g 67225-5205-02 Aekyung 14 g FDA listed
Age20S Signature Essence Pact Intense Cover 24W .42 g/14g; .7186 g/14g; .91 g/14g 67225-5204-02 Aekyung 14 g FDA listed
Age20S Signature Essence Pact Intense Cover 29C .42 g/14g; .7186 g/14g; .91 g/14g 67225-5216-02 Aekyung 14 g FDA listed
Age20S Signature Essence Pact Intense Cover 28N .42 g/14g; .7186 g/14g; .91 g/14g 67225-5206-02 Aekyung 14 g FDA listed
Age20S Signature Essence Pact Intense Cover 33N .42 g/14g; .7186 g/14g; .91 g/14g 67225-5207-02 Aekyung 14 g FDA listed
Age20S Signature Essence Pact Intense Cover 21N .42 g/14g; .7186 g/14g; .91 g/14gthis 67225-5218-03 Aekyung 14 g 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

🏛️
2025
On the market since
Aug 2025
📍
2026
Currently FDA-listed
1 year 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
67225-5218-02 1 CASE in 1 PACKAGE (67225-5218-2) / 14 g in 1 CASE (67225-5218-1) 2025-08-13 Active
67225-5218-03 You're viewing this 2 CASE in 1 BOX (67225-5218-3) / 14 g in 1 CASE (67225-5218-1) 2026-01-21 Active

Pack size FAQ

What quantity is in NDC 67225-5218-03?
NDC 67225-5218-03 is listed by the FDA — 2 case in 1 box / 14 g in 1 case.
What NDC number is used to bill for this package of AGE20S SIGNATURE ESSENCE PACT INTENSE COVER 21N Octinoxate, Octocrylene, Titanium Dioxide .42 g/14g; .7186 g/14g; .91 g/14g Cream?
Bill NDC 67225-5218-03 — the 11-digit billing format is 67225521803. 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 67225-5218-3, 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: 67225-5218-03, written without dashes as 67225521803. 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 67225-5218-03, the first segment (67225) is the labeler code FDA assigned to Aekyung Industrial Co., Ltd.; the middle segment (5218) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (03) 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 Aekyung Industrial Co., Ltd.. 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 1 other package presentation of this same product, including 14 g (67225-5218-02). 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?
Aekyung Industrial Co., Ltd. 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 30 words

■ 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.

⏱️ Dosage and Administration 98 words

Directions ■ Apply liberally 15 minutes before sun exposure. ■ Children under 6 months of age: Ask a doctor. ■ Reapply at least every 2 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. Todecrease 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.

⚠️ Warnings 4 words

For external use only

🧪 Active Ingredient 7 words

Octinoxate 6.50% Octocrylene 3.00% Titanium Dioxide 5.12%

🧪 Inactive Ingredients 126 words

WATER (AQUA), ETHYLHEXYL METHOXYCINNAMATE, TITANIUM DIOXIDE (NANO), BETULA PLATYPHYLLA JAPONICA JUICE, DIPROPYLENE GLYCOL PENTAERYTHRITYL STEARATE/CAPRATE/CAPRYLATE/ADIPATE, HYDROGENATED POLY(C6-14 OLEFIN), OCTOCRYLENE, PHENYL TRIMETHICONE NIACINAMIDE, EUPHORBIA CERIFERA (CANDELILLA) WAX, DIMETHICONE, BUTYLENE GLYCOL, ALOE BARBADENSIS LEAF EXTRACT, TRIISOSTEARIN, 1,2-HEXANEDIOL, DISODODECANE, POLYMETHYLSILSESQUIOXANE, ISODECYL NEOPENTANOATE, PROPANEDIOL, VP/HEXADECENE COPOLYMER, ALUMINUM HYDROXIDE, CETYL PEG/PPG-10/1 DIMETHICONE, SODIUM GLUTAMATE, C30-45 ALKYL METHICONE, STEARIC ACID, P-ANISIC ACID, DIMETHICONE/PEG-10/15 CROSSPOLYMER, C30-45 OLEFIN, GLYCERYL CAPRYLATE, BETULA PLATYPHYLLA JAPONICA BARK EXTRACT, GLYCERIN, TRIETHOXYCAPRYLYLSILANE, PANTHENOL, TOCOPHERYL ACETATE, CERAMIDE NP, METHYL METHACRYLATE CROSSPOLYMER, STEARYL HEPTANOATE, ADENOSINE, SILICA, HYDROLYZED HYALURONIC ACID, POLYHYDROXYSTEARIC ACID, SODIUM HYALURONATE, LACTOBACILLUS FERMENT LYSATE, HAEMATOCOCCUS PLUVIALIS EXTRACT, LINOLEIC ACID, BHT, SODIUM CITRATE, BORON NITRIDE, ASTAXANTHIN, PENTAERYTHRITYL TETRA-DI-T-BUTYL, YDROXYHYDROCINNAMATE, TOCOPHEROL, APHANOTHECE SACRUM POLYSACCHARIDE, FRAGRANCE (PARFUM), Titanium Dioxide(CI 77891), IRON OXIDES (CI 77492), IRON OXIDES (CI 77491), IRON OXIDES (CI 77499)

🎯 Purpose 1 words

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.