Home › NDC Lookup › Ingredients › Avobenzone Homosalate Octisalate › 68577-0288-00
SOFIE PAVITT FACE SPF 30 AVOBENZONE, HOMOSALATE, OCTISALATE 3 g/100mL; 5 g/100mL; 7 g/100mL Cream — NDC 68577-0288-00 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

SOFIE PAVITT FACE SPF 30 AVOBENZONE, HOMOSALATE, OCTISALATE 3 g/100mL; 5 g/100mL; 7 g/100mL Cream — NDC 68577-288-00 (Billing 68577-0288-00)

by COSMAX USA., CORP · 1 BOTTLE, PUMP in 1 CARTON / 50 mL in 1 BOTTLE, PUMP

This is a package of SOFIE PAVITT FACE SPF 30 AVOBENZONE, HOMOSALATE, OCTISALATE 3 g/100mL; 5 g/100mL; 7 g/100mL Cream from COSMAX USA., CORP, marketed since Feb 2026 and currently FDA-listed. It is this product's only package size.

NDC 68577-0288-00
🏷️ FDA NDC (as labeled) 68577-288-00 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 Aug 27, 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

NDC database record

One package, one record: these facts belong to NDC 68577-288-00 alone.

Record
FDA NDC Directory package listing · Human OTC drug
Code segments
68577 labeler · 288 product · 00 package
Package marketed since
Feb 28, 2026
Sample package
No — commercial package
Listing certified through
Dec 31, 2027
Barcode (UPC-A, from the NDC)
3 6857728800 0
FDA record last changed
Aug 27, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 68577-288-00
Product NDC 68577-288
11-digit billing NDC 68577028800
UNII G63QQF2NOX, 4X49Y0596W, V06SV4M95S
Application # M020
SPL Set ID 564ae5d2-1504-9623-e063-6394a90a2fa5
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2026-02-28
Route TOPICAL
Dosage form CREAM
Substance AVOBENZONE; OCTISALATE; HOMOSALATE
Why two NDCs? The FDA registers this code as 68577-288-00 — 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 → 68577-0288-00. 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 topical cream sunscreen containing three UV-filtering ingredients: avobenzone, homosalate, and octisalate. These active ingredients are commonly used together in sunscreen products to absorb and scatter ultraviolet radiation from the sun. The cream is formulated to provide broad-spectrum UV protection when applied to the skin. This product is marketed as an over-the-counter monograph drug, meaning it follows FDA's established guidelines for sunscreen ingredients and formulations.

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
68577-0288-00 You're viewing this Main listing 1 BOTTLE, PUMP in 1 CARTON / 50 mL in 1 BOTTLE, PUMP 2026-02-28 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Sofie Pavitt Face Spf 30 3 g/100mL; 5 g/100mL; 7 g/100mL 68577-0290-00 COSMAX 1 tube — — FDA listed —
Sofie Pavitt Face Spf 30 3 g/100mL; 5 g/100mL; 7 g/100mLthis 68577-0288-00 COSMAX 1 bottle — — FDA listed —
About this product: other versions of the same ingredient, strength and form are listed above, least expensive first, with FDA equivalence ratings where available.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

Availability & generic status

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

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

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

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 344S277G0Z
    Allantoin is a naturally derived compound that helps soften and soothe skin. In medicines, it works as a skin-conditioning agent and may help support wound healing and reduce irritation in topical formulations.
  • UNII 24WE03BX2T
    Levomenol is a naturally derived alcohol compound used as a skin-conditioning and anti-inflammatory agent in topical formulations. It helps soothe and protect the skin while improving product texture and absorption.
  • UNII 2EH13UN8D3
    A synthetic compound used as a solvent and penetration enhancer in topical formulations. It helps dissolve active ingredients and allows them to penetrate the skin more effectively.
  • UNII A9EJ3J61HQ
    A synthetic liquid derived from benzoic acid and long-chain alcohols. It functions as a solvent and penetration enhancer in topical formulations, helping active ingredients dissolve and absorb into the skin.
  • UNII 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 K48IKT5321
    A plant extract from clove buds used as a flavoring agent and natural fragrance in medications. It adds taste and aroma to improve how the medicine smells and tastes.
  • UNII 7GXZ3858RY
    Ectoine is a naturally derived protective compound used in pharmaceuticals as a stabilizer and humectant. It helps preserve the integrity of active ingredients and maintain moisture in formulations.
  • UNII S3KFG6Q5X8
    An organic chemical compound used as a UV filter in topical formulations. It helps protect the medicine or product from degradation caused by sunlight exposure during storage and use.
  • UNII 147D247K3P
    Ethylhexylglycerin is a synthetic preservative used to prevent bacteria and mold from growing in medicines and personal care products. It helps keep the product safe and stable throughout its shelf life.
  • 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 48RFF58ESG
    A plant-derived carbamate compound used as a binder and film-former in tablets and capsules. It helps hold ingredients together and may improve how the medicine breaks down in the digestive system.
  • 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 50C1307PZG
    Pentylene glycol is a humectant and preservative helper derived from petroleum or plant sources. It draws moisture into the product and helps prevent bacterial growth, keeping medicines stable during storage.
  • 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 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 NG5NG5733T
    A synthetic polymer derived from acrylic acid and taurine. It functions as a suspending agent and emulsifier, helping keep ingredients evenly distributed and preventing separation in liquid or semi-solid medicines.
  • UNII YA22H34H9Q
    A chelating agent derived from sodium and organic compounds. It binds to metal ions in the formulation to improve stability and prevent unwanted chemical reactions that could degrade the medicine.
  • 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.

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

The official label also statesInactive Ingredients Water, C12-15 Alkyl Benzoate,Glycerin, Butyloctyl Salicylate, Niacinamide, Propanediol, Pentylene Glycol Ectoin, Eugenia Caryophyllus (Clove) Bud Extract,Solidago Virgaurea (Goldenrod) Extract, Allantoin, Bisabolol, Tocopheryl Acetate, lnulin lauryl Carbamate, Sodium Polyacryloyldimethyl Taurate, Trisodium Ethylenediamine Disuccinate, Xanthan Gum,Silica,Ethylhexyl Methoxycrylene, 1,2-Hexanediol,Citric Acid,Ethylhexylglycerin, Phenoxyethanol.

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

LabelerCOSMAX USA., CORP
FDA applicationM020 (OTC MONOGRAPH DRUG)
Labeler code68577
First marketedFeb 2026
Product typeHuman Otc Drug
Portfolio4 products on file

More NDCs from COSMAX USA., CORP labeler code 68577

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 🧪 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 📄 Other Information 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 80 words ▾

DIRECTIONS Directions ​ Apply liberally and evenly15 minutes before sun exposure. Children under 6 months of age:Ask a doctor. SunProtectionMeasures.

Spending time inthe sun increases your risk of skin cancer and early skin aging.To decrease this risk,regularty use a sunscreen with abroad spectrum SPFvalue of 15 or highe rand other sun protection measures including: limit your time in the sun,especially from 10a.m.-2p.m. wearlong-sleeved shirts,pants,hats,and sunglasses. Reapply at least every 2 hours Use a water resistant sunscreen if swimming or sweating.

⏱️ Dosage and Administration 30 words ▾

USES Use Help 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

⚠️ Warnings 38 words ▾

Warnings 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 skin rash occurs Keep out of reach of children.

🧪 Active Ingredient 8 words ▾

ACTIVE INGREDIENTS: Avobenzone 3.00% Homosalate 7.00% Octisalate 5.00%

🧪 Inactive Ingredients 40 words ▾

Inactive Ingredients Water, C12-15 Alkyl Benzoate,Glycerin, Butyloctyl Salicylate, Niacinamide, Propanediol, Pentylene Glycol Ectoin, Eugenia Caryophyllus (Clove) Bud Extract,Solidago Virgaurea (Goldenrod) Extract, Allantoin, Bisabolol, Tocopheryl Acetate, lnulin lauryl Carbamate, Sodium Polyacryloyldimethyl Taurate, Trisodium Ethylenediamine Disuccinate, Xanthan Gum,Silica,Ethylhexyl Methoxycrylene, 1,2-Hexanediol,Citric Acid,Ethylhexylglycerin, Phenoxyethanol.

🎯 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 10 words ▾

Stop use and ask a doctor if skin rash occurs

📄 Keep Out of Reach of Children 6 words ▾

Keep out of reach of children.

📄 Other Information 14 words ▾

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

📄 Package Label / Principal Display Panel 10 words ▾

10 ML NDC 68577-232-02 Tube

NDC 6877-232 SOFIE Bottle 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 COSMAX USA., CORP. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
COSMAX USA., CORP 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.
← 68577-0287-00 · COSMAX 68577-0289-00 · COSMAX →
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.