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Sun face protector sunscreen broad spectrum SPF 50 Avobenzone, Homosalate, Octisalate, Octocrylene 5 g/100mL; 10 g/100mL; 3 g/100mL; 10 g/100mL Cream, 50 mL — NDC 68828-0295-01 package photo

Sun face protector sunscreen broad spectrum SPF 50 Avobenzone, Homosalate, Octisalate, Octocrylene 5 g/100mL; 10 g/100mL; 3 g/100mL; 10 g/100mL Cream, 50 mL

by Distribuidora Comercial Jafra, S.A. de C.V. · 50 mL in 1 BOTTLE (68828-295-01)
NDC 68828-0295-01
🏷️ FDA NDC (as labeled) 68828-295-01 billing pads the product segment with a zero
This package
Contains50 mL Pack sizes2 compare ↓
Also comes in: 7.5 ml 68828-0295-02
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 →

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) 68828-295-01
Product NDC 68828-295
11-digit billing NDC 68828029501
UNII 4X49Y0596W, 5A68WGF6WM, G63QQF2NOX, V06SV4M95S
Application # M020
SPL Set ID b8e1ced7-dafa-c71e-e053-2995a90a9550
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2021-01-14
Route TOPICAL
Dosage form CREAM
Substance OCTISALATE; OCTOCRYLENE; AVOBENZONE; HOMOSALATE
Why two NDCs? The FDA registers this code as 68828-295-01 — a 5-3-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the product segment → 68828-0295-01. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

🏭 Manufacturer & labeler

LabelerDistribuidora Comercial Jafra, S.A. de C.V.
FDA applicationM020 (OTC MONOGRAPH DRUG)
Labeler code68828
First marketedJan 2021
Product typeHuman Otc Drug
Portfolio75 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 sunscreen cream containing four UV-filtering ingredients: avobenzone, homosalate, octisalate, and octocrylene. These active ingredients function together as ultraviolet (UV) absorbers, typically used to help protect skin from UVA and UVB sun exposure. The product is formulated as an over-the-counter monograph drug and carries a broad-spectrum SPF 50 rating. It is applied to the skin as a protective barrier against solar radiation.

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.

💡 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 94ZLA3W45F
    Arginine is an amino acid used in medicines as a buffer and pH adjuster. It helps maintain the proper acidity level and stability of liquid formulations.
  • UNII WAO5MNK9TU
    Benzyl salicylate is a fragrant chemical compound used as a flavor and scent ingredient in medicines. It helps mask unpleasant tastes or odors in liquid or oral formulations.
  • UNII T7540GJV69
    A synthetic fragrance compound used as a flavor or scent ingredient in medicines. It helps mask unpleasant tastes or odors in the formulation to make the medication more palatable.
  • UNII 809Y72KV36
    A synthetic polymer made from acrylic acid and crosslinked with allyl pentaerythritol. It's used as a thickening agent and gelling ingredient in creams, gels, and lotions to create the proper texture and help the medicine spread and stay on the skin.
  • 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 A4VZ22K1WT
    Coumarin is a fragrant organic compound derived from plants or made synthetically. It adds pleasant flavor and aroma to medicines and is used as a flavoring agent in some formulations.
  • UNII 609A3V1SUA
    A silky liquid derived from caprylic acid that acts as an emollient and solvent in formulations. It helps dissolve active ingredients and improves the spreadability and feel of lotions, creams, and topical products.
  • 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 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 BQY1UBX046
    A plant extract from European elderberry fruit used as a flavoring agent and color source in medicines. It adds taste and natural purple coloring to tablets and liquids.
  • 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 230OU9XXE4
    A waxy substance made from glycerin and stearic acid that acts as an emulsifier to blend oily and watery ingredients together. It also helps thicken and stabilize the medicine's texture.
  • UNII 8SQ0VA4YUR
    A fragrance compound derived from natural sources, used to add pleasant scent to the medicine. It serves as a flavoring or aromatic agent to mask unpleasant tastes or improve the product's sensory appeal.
  • 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 D81QY6I88E
    Linalool is a natural fragrant oil found in plants like lavender and citrus. It's used in medicines as a flavoring agent and to mask unpleasant tastes or smells.
  • 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 YD01N1999R
    A waxy substance made from polyethylene glycol and stearic acid. It helps mix oil and water-based ingredients together and serves as an emulsifier and solubilizer in liquid and semi-solid medicines.
  • 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 T9296U138P
    A synthetic polymer derived from polyester chemistry, modified with a cyanodiphenylpropenoyl cap. It serves as a film-former and binder in pharmaceutical formulations, helping create protective coatings on tablets or improving product consistency.
  • UNII 035MV9S1C3
    A plastic-like polymer made from two chemical compounds joined together. It acts as a binder and film-former in tablets and capsules, helping hold ingredients together and create a protective coating on the medicine's surface.
  • 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.

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

The official label also statesWater, Polyester-8, Styrene/Acrylates Copolymer, Cetyl Alcohol, VP/Eicosene Copolymer, Dicaprylyl Carbonate, Glyceryl Stearate, PEG -100 Stearate, Phenoxyethanol, Arginine, Bisabolol, Glycerin, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Tocopheryl Acetate, Fragrance, Ethylhexylglycerin, Disodium EDTA, Panthenol, Sambucus Nigra Fruit Extract, Benzyl Salicylate, Coumarin, Butylphenyl Methylpropional, Linalool, Hydroxycitronellal

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.

💲 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: 7.5 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
Sun face protector sunscreen broad spectrum SPF 50 5 g/100mL; 10 g/100mL; 3 g/100mL; 10 g/100mLthis 68828-0295-01 Distribuidora 50 ml — — 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

🏛️
2021
On the market since
Jan 2021
📍
2026
Currently FDA-listed
5 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
68828-0295-01 You're viewing this 50 mL in 1 BOTTLE (68828-295-01) 2021-01-14 Active
68828-0295-02 7.5 mL in 1 BOTTLE (68828-295-02) 2021-01-14 Discontinued by firm

Pack size FAQ

What quantity is in NDC 68828-0295-01?
NDC 68828-0295-01 contains 50 mL — 50 ml in 1 bottle.
What is the difference between NDC 68828-0295-01 and NDC 68828-0295-02?
Both are Sun face protector sunscreen broad spectrum SPF 50 Avobenzone, Homosalate, Octisalate, Octocrylene 5 g/100mL; 10 g/100mL; 3 g/100mL; 10 g/100mL Cream — the drug itself is identical. NDC 68828-0295-01 is the 50 mL package, while NDC 68828-0295-02 is the 7.5 ml package.
What NDC number is used to bill for this package of Sun face protector sunscreen broad spectrum SPF 50 Avobenzone, Homosalate, Octisalate, Octocrylene 5 g/100mL; 10 g/100mL; 3 g/100mL; 10 g/100mL Cream?
Bill NDC 68828-0295-01 — the 11-digit billing format is 68828029501. 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 68828-295-01, 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: 68828-0295-01, written without dashes as 68828029501. 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 68828-0295-01, the first segment (68828) is the labeler code FDA assigned to Distribuidora Comercial Jafra, S.A. de C.V.; the middle segment (0295) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (01) 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 Distribuidora Comercial Jafra, S.A. de C.V.. 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 7.5 ml (68828-0295-02). 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?
Distribuidora Comercial Jafra, S.A. de C.V. 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.
⏱️ Dosage and Administration ⚠️ Warnings 🧪 Active Ingredient 🧪 Inactive Ingredients 🎯 Purpose
⏱️ Dosage and Administration 102 words ▾

Directions Apply liberally and evenly 15 minutes before sun exposure reapply: • after 40 minutes of swimming or sweating • immediately after towel drying • at least every 2 hours 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 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

⚠️ Warnings 56 words ▾

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

🧪 Active Ingredient 11 words ▾

Active Ingredients Purpose Avobenzone 3%..............Sunscreen Homosalate 10%.............Sunscreen Octisalate 5%..................Sunscreen Octocrylene 10%.............Sunscreen

🧪 Inactive Ingredients 43 words ▾

Inactive Ingredients Water, Polyester-8, Styrene/Acrylates Copolymer, Cetyl Alcohol, VP/Eicosene Copolymer, Dicaprylyl Carbonate, Glyceryl Stearate, PEG -100 Stearate, Phenoxyethanol, Arginine, Bisabolol, Glycerin, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Tocopheryl Acetate, Fragrance, Ethylhexylglycerin, Disodium EDTA, Panthenol, Sambucus Nigra Fruit Extract, Benzyl Salicylate, Coumarin, Butylphenyl Methylpropional, Linalool, Hydroxycitronellal

🎯 Purpose 31 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.

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 68828-0294-01 · Distribuidora 68828-0296-01 · Distribuidora →
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.