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Jacket Spf 50 Zinc Oxide, Octinoxate, Octisalate, Octisalate 75 mg/g; 75 mg/g; 50 mg/g; 50 mg/g Cream — NDC 71070-0768-04 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Jacket Spf 50 Zinc Oxide, Octinoxate, Octisalate, Octisalate 75 mg/g; 75 mg/g; 50 mg/g; 50 mg/g Cream — NDC 71070-768-04 (Billing 71070-0768-04)

by Balshi MD Dermaceuticals · 1 BOTTLE in 1 CARTON / 113 g in 1 BOTTLE

This is a package of Jacket Spf 50 Zinc Oxide, Octinoxate, Octisalate, Octisalate 75 mg/g; 75 mg/g; 50 mg/g; 50 mg/g Cream from Balshi MD Dermaceuticals, marketed since Nov 2016 and currently FDA-listed. It is this product's only package size.

NDC 71070-0768-04
🏷️ FDA NDC (as labeled) 71070-768-04 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

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 71070-768-04
Product NDC 71070-768
11-digit billing NDC 71070076804
UNII SOI2LOH54Z, 4Y5P7MUD51, 4X49Y0596W, 95OOS7VE0Y
Application # M020
SPL Set ID b82b8a46-8009-416e-8718-296a23106914
Established class (EPC) Copper Absorption Inhibitor
Physiologic effect Decreased Copper Ion Absorption
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2016-11-18
Route TOPICAL
Dosage form CREAM
Substance ZINC OXIDE; OCTINOXATE; OCTISALATE; OXYBENZONE
Why two NDCs? The FDA registers this code as 71070-768-04 — 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 → 71070-0768-04. 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?

Jacket SPF 50 is a topical cream sunscreen sold as an over-the-counter monograph product. It contains four active ingredients that work together to block ultraviolet radiation from reaching the skin: zinc oxide and octinoxate are mineral and chemical UV filters respectively, while octisalate and oxybenzone are additional chemical UV-absorbing compounds. Products like this are commonly used to help protect exposed skin from sun damage during outdoor activities.

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
71070-0768-04 You're viewing this Main listing 1 BOTTLE in 1 CARTON / 113 g in 1 BOTTLE 2016-11-18 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Jacket Spf 50 75 mg/g; 75 mg/g; 50 mg/g; 50 mg/gthis 71070-0768-04 Balshi 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

🏛️
2016
On the market since
Nov 2016
📍
2026
Currently FDA-listed
10 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.

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 H4N855PNZ1
    Alpha-tocopherol is a form of vitamin E, a fat-soluble antioxidant derived from natural or synthetic sources. In medicines, it prevents oils and fats from breaking down and becoming rancid, protecting the product's stability and shelf life.
  • 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 C5INA23HXF
    Arbutin is a natural compound found in plants that acts as a preservative in medicines. It helps prevent bacterial and fungal growth to keep the product stable and safe during storage.
  • UNII PQ6CK8PD0R
    Ascorbic acid, also known as vitamin C, is a white crystalline powder. It serves as an antioxidant to prevent degradation of other ingredients and may also function as a preservative in the formulation.
  • UNII 58B69Q84JO
    A plant-derived emulsifier made from olive oil and fatty alcohols. It helps blend oil and water ingredients together and stabilizes the product's texture in creams, lotions, and similar formulations.
  • UNII 2DMT128M1S
    A waxy solid derived from plant or animal sources. It acts as an emulsifier to blend oil and water components, and also thickens the medicine to give it the right texture and consistency.
  • UNII 0N8672707O
    A starch derived from corn kernels. It acts as a binder to hold tablet ingredients together, a filler to give the tablet bulk, and a disintegrant to help the tablet break apart in your stomach.
  • UNII YY7C30VXJT
    A natural plant extract from cucumber that adds flavor and freshness to medicines. It may also serve as a moisturizing agent or mild preservative in topical or oral formulations.
  • UNII XE7K568ILO
    A plant-derived oil from lemongrass used as a flavoring agent and fragrance component. It adds taste and aroma to medicines, making them more palatable.
  • 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 2865993309
    Ethylhexyl palmitate is an oily chemical made from palm oil and alcohol. It acts as an emollient and skin-conditioning agent in topical medicines, helping the product spread smoothly and keeping skin soft.
  • 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 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 2788Z9758H
    A plant extract from licorice root used as a sweetener, flavoring agent, and natural emulsifier in medicines. It helps improve taste and may aid in keeping ingredients evenly mixed throughout the product.
  • UNII W2ZU1RY8B0
    A plant extract from green tea leaves. It's used as an antioxidant ingredient to help preserve the medicine and maintain its stability during storage.
  • UNII BKJ0J3D1BP
    A plant-derived ingredient from sunflower flowers, used as a natural colorant and flavoring agent in medicines. It may help provide color or mild taste to the product.
  • 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 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 YRC528SWUY
    A waxy emulsifier made from plant-derived fatty alcohols. It helps blend oil and water-based ingredients together and improves how the medicine spreads and absorbs.
  • UNII 7T1F30V5YH
    A synthetic emulsifier derived from sorbitol and oleic acid. It helps mix oil and water-based ingredients together and keeps them from separating in liquid formulations.
  • UNII 56687D1Z4D
    A natural plant extract from pomegranate fruit, used as a flavor and color ingredient to enhance taste and appearance in medicines.
  • 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 MDL271E3GR
    Sorbitan olivate is an emulsifier derived from sorbitol and olive oil. It helps blend water and oil ingredients together to maintain consistent texture and appearance throughout the medicine.
  • 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 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.

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

The official label also statesAcrylates Copolymer, Aloe Barbadensis (Aloe Vera Gel) Juice, Aqua (Deionized Water), A-Arbutin, Ascorbic Acid (Vitamin C), Camellia Sinensis (Green Tea) Extract, Caprylic/Capric Triglyceride, Ceteareth 20, Cetearyl Alcohol, Cetearyl Olivate, Cetyl Alcohol Cucumis Sativus (Cucumber) Fruit Extract, Cymbopogon Schoenanthus (Lemongrass) Oil, Dimethicone, Ethylhexylgycerin, Ethylhexyl Palmitate, Glycerin, Glyceryl Stearate, Glycyrrhiza Glabra (Licorice) Root Extract, Helianthus Annuus (Sunflower) Oil, Phenoxyethanol, Polysorbate 20, Punica Granatum (Pomegranate) Extract, Sorbitan Olivate, Stearyl Alcohol, Tocopheyl Acetate (Vitamin E), Zema (Corn), Propanediol

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

LabelerBalshi MD Dermaceuticals
FDA applicationM020 (OTC MONOGRAPH DRUG)
Labeler code71070
First marketedNov 2016
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.

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 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 29 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.

⏱️ Dosage and Administration 93 words ▾

Directions Apply liberally 15 minutes before sun exposure • Reapply: • At least every 2 hours • Immediately after swimming, sweating or towel drying Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use sunscreen with broad spectrum protection and an SPF rating of 15 or higher, along with other sun protection measures including: Sun Protection Measures: Limit time in the sun, especially between 10am -2pm Wear long sleeve shirts, pants, hats and sunglasses For children under 6 months, consult a physician.

⚠️ Warnings 55 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 consult physician if irritation or rash develops Keep out if reach of children. If product is swallowed, get medical attention or contact poison control center immediately.

🧪 Active Ingredient 13 words ▾

Active Ingredients Zinc Oxide 7.50% Octinoxate 7.50% Octisalate 5.00% Oxybenzone 5.00% Purpose Sunscreen

🧪 Inactive Ingredients 76 words ▾

Other Ingredients Acrylates Copolymer, Aloe Barbadensis (Aloe Vera Gel) Juice, Aqua (Deionized Water), A-Arbutin, Ascorbic Acid (Vitamin C), Camellia Sinensis (Green Tea) Extract, Caprylic/Capric Triglyceride, Ceteareth 20, Cetearyl Alcohol, Cetearyl Olivate, Cetyl Alcohol Cucumis Sativus (Cucumber) Fruit Extract, Cymbopogon Schoenanthus (Lemongrass) Oil, Dimethicone, Ethylhexylgycerin, Ethylhexyl Palmitate, Glycerin, Glyceryl Stearate, Glycyrrhiza Glabra (Licorice) Root Extract, Helianthus Annuus (Sunflower) Oil, Phenoxyethanol, Polysorbate 20, Punica Granatum (Pomegranate) Extract, Sorbitan Olivate, Stearyl Alcohol, Tocopheyl Acetate (Vitamin E), Zema (Corn), Propanediol

🎯 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 consult physician if irritation or rash develops

📄 Keep Out of Reach of Children 19 words ▾

Keep out if reach of children. If product is swallowed, get medical attention or contact poison control center immediately.

📄 Package Label / Principal Display Panel 3 words ▾

Package Labeling: Label2

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 Balshi MD Dermaceuticals. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Balshi MD Dermaceuticals 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.
← 71070-0599-00 · BALSHI 71070-0868-04 · BALSHI →
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.