Home › NDC Lookup › Ingredients › Octinoxate, Zinc Oxide › 69219-0103-55
Extreme Protect Spf 30 Octinoxate, Zinc Oxide 5.5 g/100g; 4.12 g/100g Lotion — NDC 69219-0103-55 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Extreme Protect Spf 30 Octinoxate, Zinc Oxide 5.5 g/100g; 4.12 g/100g Lotion — NDC 69219-103-55 (Billing 69219-0103-55)

by SCIENCE OF SKINCARE LLC · 1 BOTTLE, PUMP in 1 BOX / 5 g in 1 BOTTLE, PUMP

This is a package of Extreme Protect Spf 30 Octinoxate, Zinc Oxide 5.5 g/100g; 4.12 g/100g Lotion from SCIENCE OF SKINCARE LLC, marketed since Oct 2014 and currently FDA-listed.

NDC 69219-0103-55
🏷️ FDA NDC (as labeled) 69219-103-55 billing pads the product segment with a zero
This package
Contains5 g in 1 bottle, pump Pack sizes8 compare ↓
Product page 69219-0103-01 Also comes in: 100 g 69219-103-51 240 g 69219-103-58 50 g 69219-103-02 5 g 69219-103-15 50 g 69219-103-01 100 g 69219-103-13 240 g 69219-103-28
OTC On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Jul 24, 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) 69219-103-55
Product NDC 69219-103
11-digit billing NDC 69219010355
UNII 4Y5P7MUD51, SOI2LOH54Z
UPC 0817244013655
Application # M020
SPL Set ID ecc4d304-e7e2-45b6-b9b2-2c64d3630860
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 2014-10-01
Route TOPICAL
Dosage form LOTION
Substance OCTINOXATE; ZINC OXIDE
Why two NDCs? The FDA registers this code as 69219-103-55 — 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 → 69219-0103-55. 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?

Extreme Protect SPF 30 is a topical lotion sunscreen marketed under FDA's over-the-counter monograph rules. It contains two UV filters: octinoxate and zinc oxide. These ingredients are typically used together to absorb and reflect ultraviolet radiation from the sun, helping to protect exposed skin from sunburn. This product is applied to the skin as a sun-protective barrier.

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.
Try another pack size: 100 g 240 g 50 g 5 g 50 g 100 g 240 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.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
69219-0103-13 69219-103-13 100 g in 1 BOTTLE, PUMP 2014-10-01 — Active
69219-0103-15 69219-103-15 5 g in 1 BOTTLE, PUMP 2014-10-01 — Active
69219-0103-28 69219-103-28 240 g in 1 BOTTLE, PUMP 2014-10-01 — Active
69219-0103-51 69219-103-51 1 BOTTLE, PUMP in 1 BOX / 100 g in 1 BOTTLE, PUMP 2014-10-01 — Active
69219-0103-55 You're viewing this 1 BOTTLE, PUMP in 1 BOX / 5 g in 1 BOTTLE, PUMP 2014-10-01 — Active
69219-0103-58 69219-103-58 1 BOTTLE, PUMP in 1 BOX / 240 g in 1 BOTTLE, PUMP 2023-08-01 — Active
69219-0103-01 69219-103-01 Main listing 50 g in 1 BOTTLE, PUMP 2026-04-30 — Active
69219-0103-02 69219-103-02 1 BOTTLE, PUMP in 1 BOX / 50 g in 1 BOTTLE, PUMP 2026-04-30 — Active

Pack size FAQ

What quantity is in this package?
This package is listed by the FDA — 1 bottle, pump in 1 box / 5 g in 1 bottle, pump.
What NDC number is used to bill for this package of Extreme Protect Spf 30 Octinoxate, Zinc Oxide 5.5 g/100g; 4.12 g/100g Lotion?
Use the 11-digit billing form listed in the identifiers section of this page. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Extreme Protect Spf 30 5.5 g/100g; 4.12 g/100gthis 69219-0103-55 SCIENCE 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

🏛️
2014
On the market since
Oct 2014
📍
2026
Currently FDA-listed
12 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 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 9PA5A687X5
    Asiatic acid is a natural compound extracted from plants that acts as an emollient and skin-conditioning agent in topical formulations. It helps soften and smooth the product's texture while supporting skin hydration.
  • UNII PKO39VY215
    A natural compound derived from Centella asiatica plant, used as an active botanical extract or skin-conditioning agent in topical formulations to support ingredient stability and product efficacy.
  • UNII E4F12ROE70
    A refined mineral oil derived from crude petroleum containing 13 to 14 carbon chains. It acts as a solvent, emollient, and carrier in topical formulations to help dissolve active ingredients and improve product texture and spreadability.
  • UNII 00YIU5438U
    Caprylyl glycol is a clear liquid derived from coconut oil. In medicines, it acts as a humectant to retain moisture, a preservative booster to prevent microbial growth, and a solvent to help dissolve or mix other ingredients.
  • 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 MJ2YTT4J8M
    Ethyl linoleate is a fatty acid ester derived from linoleic acid. It acts as an emollient and solvent in formulations, helping to dissolve or carry active ingredients and improve product texture and absorption.
  • 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 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 6YLY96TQL6
    A waxy substance made from glycol and stearic acid. It works as an emulsifier and thickener to help blend oil and water ingredients together and give the medicine its proper texture and consistency.
  • UNII KEH0A3F75J
    Hexylene glycol is a clear liquid alcohol used as a solvent and preservative in medicines. It helps dissolve other ingredients and keeps the product stable during storage.
  • UNII Z95S6G8201
    A synthetic surfactant derived from lauryl alcohol and ethylene oxide. It helps dissolve and mix oily and watery ingredients in liquid formulations, and may improve how the medicine spreads or is absorbed.
  • UNII M7O1N24J82
    Madecassic acid is a natural compound extracted from Centella asiatica plant. In medications, it acts as an active pharmaceutical ingredient or functional excipient that may support skin health and wound healing in topical formulations.
  • UNII X8725R883T
    A synthetic oily liquid derived from branched carboxylic acids, used as an emollient and skin-conditioning agent in topical formulations. It helps soften and smooth the product's texture while improving how it spreads on skin.
  • UNII MJ95C3OH47
    A plant extract from olive leaves used in formulations as an antioxidant and preservative. It helps protect the medicine from degradation and extend shelf life.
  • UNII 172F2WN8DV
    A fatty alcohol derived from animal or plant oils. It acts as an emollient and helps stabilize emulsions, allowing oil and water to mix evenly in the medication.
  • 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 5D6TC4BRWV
    Polyacrylamide is a synthetic polymer used as a thickener and stabilizer in medicines. It helps maintain consistent texture and prevents separation of ingredients in liquid or semi-solid formulations.
  • UNII 7913J43WZ5
    PPG-3 myristyl ether is a synthetic oil derived from propylene glycol and myristic acid. It acts as an emulsifier and texture modifier, helping blend oil and water-based ingredients and improving how the medicine feels or spreads.
  • UNII YWI33EV595
    A synthetic compound derived from a fatty alcohol, used as an emulsifier and surfactant to help mix oil and water components in medicines, and to improve how the product spreads or flows.
  • 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 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.

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

The official label also statesWater, Polyacrylamide, Tocopherol, Ethylhexyl Palmitate, PPG-3 Myristyl Ether, Cetyl Alcohol, Glycol Stearate SE, VP/Hexadecene Copolymer, Olea Europaea (Olive) Leaf Extract, Aloe Barbadensis Leaf Juice, Asiaticoside, Asiatic Acd, Madecassic Acid, Sodium Dihydrocetyl Phosphate, Ethyl Linoleate, Oleyl Alcohol, Glyceryl Stearate, Octyldodecyl Neopentanoate, Caprylyl Glycol, Hexylene Glycol, PEG-100 Stearate, C13-14 Isoparaffin, Laureth-7, 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

LabelerSCIENCE OF SKINCARE LLC
FDA applicationM020 (OTC MONOGRAPH DRUG)
Labeler code69219
First marketedOct 2014
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 📄 Other Information 📄 Questions or Comments 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 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

⏱️ Dosage and Administration 94 words ▾

DIRECTIONS APPLY LIBERALLY 15 MINUTES BEFORE SUN EXPOSURE. • Use a water resistant sunscreen if swimming or sweating • Reapply at least every 2 hours • 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 of 15 or higher and other sun protection measures including: o limit time in the sun, especially from 10 a.m.-2 p.m. o wear long-sleeve shirts, pants, hats, and sunglasses • Children under 6 months: Ask a doctor

⚠️ Warnings 6 words ▾

WARNINGS • For external use only

🧪 Active Ingredient 9 words ▾

Active Ingredients Octinoxate – 5.50% Zinc Oxide – 4.12%

🧪 Inactive Ingredients 52 words ▾

Inactive Ingredients Water, Polyacrylamide, Tocopherol, Ethylhexyl Palmitate, PPG-3 Myristyl Ether, Cetyl Alcohol, Glycol Stearate SE, VP/Hexadecene Copolymer, Olea Europaea (Olive) Leaf Extract, Aloe Barbadensis Leaf Juice, Asiaticoside, Asiatic Acd, Madecassic Acid, Sodium Dihydrocetyl Phosphate, Ethyl Linoleate, Oleyl Alcohol, Glyceryl Stearate, Octyldodecyl Neopentanoate, Caprylyl Glycol, Hexylene Glycol, PEG-100 Stearate, C13-14 Isoparaffin, Laureth-7, Phenoxyethanol.

🎯 Purpose 2 words ▾

PURPOSE SUNSCREEN

📄 Do Not Use 9 words ▾

• Do not use on damaged or broken skin

📄 When Using This Product 14 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 rash occurs

📄 Keep Out of Reach of Children 20 words ▾

Keep out of reach of children. If product is swallowed,get medical help or contact a Poison Control Center right away.

📄 Other Information 11 words ▾

Other Information PROTECT THIS PRODUCT FROM EXCESSIVE HEAT AND DIRECT SUN.

📄 Questions or Comments 9 words ▾

Questions or Comments? Call Customer Care at (888) 804-4447

📄 Package Label / Principal Display Panel 53 words ▾

Package Label - Principal Display Panel EP SPF 30 100g L EP SPF 30 100g B EP SPF 30 5g P EP SPF 30 240g L EP SPF 30 5g L EP SPF 30 50g L EP SPF 30 50g B 50g Label NDC 69219-103-01 50g Box NDC 69219-103-02 5g Pack NDC 69219-103-55

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 SCIENCE OF SKINCARE LLC. 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 7 other package presentations of this same product, including 1 bottle (69219-0103-51), 1 bottle (69219-0103-58), 1 bottle (69219-0103-02). 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?
SCIENCE OF SKINCARE LLC 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.
← 69219-0102-01 · SCIENCE 69219-0107-01 · SCIENCE →
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.