Home › NDC Lookup › Ingredients › Avobenzone, Octinoxate, Octocrylene, Oxy... › 70453-0001-01
Protect and Prime Broad Spectrum SPF30 AVOBENZONE, OCTINOXATE, OCTOCRYLENE, OXYBENZONE 30 mg/mL; 75 mg/mL; 100 mg/mL; 60 mg/mL Cream — NDC 70453-0001-01 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Protect and Prime Broad Spectrum SPF30 AVOBENZONE, OCTINOXATE, OCTOCRYLENE, OXYBENZONE 30 mg/mL; 75 mg/mL; 100 mg/mL; 60 mg/mL Cream — NDC 70453-001-01 (Billing 70453-0001-01)

by Emma Hardie Ltd · 1 BOTTLE in 1 BOX / 50 mL in 1 BOTTLE

This is a package of Protect and Prime Broad Spectrum SPF30 AVOBENZONE, OCTINOXATE, OCTOCRYLENE, OXYBENZONE 30 mg/mL; 75 mg/mL; 100 mg/mL; 60 mg/mL Cream from Emma Hardie Ltd, no longer marketed (first marketed Feb 2016), no longer in the FDA NDC Directory. It is this product's only package size.

NDC 70453-0001-01
🏷️ FDA NDC (as labeled) 70453-001-01 billing pads the product segment with a zero
OTC Discontinued Non-controlled ⚠ Discontinued by firm ⇄ 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

NDC database record

One package, one record: these facts belong to NDC 70453-001-01 alone.

Record
FDA NDC Directory package listing · Human OTC drug
Code segments
70453 labeler · 001 product · 01 package
Package marketed since
Feb 3, 2016
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Barcode (UPC-A, from the NDC)
3 7045300101 6
FDA record last changed
Jul 24, 2026
⚠️
Excluded from the active FDA NDC Directory. The labeler reported this product as discontinued, so it is excluded from the active NDC Directory. The listing was last certified through Sep 2026. A label may still appear on DailyMed, but the NDC is no longer in the current FDA NDC Directory. Search the FDA NDC Directory ↗

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 70453-001-01
Product NDC 70453-001
11-digit billing NDC 70453000101
UNII G63QQF2NOX, 4Y5P7MUD51, 5A68WGF6WM, 95OOS7VE0Y
Application # M020
SPL Set ID cdd6ffe3-2ae6-44d8-a9b8-45bb134e928c
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status Discontinued
FDA listing status Discontinued by firm (certified through Sep 2026)
Marketing start 2016-02-03
Route TOPICAL
Dosage form CREAM
Substance AVOBENZONE; OCTINOXATE; OCTOCRYLENE; OXYBENZONE
Why two NDCs? The FDA registers this code as 70453-001-01 — 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 → 70453-0001-01. 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.

Clinical

🧪 What is this product?

Protect and Prime Broad Spectrum SPF30 is a topical cream sunscreen marketed as an over-the-counter product under FDA rules for sunscreen ingredients. It contains four UV filters (avobenzone, octinoxate, octocrylene, and oxybenzone) that are typically used to help protect skin from ultraviolet radiation. This type of product is commonly applied to the skin to reduce sun exposure.

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
70453-0001-01 You're viewing this Main listing 1 BOTTLE in 1 BOX / 50 mL in 1 BOTTLE 2016-02-03 — Discontinued by firm

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Protect and Prime Broad Spectrum SPF30 30 mg/mL; 75 mg/mL; 100 mg/mL; 60 mg/mLthis 70453-0001-01 Emma 1 bottle — — Discontinued —
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
Feb 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 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 P01OUT964K
    A fragrant plant-derived alcohol used as a flavoring agent and fragrance component in medicines. It provides taste and aroma to make the product more pleasant to use.
  • UNII OY671H06VI
    A waxy compound made by combining butanediol (a four-carbon alcohol) with stearic acid (a natural fatty acid). It works as an emulsifier and thickener to help blend oil and water-based ingredients and improve the texture and stability of the product.
  • UNII LMI26O6933
    Alumina is a white powder form of aluminum oxide. It's used as a filler to add bulk to tablets and capsules, and sometimes as a thickening or anti-caking agent in powdered formulations.
  • UNII U6XF9NP8HM
    Aluminum stearate is a salt made from aluminum and stearic acid, a fatty substance. It works as a lubricant and glidant to help powder flow smoothly during manufacturing and tablet production.
  • UNII 5PWM7YLI7R
    Barley is a grain plant. It may be used in some medicines as a filler or binder to add bulk and help hold the tablet or capsule together.
  • UNII LKG8494WBH
    Benzyl alcohol is a clear liquid used as a preservative and solvent in medicines. It helps prevent bacterial and fungal growth and dissolves other ingredients to create uniform liquid formulations.
  • UNII T7EU0O9VPP
    Citral is a natural oil compound found in lemon and citrus plants. It's used in medicines as a flavoring agent and to add pleasant lemon or citrus scent to the product.
  • 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 2KAG279R6R
    Dehydroacetic acid is a synthetic preservative that prevents mold, yeast, and bacterial growth in medicines. It extends shelf life by protecting the product from spoilage during storage and use.
  • UNII V5J3537PND
    A chemical compound derived from rutin, a natural flavonoid. It serves as a colorant and antioxidant in medications, helping prevent ingredient degradation and maintain product stability during storage.
  • 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 EB41QIU6JL
    Farnesol is a natural fragrant compound found in plants. It's used in medicines as a preservative and flavoring agent to improve taste and help prevent microbial growth.
  • UNII L837108USY
    Geraniol is a natural fragrant compound found in plants like roses and lemons. It's used in medicines as a flavoring agent and to improve the taste or aroma of the product.
  • 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 42DG15CHXV
    A natural plant wax derived from sunflower seeds. It serves as a lubricant and glidant to help powders flow smoothly during manufacturing and tablet formation.
  • UNII WB5K9Y35Y9
    A synthetic crosslinked polymer made by combining hexamethylene diisocyanate with trimethylol hexyllactone. It's used as a film-former and binder to help create protective coatings on tablets or capsules and improve product stability.
  • 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 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 50D2ZE9219
    A plant extract from lemon balm leaves, used as a flavoring and aromatic ingredient to improve the taste and smell of the medicine.
  • 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 6GSJ7A6T1E
    A natural plant oil derived from Schinziophyton rautanenii seeds, used as an emollient and conditioning agent to soften the product's texture and improve skin feel in topical formulations.
  • UNII K49155WL9Y
    Shea butter is a fat extracted from shea tree nuts. It's used in medicines as an emollient and lubricant to soften the product, improve texture, and help ingredients blend smoothly together.
  • 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 47X6Y9FJJ2
    A natural plant-derived wax extracted from jojoba seeds. It acts as a coating agent, emollient, and consistency modifier to improve texture and help the medicine maintain its form.
  • UNII OJ245FE5EU
    Sodium benzoate is a salt derived from benzoic acid, a preservative. It's added to medicines to prevent growth of bacteria, fungi, and other microorganisms that could spoil the product.
  • UNII QU7E2XA9TG
    Sodium stearate is a salt derived from stearic acid, a natural fatty substance. It acts as a lubricant and binder in tablets and capsules, helping the medicine hold together and flow smoothly during manufacturing.
  • UNII 65A9F4P024
    A synthetic compound derived from the amino acid glutamate and stearic acid. It acts as an emulsifier and surfactant to help mix oil and water-based ingredients, keeping the medicine uniform throughout.
  • 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 15FIX9V2JP
    Titanium dioxide is a bright white mineral powder commonly used as a colorant and opacifying agent. It makes pills and tablets white or lighter in color and helps make coatings non-transparent.
  • 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.

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

The official label also statesWater (Aqua), caprylic/capric triglyceride, Green Wattle (Acacia Decurrens)/Jojoba (Simmondsia Chinensis)/Sunflower (Helianthis Annus) Seed Wax/Polyglyceryl-3 Esters, HDI/Trimethylol Hexyllactone Crosspolymer, Tapioca Starch, Manketti (Schinziophyton Rautaneii) Kernel Oil, Shea Butter (Vitellaria Paradoxa), Stearic Acid, Glycerin, Butylene Glycol Stearate SE, Phenoxyethanol, Benzyl Alcohol, Sodium Stearoyl Glutamate, Tocopheryl Acetate, Fragrance (Parfum), Polyhydroxystearic Acid, Geraniol, Limonene, Citronellol, Xanthan Gum, Linalool, Alumina, Aluminum Stearate, Disodium EDTA, Ethylhexylglycerin, Dehydroacetic Acid, Silica, Sodium Stearate, Polymethylsilsesquioxane, Disodium Rutinyl Disulfate, Barley (Hordeum Districhon) Extract, Lemon Balm (Melissa Officinalis) Leaf Extract, Sodium Benzoate, Citral, Citric Acid, Farnesol, Titanium Dioxide (CI 77891)

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

LabelerEmma Hardie Ltd
FDA applicationM020 (OTC MONOGRAPH DRUG)
Labeler code70453
First marketedFeb 2016
Product typeHuman Otc Drug
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 4 words ▾

Use Helps prevent sunburn

⏱️ Dosage and Administration 84 words ▾

Directions Apply generously 15 minutes before sun exposure Use a Water Resistant sunscreen if swimming or sweating Reapply at least every 2 hours 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: Sun Protection Measures. Limit time in the sun, especially from 10 a.m. - 2 p.m.

Wear long-sleeved shirts, pants, hats, and sunglasses

⚠️ Warnings 54 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 swallowed, get medical help or contact a Poison Control Center right away.

🧪 Active Ingredient 12 words ▾

Active ingredients Avobenzone 3% Octinoxate 7.5% Octocrylene 10% Oxybenzone 6% Purpose Sunscreen

🧪 Inactive Ingredients 91 words ▾

Inactive ingredients Water (Aqua), caprylic/capric triglyceride, Green Wattle (Acacia Decurrens)/Jojoba (Simmondsia Chinensis)/Sunflower (Helianthis Annus) Seed Wax/Polyglyceryl-3 Esters, HDI/Trimethylol Hexyllactone Crosspolymer, Tapioca Starch, Manketti (Schinziophyton Rautaneii) Kernel Oil, Shea Butter (Vitellaria Paradoxa), Stearic Acid, Glycerin, Butylene Glycol Stearate SE, Phenoxyethanol, Benzyl Alcohol, Sodium Stearoyl Glutamate, Tocopheryl Acetate, Fragrance (Parfum), Polyhydroxystearic Acid, Geraniol, Limonene, Citronellol, Xanthan Gum, Linalool, Alumina, Aluminum Stearate, Disodium EDTA, Ethylhexylglycerin, Dehydroacetic Acid, Silica, Sodium Stearate, Polymethylsilsesquioxane, Disodium Rutinyl Disulfate, Barley (Hordeum Districhon) Extract, Lemon Balm (Melissa Officinalis) Leaf Extract, Sodium Benzoate, Citral, Citric Acid, Farnesol, Titanium Dioxide (CI 77891)

🎯 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 9 words ▾

Stop use and ask a doctor if rash occurs

📄 Keep Out of Reach of Children 19 words ▾

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

📄 Package Label / Principal Display Panel 7 words ▾

Package Labling: Package Label Drug Facts Panel

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 No longer marketed (per FDA listing data)
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.
What does the discontinued status mean for this NDC?
The labeler reported a marketing end date (or the listing was delisted), so this specific package is no longer actively marketed. Remaining stock may still be dispensed for a time, and the NDC stays valid for historical records and claims — but data feeds (pricing, labeling) typically stop updating for it. Other package sizes or other manufacturers' versions of the same medication may still be marketed — see the equivalents section where available.
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.
Who lists this product with the FDA?
Emma Hardie 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.
← 70447-0005-01 · FAREVA 70461-0025-03 · Seqirus, →
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.