HomeNDC LookupIngredientsZinc Oxide › 56152-5003-02
Resist Wrinkle Defense SPF 30 Paulas Choice Zinc Oxide 13 g/100mL Cream, 1.5 mL — NDC 56152-5003-02 package photo

Resist Wrinkle Defense SPF 30 Paulas Choice Zinc Oxide 13 g/100mL Cream, 1.5 mL

by Cosmetic Enterprises Ltd · 1.5 mL in 1 PACKET (56152-5003-2)
NDC 56152-5003-02
🏷️ FDA NDC (as labeled) 56152-5003-2 billing pads the package segment with a zero
This package
Contains1.5 mL Pack sizes2 compare ↓
Also comes in: 60 ml 56152-5003-01
OTC On market Non-controlled
🗂️ Data synced Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →
⚠️
Other active recalls for Zinc Oxide (different manufacturers) — 6 · tap to view
These affect other manufacturers’ products for the same ingredient — not necessarily the exact NDC on this page.
Class II · Oct 31, 2025 — cGMP deviations (Blossom Pharmaceuticals) · FDA recall D-0212-2026
Class II · Oct 31, 2025 — cGMP deviations (Blossom Pharmaceuticals) · FDA recall D-0206-2026
Class II · Oct 31, 2025 — cGMP deviations (Blossom Pharmaceuticals) · FDA recall D-0202-2026
Class II · Oct 31, 2025 — cGMP deviations (Blossom Pharmaceuticals) · FDA recall D-0207-2026
Class II · Oct 31, 2025 — cGMP deviations (Blossom Pharmaceuticals) · FDA recall D-0209-2026
Class II · Oct 31, 2025 — cGMP deviations (Blossom Pharmaceuticals) · FDA recall D-0208-2026
Each entry is an official FDA enforcement report — look up any recall number in the FDA recall database ↗

🆔 Identity & classification

FDA NDC (as labeled) 56152-5003-2
Product NDC 56152-5003
11-digit billing NDC 56152500302
RxCUI 349404
UNII SOI2LOH54Z
UPC 0655439077606
Application # M020
SPL Set ID d658fdc7-9dac-47bf-8e83-1433a29a6cf6
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 2016-08-10
Route TOPICAL
Dosage form CREAM
Substance ZINC OXIDE
Why two NDCs? The FDA registers this code as 56152-5003-2 — a 5-4-1 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 package segment → 56152-5003-02. 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

LabelerCosmetic Enterprises Ltd
FDA applicationM020 (OTC MONOGRAPH DRUG)
Labeler code56152
First marketedAug 2016
Product typeHuman Otc Drug
Portfolio20 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 cream containing zinc oxide, marketed as an over-the-counter sunscreen product under FDA's OTC monograph rules. Zinc oxide is commonly used in sunscreen formulations to reflect and scatter ultraviolet light away from the skin. The product is labeled with an SPF 30 rating, which indicates its level of protection against sun exposure. This type of product is typically applied to exposed skin as part of a sun protection routine.

Supplement & herbal interactions

Some supplements/herbs that may interact with Zinc oxide (OTC drug) — tap one for details:

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 K72T3FS567
    Adenosine is a naturally occurring nucleoside compound. In medicines, it functions as an active pharmaceutical ingredient in some formulations, though when listed as an excipient it may serve as a buffering or stabilizing agent to maintain product stability and pH.
  • 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 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 0THT5PCI0R
    A silicone-based liquid that helps distribute active ingredients evenly throughout topical products. It acts as a solvent and emollient, allowing medicines to spread smoothly on skin while improving texture and absorption.
  • UNII UF7620L1W6
    A synthetic silicone polymer that acts as a thickener and absorbent in medicines. It helps create the right texture, improves how the product feels on skin or in the mouth, and can absorb excess moisture or oil in formulations.
  • UNII BQM438CTEL
    A plant-derived compound from green tea that acts as an antioxidant. It's used in formulations to help prevent degradation of active ingredients and maintain product stability over time.
  • 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 1K09F3G675
    Ferric oxide red is an inorganic iron compound used as a colorant in medicines. It gives tablets, capsules, or other dosage forms a red or reddish tint for identification and appearance.
  • UNII EX438O2MRT
    Ferric oxide yellow is a naturally occurring iron compound used as a colorant in medications. It gives tablets, capsules, and other forms a yellow or golden hue for identification and appearance.
  • UNII XM0M87F357
    A dark iron oxide compound that gives medicines their black or dark color. It's used as a colorant in tablets and capsules to help identify the product and make it visually distinctive.
  • UNII 31T0FF0472
    A red microalgae used as a natural colorant and source of astaxanthin pigment in medications and supplements. It adds color to tablets and capsules.
  • 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 Y6O7T4G8P9
    Hydrated silica is a fine powder form of silicon dioxide with absorbed water. It works as an anti-caking agent and absorbent in medicines, helping powders stay free-flowing and preventing clumping.
  • UNII 949E3KBJ1I
    Isopropyl titanium triisostearate is a titanium-based compound used in medicines as a glidant and anticaking agent. It helps powders and granules flow smoothly during manufacturing and prevents clumping in the finished product.
  • UNII 113171Q70B
    Lauroyl lysine is a compound made by combining an amino acid (lysine) with a fatty acid (lauric acid). It works as a glidant and lubricant to help powder particles flow smoothly during manufacturing and tablet compression.
  • 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 ZEL54N6W95
    A silicone-based compound that helps oils and water mix together. Used in medicines as an emulsifier and anti-foaming agent to improve texture and prevent bubbles in liquids and creams.
  • UNII 9H0AO7T794
    A silicone-based lubricant mixed with polyethylene glycol and polypropylene glycol polymers. It reduces friction between pill surfaces and equipment during manufacturing, and helps the finished product slide smoothly when swallowed.
  • 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 6OZP39ZG8H
    Polysorbate 80 is a synthetic emulsifier derived from sorbitol and oleic acid. It helps mix oil and water-based ingredients together in medications and improves how the product disperses in the body.
  • UNII CLV24I3T1D
    A plant extract from pomegranate root bark used as a natural coloring agent and flavoring component in medicines. It may also help preserve the product and provide mild astringent properties to the formulation.
  • UNII 9IKM0I5T1E
    Quercetin is a plant-derived compound called a flavonoid. It's used in some formulations as an antioxidant and stabilizer to help preserve the medicine's quality and prevent degradation during storage.
  • UNII Q369O8926L
    Resveratrol is a plant-derived compound sometimes added to supplements and fortified products. It may serve as an active nutritional ingredient rather than a traditional inactive filler, though its exact formulation role varies by product.
  • UNII 205MXS71H7
    A plant extract from white willow bark. It's used as a natural flavoring agent and may help preserve the medicine by providing mild antioxidant properties in the formulation.
  • UNII 451W47IQ8X
    Sodium chloride is common table salt. It's used in medicines as a buffer to maintain proper pH, as a filler to add bulk, or to adjust the osmotic balance in liquid formulations.
  • UNII 9LBV3F07AZ
    A synthetic, oil-soluble form of vitamin C used as an antioxidant to prevent degradation of the medicine and maintain its stability during storage.
  • UNII LDC331P08E
    A silicone-based compound that acts as a glidant and flow agent in solid medications. It reduces friction between powder particles, helping the medicine flow smoothly during manufacturing and tablet compression.
  • UNII 06YD7896S3
    A waxy, fatty substance derived from stearic acid. It acts as a thickener and texture modifier in medicines, helping control how quickly the drug dissolves and improving the product's firmness and consistency.
  • 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.

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

The official label also statesWater (Aqua), Cyclopentasiloxane, PEG-12 Dimethicone, PEG/PPG-18/18 Dimethicone, Lauroyl Lysine, Sodium Chloride, Trihydroxystearin, Dimethicone Crosspolymer, Resveratrol, Quercetin, Epigalloactechin Gallate, Tocopheryl Acetate, Tetrahexyldecyl Ascorbate, Adenosine, Bisabolol, Salix Alba (Willow) Bark Extract, Punica Granatum (Pomegranate) Extract, Haematococus Pluvialis Extract, Hydrolyzed Corn Starch, Polysorbate 80, Hydrated Silica, Triethoxycaprylylsilane, C12-15 Alkyl Benzoate, Isopropyl Titanium Triisostearate, Hexylene Glycol, Ethylhexylglycerin, Iron Oxide (CI 77491, CI 77492, CI 77499), Caprylyl Glycol, 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 DailyMedingredient 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: 60 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
Diaper Rash 130 mg/g 11673-0226-26 Target 1 tube FDA listed
Resist Wrinkle Defense SPF 30 Paulas Choice 13 g/100mLthis 56152-5003-02 Cosmetic 1.5 ml FDA listed
TENA Proskin protective cream 130 mg/g 59608-0017-01 Essity 1 tube FDA listed
Diaper Rash 130 mg/g 63941-0226-26 Valu 1 tube FDA listed
Zinc oxide 130 mg/g 64024-0226-26 Aldi, 1 tube FDA listed
CVS Health Diaper Rash 14.7 g/113g 66902-0449-04 NATURAL 1 tube Discontinued
Desitin Daily Defense Zinc Oxide Diaper Rash 130 mg/g 69968-0603-01 Kenvue 454 g FDA listed
Diaper Rash 130 mg/g 71141-0622-26 Lidl 1 tube FDA listed
Sonage Roux Tinted Day Creme with SPF 30 Sheer Tinted Moisturizer 13 g/100mL 69546-0313-02 ASA 1 jar FDA listed
Nuda Canada Solarglow Mineral Serum Sunscreen Spf30 13 g/100mL 71447-0058-01 LABORATOIRES 1 tube 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
Aug 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.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
56152-5003-01 60 mL in 1 TUBE (56152-5003-1) 2016-08-10 Active
56152-5003-02 You're viewing this 1.5 mL in 1 PACKET (56152-5003-2) 2016-08-10 Active

Pack size FAQ

What quantity is in NDC 56152-5003-02?
NDC 56152-5003-02 contains 1.5 mL — 1.5 ml in 1 packet.
What is the difference between NDC 56152-5003-02 and NDC 56152-5003-01?
Both are Resist Wrinkle Defense SPF 30 Paulas Choice Zinc Oxide 13 g/100mL Cream — the drug itself is identical. NDC 56152-5003-02 is the 1.5 mL package, while NDC 56152-5003-01 is the 60 ml package.
What NDC number is used to bill for this package of Resist Wrinkle Defense SPF 30 Paulas Choice Zinc Oxide 13 g/100mL Cream?
Bill NDC 56152-5003-02 — the 11-digit billing format is 56152500302. 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 56152-5003-2, 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: 56152-5003-02, written without dashes as 56152500302. 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 56152-5003-02, the first segment (56152) is the labeler code FDA assigned to Cosmetic Enterprises Ltd; the middle segment (5003) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (02) 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 Cosmetic Enterprises Ltd. 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 60 ml (56152-5003-01). 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?
Cosmetic Enterprises 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.

📄 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 9 words

Stop use and ask a doctor if rash occurs

⏱️ Dosage and Administration 91 words

Directions Apply liberally 15 minutes before sun exposure Use a water-resistant sunscreen if swimming or seating: Immediately after towel dyring At least every two 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 of 15 or higher and other sun protection measures, including: Limit tim in the sun, especially from 10a.m.-2p.m.

Wear long-sleeve shirts, pants, hats and sunglasses

⚠️ Warnings 18 words

Warnings For external use only When using this product keep out of eyes. Rinse with water to remove

🧪 Active Ingredient 8 words

Active Ingredients Purpose Zinc Oxide 13.0% ................. Sunscreen

🧪 Inactive Ingredients 64 words

Water (Aqua), Cyclopentasiloxane, PEG-12 Dimethicone, PEG/PPG-18/18 Dimethicone, Lauroyl Lysine, Sodium Chloride, Trihydroxystearin, Dimethicone Crosspolymer, Resveratrol, Quercetin, Epigalloactechin Gallate, Tocopheryl Acetate, Tetrahexyldecyl Ascorbate, Adenosine, Bisabolol, Salix Alba (Willow) Bark Extract, Punica Granatum (Pomegranate) Extract, Haematococus Pluvialis Extract, Hydrolyzed Corn Starch, Polysorbate 80, Hydrated Silica, Triethoxycaprylylsilane, C12-15 Alkyl Benzoate, Isopropyl Titanium Triisostearate, Hexylene Glycol, Ethylhexylglycerin, Iron Oxide (CI 77491, CI 77492, CI 77499), Caprylyl Glycol, Phenoxyethanol

🎯 Purpose 30 words

Uses Helps prevent sunburn If used as directed with otehr 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 ↗
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.