Home › NDC Lookup › Ingredients › Zinc Oxide › 84568-0552-12
🧴image loading
(from DailyMed)

New Kid on the Block Zinc Oxide 20 g/100g Lotion, 106.8 g

by Dimples Bath Co. LLC · 106.8 g in 1 TUBE (84568-552-12)
NDC 84568-0552-12
🏷️ FDA NDC (as labeled) 84568-552-12 billing pads the product segment with a zero
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 →

This page is curated, coded, and maintained by

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

⚠️
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) 84568-552-12
Product NDC 84568-552
11-digit billing NDC 84568055212
UNII SOI2LOH54Z
Application # M020
SPL Set ID 26f85758-820f-3f73-e063-6294a90a289d
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2024-11-01
Route TOPICAL
Dosage form LOTION
Substance ZINC OXIDE
Why two NDCs? The FDA registers this code as 84568-552-12 — 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 → 84568-0552-12. 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

LabelerDimples Bath Co. LLC
FDA applicationM020 (OTC MONOGRAPH DRUG)
Labeler code84568
First marketedNov 2024
Product typeHuman Otc Drug
Portfolio4 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 an over-the-counter lotion containing zinc oxide at a concentration of 20 grams per 100 grams. Zinc oxide is a mineral ingredient commonly used in topical products to protect and soothe skin. It is typically applied to the skin to create a protective barrier and is often found in products intended to help with minor skin irritation and chafing.

Supplement & herbal interactions

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

Dimethylsulfoxide (dmso)Moderate Turpentine OilModerate AlchemillaMinor
🌿 Every supplement checked against Zinc oxide (OTC drug) (3 interactions) — ranked by severity →
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.

  • 0.99 g / 100 g UNII 1QR1QRA9BU
    A fatty alcohol derived from peanut oil or made synthetically. It serves as an emollient and thickener in creams and ointments, helping create smooth texture and improve product consistency.
  • 0.27 g / 100 g UNII 6JVW35JOOJ
    Arachidyl glucoside is a plant-derived emulsifier and skin-conditioning agent made from arachidyl alcohol and glucose. It helps mix oil and water-based ingredients together in formulations and improves product texture and spreadability.
  • 0.54 g / 100 g UNII 9G1OE216XY
    Docosanol is a waxy, fatty alcohol derived from plant sources. It acts as an emollient and thickener in topical medicines, helping to soften the skin and improve product texture and stability.
  • 0.075 g / 100 g UNII S347WMO6M4
    Beta-sitosterol is a plant-derived sterol (waxy substance from vegetable oils and seeds). In medicines, it acts as an emulsifier or thickening agent to help blend oil and water-based ingredients and improve texture.
  • 0.3 g / 100 g 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.
  • 5 g / 100 g UNII 2EH13UN8D3
    A synthetic compound used as a solvent and penetration enhancer in topical formulations. It helps dissolve active ingredients and allows them to penetrate the skin more effectively.
  • 2.1 g / 100 g 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.
  • 1.8 g / 100 g UNII N7YC58165T
    A synthetic polymer made from glycerin and sebacic acid, used as a film-former and binder in medications. It helps hold tablet or capsule ingredients together and may coat the product for controlled release.
  • 0.144 g / 100 g UNII K679OBS311
    Carboxymethylcellulose sodium is a plant-derived thickening agent made from cellulose. In medicines, it acts as a binder to hold ingredients together, a disintegrant to help the tablet break apart, or a thickener in liquids.
  • 1.3 g / 100 g 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.
  • 0.75 g / 100 g 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.
  • 0.2 g / 100 g 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.
  • 0.7 g / 100 g UNII ICS790225B
    A plant-derived cleaning agent made from coconut oil and glucose. It works as a surfactant and emulsifier to help mix oil and water-based ingredients together in the formulation.
  • 8 g / 100 g UNII Q9L0O73W7L
    Coconut oil is a natural fat extracted from coconut fruit. It's used in medicines as a lubricant, emollient, or carrier to help dissolve or deliver active ingredients smoothly through the formulation.
  • 3.2 g / 100 g UNII 057N7SS26Y
    A clear, oily liquid derived from succinic acid and alcohol chains. It functions as a plasticizer and solvent in formulations, helping soften coatings and improve flexibility of film-coated tablets.
  • 0.1 g / 100 g 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.
  • 0.495 g / 100 g UNII 3W1JG795YI
    Sunflower oil is a natural vegetable oil derived from sunflower seeds. It serves as a solvent, lubricant, and carrier in medicines, helping dissolve active ingredients and improve how the medication flows and absorbs in the body.
  • 3 g / 100 g UNII 7666FJ0J9F
    A rosin-derived compound used as a film-coating agent and binder in tablets and capsules. It helps create a protective layer around the medication and improves tablet hardness.
  • 1.056 g / 100 g UNII OP1R32D61U
    Microcrystalline cellulose is a purified form of cellulose, a natural fiber from plant sources. It acts as a binder and filler in tablets and capsules, helping hold ingredients together and give the medicine its shape and size.
  • 0.9 g / 100 g 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.
  • 0.1 g / 100 g UNII YXH47AOU0F
    A synthetic fatty acid used as a thickener and stabilizer in medicines. It helps create the right texture and prevents separation of ingredients in liquid or semi-solid formulations.
  • 0.2 g / 100 g UNII R6Q3791S76
    Sodium gluconate is a salt derived from gluconic acid, a naturally occurring compound. In medicines, it functions as a buffering agent to help maintain stable pH and as a chelating agent that can bind minerals in formulations.
  • 0.2 g / 100 g UNII YSE9PPT4TH
    Hyaluronate sodium is a natural carbohydrate that holds moisture. It's used in medicines as a lubricant, thickener, and moisture-retaining agent to improve texture and delivery of the active ingredient.
  • 1.3 g / 100 g 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.
  • 0.0375 g / 100 g UNII 7QWM220FJH
    Squalene is a natural oil-like substance found in shark liver and some plants. It's used in medicines as an emulsifier to help mix oil and water-based ingredients together.
  • 0.8 g / 100 g UNII 512OYT1CRR
    Cocoa butter is a natural fat extracted from cocoa beans. It's used in medicines as a base for suppositories and as a lubricant to help pills dissolve smoothly.
  • 0.1425 g / 100 g 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.
  • 46.3 g / 100 g 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.

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

The official label also statesArachidyl Alcohol, Arachidyl Glucoside, Behenyl Alcohol, Bisabolol, Butyloctyl Salicylate, Butyrospermum Parkii (Shea) Butter,, Capryloyl Glycerin/Sebacic Acid Copolymer, Cellulose Gum, Cetearyl Alcohol, Cetyl Alcohol, Citric Acid, Coco-Glucoside, Cocos Nucifera (Coconut) OiI, Diheptyl Succinate, Ethylhexlglycerin, Methyl Dihydroabietate, Microcrystalline Cellulose, Phenoxyethanol, Polyhydroxystearic Acid, Sodium Gluconate, Sodium Hyaluronate, Sodium Stearoyl Glutamate, Theobroma Cacao (Cocoa) Seed Butter*, Tocopherol, Water

Label-section wording can be broader than the structured product block and may mention additional formulation ingredients.

Where does this data come from?
Data sourced from official FDA Structured Product Labeling (SPL) via DailyMed — ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

💲 Pricing

A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.

Price systemPer gPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
ℹ️
No price is published for this exact package yet. CMS surveys NADAC per package size, so a different pack of the same drug often has one.
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
restorsea Rejuvenating Day SPF 30 Broad Spectrum UVA UVB with Vibransea Complex 20 g/100g 57670-0000-00 RESTORSEA 1 tube — — FDA listed —
SPF 50 Mineral Sunscreen 20 g/100g 72667-0101-01 Inspec 50 g — — FDA listed —
Radically Rejuvenating SPF Day Cream 20 g/100g 54136-0152-52 Better 52 g — — FDA listed —
Seriously Soothing SPF Day Cream 20 g/100g 54136-0179-52 Better 52 g — — FDA listed —
ATTITUDE Oatmeal Sensitive Natural Mineral Sunscreen Stick Unscented SPF 30 20 g/100g 61649-0100-60 9055-7588 60 g — — FDA listed —
Attitude Kids Oatmeal sensitive mineral sunscreen unscented SPF 30 20 g/100g 61649-0162-75 9055-7588 75 g — — FDA listed —
Attitude Oatmeal sensitive mineral sunscreen unscented SPF 30 20 g/100g 61649-0165-15 9055-7588 150 g — — FDA listed —
Zinc Oxide 20 g/100g 69771-0109-38 Geri-Gentle 1 tube — — FDA listed —
Aloe UP SPF 33 Mineral 20 g/100g 61477-0231-01 Aloe 30 g — — FDA listed —
Attitude mineral sunscreen orange blossom SPF 30 20 g/100g 61649-0022-15 9055-7588 150 g — — FDA listed —
Attitude mineral sunscreen unscented SPF 30 20 g/100g 61649-0030-85 Attitude 85 g — — Discontinued —
Attitude mineral sunscreen tropical SPF 30 20 g/100g 61649-0031-85 Attitude 85 g — — Discontinued —
ATTITUDE Sunly Kids Mineral Sunscreen Stick Unscented SPF 30 20 g/100g 61649-0098-60 9055-7588 60 g — — FDA listed —
ATTITUDE Sunly Tinted Mineral Sunscreen Face Stick Unscented SPF 30 20 g/100g 61649-0097-20 9055-7588 20 g — — FDA listed —
All Good Mineral Sport Sunscreen Sunstick SPF 30 20 g/100g 75786-0220-01 Elemental 17 g — — FDA listed —
Mackenzies SPF 40 Ocean Safe Sunscreen 20 g/100g 80325-0040-02 Naturally 80 g — — FDA listed —
Zinctral 20 g/100g 59088-0627-05 PureTek 57 g — — FDA listed —
Aloe Up SPF 50 Mineral 20 g/100g 61477-0234-01 Aloe 89 g — — FDA listed —
Aloe Up SPF 50 Kids Mineral 20 g/100g 61477-0236-01 Aloe 89 g — — FDA listed —
Attitude mineral sunscreen tropical SPF 30 20 g/100g 61649-0021-15 9055-7588 150 g — — FDA listed —
ATTITUDE Oceanly Phyto-sun lip balm SPF 30 Terracotta 20 g/100g 61649-0046-08 9055-7588 8.5 g — — FDA listed —
ATTITUDE Sunly Mineral Sunscreen Stick Unscented SPF 30 20 g/100g 61649-0090-60 9055-7588 60 g — — FDA listed —
ATTITUDE Sunly Mineral Sunscreen Stick Orange Blossom SPF 30 20 g/100g 61649-0092-60 9055-7588 60 g — — FDA listed —
Attitude Kids mineral sunscreen unscented SPF 30 20 g/100g 61649-0160-15 9055-7588 150 g — — FDA listed —
Mineral Defense Sport Ceramide Spf-30 20 g/100g 73054-0108-11 SOLARA 1 applicator — — FDA listed —
ProCure Zinc Oxide 20 g/100g 55681-0017-01 Twin 28.3 g — — FDA listed —
Attitude Kids mineral sunscreen unscented SPF 30 20 g/100g 61649-0038-85 Attitude 85 g — — Discontinued —
Attitude tinted mineral sunscreen face unscented SPF 30 20 g/100g 61649-0041-30 Attitude 30 g — — Discontinued —
ATTITUDE Oatmeal Sensitive Natural Mineral Sunscreen Face Stick Unscented SPF 30 20 g/100g 61649-0101-20 9055-7588 20 g — — FDA listed —
All Good Coconut Mineral Sunscreen Sunstick SPF 30 20 g/100g 75786-0221-01 Elemental 17 g — — FDA listed —
ATTITUDE Sunly Mineral Sunscreen Face Stick Unscented SPF 30 20 g/100g 61649-0094-20 9055-7588 20 g — — FDA listed —
Medpride 20 g/100g 52410-3040-03 Shield 28 g — — FDA listed —
Medline 20 g/100g 53329-0220-07 Medline 14 g — — FDA listed —
ATTITUDE Sunly Mineral Sunscreen Stick Tropical SPF 30 20 g/100g 61649-0091-60 9055-7588 60 g — — FDA listed —
Bio Spectra Attitude 20 g/100g 61649-0120-01 9055-7588 75 g — — FDA listed —
BLDG Active Skin Repair Sun Stick Performance Sunscreen 20 g/100g 70489-1423-01 Innovacyn, 15 g — — FDA listed —
Stream2Sea SPF 50 20 g/100g 69555-0050-01 Stream2Sea 1 jar — — FDA listed —
Stream2Sea Sport Lip Balm SPF 50 20 g/100g 69555-0500-01 Stream2Sea, 4 g — — FDA listed —
ATTITUDE Sunly Kids Mineral Sunscreen Face Stick Unscented SPF 30 20 g/100g 61649-0099-20 9055-7588 20 g — — FDA listed —
Bio Spectra Attitude 20 g/100g 61649-0110-15 9055-7588 150 g — — FDA listed —
dabur 20 g/100g 68747-3040-03 Dabur 28 g — — FDA listed —
New Kid on the Block 20 g/100gthis 84568-0552-12 Dimples 106.8 g — — FDA listed —
Lasso Tallow Sunscreen Spf 50 20 g/100g 87761-0004-01 Moes 140 g — — FDA listed —
Procure 20 g/100g 55681-0304-03 TWIN 28.3 g — — FDA listed —
ATTITUDE Oceanly Phyto-sun lip balm SPF 30 Baby Rose 20 g/100g 61649-0045-08 9055-7588 8.5 g — — FDA listed —
ATTITUDE Oceanly Phyto-sun lip balm SPF 30 Peachy Shell 20 g/100g 61649-0047-08 9055-7588 8.5 g — — FDA listed —
Endit Zinc Oxide Skin Protectant 20 g/100g 64068-0402-01 Endit 454 g — — FDA listed —
Stream2Sea Reef Safer Mineral Sunscreen SPF40 20 g/100g 69555-0400-10 Stream2Sea, 1 jar — — FDA listed —
365 Whole Foods Market Sport Mineral Spf 30 20 g/100g 42681-0062-01 Whole 44 g — — FDA listed —
Stream2Sea Ecostock SPF 40 Sunscreen 20 g/100g 69555-0401-01 Stream2Sea, 14 g — — FDA listed —
Utu Broad Spectrum SPF 30 Moisturizing Body Sunscreen 20 g/100g 87952-0004-02 Utu 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

🏛️
2024
On the market since
Nov 2024
📍
2026
Currently FDA-listed
2 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.

🔬 Reported adverse events (FAERS)

Read carefully: FAERS reports are voluntary and unverified. Counts are not incidence, do not establish causation, are subject to reporting bias, and cannot be used to compare one drug to another. Shown for signal context only. Reports for Zinc Oxide — the ingredient across all brands.

Top reported reactions

Macular Degeneration460
Nausea365
Pyrexia351
Pain348
Malaise289
Weight Decreased284
Constipation257

Age at onset

Neonate6
Infant11
Child35
Adolescent8
Adult218
Elderly272

Reporter sex

0 reports
Male · 36%
Female · 64%
Unknown · 0%

Serious outcomes

Hospitalization1,367
Life-threatening166
Reports over time (by year) — tap or hover for the count & year
2020 2022 2024 2026 365 0
Most recent year is provisional (FAERS lags ~3 months).
Where does this data come from?
Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
84568-0552-12 You're viewing this 106.8 g in 1 TUBE (84568-552-12) 2024-11-01 Active

🧭 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 — Not published for this NDC No photo available yet for this listing.
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 84568-552-12, 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: 84568-0552-12, written without dashes as 84568055212. 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 84568-0552-12, the first segment (84568) is the labeler code FDA assigned to Dimples Bath Co. LLC; the middle segment (0552) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (12) 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 Dimples Bath Co. LLC. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Dimples Bath Co. 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.

📄 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
🎯 Indications and Usage 29 words ▾

Uses Helps prevent sunburn. If used as directed with other sun protection measured (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun

⏱️ Dosage and Administration 98 words ▾

Directions Directions • Apply liberally 15 minutes before sun exposure • Reapply after 80 minutes of swimming or sweating • Immediately after towel drying 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 value of 15 or higher and other sun protecting measures including • Limit time in the sun, especially from 1Oam - 2pm Wear long-sleeved shirts, pants, hats, and sunglasses • Children under 6 months Ask a doctor

⚠️ Warnings 34 words ▾

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

🧪 Active Ingredient 3 words ▾

Zinc Oxide 19.6%

🧪 Inactive Ingredients 55 words ▾

Arachidyl Alcohol, Arachidyl Glucoside, Behenyl Alcohol, Bisabolol, Butyloctyl Salicylate, Butyrospermum Parkii (Shea) Butter, , Capryloyl Glycerin/Sebacic Acid Copolymer, Cellulose Gum, Cetearyl Alcohol, Cetyl Alcohol, Citric Acid, Coco-Glucoside, Cocos Nucifera (Coconut) OiI, Diheptyl Succinate, Ethylhexlglycerin, Methyl Dihydroabietate, Microcrystalline Cellulose, Phenoxyethanol, Polyhydroxystearic Acid, Sodium Gluconate, Sodium Hyaluronate, Sodium Stearoyl Glutamate, Theobroma Cacao (Cocoa) Seed Butter*, Tocopherol, Water

🎯 Purpose 1 words ▾

Sunscreen

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 84568-0550-01 · Dimples 84568-0553-12 · Dimples →
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.