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Baby Donna SHeer SPF Sunscreen Stick Zinc Oxide 19 g/100g Stick, 16 g

by Stream2Sea, LLC · 1 CONTAINER in 1 BOX (69555-044-01) / 16 g in 1 CONTAINER
NDC 69555-0044-01
🏷️ FDA NDC (as labeled) 69555-044-01 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) 69555-044-01
Product NDC 69555-044
11-digit billing NDC 69555004401
UNII SOI2LOH54Z
UPC 0196852975938
Application # M020
SPL Set ID a1b1cdeb-e5fe-4ba1-8bb0-3c7a97dd93fe
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 2023-03-28
Route TOPICAL
Dosage form STICK
Substance ZINC OXIDE
Why two NDCs? The FDA registers this code as 69555-044-01 — 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 → 69555-0044-01. 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.

🏭 Manufacturer & labeler

LabelerStream2Sea, LLC
FDA applicationM020 (OTC MONOGRAPH DRUG)
Labeler code69555
First marketedMar 2023
Product typeHuman Otc Drug
Portfolio14 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 sunscreen stick containing zinc oxide, an OTC monograph product sold under FDA's established rule-book for sunscreen ingredients. Zinc oxide is a mineral active ingredient commonly used in sunscreens to help block and reflect ultraviolet (UV) rays from the sun. The product is formulated as a solid stick for convenient application to the skin.

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.

  • 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.
  • 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.
  • UNII WL0328HX19
    A natural plant-based wax derived from candelilla shrub leaves. It acts as a coating agent, hardener, and texture modifier to control how quickly the medicine releases and to improve the tablet or capsule's appearance and stability.
  • UNII R12CBM0EIZ
    A natural wax derived from a Brazilian palm tree, used as a coating and polish on tablets and capsules. It creates a smooth, shiny finish that protects the medicine and improves appearance.
  • UNII 2DMT128M1S
    A waxy solid derived from plant or animal sources. It acts as an emulsifier to blend oil and water components, and also thickens the medicine to give it the right texture and consistency.
  • UNII 1E5KJY107T
    A liquid mixture derived from coconut oil, coconut alkanes serve as a solvent and lubricant in medicines. They help dissolve active ingredients and reduce friction during manufacturing and tablet compression.
  • UNII 8D9H4QU99H
    A synthetic fatty acid ester derived from coconut oil, used as an emulsifier and solubilizer to help mix oil and water-based ingredients and improve how the body absorbs certain drugs.
  • 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.
  • UNII TM2TZD4G4A
    A plant-derived oily substance used as an emulsifier and solubilizer in medicines. It helps blend water and oil-based ingredients together and improves how the body absorbs certain active drugs.
  • UNII ZF94AP8MEY
    Hydrogenated castor oil is a processed plant oil made by adding hydrogen to castor oil. It's used as a binder to help hold tablet ingredients together and as a lubricant to prevent sticking during manufacturing.
  • UNII 412ZHA4T4Y
    A plant-derived oil extracted from meadowfoam seeds. It acts as an emollient and skin-conditioning agent, helping soften and smooth the product texture while improving how it spreads on skin.
  • 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 8KQ7I65XZE
    A waxy compound derived from stearic acid, used as a thickener and emulsifier to help blend oil and water-based ingredients. It improves the texture and stability of the medicine formulation.
  • 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 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.

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

The official label also statesCaprylic Capric Triglycerides, Coconut Alkanes (and) Coco-Caprylate/Caprate PolyhydroxystearicAcid, Coco caprylate/caprate, Butyrospermum Parkii (Shea) Butter Copernicia Cerifera (Carnauba) Wax, Arachidyl Alcohol (and) Behenyl Alcohol (and) Arachidyl Glucoside Candelilla Wax (Euphorbia Cerifera), Cetearyl Alcohol 50, Hydrogenated Castor Oil, Glyceryl Caprylate Meadowfoam Seed Oil,Mixed Tocopherols (Vitamin E)

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 eachPer 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
Wonderscreen Tinted Broad Spectrum SPF 30 19 g/100g 82870-0005-01 Dime 50 g — — FDA listed —
Zoey naturals Broad Spectrum SPF 50 Fragrance Free Sunscreen 19 g/100g 70793-0033-68 Absolutely 19.5 g — — FDA listed —
Lather Daily Defense Mineral SPF 45 Facial Sunscreen 19 g/100g 77394-0204-02 Lather, 1 bottle — — FDA listed —
Wonderscreen Broad Spectrum SPF 30 19 g/100g 44717-0062-01 Wasatch 50 g — — FDA listed —
Hustle Butter Spf 50 Mineral Sunscreen 19 g/100g 72014-0202-02 H.B.D.DIST. 19.5 g — — FDA listed —
Banana Boat 19 g/100g 63354-0373-01 Edgewell 74 g — — FDA listed —
SPF 30 Mineral Sunscreen 19 g/100g 83369-0003-01 Smalls 50 g — — FDA listed —
Baby Donna SHeer SPF Sunscreen Stick 19 g/100gthis 69555-0044-01 Stream2Sea, 16 g — — FDA listed —
Smart Care Mineral-Enhanced SUNSCREEN SPF 50 19 g/100g 70108-0269-01 Ashtel 170 g — — Discontinued —
Wonderscreen Broad Spectrum SPF 30 Shade 1 19 g/100g 82870-0007-01 Dime 50 g — — FDA listed —
Banana Boat 19 g/100g 63354-0374-23 Edgewell 147 g — — FDA listed —
Wonderscreen Tinted Broad Spectrum SPF 30 Shade 3 19 g/100g 82870-0008-01 Dime 50 g — — FDA listed —
Wonderscreen Broad Spectrum SPF 30 19 g/100g 82870-0001-01 Dime 50 g — — FDA listed —
Absolutely Natural Broad Spectrum SPF 50 Sunscreen 19 g/100g 70793-0035-68 Absolutely 19.5 g — — 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

🏛️
2023
On the market since
Mar 2023
📍
2026
Currently FDA-listed
3 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
69555-0044-01 You're viewing this 1 CONTAINER in 1 BOX (69555-044-01) / 16 g in 1 CONTAINER 2023-03-28 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 69555-044-01, 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: 69555-0044-01, written without dashes as 69555004401. 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 69555-0044-01, the first segment (69555) is the labeler code FDA assigned to Stream2Sea, LLC; the middle segment (0044) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (01) 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 Stream2Sea, LLC. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Stream2Sea, 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 32 words ▾

Uses Helps prevent sunburn. If used as directed with other 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 15min before sun exposure. Reapply after 80mins of swimming or sweating immediately after towel drying and at least every 2 hrs. For 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 value of 15 or higher and other sun protection measures including: limit time in the sun, especially from 10 a.m.-2 p.m. wear long-sleeved shirts, pants, hats, and sunglasses.

⚠️ Warnings 57 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 doctor if rash occurs Keep out of reach of child. If product is swallowed, get medical help or contact a Poison Control Center right away.

🧪 Active Ingredient 5 words ▾

Active Ingredient Zinc Oxide 19%

🧪 Inactive Ingredients 46 words ▾

Inactive Ingredients Caprylic Capric Triglycerides, Coconut Alkanes (and) Coco-Caprylate/Caprate PolyhydroxystearicAcid, Coco caprylate/caprate, Butyrospermum Parkii (Shea) Butter Copernicia Cerifera (Carnauba) Wax, Arachidyl Alcohol (and) Behenyl Alcohol (and) Arachidyl Glucoside Candelilla Wax (Euphorbia Cerifera), Cetearyl Alcohol 50, Hydrogenated Castor Oil, Glyceryl Caprylate Meadowfoam Seed Oil,Mixed Tocopherols (Vitamin E)

🎯 Purpose 2 words ▾

Purpose Sunscreen

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 69555-0043-01 · Stream2Sea, 69555-0045-01 · Stream2Sea, →
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.