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Hale and Hush Broad Spectrum SPF 30 SPF 30 Zinc Oxide 13.5 g/100g Cream, 55 g — NDC 83677-0610-58 package photo

Hale and Hush Broad Spectrum SPF 30 SPF 30 Zinc Oxide 13.5 g/100g Cream, 55 g

by Eclectic Solutions LLC · 55 g in 1 BOTTLE, DISPENSING (83677-610-58)
NDC 83677-0610-58
🏷️ FDA NDC (as labeled) 83677-610-58 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) 83677-610-58
Product NDC 83677-610
11-digit billing NDC 83677061058
UNII SOI2LOH54Z
Application # M020
SPL Set ID 0530904f-b02c-d8cf-e063-6294a90aa5a7
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2018-04-02
Route TOPICAL
Dosage form CREAM
Substance ZINC OXIDE
Why two NDCs? The FDA registers this code as 83677-610-58 — 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 → 83677-0610-58. 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

LabelerEclectic Solutions LLC
FDA applicationM020 (OTC MONOGRAPH DRUG)
Labeler code83677
First marketedApr 2018
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.

🩺 Clinical

🧪 What is this product?

Hale and Hush Broad Spectrum SPF 30 is a topical cream sunscreen containing zinc oxide as its active ingredient. Zinc oxide is a mineral UV filter commonly used in sunscreens to help protect skin from ultraviolet radiation. This product is marketed as an over-the-counter monograph drug, meaning it follows FDA's established rules for sunscreen products rather than being individually approved. The cream form is applied directly 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 A7E6112E4N
    A form of vitamin E used as an antioxidant in medicines. It prevents oils and fats in the product from breaking down, helping maintain stability and shelf life.
  • UNII 3K9958V90M
    A liquid solvent derived from fermentation or chemical synthesis. In medicines, alcohol dissolves active ingredients, helps preserve the product, and improves how the body absorbs certain drugs.
  • UNII J87WJ3E7VW
    A plant-derived oil from the candlenut tree, used as an emollient and natural binder to help soften the product and improve how ingredients blend together in formulations.
  • 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 FJ1H6M2JG9
    A blend of plant-derived fatty acids that helps dissolve and deliver active ingredients. It acts as a solvent and absorption enhancer in soft gelatin capsules and liquid formulations.
  • 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 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 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 BDZ3DQM98W
    Ergothioneine is a naturally occurring compound found in mushrooms and some bacteria. It's used in medicines as an antioxidant to help protect the product from degradation during storage.
  • UNII ANA2NCS6V1
    A natural oil derived from macadamia nuts, used as an emollient and conditioning agent. It helps soften the product's texture and improve how it spreads or absorbs on skin or mucous membranes.
  • UNII 7IGF0S7R8I
    Phytic acid is a naturally occurring compound found in plants that acts as a chelating agent and preservative in medicines. It helps stabilize formulations and prevent oxidation of active ingredients.
  • 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 HYE7O27HAO
    Glyceryl isostearate is a fatty substance derived from vegetable oils or animal fats. In medicines, it acts as an emulsifier to blend water and oil components together, and helps form a smooth texture in creams, ointments, and other topical products.
  • UNII YCZ8EM144Q
    A fat derived from palm oil that has been chemically treated to make it more stable. It acts as a binder and lubricant in tablets and capsules, helping hold ingredients together and prevent sticking during manufacturing.
  • UNII 9M44R3409A
    A modified corn starch where some starch molecules have hydroxypropyl groups attached. It's used as a binder and disintegrant to help hold tablet ingredients together and allow the tablet to break apart properly when swallowed.
  • UNII 3NXW29V3WO
    Hypromellose is a plant-based thickener made from cellulose. It's used in medicines as a binder to hold ingredients together, a coating for tablets, and a thickener for liquids.
  • UNII W60VYE24XC
    A synthetic oily compound used as an emollient and solvent in topical medicines. It helps soften the skin, improve product spreadability, and dissolve active ingredients for better absorption through the skin.
  • UNII 1DI56QDM62
    A natural fatty substance from soybeans that helps mix oil and water-based ingredients together. It acts as an emulsifier and lubricant in medicines to improve texture and help the product break down properly in your body.
  • 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 5N1WD9784U
    A plant-derived ingredient from honeysuckle flowers, used as a natural flavoring or fragrance component to improve taste or aroma in the medicine.
  • UNII 515610SU8C
    Macadamia oil is a plant-derived oil extracted from macadamia nuts. In medicines, it serves as an emollient and solvent to help dissolve or suspend active ingredients and improve product texture and absorption.
  • UNII J3TZF807X5
    A weak organic acid derived from fruits and vegetables. Used as a buffer to adjust pH, a flavor enhancer for tartness, and a preservative to extend shelf life in tablets, capsules, and liquid medications.
  • UNII 85O35YN6YY
    A manufactured emulsifier derived from polyethylene glycol and stearic acid. It helps blend oil and water-based ingredients in medicines and also acts as a surfactant to improve how the drug dissolves and is absorbed by the body.
  • UNII PBG27B754G
    Phellodendron amurense bark is a plant-derived ingredient from the cork tree. It functions as a natural preservative and antimicrobial agent to help maintain product stability and prevent microbial growth.
  • UNII 90TF85HH91
    A fatty substance made from glycerin and stearic acid. It works as an emulsifier to help mix oil and water-based ingredients together in the medicine, and may also help with texture and consistency.
  • 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.
  • UNII 14AN0J70WO
    A red seaweed extract used as a natural binder and thickener in medications. It helps hold tablet ingredients together and may improve the texture of liquid formulations.
  • UNII 03KCY6P7UT
    A waxy compound derived from cetyl alcohol and phosphoric acid. It acts as an emulsifier to help blend oil and water ingredients, and as a thickener to give the medicine its proper texture and consistency.
  • UNII 3641YW25N2
    A fragrant oil extracted from sandalwood tree wood, used as a flavoring agent and fragrance to improve the taste and smell of medicines.
  • UNII 55X04QC32I
    A strong alkaline chemical used to adjust and maintain the pH balance of liquid medicines. It helps keep the medicine stable and ensures it stays effective during storage.
  • UNII TU7HW0W0QT
    A salt derived from lactic acid, sodium lactate acts as a buffer and pH stabilizer in medicines. It helps maintain the product's acidity level and can also serve as a humectant to retain moisture.
  • UNII IN99IT31LN
    Sodium stearoyl lactylate is a synthetic compound made from stearic acid and lactic acid. It works as an emulsifier to help keep oils and water mixed together, and as a dough conditioner in solid dosage forms.
  • 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 101I4J0U34
    Witch hazel is a plant extract obtained from the leaves and bark of the North American shrub Hamamelis virginiana. It functions as an astringent and skin-conditioning agent in topical products, helping to tone and prepare the skin.

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

The official label also statesInactive Ingredients: Aqua (Water), Caprylic/Capric Triglyceride, Candelilla/Jojoba/Rice Bran Polyglyceryl-3 Esters, Glycerin, Isodecyl Neopentanoate, Ethyl Macadamiate, Aleurites Moluccanus Seed Oil, Hydroxypropyl Starch Phosphate, Glyceryl Stearate, Hamamelis Virginiana (Witch Hazel) Water, Ergothioneine [(L), Hordeum Distichon (Barley) Extract, Macadamia Ternifolia Seed Oil, Porphyra Umbilicalis (Red Algae) Extract, Santalum Album (Sandalwood) Extract, Phellodendron Amurense Bark Extract, Bisabolol (L-alpha), Glyceryl Isostearate, Sodium Stearoyl Lactylate, Polyglycery1-10 Pentastearate, Polyhydroxystearic Acid, Tocopheryl Acetate (D-alpha), Tocopherol (D-alpha), Lecithin, Malic Acid (L), Lonicera Caprifolium (Honeysuckle) Flower Extract, Lonicera Japonica (Honeysuckle) Flower Extract, Potassium Cetyl Phosphate, Hydrogenated Palm Glycerides, Alcohol, Cetearyl Alcohol, Behenyl Alcohol, Hydroxypropyl Methylcellulose, Sodium Lactate, Phytic Acid, Citric Acid, Sodium Hydroxide

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
Hale and Hush Broad Spectrum SPF 30 SPF 30 13.5 g/100gthis 83677-0610-58 Eclectic 55 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

🏛️
2018
On the market since
Apr 2018
📍
2026
Currently FDA-listed
8 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
83677-0610-58 You're viewing this 55 g in 1 BOTTLE, DISPENSING (83677-610-58) 2018-04-02 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 ✓ 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 83677-610-58, 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: 83677-0610-58, written without dashes as 83677061058. 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 83677-0610-58, the first segment (83677) is the labeler code FDA assigned to Eclectic Solutions LLC; the middle segment (0610) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (58) 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 Eclectic Solutions LLC. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Eclectic Solutions 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 ▾

* Help prevent sunburn * if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by th

⏱️ Dosage and Administration 88 words ▾

Directions apply liberally 15 minutes before sun exposure use a water resistant sunscreen if swimming or sweating reapply at least every 2 hours Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with broad spectrum spf of 15 or higher and other sun protection measure including: limit time in the sun, especially from 10am to 2 pm wear long-sleeve shirts, pants, hats and sunglasses children under 6 months: Ask a doctor

⚠️ Warnings 44 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. Keep out of reach of children. If swallowed, get medical help or contact a poison control center right away.

🧪 Active Ingredient 3 words ▾

Zinc Oxide 13.50%

🧪 Inactive Ingredients 103 words ▾

Inactive Ingredients: Aqua (Water), Caprylic/Capric Triglyceride, Candelilla/Jojoba/Rice Bran Polyglyceryl-3 Esters, Glycerin, Isodecyl Neopentanoate, Ethyl Macadamiate, Aleurites Moluccanus Seed Oil, Hydroxypropyl Starch Phosphate, Glyceryl Stearate, Hamamelis Virginiana (Witch Hazel) Water, Ergothioneine [(L), Hordeum Distichon (Barley) Extract, Macadamia Ternifolia Seed Oil, Porphyra Umbilicalis (Red Algae) Extract, Santalum Album (Sandalwood) Extract, Phellodendron Amurense Bark Extract, Bisabolol (L-alpha), Glyceryl Isostearate, Sodium Stearoyl Lactylate, Polyglycery1-10 Pentastearate, Polyhydroxystearic Acid, Tocopheryl Acetate (D-alpha), Tocopherol (D-alpha), Lecithin, Malic Acid (L), Lonicera Caprifolium (Honeysuckle) Flower Extract, Lonicera Japonica (Honeysuckle) Flower Extract, Potassium Cetyl Phosphate, Hydrogenated Palm Glycerides, Alcohol, Cetearyl Alcohol, Behenyl Alcohol, Hydroxypropyl Methylcellulose, Sodium Lactate, Phytic Acid, Citric Acid, Sodium Hydroxide

🎯 Purpose 1 words ▾

Sunscreen

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 83676-0436-00 · SERENU, 83678-2049-02 · Green →
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.