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Calendula Essential Hydrating Broad Spectrum SPF 30 Sunscreen Zinc Oxide 150 mg/mL Lotion — NDC 64657-0007-02 package photo

Calendula Essential Hydrating Broad Spectrum SPF 30 Sunscreen Zinc Oxide 150 mg/mL Lotion

by Naturopathica Holistic Health · 1 TUBE in 1 CARTON (64657-007-02) / 65 mL in 1 TUBE (64657-007-01)
NDC 64657-0007-02
🏷️ FDA NDC (as labeled) 64657-007-02 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) 64657-007-02
Product NDC 64657-007
11-digit billing NDC 64657000702
UNII SOI2LOH54Z
Application # M020
SPL Set ID 41d75815-e281-bf88-e063-6294a90afeff
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2025-10-23
Route TOPICAL
Dosage form LOTION
Substance ZINC OXIDE
Why two NDCs? The FDA registers this code as 64657-007-02 — 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 → 64657-0007-02. 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

LabelerNaturopathica Holistic Health
FDA applicationM020 (OTC MONOGRAPH DRUG)
Labeler code64657
First marketedOct 2025
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?

This is a topical lotion sunscreen containing zinc oxide as its active ingredient. Zinc oxide is a mineral UV filter commonly used in sunscreen products to reflect and scatter ultraviolet radiation away from the skin. This product is marketed as an over-the-counter monograph drug, meaning it follows FDA's established rules for sunscreen formulations rather than being individually reviewed for approval. The lotion form is intended for application to the skin to help reduce sun exposure.

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 344S277G0Z
    Allantoin is a naturally derived compound that helps soften and soothe skin. In medicines, it works as a skin-conditioning agent and may help support wound healing and reduce irritation in topical formulations.
  • UNII RUE8E6T4NB
    Aloe vera leaf juice is a clear gel extracted from aloe vera plant leaves. It's used in medicines as a lubricant, emollient, and preservative to soothe skin contact and help keep the product stable.
  • UNII 3SCV180C9W
    Betaine is a naturally occurring organic compound found in plants and animals. In medicines, it acts as an osmoprotectant and stabilizer, helping maintain the product's moisture balance and preserve its chemical stability during storage.
  • 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 69R58A6YLI
    Borago officinalis whole is a plant material derived from the borage plant. It may be included as a natural ingredient, filler, or botanical additive in formulations.
  • 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.
  • UNII P0M7O4Y7YD
    A plant extract from calendula flowers, traditionally used in formulations. It typically serves as a botanical ingredient that may provide color, fragrance, or skin-conditioning properties to topical products.
  • UNII UPY805K99W
    A synthetic compound derived from caprylic acid that works as a preservative and antimicrobial agent to help prevent bacterial and fungal growth in the medicine.
  • 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 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.
  • UNII 9TLV70SV6I
    A natural essential oil extracted from bitter orange peel, used as a flavoring agent to mask unpleasant tastes and improve the palatability of medicines.
  • 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.
  • 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 197M6VFC1W
    Glyceryl caprate is a naturally derived compound made from glycerin and capric acid (a fatty acid). It acts as an emulsifier and surfactant in medicines, helping to mix oil and water-based ingredients together and improve how the drug dissolves and is absorbed.
  • UNII 230OU9XXE4
    A waxy substance made from glycerin and stearic acid that acts as an emulsifier to blend oily and watery ingredients together. It also helps thicken and stabilize the medicine's texture.
  • UNII WZ7DY7GBV6
    A plant-based oil extract from soybeans that contains compounds resistant to saponification. Used in formulations as an emollient and skin-conditioning agent to improve texture and spreadability of topical or oral products.
  • UNII S270N0TRQY
    Hyaluronic acid is a naturally occurring substance found in skin and joints. In medicines, it acts as a moisturizer and thickening agent to improve texture and help the product spread smoothly.
  • UNII UDR641JW8W
    A plant-derived oil from jojoba seeds that has been broken down into smaller components. It acts as an emollient and skin-conditioning agent to help soften and smooth the product's texture.
  • UNII 724GKU717M
    Jojoba oil is a natural liquid wax extracted from jojoba plant seeds. It's used in medicines as an emollient and lubricant to soften and smooth the product, and sometimes as a carrier or penetration enhancer.
  • UNII ZBP1YXW0H8
    A fragrant oil extracted from lavender plants, used as a flavoring and scent agent in medicines to improve taste and aroma.
  • UNII D81QY6I88E
    Linalool is a natural fragrant oil found in plants like lavender and citrus. It's used in medicines as a flavoring agent and to mask unpleasant tastes or smells.
  • UNII 5K47SSQ51G
    A fragrant compound found in plants like lavender and bergamot. It's used as a flavoring and aroma agent to improve the taste and smell of medications.
  • UNII Z35I17EQOP
    A waxy substance made from glycerin and stearic acid that helps stabilize and thicken cosmetic and pharmaceutical formulations. It works as an emulsifier to blend oil and water-based ingredients together.
  • UNII YPM0ZOC2HR
    A synthetic emulsifier derived from glycerin and castor oil. It helps mix oil and water-based ingredients together in the formulation to create a uniform product and improve texture.
  • UNII ZCD6009IUF
    A plant-derived ingredient from knotweed used as a natural filler and binding agent. It helps hold the medicine's ingredients together and add bulk to tablets or capsules.
  • 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 C2BRV53B1V
    A plant-derived oil from pongamia seeds used as an emollient and skin-conditioning agent in topical formulations. It helps soften and smooth the product texture while improving how it spreads on skin.
  • UNII 5965N8W85T
    Propanediol is a clear liquid organic compound derived from vegetable sources or synthesized chemically. It acts as a humectant to retain moisture, a solvent to dissolve active ingredients, and a preservative booster in liquid medications and supplements.
  • UNII 18920M3T13
    Rosa damascena flower oil is a fragrant plant oil extracted from damask rose petals. It's used in medicines as a flavoring and aromatic agent to improve taste and scent.
  • UNII 469OTG57A2
    Sodium pyrrolidone carboxylate is a synthetic polymer derived from pyrrolidone chemistry. It functions as a solubilizer and binder in medications, helping dissolve poorly water-soluble drugs and hold tablet ingredients together.
  • UNII 65A9F4P024
    A synthetic compound derived from the amino acid glutamate and stearic acid. It acts as an emulsifier and surfactant to help mix oil and water-based ingredients, keeping the medicine uniform throughout.
  • UNII 0W8RRI5W5A
    A fatty acid derivative used as an emulsifier and surfactant in medications. It helps blend oily and water-based ingredients together to create a stable, uniform product.
  • UNII GW89575KF9
    Squalane is a lightweight oil derived from plant sources or synthesized. It acts as an emollient and lubricant in formulations, helping ingredients blend smoothly and improving product texture and spreadability.
  • UNII 24SC3U704I
    A powdery carbohydrate extracted from tapioca plant roots. It acts as a binder to hold tablet ingredients together and as a disintegrant to help the tablet break apart in your digestive system.
  • UNII 1T0ZMU8M8B
    A natural oil extracted from Tagetes minuta flowers. It's used as a fragrance and flavoring agent to improve the taste or smell of the medicine.
  • 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.
  • UNII 059QF0KO0R
    Water is a liquid solvent that dissolves and mixes ingredients together in liquid medicines, syrups, and injections. It helps distribute the active drug evenly throughout the product.
  • UNII TTV12P4NEE
    Xanthan gum is a thickening and stabilizing ingredient made from fermented corn or other sugars. It's added to medicines to improve texture, prevent separation of liquids and solids, and help the product stay consistent.

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

The official label also statesInactive Ingredients: Water (Aqua), Caprylic/Capric Triglyceride, Butyloctyl Salicylate, Feruloyl Soy Glycerides, Polyglyceryl-6 Distearate, Glycerin, Betaine, Propanediol, Tapioca Starch, Glyceryl Stearate, Sorbitan Sesquioleate, Aloe Barbadensis Leaf Juice, Calendula Officinalis Flower Extract, Allantoin, Bisabolol, Hyaluronic Acid, Squalane, Simmondsia Chinensis (Jojoba) Seed Oil, Pongamia Pinnata Seed Extract, Lavandula Angustifolia (Lavender) Oil, Glyceryl Caprylate, Dilheptyl Succinate, Polyhydroxystearic Acid, Sodium Stearoyl Glutamate, Tocopheryl Acetate, Xanthan Gum, Capryloyl Glycerin/Sebacic Acid Copolymer, Sodium PCA, Tocopherol, Caprylhydroxamic Acid, Glycine Soja (Soybean) Oil, Citric Acid, Iron Oxides (Cl 77492), Citrus Aurantium Amara (Bitter Orange) Peel Oil, Rosa Damascena Flower Oil, Tagetes Minuta Flower Oil, Borago Officinalis (Common Borage), Jojoba Esters, Polyglyceryl-6 Polyricinoleate, Silica, Polygonum Aviculare Extract, Linalool, Linalyl Acetate, Lavandula Oil / Extract

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
Proven Personalized Day Moisturizer With SPF 50 150 mg/mL 73572-0004-30 Proven 30 ml — — FDA listed —
MIAMI BEACH BUM Save Face SPF-30 Sunscreen 150 mg/mL 82812-0336-00 MIAMI 100 ml — — FDA listed —
MIAMI BEACH BUM Blocked SPF-30 Sunscreen 150 mg/mL 82812-0337-00 MIAMI 180 ml — — FDA listed —
Slip Tint Broad Spectrum SPF 35 Tinted Moisturizer 150 mg/mL 90086-0012-01 Clean 40 ml — — FDA listed —
SEAWEED BATH CO Everyday Mineral SPF 40 150 mg/mL 81159-0259-00 The 100 ml — — FDA listed —
Miami Beach Bum SPF 30 Bodyguard Face Body Mineral Sunscreen 150 mg/mL 82812-0958-00 Miami 100 ml — — FDA listed —
Slip Tint Broad Spectrum SPF 35 Sunscreen Tinted Moisturizer Shade Four 150 mg/mL 90086-0017-01 Clean 1 tube — — FDA listed —
Sqween Paint-On Sun Protection for Independent Kids Mineral Sunscreen SPF 30 150 mg/mL 83005-0002-01 Sqween 118 ml — — FDA listed —
ETADERM Tattoo Sunscreen Broad Spectrum SPF-30 150 mg/mL 84180-0472-00 NUEPHASE 118 ml — — FDA listed —
Oathology Inzincable Lip Balm SPF 35 150 mg/mL 85562-0694-00 SKINOATH 1 tube — — FDA listed —
Slip Tint Broad Spectrum SPF 35 Sunscreen Tinted Moisturizer Shade Three and Half 150 mg/mL 90086-0016-01 Clean 1 tube — — FDA listed —
Slip Tint Broad Spectrum SPF 35 Sunscreen Tinted Moisturizer Shade Five 150 mg/mL 90086-0019-01 Clean 1 tube — — FDA listed —
Sun Bum Daily Mineral Sunscreen Moisturizer Broad Spectrum SPF 30 150 mg/mL 69039-0761-02 Sun 1 bottle — — FDA listed —
Saie Sunvisor Broad Spectrum SPF 35 Sheer Moisturizer 150 mg/mL 90086-0011-01 Clean 1 tube — — FDA listed —
Slip Tint Broad Spectrum SPF 35 Sunscreen Tinted Moisturizer Shade Four and Half 150 mg/mL 90086-0018-01 Clean 1 tube — — FDA listed —
Calendula Essential Hydrating Broad Spectrum SPF 30 Sunscreen 150 mg/mLthis 64657-0007-02 Naturopathica 1 tube — — FDA listed —
Slip Tint Broad Spectrum SPF 35 Sunscreen Tinted Moisturizer Shade Three 150 mg/mL 90086-0015-01 Clean 1 tube — — FDA listed —
Slip Tint Broad Spectrum SPF 35 Sunscreen Tinted Moisturizer Shade Nine 150 mg/mL 90086-0024-01 Clean 1 tube — — FDA listed —
Sqween 100% Mineral Sunscreen Broad Spectrum SPF 30 Water Resistant 150 mg/mL 83005-0001-01 SQWEEN 60 ml — — FDA listed —
Good Weather Skin The One Daily Sun Warm Glow SPF 30 150 mg/mL 85090-0002-01 Good 1 bottle — — FDA listed —
Slip Tint Broad Spectrum SPF 35 Sunscreen Tinted Moisturizer Shade Nine and Half 150 mg/mL 90086-0025-01 Clean 1 tube — — FDA listed —
Lion Pose Ghost-Buster Broad Spectrum Spf 42 Sunscreen 150 mg/mL 83605-0001-01 Lion 2 ml — — Discontinued —
Cancer Council Mineral Fluid SPF50 150 mg/mL 84258-0006-01 Vitality 1 tube — — FDA listed —
Slip Tint Broad Spectrum SPF 35 Sunscreen Tinted Moisturizer Shade One 150 mg/mL 90086-0013-01 Clean 1 tube — — FDA listed —
Slip Tint Broad Spectrum SPF 35 Sunscreen Tinted Moisturizer ShadeTwo 150 mg/mL 90086-0014-01 Clean 1 tube — — FDA listed —
Slip Tint Broad Spectrum SPF 35 Sunscreen Tinted Moisturizer Shade Eight 150 mg/mL 90086-0023-01 Clean 1 tube — — FDA listed —
Duke Cannon Supply Co. Daily Defense Face Mineral Sunscreen Broad Spectrum SPF 32 150 mg/mL 71782-0201-03 DUKE 1 tube — — FDA listed —
Slip Tint Broad Spectrum SPF 35 Sunscreen Tinted Moisturizer Shade Ten 150 mg/mL 90086-0026-01 Clean 1 tube — — FDA listed —
Slip Tint Broad Spectrum SPF 35 Sunscreen Tinted Moisturizer Shade Five and Half 150 mg/mL 90086-0020-01 Clean 1 tube — — FDA listed —
Slip Tint Broad Spectrum SPF 35 Sunscreen Tinted Moisturizer Shade Six 150 mg/mL 90086-0021-01 Clean 1 tube — — FDA listed —
Lion Pose Unghosted Tinted Mineral Spf 42 Uva Uvb Sunscreen 150 mg/mL 83605-0002-01 Lion 1 bottle — — FDA listed —
Slip Tint Broad Spectrum SPF 35 Sunscreen Tinted Moisturizer Shade Seven 150 mg/mL 90086-0022-01 Clean 1 tube — — FDA listed —
Sqween Mineral Sunscreen Broad Spectrum SPF 30 Light Green 150 mg/mL 83005-0005-01 Sqween 60 ml — — FDA listed —
Sqween Mineral Sunscreen Broad Spectrum SPF 30 Blue 150 mg/mL 83005-0003-01 Sqween 60 ml — — FDA listed —
Sqween Mineral Sunscreen Broad Spectrum SPF 30 Blue 150 mg/mL 58419-0011-00 Atlantis 60 ml — — FDA listed —
Sqween Mineral Sunscreen Broad Spectrum SPF 30 Pink 150 mg/mL 83005-0006-01 Sqween 60 ml — — FDA listed —
Sqween Mineral Sunscreen Broad Spectrum SPF 30 Gold 150 mg/mL 83005-0004-01 Sqween 60 ml — — FDA listed —
Sqween Mineral Sunscreen Broad Spectrum SPF 30 Rose Gold 150 mg/mL 83005-0007-01 Sqween 60 ml — — 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

🏛️
2025
On the market since
Oct 2025
📍
2026
Currently FDA-listed
1 year 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 Calendula Essential Hydrating Broad Spectrum SPF 30 Sunscreen (this brand).

Top reported reactions

Macular Degeneration460
Pyrexia306
Nausea290
Pain282
Malaise261
Weight Decreased236
Therapeutic Product Effect Incomplete214

Age at onset

Neonate5
Infant8
Child28
Adolescent5
Adult110
Elderly192

Reporter sex

1,941 reports
Male · 37%
Female · 63%
Unknown · 0%

Serious outcomes

Hospitalization988
Death204
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 155 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
64657-0007-02 You're viewing this 1 TUBE in 1 CARTON (64657-007-02) / 65 mL in 1 TUBE (64657-007-01) 2025-10-23 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 64657-007-02, 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: 64657-0007-02, written without dashes as 64657000702. 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 64657-0007-02, the first segment (64657) is the labeler code FDA assigned to Naturopathica Holistic Health; the middle segment (0007) 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 Naturopathica Holistic Health. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Naturopathica Holistic Health 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 measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun

⏱️ Dosage and Administration 92 words ▾

Directions Directions Apply liberally 15 minutes before sun exposure Reapply at least every 2 hours use a water resistant sunscreen if swimming or sweating 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 Children under 6 months of age: ask a doctor

⚠️ Warnings 4 words ▾

For external use only

🧪 Active Ingredient 7 words ▾

Active Ingredients Purpose Zinc Oxide 15% ..............................................Sunscreen

🧪 Inactive Ingredients 114 words ▾

Inactive Ingredients: Water (Aqua), Caprylic/Capric Triglyceride, Butyloctyl Salicylate, Feruloyl Soy Glycerides, Polyglyceryl-6 Distearate, Glycerin, Betaine, Propanediol, Tapioca Starch, Glyceryl Stearate, Sorbitan Sesquioleate, Aloe Barbadensis Leaf Juice, Calendula Officinalis Flower Extract, Allantoin, Bisabolol, Hyaluronic Acid, Squalane, Simmondsia Chinensis (Jojoba) Seed Oil, Pongamia Pinnata Seed Extract, Lavandula Angustifolia (Lavender) Oil, Glyceryl Caprylate, Dilheptyl Succinate, Polyhydroxystearic Acid, Sodium Stearoyl Glutamate, Tocopheryl Acetate, Xanthan Gum, Capryloyl Glycerin/Sebacic Acid Copolymer, Sodium PCA, Tocopherol, Caprylhydroxamic Acid, Glycine Soja (Soybean) Oil, Citric Acid, Iron Oxides (Cl 77492), Citrus Aurantium Amara (Bitter Orange) Peel Oil, Rosa Damascena Flower Oil, Tagetes Minuta Flower Oil, Borago Officinalis (Common Borage), Jojoba Esters, Polyglyceryl-6 Polyricinoleate, Silica, Polygonum Aviculare Extract, Linalool, Linalyl Acetate, Lavandula Oil / Extract

🎯 Purpose 5 words ▾

Purpose Purpose Zinc Oxide 15%..............................................Sunscreen

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 64651-7749-01 · Revision, 64661-0217-30 · Jaymac →
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.