Home › NDC Lookup › Ingredients › Titanium Dioxide Zinc Oxide › 81678-0001-05
SUMMER FRIDAYS SHADEDROPS BROAD SPECTRUM MINERAL MILK SUNSCREEN SPF 50 TITANIUM DIOXIDE, ZINC OXIDE 54.6 mg/mL; 59.3 mg/mL Emulsion — NDC 81678-0001-05 package photo

SUMMER FRIDAYS SHADEDROPS BROAD SPECTRUM MINERAL MILK SUNSCREEN SPF 50 TITANIUM DIOXIDE, ZINC OXIDE 54.6 mg/mL; 59.3 mg/mL Emulsion

by Summer Friday's LLC · 1 TUBE in 1 CARTON (81678-001-05) / 5 mL in 1 TUBE
NDC 81678-0001-05
🏷️ FDA NDC (as labeled) 81678-001-05 billing pads the product segment with a zero
This package
Contains5 mL in 1 tube Pack sizes3 compare ↓
Also comes in: 15 mL 81678-0001-15 50 mL 81678-0001-50
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 Titanium Dioxide, Zinc Oxide (different manufacturers) — 1 · tap to view
These affect other manufacturers’ products for the same ingredient — not necessarily the exact NDC on this page.
Class II · Sep 3, 2024 — Microbial Contamination of Non-Sterile Product (Vivier Pharma, Inc.) · FDA recall D-0662-2024
Each entry is an official FDA enforcement report — look up any recall number in the FDA recall database ↗

🆔 Identity & classification

FDA NDC (as labeled) 81678-001-05
Product NDC 81678-001
11-digit billing NDC 81678000105
UNII 15FIX9V2JP, SOI2LOH54Z
Application # M020
SPL Set ID 4d3e982f-3489-dce2-e063-6294a90a1b9d
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2026-05-05
Route TOPICAL
Dosage form EMULSION
Substance TITANIUM DIOXIDE; ZINC OXIDE
Why two NDCs? The FDA registers this code as 81678-001-05 — 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 → 81678-0001-05. 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

LabelerSummer Friday's LLC
FDA applicationM020 (OTC MONOGRAPH DRUG)
Labeler code81678
First marketedMay 2026
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 sunscreen emulsion (milk) marketed as an over-the-counter monograph product under FDA's established rules for sunscreens. It contains two mineral UV filters: titanium dioxide and zinc oxide. These ingredients are commonly used together in mineral sunscreens to reflect and scatter ultraviolet rays from the sun's surface, typically applied to skin to help reduce sun exposure.

Supplement & herbal interactions

🌿 Drug–supplement interaction checker →
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

🧪 Inactive Ingredients / Excipients

Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

  • UNII 9E8X80D2L0
    A synthetic form of vitamin E used as an antioxidant and preservative in medications. It helps prevent the active ingredients from degrading when exposed to oxygen or light.
  • UNII TR046Y3K1G
    A liquid alcohol derived from petroleum or plant sources. It acts as a solvent and humectant in medicines, helping dissolve active ingredients and retain moisture in the formulation.
  • 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 LMI26O6933
    Alumina is a white powder form of aluminum oxide. It's used as a filler to add bulk to tablets and capsules, and sometimes as a thickening or anti-caking agent in powdered formulations.
  • UNII 2V52R0NHXW
    Ascorbyl glucoside is a stable form of vitamin C derived from ascorbic acid and glucose. It functions as an antioxidant in medicines to protect other ingredients from breaking down when exposed to air or light.
  • UNII LKG8494WBH
    Benzyl alcohol is a clear liquid used as a preservative and solvent in medicines. It helps prevent bacterial and fungal growth and dissolves other ingredients to create uniform liquid 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 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 T9D99G2B1R
    Caramel is a brown coloring substance made by heating sugar. It's added to medicines to give them color and sometimes a slight sweet taste without affecting how the drug works.
  • UNII 4370DF050B
    Ceramide NP is a waxy, lipid-based substance that mimics natural skin oils. It's used in topical formulations as an emollient and skin-conditioning agent to help soften, smooth, and protect the skin barrier.
  • UNII FGL3685T2X
    Chamomile is a plant extract used in medications as a flavoring agent and for its mild soothing properties in formulations. It helps improve taste and aroma of the medicine.
  • 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 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 3V5U97P248
    A synthetic organic compound used as a UV filter and stabilizer in medications. It helps protect the drug from light degradation and may improve shelf life in formulations exposed to sunlight.
  • UNII JFB4DJZ8BR
    A modified corn starch created by chemically linking starch molecules. It acts as a binder to hold tablet ingredients together and as a disintegrant to help the tablet break apart in the digestive system.
  • UNII 7GXZ3858RY
    Ectoine is a naturally derived protective compound used in pharmaceuticals as a stabilizer and humectant. It helps preserve the integrity of active ingredients and maintain moisture in formulations.
  • UNII S3KFG6Q5X8
    An organic chemical compound used as a UV filter in topical formulations. It helps protect the medicine or product from degradation caused by sunlight exposure during storage and use.
  • 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 H1109Z9J4N
    A natural emulsifier derived from soybean oil. It helps mix oil and water-based ingredients together, ensuring even distribution of active ingredients throughout the medicine.
  • UNII HIE492ZZ3T
    Phenoxyethanol is a synthetic preservative and antimicrobial agent used to prevent bacterial and fungal growth in medicines and cosmetic products, extending shelf life and maintaining product safety.
  • UNII 84YE9R8P8T
    A synthetic emulsifier derived from glycerin and isostearic acid. It helps blend oil and water-based ingredients together and stabilizes the product's texture in cosmetics and topical formulations.
  • 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 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 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 ETJ7Z6XBU4
    Silicon dioxide is a naturally occurring mineral used as a glidant and anti-caking agent. It helps powder ingredients flow smoothly and prevents clumping during manufacturing and storage.
  • UNII 241ATL177A
    Soybean oil is a natural plant oil derived from soybean seeds. It's used in medicines as a solvent and carrier to help dissolve or suspend active ingredients and improve how the body absorbs them.
  • UNII 4ELV7Z65AP
    Stearic acid is a fatty acid derived from plant or animal sources. It acts as a binder and lubricant in tablets and capsules, helping them hold together and flow smoothly during manufacturing.
  • UNII YP632MQS35
    A polysaccharide (sugar-based polymer) produced by a bacterium, used as a thickener and stabilizer to give medicines a consistent texture and prevent separation of ingredients.
  • 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 LDC331P08E
    A silicone-based compound that acts as a glidant and flow agent in solid medications. It reduces friction between powder particles, helping the medicine flow smoothly during manufacturing and tablet compression.
  • UNII 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.

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

The official label also statesWATER/AQUA/EAU, CAPRYLIC/CAPRIC TRIGLYCERIDE, BUTYLOCTYL SALICYLATE, PROPANEDIOL, COCONUT ALKANES, BUTYROSPERMUM PARKII (SHEA) BUTTER, ALUMINA, POLYGLYCERYL-10 DIISOSTEARATE, GLYCERIN, CERAMIDE NP, CHAMOMILLA RECUTITA (MATRICARIA) FLOWER EXTRACT, ETHYLHEXYL METHOXYCRYLENE, ALLANTOIN, POLYHYDROXYSTEARIC ACID, HYDROGENATED LECITHIN, ECTOIN, COCO-CAPRYLATE/CAPRATE, STEARIC ACID, SUCCINOGLYCAN, TOCOPHEROL, ASCORBYL GLUCOSIDE, GLYCINE SOJA (SOYBEAN) OIL, TRIETHOXYCAPRYLYLSILANE, 1,2-HEXANEDIOL, BENZYL ALCOHOL, PHENOXYETHANOL, TOCOPHERYL ACETATE, SILICA, XANTHAN GUM, DISTARCH PHOSPHATE, CAPRYLHYDROXAMIC ACID, DIETHYLHEXYL SYRINGYLIDENEMALONATE, CARAMEL.

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 mLPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
ℹ️
No price is published for this exact package yet. CMS surveys NADAC per package size, so a different pack of the same drug often has one.
Try another pack size: 15 mL 50 mL
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Summer Fridays Shadedrops Broad Spectrum Mineral Milk Sunscreen Spf 50 54.6 mg/mL; 59.3 mg/mLthis 81678-0001-05 Summer 1 tube — — FDA listed —
About this product: other versions of the same ingredient, strength and form are listed above, least expensive first, with FDA equivalence ratings where available.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

⏳ Availability & generic status

🏛️
2026
On the market since
May 2026
📍
2026
Currently FDA-listed
listed with the FDA
🔒
·
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
81678-0001-05 You're viewing this 1 TUBE in 1 CARTON (81678-001-05) / 5 mL in 1 TUBE 2026-05-05 Active
81678-0001-15 1 BOTTLE, PLASTIC in 1 CARTON (81678-001-15) / 15 mL in 1 BOTTLE, PLASTIC 2026-05-05 Active
81678-0001-50 1 BOTTLE, PLASTIC in 1 CARTON (81678-001-50) / 50 mL in 1 BOTTLE, PLASTIC 2026-05-05 Active

Pack size FAQ

What quantity is in NDC 81678-0001-05?
NDC 81678-0001-05 is listed by the FDA — 1 tube in 1 carton / 5 ml in 1 tube.
What NDC number is used to bill for this package of SUMMER FRIDAYS SHADEDROPS BROAD SPECTRUM MINERAL MILK SUNSCREEN SPF 50 TITANIUM DIOXIDE, ZINC OXIDE 54.6 mg/mL; 59.3 mg/mL Emulsion?
Bill NDC 81678-0001-05 — the 11-digit billing format is 81678000105. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

🧭 About this NDC listing & data coverage

Over-the-counter (OTC) product
What data is (and isn’t) available for this NDC — tap to expand
NDC identity (package / product / labeler codes) ✓ Available
Labeler ✓ Available
Product & package description ✓ Available
Marketing category & status ✓ Available
Active ingredient / dosage form / route ✓ Available
FDA label (SPL via DailyMed) ✓ Available
Package photos ✓ Available
Inactive ingredients (structured) ✓ Available
NADAC pharmacy acquisition price (CMS) — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
Orange Book / therapeutic-equivalence data — Not published for this NDC Applies only to products approved under an NDA/ANDA; many listings are out of scope.
HCPCS J-code billing crosswalk — Not published for this NDC Most self-administered / retail products have no J-code — that is normal.
Medicaid utilization (CMS SDUD) — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold.
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Is this NDC FDA-approved?
An NDC listing does not by itself establish FDA approval — the NDC Directory records that a product is listed with FDA, not that it was reviewed and approved. This listing's marketing category is "Otc Monograph Drug". Products approved under an application carry an NDA, ANDA, or BLA number.
Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The FDA registers it as 81678-001-05, 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: 81678-0001-05, written without dashes as 81678000105. 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 81678-0001-05, the first segment (81678) is the labeler code FDA assigned to Summer Friday's LLC; the middle segment (0001) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (05) 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 Summer Friday's LLC. Listing status can change — the directory data on this page refreshes weekly.
Does this product come in other package sizes?
Yes — the FDA directory lists 2 other package presentations of this same product, including 1 bottle (81678-0001-15), 1 bottle (81678-0001-50). Each has its own NDC and its own page — see the package list near the top of this page.
Who lists this product with the FDA?
Summer Friday's 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 30 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 104 words ▾

Directions • Shake well • Apply liberally 15 minutes before sun exposure • Use a water resistant sunscreen if swimming or sweating • Reapply at least every 2 hours • Children under 6 months of age: Ask a doctor • Sun Protection Measures . Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including: • Limit time in the sun, especially from 10 AM – 2 PM • 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 a doctor if rash occurs. Keep out of reach of children. If product is swallowed, get medical help or contact a poison control center right away.

🧪 Active Ingredient 8 words ▾

Active ingredients Titanium Dioxide 5.46% Zinc Oxide 5.93%

🧪 Inactive Ingredients 62 words ▾

Inactive ingredients WATER/AQUA/EAU, CAPRYLIC/CAPRIC TRIGLYCERIDE, BUTYLOCTYL SALICYLATE, PROPANEDIOL, COCONUT ALKANES, BUTYROSPERMUM PARKII (SHEA) BUTTER, ALUMINA, POLYGLYCERYL-10 DIISOSTEARATE, GLYCERIN, CERAMIDE NP, CHAMOMILLA RECUTITA (MATRICARIA) FLOWER EXTRACT, ETHYLHEXYL METHOXYCRYLENE, ALLANTOIN, POLYHYDROXYSTEARIC ACID, HYDROGENATED LECITHIN, ECTOIN, COCO-CAPRYLATE/CAPRATE, STEARIC ACID, SUCCINOGLYCAN, TOCOPHEROL, ASCORBYL GLUCOSIDE, GLYCINE SOJA (SOYBEAN) OIL, TRIETHOXYCAPRYLYLSILANE, 1,2-HEXANEDIOL, BENZYL ALCOHOL, PHENOXYETHANOL, TOCOPHERYL ACETATE, SILICA, XANTHAN GUM, DISTARCH PHOSPHATE, CAPRYLHYDROXAMIC ACID, DIETHYLHEXYL SYRINGYLIDENEMALONATE, CARAMEL .

🎯 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 ↗
← 81672-5051-01 · Organon 81679-0203-50 · Hutton, →
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.