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Tropical Sands SPF-30 Broad Spectrum Sunscreen (Coconut) TITANIUM DIOXIDE, ZINC OXIDE 60 mg/mL; 60 mg/mL Cream, 236 mL — NDC 71221-0793-08 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Tropical Sands SPF-30 Broad Spectrum Sunscreen (Coconut) TITANIUM DIOXIDE, ZINC OXIDE 60 mg/mL; 60 mg/mL Cream, 236 mL — NDC 71221-793-08 (Billing 71221-0793-08)

by Elements Brands, Inc. · 236 mL in 1 BOTTLE

This is a package of 236 mL of Tropical Sands SPF-30 Broad Spectrum Sunscreen (Coconut) TITANIUM DIOXIDE, ZINC OXIDE 60 mg/mL; 60 mg/mL Cream from Elements Brands, Inc., marketed since Feb 2017 and currently FDA-listed. It is this product's only package size.

NDC 71221-0793-08
🏷️ FDA NDC (as labeled) 71221-793-08 billing pads the product segment with a zero
OTC On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed 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

NDC database record

One package, one record: these facts belong to NDC 71221-793-08 alone.

Record
FDA NDC Directory package listing · Human OTC drug
Code segments
71221 labeler · 793 product · 08 package
Package marketed since
Feb 22, 2017
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Barcode (UPC)
0857775002131
FDA record last changed
Jul 24, 2026
⚠️
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

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 71221-793-08
Product NDC 71221-793
11-digit billing NDC 71221079308
UNII 15FIX9V2JP, SOI2LOH54Z
UPC 0857775002131
Application # M020
SPL Set ID 4935f888-cd92-61d1-e054-00144ff8d46c
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 2017-02-22
Route TOPICAL
Dosage form CREAM
Substance TITANIUM DIOXIDE; ZINC OXIDE
Why two NDCs? The FDA registers this code as 71221-793-08 — 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 → 71221-0793-08. 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.

Clinical

🧪 What is this product?

Tropical Sands SPF-30 Broad Spectrum Sunscreen is a topical cream containing titanium dioxide and zinc oxide, both mineral UV filters. These ingredients are commonly used in sunscreen products to help protect skin from ultraviolet (UV) radiation by reflecting and scattering UV rays. This is an over-the-counter monograph product, meaning it is marketed under FDA's established rules for sunscreen ingredients and category rather than as an individually reviewed application.

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.

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.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
71221-0793-08 You're viewing this Main listing 236 mL in 1 BOTTLE 2017-02-22 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Coral Safe SPF-30 Broad Spectrum Sunscreen 60 mg/mL; 60 mg/mL 71221-0791-06 Elements 177 ml — — FDA listed —
Coral Safe SPF-30 Broad Spectrum Sunscreen 60 mg/mL; 60 mg/mL 71221-0792-08 Elements 236 ml — — FDA listed —
Tropical Sands SPF-30 Broad Spectrum Sunscreen (Coconut) 60 mg/mL; 60 mg/mLthis 71221-0793-08 Elements 236 ml — — FDA listed —
Tropical Sands, SPF-50 Broad Spectrum Sunscreen 60 mg/mL; 60 mg/mL 71221-0794-54 Elements 159 ml — — FDA listed —
Tropical Sands SPF-30 Broad Spectrum Sunscreen 60 mg/mL; 60 mg/mL 71221-0795-06 Elements 177 ml — — FDA listed —
Tropical Sands SPF-30 Broad Spectrum Sunscreen 60 mg/mL; 60 mg/mL 71221-0796-08 Elements 236 ml — — FDA listed —
Pure Haven Body Spf 30 60 mg/mL; 60 mg/mL 71355-0349-00 Pure 90 ml — — FDA listed —
Pure Haven Essentials 60 mg/mL; 60 mg/mL 71355-0819-03 Pure 90 ml — — FDA listed —
koa protect our ocean life OXYBENZONE FREE Broad Spectrum SPF 30 UVA UVB Protection Sunscreen 60 mg/mL; 60 mg/mL 71889-0350-08 Kapa'ihi, 1 bottle — — FDA listed —
ONCODERM Rx Mineral Sunscreen SPF-30 60 mg/mL; 60 mg/mL 75087-0074-04 Oncoderm, 118 ml — — FDA listed —
KOVR All-Natural SPF-30 Moisturizing Sunscreen for Men 60 mg/mL; 60 mg/mL 83531-0497-00 ACTIVE 118 ml — — FDA listed —
KOVR All-Natural SPF-30 Moisturizing Sunscreen for Women 60 mg/mL; 60 mg/mL 83531-0499-00 ACTIVE 118 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

🏛️
2017
On the market since
Feb 2017
📍
2026
Currently FDA-listed
9 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.

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 H4N855PNZ1
    Alpha-tocopherol is a form of vitamin E, a fat-soluble antioxidant derived from natural or synthetic sources. In medicines, it prevents oils and fats from breaking down and becoming rancid, protecting the product's stability and shelf life.
  • UNII 9S60Q72309
    A plant-derived ingredient made from safflower seed components. It acts as an emulsifier and carrier to help distribute oils and active ingredients evenly throughout the medicine.
  • UNII 09FUA47KNA
    Cetearyl glucoside is a plant-derived surfactant made from vegetable oils and glucose. It helps oils and water mix together in creams and lotions, and can also soften and smooth the skin feel of the product.
  • UNII 58B69Q84JO
    A plant-derived emulsifier made from olive oil and fatty alcohols. It helps blend oil and water ingredients together and stabilizes the product's texture in creams, lotions, and similar 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 Q9L0O73W7L
    Coconut oil is a natural fat extracted from coconut fruit. It's used in medicines as a lubricant, emollient, or carrier to help dissolve or deliver active ingredients smoothly through the formulation.
  • UNII 2R04ONI662
    Eucalyptus oil is a fragrant liquid extracted from eucalyptus tree leaves. It's used in medicines as a flavor, scent, or soothing agent in topical products and cough preparations.
  • UNII WQ29KQ9POT
    Gluconolactone is a mild organic acid derived from glucose. It functions as a buffer and pH regulator in medicines, helping maintain stable acidity levels and improve product stability.
  • 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 W2ZU1RY8B0
    A plant extract from green tea leaves. It's used as an antioxidant ingredient to help preserve the medicine and maintain its stability during storage.
  • UNII BKJ0J3D1BP
    A plant-derived ingredient from sunflower flowers, used as a natural colorant and flavoring agent in medicines. It may help provide color or mild taste to the product.
  • 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 MDL271E3GR
    Sorbitan olivate is an emulsifier derived from sorbitol and olive oil. It helps blend water and oil ingredients together to maintain consistent texture and appearance throughout the medicine.
  • 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.

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

The official label also statesAqua (Deionized Water), Butyrospermum Parkii (Shea) Butter, Camellia Sinensis (Green Tea) Extract, Carthamus Tinctorius (Safflower) Oleosomes, Cetearyl Alcohol, Cetearyl Glucoside, Cetearyl Olivate, Cocos Nucifera (Coconut) Oil, Eucalyptus Globulus (Eucalyptus) Oil, Gluconolactone, Glycerin, Helianthus Annuus (Sunflower) Seed Oil, Lecithin, Simmondsia Chinensis (Jojoba) Oil, Sorbitan Olivate, Tocopheryl (VItamin E), Xanthan Gum, Coconut-Derived Natural Fragrance.

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.

Manufacturer & labeler

LabelerElements Brands, Inc.
FDA applicationM020 (OTC MONOGRAPH DRUG)
Labeler code71221
First marketedFeb 2017
Product typeHuman Otc Drug
Portfolio6 products on file

More NDCs from Elements Brands, Inc. labeler code 71221

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.

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 31 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 100 words ▾

Directions: • Apply liberally 15 minutes before sun exposure • Reapply: • After 80 minutes of swimming or sweating • Immediately after towel drying • At least every 2 hours • 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 of 15 or higher and other sun protection measures including: •Limit time in the sun, especially from 10 am – 2 pm. •Wear long sleeve shirts, pants, hats and sunglasses. •For children under 6 months: consult a physician.

Sun Protection Measures:

⚠️ Warnings 59 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 or irritation occurs. Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.

🧪 Active Ingredient 10 words ▾

Active Ingredients Titanium Dioxide (6.0%) Zinc Oxide (6.0%) Purpose Sunscreen

🧪 Inactive Ingredients 54 words ▾

Inactive Ingredients: Aqua (Deionized Water), Butyrospermum Parkii (Shea) Butter, Camellia Sinensis (Green Tea) Extract, Carthamus Tinctorius (Safflower) Oleosomes, Cetearyl Alcohol, Cetearyl Glucoside, Cetearyl Olivate, Cocos Nucifera (Coconut) Oil, Eucalyptus Globulus (Eucalyptus) Oil, Gluconolactone, Glycerin, Helianthus Annuus (Sunflower) Seed Oil, Lecithin, Simmondsia Chinensis (Jojoba) Oil, Sorbitan Olivate, Tocopheryl (VItamin E), Xanthan Gum, Coconut-Derived Natural Fragrance.

🎯 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 ↗

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 Tropical Sands SPF-30 Broad Spectrum Sunscreen (Coconut) (this brand).

Top reported reactions

Application Site Acne1
Application Site Hypersensitivity1
Application Site Vesicles1

Reporter sex

1 reports
Female · 100%

Serious outcomes

Hospitalization1
Reports over time (by year) — tap or hover for the count & year
2025 2026 1 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.

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 form printed on the packaging and shown on DailyMed is the one the FDA registered. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero and the dashes are dropped. The Identity section at the top of this page lists each form of this code.
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 Elements Brands, Inc.. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Elements Brands, Inc. 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.
← 71221-0792-08 · Elements 71221-0794-54 · Elements →
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.