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SPF 15 Lip and SPF 30 Sunscreen AVOBENZONE, HOMOSALATE, OCTOCRYLENE, OCTISALATE Kit — NDC 70412-0819-10 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

SPF 15 Lip and SPF 30 Sunscreen AVOBENZONE, HOMOSALATE, OCTOCRYLENE, OCTISALATE Kit — NDC 70412-819-10 (Billing 70412-0819-10)

by Zhejiang Ayan Biotech Co.,Ltd. · 1 KIT in 1 KIT * 4.5 g in 1 TUBE * 2 g in 1 TUBE

This is a package of SPF 15 Lip and SPF 30 Sunscreen AVOBENZONE, HOMOSALATE, OCTOCRYLENE, OCTISALATE Kit from Zhejiang Ayan Biotech Co.,Ltd., marketed since Jun 2018 and currently FDA-listed. It is this product's only package size.

NDC 70412-0819-10
🏷️ FDA NDC (as labeled) 70412-819-10 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 70412-819-10 alone.

Record
FDA NDC Directory package listing · Human OTC drug
Code segments
70412 labeler · 819 product · 10 package
Package marketed since
Jun 1, 2018
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Barcode (UPC-A, from the NDC)
3 7041281910 2
FDA record last changed
Jul 24, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 70412-819-10
Product NDC 70412-819
11-digit billing NDC 70412081910
Application # M020
SPL Set ID 0b385246-dc77-6874-e063-6394a90a5959
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2018-06-01
Route TOPICAL
Dosage form KIT
Why two NDCs? The FDA registers this code as 70412-819-10 — 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 → 70412-0819-10. 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?

This kit contains two topical sunscreen products: an SPF 15 lip balm and an SPF 30 body sunscreen. The active ingredients (avobenzone, homosalate, octocrylene, and octisalate) are ultraviolet (UV) filters commonly used in sunscreen formulations to help absorb or scatter UV rays from the sun. This is an over-the-counter monograph product, meaning it is marketed under FDA's established rules for sunscreen ingredients rather than through individual product approval.

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

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
70412-0819-10 You're viewing this Main listing 1 KIT in 1 KIT * 4.5 g in 1 TUBE * 2 g in 1 TUBE 2018-06-01 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
REDEFINE Triple Defense .02 g/mL; .068 g/mL; .044 g/mL; .034 g/mL 14222-2252-01 Rodan 1 bottle — — FDA listed —
Aruba Aloe broad spectrum SPF 15 Lip sunscreen and Moisturizer 30 mg/g; 73.4 mg/g; 50 mg/g; 50 mg/g 53675-0208-00 Aruba 4.8 g — — FDA listed —
SPF30 Sunscreen 30 mg/g; 100 mg/g; 100 mg/g; 50 mg/g 70412-0211-15 Zhejiang 15 g — — FDA listed —
SPF15 Sunscreen 20 mg/g; 80 mg/g; 55 mg/g; 20 mg/g 70412-0212-02 Zhejiang 2 g — — FDA listed —
SPF 15 Lip and SPF 30 Sunscreenthis 70412-0819-10 Zhejiang 1 kit — — FDA listed —
SPF 30 Sunscreen 30 mg/mL; 100 mg/mL; 100 mg/mL; 50 mg/mL 71160-0331-30 Tekweld 1 bottle — — FDA listed —
SPF 30 Sunscreen 30 mg/mL; 100 mg/mL; 100 mg/mL; 50 mg/mL 71160-0338-10 Tekweld 1 bottle — — FDA listed —
ALLIES OF SKIN The One SPF-50 Invisible Sunscreen 30 mg/mL; 70 mg/mL; 100 mg/mL; 50 mg/mL 83852-0438-03 ALLIES 3 ml — — FDA listed —
SPF30 unseen sunscreen stick 01 3 g/100g; 10 g/100g; 10 g/100g; 5 g/100g 82953-0047-01 Cosmuses 10 g — — FDA listed —
Sunscreen SPF 30 30 mg/mL; 100 mg/mL; 100 mg/mL; 50 mg/mL 80524-0002-30 Tempo 30 ml — — FDA listed —
Curology Daily Moisturizing 4 g/100mL; 5 g/100mL; 6 g/100mL; 1.5 g/100mL 82575-0400-00 Curology, 1 tube — — FDA listed —
Rose Gold Sun Shield Body Glow SPF45 50 mg/mL; 100 mg/mL; 30 mg/mL; 100 mg/mL 84130-0002-50 Koco 150 ml — — FDA listed —
Sun on the Run Kit 84130-0009-98 Koco 1 kit — — FDA listed —
Spf15 20 mg/g; 80 mg/g; 55 mg/g; 20 mg/g 70412-0316-07 Zhejiang 2 g — — FDA listed —
Sun Shield On-the-Glow Sheer Stick SPF40 10 g/100g; 5 g/100g; 3 g/100g; 10 g/100g 84130-0004-10 Koco 30 g — — FDA listed —
Sun Voyage Kit 84130-0013-97 Koco 1 kit — — FDA listed —
5281 Sunscreen 30 mg/mL; 100 mg/mL; 100 mg/mL; 50 mg/mL 76138-0219-05 Innovation 15 ml — — FDA listed —
Eva Claire Natural Professional Sunscreen 4.35 g/50mL; 3.65 g/50mL; .7 g/50mL; 2.4 g/50mL 87364-0100-02 Eva 1 tube — — FDA listed —
REVERSE Brightening Defense Fluid .028 g/mL; .093 g/mL; .061 g/mL; .0467 g/mL 14222-2300-01 Rodan 1 tube — — FDA listed —
5298 Sunscreen 30 mg/mL; 100 mg/mL; 100 mg/mL; 50 mg/mL 76138-0220-02 Innovation 60 ml — — FDA listed —
5299 Sunscreen 30 mg/mL; 100 mg/mL; 100 mg/mL; 50 mg/mL 76138-0221-06 Innovation 20 ml — — FDA listed —
Sun Essentials SPF Duo Kit 84130-0008-99 Koco 1 kit — — FDA listed —
Dr. Idriss Major Fade Disco Block Whipped Sunscreen SPF 50 5 g/100mL; 10 g/100mL; 3 g/100mL; 7 g/100mL 85246-0100-01 PILLOWTALKDERM 1 tube — — FDA listed —
Aruba Aloe Hydrating Aloe Rich Sunscreen SPF 50 30 mg/mL; 73.4 mg/mL; 100 mg/mL; 50 mg/mL 53675-0210-01 Aruba 59 ml — — FDA listed —
Aruba Aloe Hydrating Aloe Rich Sunscreen SPF 30 30 mg/mL; 73.4 mg/mL; 100 mg/mL; 50 mg/mL 53675-0211-01 Aruba 59 ml — — FDA listed —
5407 Sunscreen 3 g/100mL; 10 g/100mL; 10 g/100mL; 5 g/100mL 76138-0223-01 Innovation 30 ml — — FDA listed —
Aruba Aloe Hydrating Aloe Rich Sunscreen SPF 15 30 mg/mL; 73.4 mg/mL; 50 mg/mL; 50 mg/mL 53675-0214-00 Aruba 177 ml — — FDA listed —
5283 Sunscreen 3 g/100mL; 10 g/100mL; 10 g/100mL; 5 g/100mL 76138-0222-01 Innovation 30 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

🏛️
2018
On the market since
Jun 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.

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.

From the label’s inactive-ingredient sectionMineral Oil, Beeswax(Cera Alba), Cera Microcristallina, Ozokerite, Polyisobutene, Cocos Nucifera (Coconut) Oil, Ethylhexyl Palmitate, Polyethylene, Tridecyl Trimellitate, Butyrospermum Parkii (Shea Butter), BHT, Tocopheryl Acetate, Fragrance. Mineral Oil, Cera Microcristallina, Polyisobutene, Cocos Nucifera (Coconut) Oil, Ethylhexyl Palmitate, Polyethylene, Hydroxystearic Acid, Butyrospermum Parkii (Shea Butter), Tridecyl Trimellitate, Ozokerite, Synthetic Wax, Dextrin Palmitate, BHT, Tocopheryl Acetate, Fragrance.

This is label-wide narrative text, not a normalized exact-product ingredient list. A label can cover multiple strengths or packages.

Where does this data come from?
Source: official FDA Structured Product Labeling (SPL) via DailyMed and the openFDA label index. Structured IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.

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

LabelerZhejiang Ayan Biotech Co.,Ltd.
FDA applicationM020 (OTC MONOGRAPH DRUG)
Labeler code70412
First marketedJun 2018
Product typeHuman Otc Drug
Portfolio23 products on file

More NDCs from Zhejiang Ayan Biotech Co.,Ltd. labeler code 70412

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 📄 Do Not Use 📄 When Using This Product 📄 Stop Use and Ask a Doctor If 📄 Keep Out of Reach of Children 📄 Questions or Comments 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 10 words ▾

Uses • Helps prevent sunburn.

Uses • Helps prevent sunburn.

⏱️ Dosage and Administration 68 words ▾

Directions • 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: Ask a doctor.

Directions • 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: Ask a doctor.

⚠️ Warnings 112 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.

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 24 words ▾

Active Ingredients Homosalate 2% Avobenzone 8% Octocrylene 5.5% Octisalate 2% Purpose Sunscreen

Active Ingredients Homosalate 2% Avobenzone 8% Octocrylene 5.5% Octisalate 2% Purpose Sunscreen

🧪 Inactive Ingredients 58 words ▾

Inactive Ingredients Mineral Oil, Beeswax(Cera Alba), Cera Microcristallina, Ozokerite, Polyisobutene, Cocos Nucifera (Coconut) Oil, Ethylhexyl Palmitate, Polyethylene, Tridecyl Trimellitate, Butyrospermum Parkii (Shea Butter), BHT, Tocopheryl Acetate, Fragrance.

Inactive Ingredients Mineral Oil, Cera Microcristallina, Polyisobutene, Cocos Nucifera (Coconut) Oil, Ethylhexyl Palmitate, Polyethylene, Hydroxystearic Acid, Butyrospermum Parkii (Shea Butter), Tridecyl Trimellitate, Ozokerite, Synthetic Wax, Dextrin Palmitate, BHT, Tocopheryl Acetate, Fragrance.

🎯 Purpose 4 words ▾

Purpose Sunscreen

Purpose Sunscreen

📄 Do Not Use 16 words ▾

Do not use on damaged or broken skin.

Do not use on damaged or broken skin.

📄 When Using This Product 26 words ▾

When using this product keep out of eyes. Rinse with water to remove.

When using this product keep out of eyes. Rinse with water to remove.

📄 Stop Use and Ask a Doctor If 18 words ▾

Stop use and ask a doctor if rash occurs.

Stop use and ask a doctor if rash occurs.

📄 Keep Out of Reach of Children 42 words ▾

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

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

📄 Questions or Comments 8 words ▾

Questions? Call AP Specialties

Questions? Call AP Specialties

📄 Package Label / Principal Display Panel 3 words ▾

Package Labeling: Label2

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 AVOBENZONE, HOMOSALATE, OCTOCRYLENE, OCTISALATE — the ingredient across all brands.

Top reported reactions

Rash14
Erythema11
Acne10
Dry Skin10
Sunburn9
Malignant Melanoma8
Condition Aggravated7

Age at onset

Child1
Adult9
Elderly11

Reporter sex

146 reports
Male · 34%
Female · 66%

Serious outcomes

Hospitalization22
Death6
Disabling3
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 14 1
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 Kit / multi-component package

Kit / multi-component package

This NDC identifies a kit — a package containing more than one component. Structured data (pricing, ingredients, equivalents) is often reported per component rather than for the kit NDC itself, which can make this page look thinner than the components' own pages.

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 Zhejiang Ayan Biotech Co.,Ltd.. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Zhejiang Ayan Biotech Co.,Ltd. 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.
← 70412-0818-01 · Zhejiang 70413-0553-97 · Lice →
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.