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doTERRA sun Lip Balm Mineral Sunscreen 8.7 g/100g Stick, 3.5 g — NDC 71630-0116-34 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

doTERRA sun Lip Balm Mineral Sunscreen 8.7 g/100g Stick, 3.5 g — NDC 71630-116-34 (Billing 71630-0116-34)

by doTERRA International, LLC · 3.5 g in 1 TUBE

This is a package of 3.5 g of doTERRA sun Lip Balm Mineral Sunscreen 8.7 g/100g Stick from doTERRA International, LLC, marketed since Sep 2024 and currently FDA-listed. It is this product's only package size.

NDC 71630-0116-34
🏷️ FDA NDC (as labeled) 71630-116-34 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 71630-116-34 alone.

Record
FDA NDC Directory package listing · Human OTC drug
Code segments
71630 labeler · 116 product · 34 package
Package marketed since
Sep 2, 2024
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Barcode (UPC-A, from the NDC)
3 7163011634 9
FDA record last changed
Jul 24, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 71630-116-34
Product NDC 71630-116
11-digit billing NDC 71630011634
UNII SOI2LOH54Z
Application # M020
SPL Set ID 20afcd34-efa6-30a7-e063-6394a90ab517
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2024-09-02
Route TOPICAL
Dosage form STICK
Substance ZINC OXIDE
Why two NDCs? The FDA registers this code as 71630-116-34 — 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 → 71630-0116-34. 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 is a topical stick-form sunscreen lip balm marketed as an over-the-counter monograph product. Zinc oxide is the active ingredient and functions as a physical (mineral) ultraviolet filter, typically used to help protect skin from sun damage when applied to the lips and surrounding area. The product delivers this ingredient in a balm formulation designed for convenient topical use.

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
71630-0116-34 You're viewing this Main listing 3.5 g in 1 TUBE 2024-09-02 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
doTERRA sun Lip Balm Mineral Sunscreen 8.7 g/100gthis 71630-0116-34 doTERRA 3.5 g — — FDA listed —
About this product: other versions of the same ingredient, strength and form are listed above, least expensive first, with FDA equivalence ratings where available.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

Availability & generic status

🏛️
2024
On the market since
Sep 2024
📍
2026
Currently FDA-listed
2 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 LP618AV2EA
    A natural oil derived from chamomile and other plants. It serves as a fragrance and flavoring agent to improve the taste and smell of the medicine.
  • UNII 66YXD4DKO9
    A natural oil extracted from almond kernels. It's used in medicines as an emollient and solvent to help dissolve or suspend active ingredients and improve texture in topical and oral formulations.
  • UNII KIZ4X2EHYX
    A plant extract from the aloe vera leaf, used in medicines as a moisturizing agent and skin-conditioning ingredient. It helps soften and soothe the product's texture in topical formulations.
  • UNII 6VNO72PFC1
    A natural oil extracted from avocado fruit. It's used in medicines as an emollient and carrier to help dissolve or deliver active ingredients and improve how the product feels on skin or mucous membranes.
  • UNII 5T1XCE6K8K
    A plant oil extracted from boswellia serrata resin, a tree native to India and Africa. Used as a flavoring agent, fragrance component, or carrier oil in formulations.
  • UNII N442D9VO79
    A synthetic organic liquid used as a solvent and skin-conditioning agent in topical formulations. It helps dissolve active ingredients and improves how the medicine spreads and feels on the skin.
  • 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 0C9AC7D6XU
    A plant-derived fat from shea nut kernels that remains after soap-making. It acts as a moisturizer, emollient, and texture enhancer in topical formulations, helping soften skin and improve product spreadability.
  • UNII WL0328HX19
    A natural plant-based wax derived from candelilla shrub leaves. It acts as a coating agent, hardener, and texture modifier to control how quickly the medicine releases and to improve the tablet or capsule's appearance and stability.
  • UNII 595AO13F11
    Carrot seed oil is a plant-based oil extracted from carrot seeds. It's used in medicines as a flavor and fragrance component, and may help distribute active ingredients evenly throughout the formulation.
  • UNII 5EMV416J82
    A natural plant extract from safflower flowers used as a colorant and dye in medicines. It provides yellow to reddish tones to tablets and capsules.
  • UNII 8MFF77J91V
    A natural extract from mandarin orange peel used as a flavoring agent and fragrance in medicines. It provides taste and aroma to make the product more palatable.
  • UNII 512OYT1CRR
    Cocoa butter is a natural fat extracted from cocoa beans. It's used in medicines as a base for suppositories and as a lubricant to help pills dissolve smoothly.
  • UNII 245J88W96L
    A plant-derived ingredient from coconut that acts as a filler and texture agent in medications. It helps create the proper consistency and bulk needed for tablets or capsules.
  • UNII 0MK18YOA5G
    A plant extract from lemongrass used as a flavoring and fragrance agent in medicines. It adds taste and aroma to make the product more pleasant to take.
  • UNII 42DG15CHXV
    A natural plant wax derived from sunflower seeds. It serves as a lubricant and glidant to help powders flow smoothly during manufacturing and tablet formation.
  • UNII 17S27ZT6KR
    A plant extract from sunflower seeds used as a natural emulsifier and skin-conditioning agent in topical formulations. It helps blend oil and water components together and softens the product texture.
  • UNII 391Z7DAJ6V
    A plant extract from Italian helichrysum (curry plant), used as a natural flavoring agent or fragrance ingredient in medicines to improve taste or aroma.
  • UNII W77QUB6GXO
    Heptyl undecylenate is a synthetic ester compound used as a preservative and antimicrobial agent in medications. It helps prevent bacterial and fungal growth to maintain product stability and safety during storage.
  • UNII Y9H1V576FH
    Honey is a natural sweetener made by bees from flower nectar. In medicines, it adds sweetness to improve taste and may help soothe throat irritation in lozenges or syrups.
  • UNII H91OP27WW5
    A plant extract from Leptospermum scoparium, commonly known as manuka tree. It's used in formulations as a natural preservative and antimicrobial agent to help maintain product stability.
  • UNII C3M81465G5
    Spearmint oil is a natural flavoring extract from spearmint plants. It's added to medicines to improve taste and mask bitter flavors, making medications easier to take.
  • UNII 788QAG3W8A
    A synthetic polymer that combines polyethylene glycol, glycidyl ether, and sodium hyaluronate. It acts as a thickener and film-former in topical products, helping maintain texture and improve how the medicine spreads on skin.
  • UNII CH428W5O62
    A plant-derived emulsifier made from jojoba oil that has been chemically broken down and converted to potassium salts. It helps mix oil and water-based ingredients together in the formulation and improves product texture and stability.
  • UNII 7EK4SFN1TX
    A natural oil derived from castor bean seeds, used as a lubricant and emollient to help the medicine slide smoothly during manufacturing and improve how it feels when taken.
  • UNII M3CL7US2ZG
    A natural plant extract from red raspberry seeds. It's used as an antioxidant and flavoring agent to help preserve the medicine and improve its taste.
  • UNII QZK412ZY4H
    A plant extract from Schinziophyton rautanenii, a tree native to Africa. It functions as a natural moisturizer and skin-conditioning agent in topical formulations.
  • UNII D24K2Q1F6H
    A plant oil extracted from jojoba seeds. It acts as an emollient and conditioning agent in topical formulations, helping soften skin and improve product texture and spreadability.
  • UNII I289C8TPSV
    A plant-derived compound made from beta-sitosterol (a natural substance in plants) combined with sulfate. It acts as a solubilizer and emulsifier to help mix oil and water-based ingredients in the medicine.
  • UNII 7QWM220FJH
    Squalene is a natural oil-like substance found in shark liver and some plants. It's used in medicines as an emulsifier to help mix oil and water-based ingredients together.
  • UNII 6TC6NN0876
    A natural sweetener extracted from stevia plant leaves. It sweetens the medicine to improve taste without adding calories, helping make medications easier to take.
  • 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.

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

The official label also statesInactive ingredients Simmondsia chinensis (Jojoba) Seed Oil, Heptyl Undecylenate, Euphorbia cerifera (Candelilla) Wax, Prunus amygdalus dulcis (Sweet Almond) Oil, Jojoba Esters, Persea gratissima (Avocado) Oil, Theobroma cacao (Cocoa) Seed Butter, Butyloctyl Salicylate, Rubus idaeus (Raspberry) Seed Oil, Butyrospermum parkii (Shea) Butter, Daucus carota sativa (Carrot) Seed Oil, Boswellia carterii (Frankincense) Oil, Helichrysum italicum Flower/Leaf/Stem Oil, Cocos nucifera (Coconut) Fruit Extract, Helianthus annuus (Sunflower) Seed Oil, Bisabolol, Cymbopogon flexuosus (Lemongrass) Oil, Mentha spicata (Spearmint) Leaf/Stem Oil, Leptospermum scoparium (Manuka) Branch/Leaf Oil, Schinziophyton rautanenii (Mongongo) Kernel Oil, Stevia rebaudiana Leaf/Stem Extract, Beta-Sitosterol, Squalene, Carthamus tinctorius (Safflower) Seed Oil, Ricinus communis (Castor) Seed Oil, Aloe barbadensis (Aloe) Extract, Helianthus annuus (Sunflower) Seed Wax, Honey, Tocopherol, Sodium Hyaluronate, Citrus nobilis (Mandarin Orange) Peel Oil

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

LabelerdoTERRA International, LLC
FDA applicationM020 (OTC MONOGRAPH DRUG)
Labeler code71630
First marketedSep 2024
Product typeHuman Otc Drug
Portfolio10 products on file

More NDCs from doTERRA International, LLC labeler code 71630

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 📦 Storage and Handling 🧪 Active Ingredient 🧪 Inactive Ingredients 🎯 Purpose 📄 When Using This Product 📄 Stop Use and Ask a Doctor If 📄 Keep Out of Reach of Children 📄 Package Label / Principal Display Panel
🎯 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 38 words ▾

Directions For sunscreen use: • apply liberally 15 minutes before sun exposure • use a water resistant sunscreen if swimming or sweating • reapply at least every two hours Children under 6 months of age: ask a doctor

⚠️ Warnings 54 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 swallowed, get medical help or contact a Poison Control Center right away.

📦 Storage and Handling 12 words ▾

Other information • protect this product from excessive heat and direct sun.

🧪 Active Ingredient 7 words ▾

Active Ingredient Purpose Zinc Oxide 8.5% ........................Sunscreen

🧪 Inactive Ingredients 120 words ▾

Inactive ingredients Simmondsia chinensis (Jojoba) Seed Oil, Heptyl Undecylenate, Euphorbia cerifera (Candelilla) Wax, Prunus amygdalus dulcis (Sweet Almond) Oil, Jojoba Esters, Persea gratissima (Avocado) Oil, Theobroma cacao (Cocoa) Seed Butter, Butyloctyl Salicylate, Rubus idaeus (Raspberry) Seed Oil, Butyrospermum parkii (Shea) Butter, Daucus carota sativa (Carrot) Seed Oil, Boswellia carterii (Frankincense) Oil, Helichrysum italicum Flower/Leaf/Stem Oil, Cocos nucifera (Coconut) Fruit Extract, Helianthus annuus (Sunflower) Seed Oil, Bisabolol, Cymbopogon flexuosus (Lemongrass) Oil, Mentha spicata (Spearmint) Leaf/Stem Oil, Leptospermum scoparium (Manuka) Branch/Leaf Oil, Schinziophyton rautanenii (Mongongo) Kernel Oil, Stevia rebaudiana Leaf/Stem Extract, Beta-Sitosterol, Squalene, Carthamus tinctorius (Safflower) Seed Oil, Ricinus communis (Castor) Seed Oil, Aloe barbadensis (Aloe) Extract, Helianthus annuus (Sunflower) Seed Wax, Honey, Tocopherol, Sodium Hyaluronate, Citrus nobilis (Mandarin Orange) Peel Oil

🎯 Purpose 1 words ▾

Sunscreen

📄 When Using This Product 38 words ▾

Directions For sunscreen use: • apply liberally 15 minutes before sun exposure • use a water resistant sunscreen if swimming or sweating • reapply at least every two hours Children under 6 months of age: ask a doctor

📄 Stop Use and Ask a Doctor If 9 words ▾

Stop use and ask a doctor if rash occurs

📄 Keep Out of Reach of Children 19 words ▾

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

📄 Package Label / Principal Display Panel 2 words ▾

Carton Label

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗

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 doTERRA International, LLC. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
doTERRA International, 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.
← 71630-0098-50 · doTERRA 71630-0147-15 · doTERRA →
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.