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Mary Kay TimeWise Daytime Defender Sunscreen Broad Spectrum SPF 30 Avobenzone/Octisalate/Octocrylene 4.5 g/100g; 9 g/100g; 3 g/100g Lotion, 1 bottle — NDC 51531-7385-01 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Mary Kay TimeWise Daytime Defender Sunscreen Broad Spectrum SPF 30 Avobenzone/Octisalate/Octocrylene 4.5 g/100g; 9 g/100g; 3 g/100g Lotion, 1 bottle — NDC 51531-7385-1 (Billing 51531-7385-01)

by Mary Kay Inc. · 1 BOTTLE, PUMP in 1 CARTON / 29.783 g in 1 BOTTLE, PUMP

This is a package of 1 bottle of Mary Kay TimeWise Daytime Defender Sunscreen Broad Spectrum SPF 30 Avobenzone/Octisalate/Octocrylene 4.5 g/100g; 9 g/100g; 3 g/100g Lotion from Mary Kay Inc., marketed since Jul 2023 and currently FDA-listed. It is this product's only package size.

NDC 51531-7385-01
🏷️ FDA NDC (as labeled) 51531-7385-1 billing pads the package segment with a zero
OTC On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Aug 27, 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

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 51531-7385-1
Product NDC 51531-7385
11-digit billing NDC 51531738501
UNII 4X49Y0596W, 5A68WGF6WM, G63QQF2NOX
Application # M020
SPL Set ID 00f0f30d-236a-fd45-e063-6294a90a747d
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2023-07-20
Route TOPICAL
Dosage form LOTION
Substance OCTISALATE; OCTOCRYLENE; AVOBENZONE
Why two NDCs? The FDA registers this code as 51531-7385-1 — a 5-4-1 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 package segment → 51531-7385-01. 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?

Mary Kay TimeWise Daytime Defender Sunscreen Broad Spectrum SPF 30 is a topical lotion sunscreen product marketed as an over-the-counter monograph drug. It contains three ultraviolet (UV) filter ingredients: avobenzone, octisalate, and octocrylene. These active ingredients are typically used together to absorb and scatter UVA and UVB rays from sunlight, functioning as physical and chemical UV blockers. Products containing these filters are commonly used to help protect skin from 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.

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
51531-7385-01 You're viewing this Main listing 1 BOTTLE, PUMP in 1 CARTON / 29.783 g in 1 BOTTLE, PUMP 2023-07-20 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Mary Kay TimeWise Daytime Defender Sunscreen Broad Spectrum SPF 30 4.5 g/100g; 9 g/100g; 3 g/100gthis 51531-7385-01 Mary 1 bottle — — 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

🏛️
2023
On the market since
Jul 2023
📍
2026
Currently FDA-listed
3 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 3K9958V90M
    A liquid solvent derived from fermentation or chemical synthesis. In medicines, alcohol dissolves active ingredients, helps preserve the product, and improves how the body absorbs certain drugs.
  • 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 I9PJ0O6294
    A modified starch derived from corn or potato starch with aluminum salt and octenylsuccinic acid added. It acts as a binder to hold tablet ingredients together and as a thickening agent in liquid formulations.
  • UNII W59H9296ZG
    A synthetic polymer made from acrylic compounds and vinylpyrrolidone. It works as a film-former and thickener in topical products, helping create a smooth texture and improve how the medication spreads on skin.
  • UNII Q95M2P1KJL
    A silicone-based ingredient that acts as a lubricant and glidant. It helps the tablet or capsule move smoothly through manufacturing equipment and improves powder flow during production.
  • UNII 8FA93U5T67
    A waxy substance made from plant oils that acts as an emulsifier and thickener. It helps mix oil and water components in the medicine and gives the product a smooth texture.
  • UNII 92RU3N3Y1O
    Dimethicone is a silicone-based oil that acts as an anti-foaming agent and lubricant in medicines. It reduces gas bubbles in liquid formulations and helps coat and protect the stomach lining when ingested.
  • UNII E107L85C40
    Dipropylene glycol is a clear liquid made from propylene glycol. It acts as a solvent and humectant in medicines, helping dissolve active ingredients and retain moisture in the formulation.
  • UNII QI9A6U005W
    A synthetic cleansing agent derived from coconut oil and polyethylene glycol. In medicines, it acts as a surfactant to help mix oil and water-based ingredients and improve how the product spreads or dissolves.
  • UNII 8NLQ36F6MM
    Edetate disodium anhydrous is a chemical compound that binds to metal ions in a medicine. It's used as a stabilizer to prevent unwanted chemical reactions and help keep the drug product effective during storage.
  • UNII ANA2NCS6V1
    A natural oil derived from macadamia nuts, used as an emollient and conditioning agent. It helps soften the product's texture and improve how it spreads or absorbs on skin or mucous membranes.
  • UNII 147D247K3P
    Ethylhexylglycerin is a synthetic preservative used to prevent bacteria and mold from growing in medicines and personal care products. It helps keep the product safe and stable throughout its shelf life.
  • 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 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 G1L3HT4CMH
    A synthetic compound used in medicines as a preservative and antimicrobial agent. It helps prevent bacterial and fungal growth, extending the product's shelf life.
  • UNII 25X51I8RD4
    Niacinamide is a form of vitamin B3, a water-soluble nutrient. In medicines, it may be added as a nutritional supplement or to support skin health, though its primary role here is as an active ingredient rather than a traditional inactive filler.
  • UNII Q46328TRNK
    A short-chain protein fragment made of 10 amino acids linked together. Used in formulations as a skin-conditioning agent or penetration enhancer to help active ingredients absorb into skin or improve product texture.
  • 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 18V8PAQ629
    Prickly pear fruit is a natural plant extract used as a flavor and color ingredient in medicines. It adds taste and visual appeal to oral products like tablets and liquids.
  • 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 Q369O8926L
    Resveratrol is a plant-derived compound sometimes added to supplements and fortified products. It may serve as an active nutritional ingredient rather than a traditional inactive filler, though its exact formulation role varies by product.
  • UNII 978D8U419H
    A yeast strain commonly used in food and pharmaceutical manufacturing. In medicines, it may serve as a filler, culture medium carrier, or source of beneficial compounds in probiotic formulations.
  • 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 OJ245FE5EU
    Sodium benzoate is a salt derived from benzoic acid, a preservative. It's added to medicines to prevent growth of bacteria, fungi, and other microorganisms that could spoil the product.
  • UNII 274KW0O50M
    Sucrose stearate is a compound made from sugar and stearic acid (a fatty substance). It works as an emulsifier and surfactant to help mix oils and water-based ingredients together in the medicine.
  • UNII 035MV9S1C3
    A plastic-like polymer made from two chemical compounds joined together. It acts as a binder and film-former in tablets and capsules, helping hold ingredients together and create a protective coating on the medicine's surface.
  • 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.
  • UNII 2ZA36H0S2V
    Beeswax is a natural wax produced by honeybees. In medicines, it works as a coating agent and thickener to control how fast the drug dissolves and improve the product's texture and appearance.

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

The official label also stateswater/eau/aqua, propanediol, glycerin, silica, caprylyl methicone, ceteareth-25, aluminum starch octenylsuccinate, ammonium acryloyldimethyltaurate/VP copolymer, beeswax/ cire d'abeille/cera alba, glyceryl stearate, niacinamide, dimethicone, phenoxyethanol, disodium ethylene dicocamide PEG-15 disulfate, VP/eicosene copolymer, hydroxyacetophenone, opuntia ficus-indica fruit extract, xanthan gum, disodium EDTA, ethylhexylglycerin, saccharomyces cerevisiae extract, sucrose stearate, alcohol, dipropylene glycol, ethyl macadamiate, resveratrol, sodium benzoate, tocopheryl acetate, oligopeptide-1.

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

LabelerMary Kay Inc.
FDA applicationM020 (OTC MONOGRAPH DRUG)
Labeler code51531
First marketedJul 2023
Product typeHuman Otc Drug
Portfolio21 products on file
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 📄 Other Information 📄 Questions or Comments 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 4 words ▾

Uses Helps prevent sunburn.

⏱️ Dosage and Administration 99 words ▾

Directions Adults and children over 6 months of age: ■ apply liberally15 minutes before sun exposure ■ use a water-resistant sunscreen if swimming or sweating ■ reapply at least every 2 hours ■ 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 of 15 or higher and other sun protection measures including: • limit time in the sun, especially from10 a.m.–2 p.m. • wear long-sleeve shirts, pants, hatsand sunglasses ■ children under 6 months: Ask a doctor

⚠️ Warnings 56 words ▾

Warnings For external use only. Do not use on broken skin. When using this product avoid contact with eyes. If contact occurs, rinse thoroughly with water. 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 11 words ▾

Active ingredients Avobenzone 3% (w/w) Octisalate 4.5% (w/w) Octocrylene 9% (w/w)

🧪 Inactive Ingredients 57 words ▾

Inactive ingredients water/eau/aqua, propanediol, glycerin, silica, caprylyl methicone, ceteareth-25, aluminum starch octenylsuccinate, ammonium acryloyldimethyltaurate/VP copolymer, beeswax/ cire d'abeille/cera alba, glyceryl stearate, niacinamide, dimethicone, phenoxyethanol, disodium ethylene dicocamide PEG-15 disulfate, VP/eicosene copolymer, hydroxyacetophenone, opuntia ficus-indica fruit extract, xanthan gum, disodium EDTA, ethylhexylglycerin, saccharomyces cerevisiae extract, sucrose stearate, alcohol, dipropylene glycol, ethyl macadamiate, resveratrol, sodium benzoate, tocopheryl acetate, oligopeptide-1.

🎯 Purpose 2 words ▾

Purpose Sunscreen

📄 Do Not Use 6 words ▾

Do not use on broken skin.

📄 When Using This Product 15 words ▾

When using this product avoid contact with eyes. If contact occurs, rinse thoroughly with water.

📄 Stop Use and Ask a Doctor If 9 words ▾

Stop use and ask a doctor if rash occurs.

📄 Keep Out of Reach of Children 21 words ▾

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

📄 Other Information 15 words ▾

Other information ■ protect the product in this container from excessive heat and direct sun.

📄 Questions or Comments 2 words ▾

Questions? 1-800-627-9529

📄 Package Label / Principal Display Panel 29 words ▾

Principal Display Panel - 29 ml carton Mary Kay TimeWise DAYTIME DEFENDER SUNSCREEN BROAD SPECTRUM SPF 30 1 FL. OZ. / 29 mL Image of Daytime Defender Sunscreen carton

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 Mary Kay TimeWise Daytime Defender Sunscreen Broad Spectrum SPF 30 (this brand).

Top reported reactions

General Physical Health Deterioration1
Hypersensitivity1
Mental Impairment1
Rash1
Skin Burning Sensation1

Reporter sex

3 reports
Male · 100%
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 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 Mary Kay Inc.. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Mary Kay 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.
← 51531-7287-01 · Mary 51531-8434-00 · Mary →
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.