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(from DailyMed)

Naturium Dew Glow Tinted Moisturizer SPF50 Homosalate, Octisalate, Avobenzone 10 g/50mL; 3 g/50mL; 5 g/50mL Lotion

by e.l.f. Cosmetics, Inc. · 1 TUBE in 1 CARTON (76354-131-01) / 50 mL in 1 TUBE
NDC 76354-0131-01
🏷️ FDA NDC (as labeled) 76354-131-01 billing pads the product segment with a zero
OTC On market Non-controlled
🗂️ Data synced Aug 27, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

🆔 Identity & classification

FDA NDC (as labeled) 76354-131-01
Product NDC 76354-131
11-digit billing NDC 76354013101
UNII V06SV4M95S, G63QQF2NOX, 4X49Y0596W
Application # M020
SPL Set ID 0d82f310-f87a-f76d-e063-6294a90af251
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2023-12-27
Route TOPICAL
Dosage form LOTION
Substance HOMOSALATE; AVOBENZONE; OCTISALATE
Why two NDCs? The FDA registers this code as 76354-131-01 — 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 → 76354-0131-01. 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.

🏭 Manufacturer & labeler

Labelere.l.f. Cosmetics, Inc.
FDA applicationM020 (OTC MONOGRAPH DRUG)
Labeler code76354
First marketedDec 2023
Product typeHuman Otc Drug
Portfolio158 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.

🩺 Clinical

🧪 What is this product?

Naturium Dew Glow Tinted Moisturizer SPF50 is a topical lotion marketed as an over-the-counter sunscreen product under FDA's OTC monograph rules. It contains three active ingredients: homosalate, octisalate, and avobenzone, which are ultraviolet light absorbers typically used together in sunscreen formulations to help protect skin from UVA and UVB sun exposure. The lotion is tinted, suggesting it also functions as a cosmetic moisturizer for facial use.

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 105S6I733Z
    A natural oil extracted from chamomile and other plants. It acts as a fragrance and flavoring agent to improve the taste and smell of the medicine.
  • 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 6MW60CB71P
    A stabilized form of vitamin C used as an antioxidant in medicines. It prevents other ingredients from breaking down or discoloring during storage.
  • UNII A9EJ3J61HQ
    A synthetic liquid derived from benzoic acid and long-chain alcohols. It functions as a solvent and penetration enhancer in topical formulations, helping active ingredients dissolve and absorb into the skin.
  • 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 XF417D3PSL
    Anhydrous citric acid is a sour, crystalline powder derived from citric acid with water removed. In medicines, it acts as a buffer to control pH, adds tartness to improve taste, and helps tablets disintegrate.
  • UNII 4V59G5UW9X
    Argan oil is a plant-derived oil from argan tree kernels. It's used in medicines as an emollient and skin-conditioning agent to help soften and moisturize the product's texture.
  • UNII BOJ6T9AR90
    A heat-resistant glass made from silicon and boron compounds. It's used as the material for vials, bottles, and containers that hold medicines, protecting the drug from contamination and degradation.
  • UNII 1N032N7MFO
    A brown-colored mineral form of iron oxide used as a colorant in tablets and capsules. It gives medicines their brown or tan appearance without affecting how the drug works.
  • 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 E00JL9G9K0
    A plant-derived cleaning agent made from coconut oil and natural sugars. It works as a solubilizer and emulsifier to help mix water and oil-based ingredients together in the medicine.
  • 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 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 S270N0TRQY
    Hyaluronic acid is a naturally occurring substance found in skin and joints. In medicines, it acts as a moisturizer and thickening agent to improve texture and help the product spread smoothly.
  • 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 H5ZUQ6V4AK
    Octadecene is a synthetic hydrocarbon derived from petroleum. It works as a lubricant and glidant to help powder flow smoothly during tablet manufacturing and packaging.
  • UNII X9N69O5R5X
    A synthetic polymer derived from petroleum that serves as a binder and thickening agent. It helps hold tablet or capsule ingredients together and controls how quickly the medicine releases in your body.
  • 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 1DXE3F3OZX
    A synthetic polymer that forms a gel-like network. It absorbs and holds water, thickens the medicine, and helps keep ingredients evenly mixed throughout the formulation.
  • UNII 55X04QC32I
    A strong alkaline chemical used to adjust and maintain the pH balance of liquid medicines. It helps keep the medicine stable and ensures it stays effective during storage.
  • UNII 65A9F4P024
    A synthetic compound derived from the amino acid glutamate and stearic acid. It acts as an emulsifier and surfactant to help mix oil and water-based ingredients, keeping the medicine uniform throughout.
  • UNII 06XEA2VD56
    Sorbitan oleate is an emulsifier derived from sorbitol and oleic acid. It helps mix oil and water-based ingredients together and keeps them from separating in the medicine.
  • 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 GW89575KF9
    Squalane is a lightweight oil derived from plant sources or synthesized. It acts as an emollient and lubricant in formulations, helping ingredients blend smoothly and improving product texture and spreadability.
  • 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 YA22H34H9Q
    A chelating agent derived from sodium and organic compounds. It binds to metal ions in the formulation to improve stability and prevent unwanted chemical reactions that could degrade 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.

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

The official label also statesAqua/Water/Eau, Butyloctyl Salicylate, C12-15 Alkyl Benzoate, Calcium Sodium Borosilicate, Glycerin, Glyceryl Stearate, Ethylhexyl Methoxycrylene, VP/Eicosene Copolymer, Stearyl Dimethicone, Argania Spinosa Kernel Oil, Tocopheryl Acetate, 1,2-Hexandiol, Niacinamide, Sodium Stearoyl Glutamate, Tocopherol, Cetearyl Olivate, Bisabolol, 3-O-Ethyl Ascorbic Acid, Sodium Hyaluronate, Squalane, Ammonium Acryloyldimethyltaurate/VP Copolymer, Hydroxyacetophnone, Silica, Octadecene, Sorbitan Olivate, Sorbitan Oleate, Caprylyl/Capryl Glucoside, Xanthan Gum, Sodium Acrylate/Sodium Acryloyldimethyltaurate/VP Copolymer, Hydroxyacetophenone, Silica, Octadecene, Sorbitan Olivate, Sorbitan Oleate, Caprylyl/Capryl Glucoside, Xanthan Gum, Sodium Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Trisodium Ethylenediamine Disuccinate, Polyisobutene, Citric Acid, Sodium Hydroxide May Contain: Iron Oxide (CI 77491), Iron Oxide (CI 77492), Iron Oxide (CI 77499)

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 DailyMedingredient 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 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.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Naturium Dew Glow Tinted Moisturizer SPF50-medium 10 g/50mL; 3 g/50mL; 5 g/50mL 76354-0132-01 e.l.f. 1 tube FDA listed
Naturium Dew Glow Tinted Moisturizer SPF50-light 10 g/50mL; 3 g/50mL; 5 g/50mL 59735-0922-02 PML 1 tube FDA listed
Naturium Dew Glow Tinted Moisturizer SPF50-deep 10 g/50mL; 3 g/50mL; 5 g/50mL 59735-0923-02 PML 1 tube FDA listed
Naturium Dew Glow Tinted Moisturizer SPF50-medium 10 g/50mL; 3 g/50mL; 5 g/50mL 59735-0921-02 PML 1 tube FDA listed
Naturium Dew Glow Tinted Moisturizer SPF50 10 g/50mL; 3 g/50mL; 5 g/50mLthis 76354-0131-01 e.l.f. 1 tube FDA listed
Naturium Dew Glow Tinted Moisturizer SPF50-deep 10 g/50mL; 3 g/50mL; 5 g/50mL 76354-0133-01 e.l.f. 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

🏛️
2023
On the market since
Dec 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.

🔬 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 Homosalate, Octisalate, Avobenzone — the ingredient across all brands.

Top reported reactions

Fatigue16
Pain15
Dyspnoea14
Nausea14
Chronic Kidney Disease13
Constipation13
Dizziness13

Age at onset

Child3
Adult14
Elderly21

Reporter sex

0 reports
Male · 30%
Female · 70%

Serious outcomes

Hospitalization60
Disabling9
Death8
Reports over time (by year) — tap or hover for the count & year
2020 2022 2024 2026 14 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.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
76354-0131-01 You're viewing this 1 TUBE in 1 CARTON (76354-131-01) / 50 mL in 1 TUBE 2023-12-27 Active

🧭 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 — Not published for this NDC No photo available yet for this listing.
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 76354-131-01, 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: 76354-0131-01, written without dashes as 76354013101. 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 76354-0131-01, the first segment (76354) is the labeler code FDA assigned to e.l.f. Cosmetics, Inc.; the middle segment (0131) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (01) 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 e.l.f. Cosmetics, Inc.. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
e.l.f. Cosmetics, 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.

📄 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 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 signs of aging caused by the sun.

⏱️ Dosage and Administration 103 words

Directions For sunscreen use: Apply generously and evenly 15 minutes before sun exposure. Apply to all skin exposed to the sun. Use a water-resistant sunscreen if swimming or sweating.

Reapply at least every 2 hours. Sun Protection Measures: Spending time in the sun increases risk of skin cancer and early 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 10:00 a.m. - 2:00 p.m.

Wear long sleeved shirts, pants, hats, and sunglasses. Children under 6 months of age: Ask a doctor.

⚠️ Warnings 33 words

For external use only. on damaged or broken skin. keep out of eyes. Rinse with water to remove. if product is swallowed, get medical help or contact a Poison Control Center right away.

🧪 Active Ingredient 6 words

Avobenzone 3.0% Homosalate 10.0% Octisalate 5.0%

🧪 Inactive Ingredients 95 words

Aqua/Water/Eau, Butyloctyl Salicylate, C12-15 Alkyl Benzoate, Calcium Sodium Borosilicate, Glycerin, Glyceryl Stearate, Ethylhexyl Methoxycrylene, VP/Eicosene Copolymer, Stearyl Dimethicone, Argania Spinosa Kernel Oil, Tocopheryl Acetate, 1,2-Hexandiol, Niacinamide, Sodium Stearoyl Glutamate, Tocopherol, Cetearyl Olivate, Bisabolol, 3-O-Ethyl Ascorbic Acid, Sodium Hyaluronate, Squalane, Ammonium Acryloyldimethyltaurate/VP Copolymer, Hydroxyacetophnone, Silica, Octadecene, Sorbitan Olivate, Sorbitan Oleate, Caprylyl/Capryl Glucoside, Xanthan Gum, Sodium Acrylate/Sodium Acryloyldimethyltaurate/VP Copolymer, Hydroxyacetophenone, Silica, Octadecene, Sorbitan Olivate, Sorbitan Oleate, Caprylyl/Capryl Glucoside, Xanthan Gum, Sodium Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Trisodium Ethylenediamine Disuccinate, Polyisobutene, Citric Acid, Sodium Hydroxide May Contain: Iron Oxide (CI 77491), Iron Oxide (CI 77492), Iron Oxide (CI 77499)

🎯 Purpose 1 words

Sunscreen

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