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Well People Bio Tint SPF 30 Sunscreen 10w ZINC OXIDE 200 mg/mL Cream, 1 bottle — NDC 76354-0475-01 package photo

Well People Bio Tint SPF 30 Sunscreen 10w ZINC OXIDE 200 mg/mL Cream, 1 bottle

by e.l.f. Cosmetics, Inc · 1 BOTTLE in 1 BOX (76354-475-01) / 35.5 mL in 1 BOTTLE
NDC 76354-0475-01
🏷️ FDA NDC (as labeled) 76354-475-01 billing pads the product segment with a zero
OTC On market Non-controlled
🗂️ Data synced 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

⚠️
Other active recalls for Zinc Oxide (different manufacturers) — 6 · tap to view
These affect other manufacturers’ products for the same ingredient — not necessarily the exact NDC on this page.
Class II · Oct 31, 2025 — cGMP deviations (Blossom Pharmaceuticals) · FDA recall D-0212-2026
Class II · Oct 31, 2025 — cGMP deviations (Blossom Pharmaceuticals) · FDA recall D-0206-2026
Class II · Oct 31, 2025 — cGMP deviations (Blossom Pharmaceuticals) · FDA recall D-0202-2026
Class II · Oct 31, 2025 — cGMP deviations (Blossom Pharmaceuticals) · FDA recall D-0207-2026
Class II · Oct 31, 2025 — cGMP deviations (Blossom Pharmaceuticals) · FDA recall D-0209-2026
Class II · Oct 31, 2025 — cGMP deviations (Blossom Pharmaceuticals) · FDA recall D-0208-2026
Each entry is an official FDA enforcement report — look up any recall number in the FDA recall database ↗

🆔 Identity & classification

FDA NDC (as labeled) 76354-475-01
Product NDC 76354-475
11-digit billing NDC 76354047501
UNII SOI2LOH54Z
Application # M020
SPL Set ID c8a935e6-f7ac-4e3a-e053-2a95a90a877a
Established class (EPC) Copper Absorption Inhibitor
Physiologic effect Decreased Copper Ion Absorption
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2021-09-01
Route TOPICAL
Dosage form CREAM
Substance ZINC OXIDE
Why two NDCs? The FDA registers this code as 76354-475-01 — 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 → 76354-0475-01. 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 marketedSep 2021
Product typeHuman Otc Drug
Portfolio43 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?

This is an over-the-counter sunscreen cream containing zinc oxide, a mineral UV filter that is commonly used in sunscreen products to help block ultraviolet light from reaching the skin. The product is applied topically to exposed skin and is marketed as an OTC monograph drug, meaning it follows FDA's established rules for sunscreen ingredients and formulations rather than undergoing individual approval. Zinc oxide functions as a broad-spectrum UV reflectant and is typically used to help protect skin from sun exposure.

Supplement & herbal interactions

Some supplements/herbs that may interact with Zinc oxide (OTC drug) — tap one for details:

Dimethylsulfoxide (dmso)Moderate Turpentine OilModerate AlchemillaMinor
🌿 Every supplement checked against Zinc oxide (OTC drug) (3 interactions) — ranked by severity →
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 ZY81Z83H0X
    Aloe vera leaf is a plant extract derived from the aloe plant. It is used in medicines as a natural moisturizer and skin-soothing agent in topical formulations.
  • UNII SY01LVD4G4
    A plant-based oil extracted from broccoli seeds. It acts as an emollient and texture agent in formulations, helping to soften ingredients and improve how the medicine feels or applies.
  • UNII 3XUS85K0RA
    Butylene glycol is a clear liquid derived from petroleum or plants that acts as a humectant, solvent, and preservative booster in medicines. It helps keep formulations stable, dissolve active ingredients, and maintain moisture in topical products.
  • 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 SQE6VB453K
    A calcium salt derived from gluconic acid. It acts as a buffer and mineral supplement in formulations, helping maintain stable pH and adding nutritional calcium content to the product.
  • UNII Q9L0O73W7L
    Coconut oil is a natural fat extracted from coconut fruit. It's used in medicines as a lubricant, emollient, or carrier to help dissolve or deliver active ingredients smoothly through the formulation.
  • UNII 8D9H4QU99H
    A synthetic fatty acid ester derived from coconut oil, used as an emulsifier and solubilizer to help mix oil and water-based ingredients and improve how the body absorbs certain drugs.
  • UNII 0QW9S92J3K
    A plant-based oil extracted from Crambe abyssinica seeds. It acts as an emollient and skin-conditioning agent in topical formulations, helping to soften and smooth the product texture while improving how it spreads on skin.
  • UNII X687XDK09L
    A clay mineral processed to carry positive charges, used as a thickener and suspending agent in liquid medicines. It helps keep solid particles evenly distributed throughout the product.
  • UNII 7IGF0S7R8I
    Phytic acid is a naturally occurring compound found in plants that acts as a chelating agent and preservative in medicines. It helps stabilize formulations and prevent oxidation of active ingredients.
  • UNII WQ29KQ9POT
    Gluconolactone is a mild organic acid derived from glucose. It functions as a buffer and pH regulator in medicines, helping maintain stable acidity levels and improve product stability.
  • UNII PDC6A3C0OX
    Glycerin is a clear, thick liquid derived from plant oils or fats. It acts as a humectant to retain moisture, a sweetener, and a solvent in medications.
  • UNII B68LJT9544
    A fatty acid derivative used as a preservative and antimicrobial agent in topical medicines. It helps prevent bacterial and fungal growth to maintain product stability and safety.
  • UNII TM2TZD4G4A
    A plant-derived oily substance used as an emulsifier and solubilizer in medicines. It helps blend water and oil-based ingredients together and improves how the body absorbs certain active drugs.
  • UNII 949E3KBJ1I
    Isopropyl titanium triisostearate is a titanium-based compound used in medicines as a glidant and anticaking agent. It helps powders and granules flow smoothly during manufacturing and prevents clumping in the finished product.
  • UNII X33R8U0062
    Isostearic acid is a fatty acid derived from vegetable oils. It acts as an emulsifier and lubricant in medicines, helping blend ingredients together and reducing friction during tablet or capsule manufacturing.
  • UNII 724GKU717M
    Jojoba oil is a natural liquid wax extracted from jojoba plant seeds. It's used in medicines as an emollient and lubricant to soften and smooth the product, and sometimes as a carrier or penetration enhancer.
  • UNII DE08037SAB
    Magnesium sulfate is a mineral salt that acts as an osmotic agent in medications. It draws water into the intestines to soften stool or is used as a filler and processing aid in some solid dosage forms.
  • UNII 7CVR7L4A2D
    A starch-derived carbohydrate produced by breaking down corn, potato, or tapioca starch. It functions as a filler and binder to give the medicine bulk and texture, and sometimes as a mild sweetener or texture enhancer in powders and tablets.
  • UNII C9H2L21V7U
    A fat derived from coconut or palm oil containing shorter fatty acid chains. It serves as a solvent and carrier to help dissolve or suspend active ingredients, improving absorption and stability in liquid formulations.
  • UNII 7Q0OK5DOT4
    A plant-derived emulsifier made from glycerin and ricinoleic acid (from castor oil). It helps blend oil and water-based ingredients together in formulations and improves product texture and stability.
  • UNII 820DPX33S7
    A synthetic emulsifier derived from glycerin and fatty acids. It helps mix oil and water-based ingredients together and keeps them evenly blended throughout the product.
  • UNII 1VPU26JZZ4
    Potassium sorbate is a salt derived from sorbic acid, a naturally occurring preservative. It prevents growth of mold, yeast, and some bacteria, extending the medicine's shelf life.
  • UNII 9S8867952A
    A plant-derived oil from raspberry seeds used as an emollient and skin-conditioning agent in topical formulations. It helps soften the product texture and improve skin feel.
  • UNII 8M1P49MWAP
    A plant oil extracted from wild rose seeds. It serves as an emollient and skin-conditioning agent in topical medicines, helping soften and moisturize the product's texture.
  • UNII V2CI786FPG
    A plant-derived emollient made from shea butter, used in topical formulations to soften the skin and improve texture. It helps stabilize oil and water mixtures and creates a smooth, spreadable consistency in creams and ointments.
  • 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 3W1JG795YI
    Sunflower oil is a natural vegetable oil derived from sunflower seeds. It serves as a solvent, lubricant, and carrier in medicines, helping dissolve active ingredients and improve how the medication flows and absorbs in the body.
  • 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 7K3W1BIU6K
    A synthetic oil derived from glycerin and hexanoic acid. It acts as an emollient and lubricant in topical formulations to soften skin and improve product spreadability.
  • 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.

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

The official label also statesWater (Aqua), Coco-Caprylate/Caprate, Polyglyceryl-3 Polyricinoleate, Glycerin, Triethylhexanoin, Butyloctyl Salicylate, Butylene Glycol Dicaprylate/Dicaprate, Caprylic/Capric Triglyceride, Polyglyceryl-4 Isostearate, Magnesium Sulfate, Disteardimonium Hectorite, Shea Butter Ethyl Esters, Polyhydoxystearic Acid, Lecithin, Isostearic Acid, Gluconolactone, Cocos Nucifera (Coconut) Oil/Cocos Nucifera Oil*, Tocopherol, Helianthus Annuus (Sunflower) Seed Oil/ Helianthus Annuus Seed Oil, Simmondsia Chinensis (Jojoba) Seed Oil/ Simmondsia Chinensis Seed Oil*, Rubus Idaeus (Raspberry) Seed Oil/ Rubus Idaeus Seed Oil, Rosa Rubiginosa Seed Oil, Hippophase Rhamnoides (Sea Buckthorn) Oil/Hippophae Rhamnoides Oil, Crambe Abyssinica Seed Oil, Brassica Oleracea Italica (Broccoli) Seed Oil/ Brasica Oleracea Italica Oil, Aloe Barbadensis (Aloe) Leaf Juice/Aloe Barbadensis Leaf Juice, Maltodextrin, Potassium Sorbate, Glyceryl Caprylate, Sodium Benzoate, Isopropyl Titanium Triisostearate, Glyceryl Undecylenate, Calcium Gluconate, Phytic Acid MAY CONTAIN: Titanium Dioxide (CI 77891), Iron Oxides (CI 77491, CI 77492, CI 77499) *Organic Ingredients

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.

💲 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
Lilikoi Mineral Defense Sport Sunscreen SPF 30 200 mg/mL 15751-3040-05 Eminence 1 tube — — FDA listed —
Eminence Tropical Vanilla Day Cream SPF 40 Sunscreen 200 mg/mL 15751-3500-01 Eminence 1 jar — — FDA listed —
Eminence Lilikoi Daily Defense Moisturizer SPF 40 Sunscreen 200 mg/mL 15751-3501-01 Eminence 1 jar — — FDA listed —
Eminence Bright Skin Moisturizer SPF 40 Sunscreen 200 mg/mL 15751-3503-01 Eminence 1 jar — — FDA listed —
Sport Broad Spectrum SPF50 Water Resistant 80 minutes Mineral Sunscreen UVA UVB Protection Stick 200 mg/mL 53675-0203-00 Aruba 30 ml — — FDA listed —
Broad Spectrum SPF50 Water Resistant (80 minutes) Mineral Sunscreen UVA UVB Protection Stick for Kids 200 mg/mL 53675-0205-00 Aruba 30 ml — — FDA listed —
THINKSPORT sunscreen SPF 50 200 mg/mL 60781-1001-03 thinkOperations,LLC 89 ml — — FDA listed —
THINKSPORT Kids sunscreen SPF 50 200 mg/mL 60781-1002-03 thinkOperations,LLC 89 ml — — FDA listed —
THINKBABY Baby Sunscreen SPF 50 200 mg/mL 60781-1003-03 thinkOperations,LLC 89 ml — — FDA listed —
Think Every Day Face Sunscreen SPF 30 200 mg/mL 60781-1011-01 thinkOperations,LLC 59 ml — — FDA listed —
Think Aloe and Tea Leaves Zinc oxide 200 mg/mL 60781-4698-01 thinkOperations,LLC 89 ml — — FDA listed —
Raw Elements Daily Moisturizer Broad Spectrum SPF30 200 mg/mL 70680-0305-00 Raw 80 ml — — FDA listed —
SUNNY Q Broad Spectrum SPF-30 200 mg/mL 81738-0138-00 Sunny 100.55 ml — — FDA listed —
TIGER BABY Baby Sunscreen SPF-50 200 mg/mL 82247-0278-00 BRICKELL 5 ml — — FDA listed —
JOYSPRING Kids Mineral Sunscreen SPF-30 200 mg/mL 82552-0354-00 JOYSPRING 30 ml — — FDA listed —
JOY SPRING Kids Mineral Sunscreen SPF-30 200 mg/mL 82552-0356-00 JOYSPRING 90 ml — — FDA listed —
Well People Bio Tint SPF 30 Sunscreen 2w 200 mg/mL 76354-0471-01 e.l.f. 1 bottle — — FDA listed —
Babo Botanicals Super Shield Mineral Sunscreen SPF50 200 mg/mL 79265-7778-01 Babo 89 ml — — FDA listed —
GLC OG Natural Tinted SPF 30 Sunscreen 200 mg/mL 84747-0530-00 GUD 1 jar — — FDA listed —
Sun Bum 50 Mineral Sunscreen 1 OZ 200 mg/mL 69039-0797-01 Sun 30 ml — — FDA listed —
Everyday Coverage Tinted Sunscreen - Extra Light Tint 200 mg/mL 72592-0001-60 MV 60 ml — — FDA listed —
Well People Bio Tint SPF 30 Sunscreen 9w 200 mg/mL 76354-0474-01 e.l.f. 1 bottle — — FDA listed —
Well People Bio Tint SPF 30 Sunscreen 14w 200 mg/mL 76354-0479-01 e.l.f. 1 bottle — — FDA listed —
Well People Bio Tint SPF 30 Sunscreen 3N 200 mg/mL 76354-0480-01 e.l.f. 1 bottle — — FDA listed —
Dr. Mercola Broad Spectrum 200 mg/mL 71239-0787-23 Natural 236 ml — — FDA listed —
Vitamin C BB Beauty Balm Sheer Tint SFP 30 200 mg/mL 55560-0108-01 Andalou 1 tube — — FDA listed —
Everyday Coverage Tinted Sunscreen - Light Tint 200 mg/mL 72592-0002-60 MV 60 ml — — FDA listed —
Well People Bio Tint SPF 30 Sunscreen 12w 200 mg/mL 76354-0477-01 e.l.f. 1 bottle — — FDA listed —
Well People Bio Tint SPF 30 Sunscreen 5N 200 mg/mL 76354-0481-01 e.l.f. 1 bottle — — FDA listed —
Derma E Vitamin C Weightless Moisturizer SPF 45 200 mg/mL 54108-0359-01 derma 1 bottle — — FDA listed —
Kypris Pot of Shade Heliotropic Broad Spectrum SPF 30 Sunscreen And Primer 200 mg/mL 70608-0001-01 Kypris 1 jar — — FDA listed —
Everyday Coverage Tinted Sunscreen - Medium Tint 200 mg/mL 72592-0003-60 MV 60 ml — — FDA listed —
Well People Bio Tint SPF 30 Sunscreen 13w 200 mg/mL 76354-0478-01 e.l.f. 1 bottle — — FDA listed —
1000 Roses CC Color plus Correct Sheer Beige SPF 30 200 mg/mL 55560-0110-01 Andalou 1 tube — — FDA listed —
Well People Bio Tint SPF 30 Sunscreen 1C 200 mg/mL 76354-0470-01 e.l.f. 1 bottle — — FDA listed —
Well People Bio Tint SPF 30 Sunscreen 11w 200 mg/mL 76354-0476-01 e.l.f. 1 bottle — — FDA listed —
Well People Bio Tint SPF 30 Sunscreen 8N 200 mg/mL 76354-0483-01 e.l.f. 1 bottle — — FDA listed —
Babo Botanicals Sensitive Baby Mineral Sunscreen SPF50 200 mg/mL 79265-8758-01 Babo 89 ml — — FDA listed —
Thinkbaby Clear Zinc SPF 30 200 mg/mL 60781-4175-03 thinkOperations,LLC 89 ml — — FDA listed —
Baby Bum Mineral 50 Sunscreen 200 mg/mL 69039-0686-00 Sun 88 ml — — FDA listed —
Well People Bio Tint SPF 30 Sunscreen 4W 200 mg/mL 76354-0472-01 e.l.f. 1 bottle — — FDA listed —
Well People Bio Tint SPF 30 Sunscreen 7N 200 mg/mL 76354-0482-01 e.l.f. 1 bottle — — FDA listed —
Perfecting BB Beauty Balm Natural Tint SPF 30 200 mg/mL 55560-0104-01 Andalou 1 tube — — FDA listed —
Sun Bum 50 Mineral Sunscreen 200 mg/mL 69039-0728-01 Sun 88 ml — — FDA listed —
Vivaiodays Sunscreen with Turmeric 200 mg/mL 71778-0002-01 5SENCO 100 ml — — FDA listed —
Ultra Violette Future Screen Broad Spectrum SPF 50 200 mg/mL 84803-0103-15 Grace 15 ml — — FDA listed —
Well People Bio Tint SPF 30 Sunscreen 10w 200 mg/mLthis 76354-0475-01 e.l.f. 1 bottle — — FDA listed —
1000 Roses CC Color Plus Correct Sheer Tan SPF 30 200 mg/mL 55560-0106-01 Andalou 1 tube — — FDA listed —
Sun Bum 50 Mineral Sunscreen 32 OZ 200 mg/mL 69039-0718-01 Sun 946 ml — — FDA listed —
Well People Bio Tint SPF 30 Sunscreen 6w 200 mg/mL 76354-0473-01 e.l.f. 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

🏛️
2021
On the market since
Sep 2021
📍
2026
Currently FDA-listed
5 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 Well People Bio Tint SPF 30 Sunscreen 10w (this brand).

Top reported reactions

Macular Degeneration460
Pyrexia306
Nausea290
Pain282
Malaise261
Weight Decreased236
Therapeutic Product Effect Incomplete214

Age at onset

Neonate5
Infant8
Child28
Adolescent5
Adult110
Elderly192

Reporter sex

1,941 reports

Serious outcomes

Death204
Disabling32
Reports over time (by year) — tap or hover for the count & year
2023 2024 2025 2026 270 82
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
76354-0475-01 You're viewing this 1 BOTTLE in 1 BOX (76354-475-01) / 35.5 mL in 1 BOTTLE 2021-09-01 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 ✓ 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 FDA registers it as 76354-475-01, 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: 76354-0475-01, written without dashes as 76354047501. 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 76354-0475-01, the first segment (76354) is the labeler code FDA assigned to e.l.f. Cosmetics, Inc; the middle segment (0475) 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 ⏱️ Dosage and Administration ⚠️ Warnings 🧪 Active Ingredient 🧪 Inactive Ingredients 🎯 Purpose
🎯 Indications and Usage 29 words ▾

Use 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 88 words ▾

Directions Apply liberally 15 minutes before sun exposure. Reapply at least every 2 hours. Use water resistant sunscreen if swimming or sweating.

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 value of 15 or higher and other sun protection measures including:limit time in sun, especially from 10 a.m.-2 p.m., wear long-sleeved shirts, pants, hats and sunglasses. Children under 6 months of age: ask a doctor.

Sun Protection Measures:

⚠️ Warnings 54 words ▾

Warning 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.

🧪 Active Ingredient 7 words ▾

Active ingredient Zinc Oxide 20% Purpose Sunscreen

🧪 Inactive Ingredients 131 words ▾

Inactive Ingredients Water (Aqua), Coco-Caprylate/Caprate, Polyglyceryl-3 Polyricinoleate, Glycerin, Triethylhexanoin, Butyloctyl Salicylate, Butylene Glycol Dicaprylate/Dicaprate, Caprylic/Capric Triglyceride, Polyglyceryl-4 Isostearate, Magnesium Sulfate, Disteardimonium Hectorite, Shea Butter Ethyl Esters, Polyhydoxystearic Acid, Lecithin, Isostearic Acid, Gluconolactone, Cocos Nucifera (Coconut) Oil/Cocos Nucifera Oil*, Tocopherol, Helianthus Annuus (Sunflower) Seed Oil/ Helianthus Annuus Seed Oil, Simmondsia Chinensis (Jojoba) Seed Oil/ Simmondsia Chinensis Seed Oil*, Rubus Idaeus (Raspberry) Seed Oil/ Rubus Idaeus Seed Oil, Rosa Rubiginosa Seed Oil, Hippophase Rhamnoides (Sea Buckthorn) Oil/Hippophae Rhamnoides Oil, Crambe Abyssinica Seed Oil, Brassica Oleracea Italica (Broccoli) Seed Oil/ Brasica Oleracea Italica Oil, Aloe Barbadensis (Aloe) Leaf Juice/Aloe Barbadensis Leaf Juice, Maltodextrin, Potassium Sorbate, Glyceryl Caprylate, Sodium Benzoate, Isopropyl Titanium Triisostearate, Glyceryl Undecylenate, Calcium Gluconate, Phytic Acid MAY CONTAIN: Titanium Dioxide (CI 77891), Iron Oxides (CI 77491, CI 77492, CI 77499) *Organic Ingredients

🎯 Purpose 2 words ▾

Purpose Sunscreen

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 76354-0474-01 · e.l.f. 76354-0476-01 · e.l.f. →
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.