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Derma E Vitamin C Weightless Moisturizer SPF 45 Zinc oxide 200 mg/mL Lotion — NDC 54108-0359-1 (Billing 54108-0359-01)

by derma e · 1 BOTTLE in 1 BOX / 60 mL in 1 BOTTLE

This is a package of Derma E Vitamin C Weightless Moisturizer SPF 45 Zinc oxide 200 mg/mL Lotion from derma e, marketed since May 2024 and currently FDA-listed. It is this product's only package size.

NDC 54108-0359-01
🏷️ FDA NDC (as labeled) 54108-0359-1 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 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

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 54108-0359-1
Product NDC 54108-0359
11-digit billing NDC 54108035901
UNII SOI2LOH54Z
Application # M020
SPL Set ID a3b404a6-e4b1-4c08-a8ef-77446dd2e411
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2024-05-22
Route TOPICAL
Dosage form LOTION
Substance ZINC OXIDE
Why two NDCs? The FDA registers this code as 54108-0359-1 — 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 → 54108-0359-01. 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?

This is a topical lotion moisturizer marketed as an over-the-counter sunscreen product. The active ingredient, zinc oxide, is a mineral UV filter commonly used in sunscreen formulations to help protect skin from ultraviolet radiation. This product is regulated under the FDA's over-the-counter monograph rules for sunscreen products rather than as an individually approved application. The lotion is intended for topical application to the skin.

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.

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
54108-0359-01 You're viewing this Main listing 1 BOTTLE in 1 BOX / 60 mL in 1 BOTTLE 2024-05-22 — Active

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/mLthis 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/mL 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

🏛️
2024
On the market since
May 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 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 H7UGK1GJCU
    Aspalathus linearis leaf is a plant extract from rooibos tea. It's used in medicines as a natural flavor and color agent, and may help preserve the product's stability.
  • UNII 1G1EAA320L
    Celery seed is a plant-derived ingredient used as a flavoring agent and natural seasoning in medicines. It adds taste to make oral products more palatable for patients.
  • UNII ISE9I7DNUG
    Cocoglycerides are fatty substances derived from coconut oil. They act as emulsifiers and solubilizers in medicines, helping blend water and oil-based ingredients together and improve how the body absorbs certain drugs.
  • UNII 69W9UMG3P8
    A synthetic oily compound used as a plasticizer and solvent in medicines. It helps soften and improve flexibility of coatings on tablets and capsules, and aids in dissolving or dispersing active ingredients in liquid formulations.
  • UNII HTC7G3S2PV
    Ethylhexyl olivate is an emollient and skin-conditioning agent derived from olive oil. It helps soften the product's texture and improves how the medicine 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 4110YT348C
    Flax seed is a plant-derived natural ingredient used as a binder and filler in medications. It helps hold tablet or capsule contents together and adds bulk to the formulation.
  • UNII 5EM498GW35
    A mixture of aromatic compounds used to add pleasant smell to the medicine. Fragrance helps mask unpleasant tastes or odors, making the medication easier to take.
  • 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 UDR641JW8W
    A plant-derived oil from jojoba seeds that has been broken down into smaller components. It acts as an emollient and skin-conditioning agent to help soften and smooth the product's texture.
  • 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 76LN7P7UCU
    Lauryl glucoside is a mild plant-based cleansing agent made from coconut oil and glucose. It's used in medicines as a surfactant to help dissolve and distribute ingredients evenly throughout the formulation.
  • UNII 834K0WOS5G
    A natural fat extracted from sunflower seeds. It acts as an emulsifier and lubricant in medicines, helping mix ingredients that don't normally blend together and allowing the product to flow smoothly during manufacturing.
  • 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 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 WV9CM0O67Z
    Panthenol is a humectant and skin-conditioning agent derived from pantothenic acid. It's added to medicines to help retain moisture and soothe skin irritation.
  • 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 88496G1ERL
    Sodium phytate is a plant-derived salt used in medications as a chelating agent and preservative. It helps stabilize formulations and may improve how the body absorbs certain minerals in the medicine.
  • UNII 9229XJ4V12
    A synthetic emulsifier made from glycerin and fatty acids. It helps blend oil and water-based ingredients in formulations, keeping them mixed and preventing separation.
  • 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 YXH47AOU0F
    A synthetic fatty acid used as a thickener and stabilizer in medicines. It helps create the right texture and prevents separation of ingredients in liquid or semi-solid formulations.
  • UNII 836SJG51DR
    Sodium ascorbyl phosphate is a derivative of vitamin C that acts as an antioxidant and preservative in medications. It helps protect the drug's active ingredients from degradation caused by air and light exposure.
  • UNII H8AV0SQX4D
    A modified starch derived from potato or corn starch. It absorbs water quickly and helps tablets or capsules break apart and dissolve in the stomach, acting as a disintegrant to ensure the medicine releases its active ingredients properly.
  • UNII QE6F49RPJ1
    A natural oil derived from sorbitol and oleic acid. It works as an emulsifier and solubilizer to help mix oil and water-based ingredients together and improve how the medicine dissolves or spreads in the body.
  • UNII 9LBV3F07AZ
    A synthetic, oil-soluble form of vitamin C used as an antioxidant to prevent degradation of the medicine and maintain its stability during storage.
  • UNII 15FIX9V2JP
    Titanium dioxide is a bright white mineral powder commonly used as a colorant and opacifying agent. It makes pills and tablets white or lighter in color and helps make coatings non-transparent.
  • 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.

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

The official label also statesApium Gravelones (Celery) Seed Extract, Aspalathus Linearis (Rooibos) Leaf Extract, Caprylic/Capric Triglyceride, Cocoglycerides, Diethylhexyl Succinate, Ethylhexylglycerin, Ethylhexyl Olivate, Glycerin, Isostearic Acid, Jojoba Esters, Lauryl Glucoside, Lecithin, Linum Usitatissimum (Linseed) Seed Extract, Natural Fragrance Oil, Niacinamide, Panthenol, Phenoxyethanol, Polyglyceryl-2 Dipolyhydroxystearate, Polyglyceryl-3 Polyricinoleate, Polyhydroxystearic Acid, Purified Water, Sodium Ascorbyl Phosphate, Sodium Carboxymethyl Starch, Sodium Phytate, Sorbitan Trioleate, Tetrahexyldecyl Ascorbate, Titanium Dioxide, Tocopheryl Acetate Vitamin E), Xanthan Gum. *Certified 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.

Manufacturer & labeler

Labelerderma e
FDA applicationM020 (OTC MONOGRAPH DRUG)
Labeler code54108
First marketedMay 2024
Product typeHuman Otc Drug
Portfolio14 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 📦 Storage and Handling 🧪 Active Ingredient 🧪 Inactive Ingredients 🎯 Purpose
🎯 Indications and Usage 29 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 93 words ▾

Directions shake well apply liberally 15 minutes before sun exposure Children under 6 months of age: Ask a doctor 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 broad spectrum SPF of 15 or higher and other sun protection measures including: limit time in the sun, especially from 10 a.m. – 2 p.m. wear long-sleeve shirts, pants, hats, and sunglasses reapply at least every 2 hours use a water resistant sunscreen if swimming or sweating

⚠️ Warnings 57 words ▾

Warnings For external use only Do not use on damaged or broken skin When using this product keep out of eyes. Rinse with water to remove. Stop use and ask a doctor if rash occurs Keep out of reach of children . If product is swallowed, get medical help or contact a Poison Control Center right away.

📦 Storage and Handling 11 words ▾

Other information protect this product from excessive heat and direct sun

🧪 Active Ingredient 5 words ▾

Active Ingredient Zinc Oxide 20%

🧪 Inactive Ingredients 70 words ▾

Inactive Ingredients Apium Gravelones (Celery) Seed Extract, Aspalathus Linearis (Rooibos) Leaf Extract, Caprylic/Capric Triglyceride, Cocoglycerides, Diethylhexyl Succinate, Ethylhexylglycerin, Ethylhexyl Olivate, Glycerin, Isostearic Acid, Jojoba Esters, Lauryl Glucoside, Lecithin, Linum Usitatissimum (Linseed) Seed Extract, Natural Fragrance Oil, Niacinamide, Panthenol, Phenoxyethanol, Polyglyceryl-2 Dipolyhydroxystearate, Polyglyceryl-3 Polyricinoleate, Polyhydroxystearic Acid, Purified Water, Sodium Ascorbyl Phosphate, Sodium Carboxymethyl Starch, Sodium Phytate, Sorbitan Trioleate, Tetrahexyldecyl Ascorbate, Titanium Dioxide, Tocopheryl Acetate Vitamin E), Xanthan Gum. *Certified 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 ↗

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 Zinc oxide — the ingredient across all brands.

Top reported reactions

Macular Degeneration460
Nausea365
Pyrexia351
Pain348
Malaise289
Weight Decreased284
Constipation257

Age at onset

Neonate6
Infant11
Child35
Adolescent8
Adult218
Elderly272

Reporter sex

3,195 reports
Male · 36%
Female · 64%
Unknown · 0%

Serious outcomes

Hospitalization1,367
Death290
Life-threatening166
Disabling63
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 266 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 — 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 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 derma e. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
derma e 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.
← 54092-0702-01 · Takeda 54108-0418-01 · derma →
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.