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RMS SUNCOVERUP SUPER TINT SPF 50 MAHOGANY Zinc Oxide 120 mg/mL Lotion — NDC 83249-0010-01 package photo

RMS SUNCOVERUP SUPER TINT SPF 50 MAHOGANY Zinc Oxide 120 mg/mL Lotion

by Rms organics LLC · 1 BOTTLE, GLASS in 1 CARTON (83249-010-01) / 30 mL in 1 BOTTLE, GLASS
NDC 83249-0010-01
🏷️ FDA NDC (as labeled) 83249-010-01 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) 83249-010-01
Product NDC 83249-010
11-digit billing NDC 83249001001
UNII SOI2LOH54Z
Application # M020
SPL Set ID 1a1aebea-ed0c-ac92-e063-6294a90aeae6
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2024-09-01
Route TOPICAL
Dosage form LOTION
Substance ZINC OXIDE
Why two NDCs? The FDA registers this code as 83249-010-01 — 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 → 83249-0010-01. 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

LabelerRms organics LLC
FDA applicationM020 (OTC MONOGRAPH DRUG)
Labeler code83249
First marketedSep 2024
Product typeHuman Otc Drug
Portfolio20 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?

RMS Suncoverup Super Tint SPF 50 Mahogany is a tinted sunscreen lotion applied to the skin. It contains zinc oxide, a mineral active ingredient commonly used in sunscreens to reflect and scatter ultraviolet (UV) light away from the skin. This OTC monograph product is marketed without individual FDA approval but follows established safety and effectiveness standards for over-the-counter sunscreen ingredients. The lotion is intended to be used on exposed skin surfaces to help reduce UV 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 LKG8494WBH
    Benzyl alcohol is a clear liquid used as a preservative and solvent in medicines. It helps prevent bacterial and fungal growth and dissolves other ingredients to create uniform liquid formulations.
  • UNII P0M7O4Y7YD
    A plant extract from calendula flowers, traditionally used in formulations. It typically serves as a botanical ingredient that may provide color, fragrance, or skin-conditioning properties to topical products.
  • UNII 00YIU5438U
    Caprylyl glycol is a clear liquid derived from coconut oil. In medicines, it acts as a humectant to retain moisture, a preservative booster to prevent microbial growth, and a solvent to help dissolve or mix other ingredients.
  • UNII OO4K72NZ2X
    A plant-derived powder from quinoa seeds, used as a filler and binding agent to give the tablet or capsule structure and help hold its ingredients together during manufacturing and storage.
  • 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 2RF6EJ0M85
    Diatomaceous earth is a fine powder made from fossilized remains of diatoms, tiny aquatic organisms. It acts as a glidant and anti-caking agent, helping medicine flow smoothly during manufacturing and preventing clumping in the final product.
  • UNII 1L0VKZ185E
    A plant-derived ingredient from horsetail grass. It may be used as a natural filler or texture agent in herbal formulations.
  • UNII 2865993309
    Ethylhexyl palmitate is an oily chemical made from palm oil and alcohol. It acts as an emollient and skin-conditioning agent in topical medicines, helping the product spread smoothly and keeping skin soft.
  • UNII EG3PA2K3K5
    Ethylhexyl stearate is a waxy oil made from stearic acid and ethylhexyl alcohol. In medicines, it acts as an emollient and thickener to improve texture and help the product spread smoothly on skin or dissolve properly.
  • UNII 1K09F3G675
    Ferric oxide red is an inorganic iron compound used as a colorant in medicines. It gives tablets, capsules, or other dosage forms a red or reddish tint for identification and appearance.
  • UNII EX438O2MRT
    Ferric oxide yellow is a naturally occurring iron compound used as a colorant in medications. It gives tablets, capsules, and other forms a yellow or golden hue for identification and appearance.
  • UNII XM0M87F357
    A dark iron oxide compound that gives medicines their black or dark color. It's used as a colorant in tablets and capsules to help identify the product and make it visually distinctive.
  • 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 2788Z9758H
    A plant extract from licorice root used as a sweetener, flavoring agent, and natural emulsifier in medicines. It helps improve taste and may aid in keeping ingredients evenly mixed throughout the product.
  • UNII Y5CFT48S90
    A plant extract from the Indian sarsaparilla root used in traditional medicine formulations. It may function as a flavoring agent, natural colorant, or traditional ingredient to support the product's intended use.
  • UNII A6V4CUE7PV
    A plant extract from St. John's Wort flowers used as a coloring agent and botanical additive in some formulations. It may provide natural pigmentation and traditional herbal properties to the medicine.
  • 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 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 24WE03BX2T
    Levomenol is a naturally derived alcohol compound used as a skin-conditioning and anti-inflammatory agent in topical formulations. It helps soothe and protect the skin while improving product texture and absorption.
  • 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 N8F53B3R4R
    A synthetic humectant and solvent derived from propane. It draws and holds moisture in the formulation, helping keep the medicine stable and improving texture or flow in liquid and semi-solid products.
  • 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 XO45V955LT
    A natural oil extract from olives that contains compounds resistant to saponification. Used as an emollient and skin-conditioning agent to improve product texture and spreadability in topical formulations.
  • UNII MJ95C3OH47
    A plant extract from olive leaves used in formulations as an antioxidant and preservative. It helps protect the medicine from degradation and extend shelf life.
  • UNII W4X7H8GYFM
    Polyethylene glycol (PEA) is a synthetic polymer derived from petroleum. It functions as a solvent, lubricant, and binder in medications to improve texture, reduce sticking, and help bind ingredients together.
  • UNII 0F897O3O4M
    A naturally occurring alcohol derived from plants or synthesized chemically. It functions as a preservative and flavoring agent in medicines, helping prevent microbial growth and add pleasant taste to oral products.
  • UNII 46P231IQV8
    A synthetic emulsifier derived from glycerin and fatty acids. It helps blend oil and water-based ingredients together in cosmetic and pharmaceutical formulations to create stable, uniform products.
  • 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 687U3PEB2Y
    A complex emulsifier made from glycerin and fatty acids. It helps blend oil and water-based ingredients together and improves the texture and stability of creams, lotions, and other formulated products.
  • 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 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 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 451W47IQ8X
    Sodium chloride is common table salt. It's used in medicines as a buffer to maintain proper pH, as a filler to add bulk, or to adjust the osmotic balance in liquid formulations.
  • 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 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 OLX698AH5P
    A clay mineral processed with a quaternary ammonium compound. It acts as a glidant and anti-caking agent to improve powder flow and prevent clumping in tablets and capsules.
  • UNII 5EHL50I4MY
    A sodium salt compound used as a chelating agent in medicines. It binds to metals and minerals to improve stability, prevent discoloration, and help the medication stay effective longer.
  • 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 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 856YO1Z64F
    Turmeric is a natural spice derived from the turmeric plant root. It serves as a colorant in medicines, giving products a yellow or golden appearance, and may also provide mild flavoring.
  • 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 V038D626IF
    A plant extract from Withania somnifera root, traditionally used in herbal preparations. It may function as an active botanical ingredient or filler in formulations, though its primary role depends on the specific product formulation.

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

The official label also statesWater/Aqua/Eau, Coco-Caprylate/Caprate, Caprylic/Capric Triglyceride, Shea Butter Ethyl Esters, Glycerin, Polyglyceryl-3 Polyricinoleate, Glyceryl Oleate, Methylpropanediol, Silica, Sodium Chloride, Polyglyceryl-4 Diisostearate/Polyhydroxystearate/Sebacate, Caprylyl Glycol, Bisabolol, Diatomaceous Earth/Solum Diatomeae/Terra de diatomees, Lecithin, Ethylhexyl Palmitate, Ethylhexyl Stearate, Stearalkonium Hectorite, Polyglyceryl-3 Diisostearate, Phenylpropanol, *Simmondsia Chinensis (Jojoba) Seed Oil, Tocopherol (non-GMO), Olea Europaea (Olive) Oil Unsaponifiables, Squalane (vegetable), Tetrasodium Glutamate Diacetate, Niacinamide, *Calendula Officinalis (Marigold) Flower Extract, *Curcuma Longa (Turmeric) Root Powder, *Equisetum Arvense (Horsetail) Leaf Extract, *Hemidesmus Indicus (Country Sarsaparilla) Root Powder, *Hypericum Perforatum (St. John's Wort) Flower Extract, Pisum Sativum (Pea) Seed Extract, *Withania Somnifera (Ashwagandha) Root Extract, *Glycyrrhiza Glabra (Licorice) Root, *Olea Europaea (Olive) Leaf Extract, Benzyl Alcohol, Chenopodium Quinoa Seed Extract, Potassium Sorbate, Sodium Benzoate, Sodium Hydroxide, Titanium Dioxide (CI 77891), Iron Oxides (CI 77491, CI 77492, CI 77499). *Certified Organic

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
Cetaphil Sheer Mineral Face Liquid Sunscreen SPF 50 120 mg/mL 00299-4110-00 Galderma 1 bottle — — FDA listed —
Personalized Day Moisturizer with SPF 120 mg/mL 73572-0003-30 Proven 30 ml — — FDA listed —
Personalized Day Moisturizer with SPF 50 120 mg/mL 73572-0007-01 Proven 30 ml — — FDA listed —
KISS MY FACE SPF-50 Baby Mineral Sunscreen 120 mg/mL 74154-0317-00 WINDMILL 118 ml — — FDA listed —
KISS MY FACE SPF-50 Daily Mineral Sunscreen 120 mg/mL 74154-0318-00 WINDMILL 118 ml — — FDA listed —
KISS MY FACE SPF-50 Face Factor Mineral Sunscreen 120 mg/mL 74154-0319-00 WINDMILL 59 ml — — FDA listed —
Halo Glow Skin Tint SPF 50 84513 120 mg/mL 76354-0559-01 e.l.f. 1 tube — — FDA listed —
Halo Glow Skin Tint SPF 50 84514 120 mg/mL 76354-0560-01 e.l.f. 1 tube — — FDA listed —
Halo Glow Skin Tint SPF50 -84520 120 mg/mL 76354-0666-01 e.l.f. 1 tube — — FDA listed —
Rms Suncoverup Super Tint Spf 50 Alabaster 120 mg/mL 83249-0004-01 Rms 1 bottle — — FDA listed —
Rms Suncoverup Super Tint Spf 50 Spice 120 mg/mL 83249-0013-01 Rms 1 bottle — — FDA listed —
Luminous Defense SPF 50 120 mg/mL 84163-0056-15 Levels 1 bottle — — FDA listed —
Guidance To Glow Tru Spf 35 120 mg/mL 84444-0506-00 GUIDANCE 1 tube — — FDA listed —
Avene Face Sunscreen SPF 50 120 mg/mL 64760-0782-01 Pierre 1 tube — — FDA listed —
Halo Glow Skin Tint SPF 50 84510 120 mg/mL 76354-0556-01 e.l.f. 1 tube — — FDA listed —
Halo Glow Skin Tint SPF 50 84512 120 mg/mL 76354-0558-01 e.l.f. 1 tube — — FDA listed —
Halo Glow Skin Tint SPF50 -84521 120 mg/mL 76354-0667-01 e.l.f. 1 tube — — FDA listed —
Rms Suncoverup Super Tint Spf 50 Tawny 120 mg/mL 83249-0015-01 Rms 1 bottle — — FDA listed —
Avene Multi-Defense Fluid 120 mg/mL 64760-0778-01 Pierre 1 tube — — FDA listed —
Rms Suncoverup Super Tint Spf 50 Mocha 120 mg/mL 83249-0011-01 Rms 1 bottle — — FDA listed —
Rms Suncoverup Super Tint Spf 50 Toffee 120 mg/mL 83249-0016-01 Rms 1 bottle — — FDA listed —
Halo Glow Skin Tint SPF 50 84515 120 mg/mL 76354-0561-01 e.l.f. 1 tube — — FDA listed —
Halo Glow Skin Tint SPF50 -84518 120 mg/mL 76354-0664-01 e.l.f. 1 tube — — FDA listed —
Rms Suncoverup Super Tint Spf 50 Honey 120 mg/mL 83249-0008-01 Rms 1 bottle — — FDA listed —
Rms Suncoverup Super Tint Spf 50 Ivory 120 mg/mL 83249-0009-01 Rms 1 bottle — — FDA listed —
Halo Glow Skin Tint SPF 50 84504 120 mg/mL 76354-0550-01 e.l.f. 1 tube — — FDA listed —
Halo Glow Skin Tint SPF 50 84508 120 mg/mL 76354-0554-01 e.l.f. 1 tube — — FDA listed —
Rms Suncoverup Super Tint Spf 50 Tan 120 mg/mL 83249-0014-01 Rms 1 bottle — — FDA listed —
Avene Multi-Defense Fluid Tinted 120 mg/mL 64760-0779-01 Pierre 1 tube — — FDA listed —
Halo Glow Skin Tint SPF 50 84509 120 mg/mL 76354-0555-01 e.l.f. 1 tube — — FDA listed —
Halo Glow Skin Tint SPF 50 84511 120 mg/mL 76354-0557-01 e.l.f. 1 tube — — FDA listed —
Halo Glow Skin Tint SPF 50 84506 120 mg/mL 76354-0552-01 e.l.f. 1 tube — — FDA listed —
Rms Suncoverup Super Tint Spf 50 Buff 120 mg/mL 83249-0005-01 Rms 1 bottle — — FDA listed —
Rms Suncoverup Super Tint Spf 50 Cameo 120 mg/mL 83249-0006-01 Rms 1 bottle — — FDA listed —
Rms Suncoverup Super Tint Spf 50 Mahogany 120 mg/mLthis 83249-0010-01 Rms 1 bottle — — FDA listed —
Halo Glow Skin Tint SPF 50 84507 120 mg/mL 76354-0553-01 e.l.f. 1 tube — — FDA listed —
Halo Glow Skin Tint SPF50 -84516 120 mg/mL 76354-0662-01 e.l.f. 1 tube — — FDA listed —
Halo Glow Skin Tint SPF50 -84517 120 mg/mL 76354-0663-01 e.l.f. 1 tube — — FDA listed —
Rms Suncoverup Super Tint Spf 50 Caramel 120 mg/mL 83249-0007-01 Rms 1 bottle — — FDA listed —
Rms Suncoverup Super Tint Spf 50 Sand 120 mg/mL 83249-0012-01 Rms 1 bottle — — FDA listed —
Bubble Solar Mate Daily Mineral Sunscreen SPF 40 120 mg/mL 83509-0156-01 Bubble 1 tube — — FDA listed —
Halo Glow Skin Tint SPF50 -84519 120 mg/mL 76354-0665-01 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

🏛️
2024
On the market since
Sep 2024
📍
2026
Currently FDA-listed
2 years listed
🔒
·
No generic listed yet
brand only
ℹ️No FDA-approved generic found

We did not find an FDA-approved generic match for this exact strength, form and route.

Where does this data come from?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

🔬 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 RMS SUNCOVERUP SUPER TINT SPF 50 MAHOGANY (this brand).

Top reported reactions

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

Reporter sex

1,941 reports
Male · 37%
Female · 63%
Unknown · 0%
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 272 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
83249-0010-01 You're viewing this 1 BOTTLE, GLASS in 1 CARTON (83249-010-01) / 30 mL in 1 BOTTLE, GLASS 2024-09-01 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 83249-010-01, 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: 83249-0010-01, written without dashes as 83249001001. 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 83249-0010-01, the first segment (83249) is the labeler code FDA assigned to Rms organics LLC; the middle segment (0010) 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 Rms organics LLC. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Rms organics LLC is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as an over-the-counter product, so it does not require a prescription. Follow the package directions, and ask your pharmacist if you are unsure whether it is right for you.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.

📄 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 30 words ▾

Uses Helps prevent sunburn If used as directed with other sun protective measures (see Directions ), decreases the risk of skin cancer and early skin aging caused by the sun.

⏱️ Dosage and Administration 97 words ▾

Directions shake well. apply liberally 15 minutes before sun exposure reapply: at least every 2 hours for sun protection use a water resistant sunscreen if swimming or sweating 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 value 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-sleeved shirts, pants, hats and sunglasses Children under 6 months: Ask a doctor

⚠️ Warnings 56 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.

🧪 Active Ingredient 5 words ▾

Active ingredient Zinc Oxide 12%

🧪 Inactive Ingredients 130 words ▾

Inactive ingredients Water/Aqua/Eau, Coco-Caprylate/Caprate, Caprylic/Capric Triglyceride, Shea Butter Ethyl Esters, Glycerin, Polyglyceryl-3 Polyricinoleate, Glyceryl Oleate, Methylpropanediol, Silica, Sodium Chloride, Polyglyceryl-4 Diisostearate/Polyhydroxystearate/Sebacate, Caprylyl Glycol, Bisabolol, Diatomaceous Earth/Solum Diatomeae/Terra de diatomees, Lecithin, Ethylhexyl Palmitate, Ethylhexyl Stearate, Stearalkonium Hectorite, Polyglyceryl-3 Diisostearate, Phenylpropanol, *Simmondsia Chinensis (Jojoba) Seed Oil, Tocopherol (non-GMO), Olea Europaea (Olive) Oil Unsaponifiables, Squalane (vegetable), Tetrasodium Glutamate Diacetate, Niacinamide, *Calendula Officinalis (Marigold) Flower Extract, *Curcuma Longa (Turmeric) Root Powder, *Equisetum Arvense (Horsetail) Leaf Extract, *Hemidesmus Indicus (Country Sarsaparilla) Root Powder, *Hypericum Perforatum (St.

John's Wort) Flower Extract, Pisum Sativum (Pea) Seed Extract, *Withania Somnifera (Ashwagandha) Root Extract, *Glycyrrhiza Glabra (Licorice) Root, *Olea Europaea (Olive) Leaf Extract, Benzyl Alcohol, Chenopodium Quinoa Seed Extract, Potassium Sorbate, Sodium Benzoate, Sodium Hydroxide, Titanium Dioxide (CI 77891), Iron Oxides (CI 77491, CI 77492, CI 77499). *Certified Organic

🎯 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 ↗
← 83249-0009-01 · Rms 83249-0011-01 · Rms →
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.