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Earth Baby Broad Spectrum SPF 30 Sunscreen 3 g/100g; 5 g/100g Cream — NDC 62588-0907-02 package photo

Earth Baby Broad Spectrum SPF 30 Sunscreen 3 g/100g; 5 g/100g Cream

by Earth Baby, Inc. · 1 TUBE in 1 BOX (62588-907-02) / 50 g in 1 TUBE
NDC 62588-0907-02
🏷️ FDA NDC (as labeled) 62588-907-02 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 →

This page is curated, coded, and maintained by

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

🆔 Identity & classification

FDA NDC (as labeled) 62588-907-02
Product NDC 62588-907
11-digit billing NDC 62588090702
UNII SOI2LOH54Z, 15FIX9V2JP
Application # M020
SPL Set ID 42556876-74ea-38e6-e054-00144ff8d46c
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2019-02-01
Route TOPICAL
Dosage form CREAM
Substance ZINC OXIDE; TITANIUM DIOXIDE
Why two NDCs? The FDA registers this code as 62588-907-02 — 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 → 62588-0907-02. 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

LabelerEarth Baby, Inc.
FDA applicationM020 (OTC MONOGRAPH DRUG)
Labeler code62588
First marketedFeb 2019
Product typeHuman Otc Drug
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?

Earth Baby Broad Spectrum SPF 30 Sunscreen is a topical cream containing titanium dioxide and zinc oxide as active ingredients. These mineral compounds are commonly used in sunscreens to reflect and scatter ultraviolet radiation away from the skin. This product is marketed as an over-the-counter monograph drug under FDA regulation for the sunscreen category.

Supplement & herbal interactions

🌿 Drug–supplement interaction checker →
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

🧪 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 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 V5VD430YW9
    A plant-derived substance from the aloe vera leaf. Used in medicines as a natural flavor, skin-soothing agent in topical products, and sometimes as a mild laxative ingredient in oral formulations.
  • UNII 5QB0T2IUN0
    Aluminum hydroxide is a white powder mineral compound used as an antacid ingredient in some formulations. It works as a buffer and pH regulator to help neutralize stomach acid in the medicine.
  • 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 O4M0347C6A
    C20-22 alcohols are fatty alcohols derived from natural oils or fats. They act as emulsifiers and thickeners in medicines, helping blend oil and water-based ingredients and give the product its desired texture.
  • UNII L4VKP0Y7RP
    A synthetic chemical compound derived from fatty acids with 20-22 carbon atoms, combined with phosphate. It functions as an emulsifier and surfactant to help mix oil and water-based ingredients evenly throughout the medicine.
  • 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 9S60Q72309
    A plant-derived ingredient made from safflower seed components. It acts as an emulsifier and carrier to help distribute oils and active ingredients evenly throughout 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 609A3V1SUA
    A silky liquid derived from caprylic acid that acts as an emollient and solvent in formulations. It helps dissolve active ingredients and improves the spreadability and feel of lotions, creams, and topical products.
  • 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 YSE9PPT4TH
    Hyaluronate sodium is a natural carbohydrate that holds moisture. It's used in medicines as a lubricant, thickener, and moisture-retaining agent to improve texture and delivery of the active ingredient.
  • UNII 5N1WD9784U
    A plant-derived ingredient from honeysuckle flowers, used as a natural flavoring or fragrance component to improve taste or aroma in the medicine.
  • UNII 4465L2WS4Y
    A plant extract from Japanese honeysuckle flowers used as a natural flavoring and fragrance ingredient in medicines. It may also help preserve the product and add pleasant taste or aroma.
  • UNII U34MFR958F
    A natural plant material derived from the mango tree, used as a filler and binder to give the medicine its shape and help hold ingredients together in tablet or capsule form.
  • UNII G0R4UBI2ZZ
    Matricaria chamomilla, commonly known as chamomile, is a plant extract used in medicines as a flavoring agent and natural fragrance component. It may also provide mild soothing properties to the formulation.
  • UNII X8725R883T
    A synthetic oily liquid derived from branched carboxylic acids, used as an emollient and skin-conditioning agent in topical formulations. It helps soften and smooth the product's texture while improving how it spreads on skin.
  • UNII RLA2U05Z4Q
    A silicone-based compound that acts as an emulsifier and skin-conditioning agent in topical formulations. It helps blend oil and water components together and creates a smooth, protective texture on the skin's surface.
  • UNII K49155WL9Y
    Shea butter is a fat extracted from shea tree nuts. It's used in medicines as an emollient and lubricant to soften the product, improve texture, and help ingredients blend smoothly together.
  • 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 4ELV7Z65AP
    Stearic acid is a fatty acid derived from plant or animal sources. It acts as a binder and lubricant in tablets and capsules, helping them hold together and flow smoothly during manufacturing.
  • 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 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.

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

The official label also statesAloe Barbadensis Leaf Juice*, Octyldodecyl Neopentanoate, Carthamus Tinctorius (Safflower) Oleosomes*, Aqua/Water, Glycerin, Dicaprylyl Carbonate, Butyrospermum Parkii (Shea) Butter, Chamomillla Recutita (Matricaria) Flower/Leaf/Stem Extract*, Cyclopentasiloxane, Polyglyceryl-3-Polymethylsiloxyethyl Dimethicone, Aluminum Hydroxide, Stearic Acid, Lonicera Japonica (Honeysuckle) Flower Extract, Lonicera Caprifolium (Honeysuckle) Flower Extract, Mangifera Indica (Mango) Fruit Extract, Sodium Hyaluronate, Cetearyl Olivate, Sorbitan Olivate, C20-22 Alkyl Phosphate, C20-22 Alcohols, Trisodium Ethylenediamine Disuccinate, Sclerotium Gum, Jojoba Alcohol, Potassium Jojobate, Butylene Glycol, Citric Acid, Caprylyl Glycol, 1,2-Hexanediol, Parfum/Natural Fragrance.

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
Earth Baby Broad Spectrum SPF 30 3 g/100g; 5 g/100gthis 62588-0907-02 Earth 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

🏛️
2019
On the market since
Feb 2019
📍
2026
Currently FDA-listed
7 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 Earth Baby Broad Spectrum SPF 30 (this brand).

Top reported reactions

Rash13
Acne10
Sunburn9
Dry Skin8
Erythema8
Malignant Melanoma8
Headache7

Reporter sex

139 reports

Serious outcomes

Hospitalization22
Death6
Disabling3
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 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
62588-0907-02 You're viewing this 1 TUBE in 1 BOX (62588-907-02) / 50 g in 1 TUBE 2019-02-01 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 62588-907-02, 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: 62588-0907-02, written without dashes as 62588090702. 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 62588-0907-02, the first segment (62588) is the labeler code FDA assigned to Earth Baby, Inc.; the middle segment (0907) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (02) 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 Earth Baby, Inc.. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Earth Baby, 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 27 words ▾

Helps prevent sunburn. If used as directed with other sun protection measures (See Sun Alert), decreases the risk of skin cancer and early skinaging by the sun.

⏱️ Dosage and Administration 31 words ▾

Directions: Apply liberally 30 minutes before sun exposure. Reapply after 40 minutes, after towel drying, swimming, or perspiring, atleast every 2 hours. Children under six months of age, ask a doctor

⚠️ Warnings 4 words ▾

For external use only.

🧪 Active Ingredient 6 words ▾

Titanium Dioxide 5% Zinc Oxide 3%

🧪 Inactive Ingredients 74 words ▾

Aloe Barbadensis Leaf Juice*, Octyldodecyl Neopentanoate, Carthamus Tinctorius (Safflower) Oleosomes*, Aqua/Water, Glycerin, Dicaprylyl Carbonate, Butyrospermum Parkii (Shea) Butter, Chamomillla Recutita (Matricaria) Flower/Leaf/Stem Extract*, Cyclopentasiloxane, Polyglyceryl-3-Polymethylsiloxyethyl Dimethicone, Aluminum Hydroxide, Stearic Acid, Lonicera Japonica (Honeysuckle) Flower Extract, Lonicera Caprifolium (Honeysuckle) Flower Extract, Mangifera Indica (Mango) Fruit Extract, Sodium Hyaluronate, Cetearyl Olivate, Sorbitan Olivate, C20-22 Alkyl Phosphate, C20-22 Alcohols, Trisodium Ethylenediamine Disuccinate, Sclerotium Gum, Jojoba Alcohol, Potassium Jojobate, Butylene Glycol, Citric Acid, Caprylyl Glycol, 1,2-Hexanediol, Parfum/Natural Fragrance.

🎯 Purpose 1 words ▾

Sunscreen.

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 62588-0904-02 · Earth 62598-0001-01 · Millennium →
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.