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Cetaphil Healthy Renew Day Cream Broad Spectrum SPF 30 homosalate, octocrylene, octisalate, avobenzone 95 mg/g; 95 mg/g; 48 mg/g; 28 mg/g Lotion — NDC 0299-4136-00 (Billing 00299-4136-00)

by Galderma Laboratories, L.P. · 1 TUBE in 1 CARTON / 48 g in 1 TUBE

This is a package of Cetaphil Healthy Renew Day Cream Broad Spectrum SPF 30 homosalate, octocrylene, octisalate, avobenzone 95 mg/g; 95 mg/g; 48 mg/g; 28 mg/g Lotion from Galderma Laboratories, L.P., marketed since Apr 2023 and currently FDA-listed. It is this product's only package size.

NDC 00299-4136-00
🏷️ FDA NDC (as labeled) 0299-4136-00 billing pads the labeler segment with a zero
OTC On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed 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

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 0299-4136-00
Product NDC 0299-4136
11-digit billing NDC 00299413600
UNII V06SV4M95S, 5A68WGF6WM, 4X49Y0596W, G63QQF2NOX
Application # M020
SPL Set ID 5b4e25ad-cd72-4960-9259-fc710bfd59da
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2023-04-12
Route TOPICAL
Dosage form LOTION
Substance HOMOSALATE; OCTOCRYLENE; OCTISALATE; AVOBENZONE
Why two NDCs? The FDA registers this code as 0299-4136-00 — a 4-4-2 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 labeler segment → 00299-4136-00. 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?

Cetaphil Healthy Renew Day Cream is a topical lotion formulated as an over-the-counter sunscreen under FDA monograph rules. It contains four UV filter ingredients (homosalate, octocrylene, octisalate, and avobenzone) that are typically used to absorb and scatter ultraviolet radiation from the sun. The product is commonly applied to the skin to help reduce exposure to UVA and UVB rays. This lotion also functions as a daytime facial moisturizer with sun protection.

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.

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
00299-4136-00 You're viewing this Main listing 1 TUBE in 1 CARTON / 48 g in 1 TUBE 2023-04-12 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Cetaphil Healthy Renew Day Cream Broad Spectrum SPF 30 95 mg/g; 95 mg/g; 48 mg/g; 28 mg/gthis 00299-4136-00 Galderma 1 tube — — FDA listed —
About this product: other versions of the same ingredient, strength and form are listed above, least expensive first, with FDA equivalence ratings where available.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

Availability & generic status

🏛️
2023
On the market since
Apr 2023
📍
2026
Currently FDA-listed
3 years listed
🔒
·
No generic listed yet
brand only
ℹ️No FDA-approved generic found

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

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

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 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 K72T3FS567
    Adenosine is a naturally occurring nucleoside compound. In medicines, it functions as an active pharmaceutical ingredient in some formulations, though when listed as an excipient it may serve as a buffering or stabilizing agent to maintain product stability and pH.
  • UNII 8JZ8B2V1OV
    A plant extract from Buddleja davidii (butterfly bush) used in formulations as a natural flavoring agent or botanical ingredient to add taste, aroma, or plant-derived properties to the medicine.
  • 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 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 59TL3WG5CO
    A synthetic polymer made by crosslinking acrylic acid with allyl sucrose. It thickens liquids, forms gels, and helps control how fast the medicine is released in your body.
  • 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 2968PHW8QP
    A weak organic acid derived from citrus fruits or made through fermentation. It works as a buffer to control pH, a preservative to extend shelf life, and a flavoring agent in medications.
  • UNII E107L85C40
    Dipropylene glycol is a clear liquid made from propylene glycol. It acts as a solvent and humectant in medicines, helping dissolve active ingredients and retain moisture in the formulation.
  • 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 PDC6A3C0OX
    Glycerin is a clear, thick liquid derived from plant oils or fats. It acts as a humectant to retain moisture, a sweetener, and a solvent in medications.
  • UNII 230OU9XXE4
    A waxy substance made from glycerin and stearic acid that acts as an emulsifier to blend oily and watery ingredients together. It also helps thicken and stabilize the medicine's texture.
  • UNII 1394NXB9L6
    A plant-derived protein from soybeans that has been broken down into smaller pieces using enzymes. It acts as a binder and texture agent, helping hold ingredients together and improve the product's consistency and mouthfeel.
  • UNII SDW6SS1K6I
    A plant extract from alpine edelweiss root. It's used as a natural flavoring or fragrance ingredient and may help preserve the product by providing antioxidant properties.
  • 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 2V16EO95H1
    Palmitic acid is a saturated fatty acid derived from plant and animal sources. It serves as an emulsifier and lubricant in medicines, helping ingredients mix smoothly and preventing sticking during manufacturing.
  • 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 03KCY6P7UT
    A waxy compound derived from cetyl alcohol and phosphoric acid. It acts as an emulsifier to help blend oil and water ingredients, and as a thickener to give the medicine its proper texture and consistency.
  • UNII 5965N8W85T
    Propanediol is a clear liquid organic compound derived from vegetable sources or synthesized chemically. It acts as a humectant to retain moisture, a solvent to dissolve active ingredients, and a preservative booster in liquid medications and supplements.
  • UNII 7N2B70SFEZ
    Rice germ is the nutrient-rich inner layer of the rice grain. It's used in medicines as a filler and bulking agent to add volume and help bind ingredients together in tablets and capsules.
  • 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 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 IN99IT31LN
    Sodium stearoyl lactylate is a synthetic compound made from stearic acid and lactic acid. It works as an emulsifier to help keep oils and water mixed together, and as a dough conditioner in solid dosage forms.
  • 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 CW657OBU4N
    A plant extract from thyme used as a flavoring agent and preservative in medicines. It adds taste and aroma while helping protect the product from spoilage.
  • 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 2ZA36H0S2V
    Beeswax is a natural wax produced by honeybees. In medicines, it works as a coating agent and thickener to control how fast the drug dissolves and improve the product's texture and appearance.

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

The official label also statesWATER, GLYCERIN, DIPROPYLENE GLYCOL, PANTHENOL, BUTYLOCTYL SALICYLATE, SILICA, BEESWAX, NIACINAMIDE, CETEARYL OLIVATE, SODIUM STEAROYL LACTYLATE, GLYCERYL STEARATE, POTASSIUM CETYL PHOSPHATE, SORBITAN OLIVATE, TOCOPHERYL ACETATE, CAPRYLYL GLYCOL, ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER, PALMITIC ACID, ETHYLHEXYLGLYCERIN, LEONTOPODIUM ALPINUM EXTRACT, STEARIC ACID, 1,2-HEXANEDIOL, ORYZA SATIVA (RICE) LEES EXTRACT, SODIUM HYDROXIDE, PROPANEDIOL, ADENOSINE, CITRIC ACID, HYDROLYZED SOY FLOUR, BUDDLEJA DAVIDII EXTRACT, THYMUS VULGARIS (THYME) EXTRACT

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

LabelerGalderma Laboratories, L.P.
FDA applicationM020 (OTC MONOGRAPH DRUG)
Labeler code00299
First marketedApr 2023
Product typeHuman Otc Drug
Portfolio50 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 🧪 Active Ingredient 🧪 Inactive Ingredients 🎯 Purpose 📄 Do Not Use 📄 When Using This Product 📄 Stop Use and Ask a Doctor If 📄 Keep Out of Reach of Children 📄 Questions or Comments 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 30 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 114 words ▾

Directions apply liberally 15 minutes before sun exposure use a water resistant sunscreen if swimming or sweating reapply at least every 2 hours 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 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 Other information protect the product in this container from excessive heat and direct sun may stain or damage some fabrics

⚠️ Warnings 5 words ▾

Warnings For external use only

🧪 Active Ingredient 17 words ▾

Active Ingredients.....Purpose Homosalate 9.5% .................Sunscreen Octocrylene 9.5% .........… Sunscreen Octisalate 4.8% ...............… Sunscreen Avobenzone 2.8% ................. Sunscreen

🧪 Inactive Ingredients 62 words ▾

Inactive Ingredients WATER, GLYCERIN, DIPROPYLENE GLYCOL, PANTHENOL, BUTYLOCTYL SALICYLATE, SILICA, BEESWAX, NIACINAMIDE, CETEARYL OLIVATE, SODIUM STEAROYL LACTYLATE, GLYCERYL STEARATE, POTASSIUM CETYL PHOSPHATE, SORBITAN OLIVATE, TOCOPHERYL ACETATE, CAPRYLYL GLYCOL, ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER, PALMITIC ACID, ETHYLHEXYLGLYCERIN, LEONTOPODIUM ALPINUM EXTRACT, STEARIC ACID, 1,2-HEXANEDIOL, ORYZA SATIVA (RICE) LEES EXTRACT, SODIUM HYDROXIDE, PROPANEDIOL, ADENOSINE, CITRIC ACID, HYDROLYZED SOY FLOUR, BUDDLEJA DAVIDII EXTRACT, THYMUS VULGARIS (THYME) EXTRACT

🎯 Purpose 2 words ▾

Purpose Sunscreen

📄 Do Not Use 9 words ▾

Do not use ▪ on damaged or broken skin

📄 When Using This Product 15 words ▾

When using this product • keep out of eyes. Rinse with water to remove .

📄 Stop Use and Ask a Doctor If 10 words ▾

Stop use and ask a doctor if • rash occurs.

📄 Keep Out of Reach of Children 19 words ▾

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

📄 Questions or Comments 4 words ▾

Questions or comments? 1-866-735-4137

📄 Package Label / Principal Display Panel 67 words ▾

Principal Display Panel -

1.7OZ Carton Cetaphil® DAY CREAM HEALTHY RENEW 30 BROAD SPECTRUM SPF 30 (UVA/UVB) SUNSCREEN Retinol Alternative All Skin Types Hydrates, and visibly smooths fine lines Purified Peptides, Vitamins B3 & B5 Dermatologist Recommended Sensitive Skin Icon NET WT

1.7OZ (48 g) Distributed by: Galderma Laboratories, L.P., Dallas, TX 75201 USA All trademarks are the property of their respective owners. cetaphil.com P57224-2

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 Homosalate, octocrylene, octisalate, avobenzone — the ingredient across all brands.

Top reported reactions

Application Site Burn1
Hypersensitivity1

Reporter sex

2 reports
Female · 100%
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 Galderma Laboratories, L.P.. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Galderma Laboratories, L.P. 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.
← 00299-4135-00 · Galderma 00299-4137-00 · Galderma →
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.