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Beauty 360 Accelerated Wrinkle Repair Moisturizer homosalate, octisalate, avobenzone, octocrylene 40 g/2mL; 40 g/2mL; 20 g/2mL; 20 g/2mL Liquid — NDC 68634-054-01 (Billing 68634-0054-01)

by AMCOL Health & Beauty Solutions, Inc. DBA · 1 BOTTLE in 1 CARTON / 30 mL in 1 BOTTLE

This is a package of Beauty 360 Accelerated Wrinkle Repair Moisturizer homosalate, octisalate, avobenzone, octocrylene 40 g/2mL; 40 g/2mL; 20 g/2mL; 20 g/2mL Liquid from AMCOL Health & Beauty Solutions, Inc. DBA, marketed since Apr 2016 and currently FDA-listed. It is this product's only package size.

NDC 68634-0054-01
🏷️ FDA NDC (as labeled) 68634-054-01 billing pads the product 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 →

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 68634-054-01
Product NDC 68634-054
11-digit billing NDC 68634005401
UNII V06SV4M95S, 4X49Y0596W, G63QQF2NOX, 5A68WGF6WM
UPC 0050428382523
Application # part352
SPL Set ID 4574f5b5-0429-43ca-a2a9-bacd75494c78
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH NOT FINAL
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2016-04-01
Route TOPICAL
Dosage form LIQUID
Substance HOMOSALATE; OCTISALATE; AVOBENZONE; OCTOCRYLENE
Why two NDCs? The FDA registers this code as 68634-054-01 — 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 → 68634-0054-01. 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?

Beauty 360 Accelerated Wrinkle Repair Moisturizer is a topical liquid product marketed as an over-the-counter monograph drug. It contains four active ingredients (avobenzone, homosalate, octisalate, and octocrylene) that function as ultraviolet (UV) filters commonly used in sunscreen formulations. These ingredients are typically included to help protect skin from UVA and UVB radiation. The product is applied to the skin as a moisturizer with sun protection.

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 mLPer 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
68634-0054-01 You're viewing this Main listing 1 BOTTLE in 1 CARTON / 30 mL in 1 BOTTLE 2016-04-01 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Beauty 360 Accelerated Wrinkle Repair Moisturizer 40 g/2mL; 40 g/2mL; 20 g/2mL; 20 g/2mLthis 68634-0054-01 AMCOL 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

🏛️
2016
On the market since
Apr 2016
📍
2026
Currently FDA-listed
10 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.

Loading inactive ingredients from the official FDA label in the background. No external source is being called by this page request.
Where does this data come from?
Source: official FDA Structured Product Labeling (SPL) via DailyMed and the openFDA label index. Structured IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.

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

LabelerAMCOL Health & Beauty Solutions, Inc. DBA
FDA applicationpart352 (OTC MONOGRAPH NOT FINAL)
Labeler code68634
First marketedApr 2016
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 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 cause by the sun.

⏱️ Dosage and Administration 89 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: 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

⚠️ Warnings 54 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 swallowed, get medical help or contact a Poison Control Center right away.

🧪 Active Ingredient 10 words ▾

Active ingredients Avobenzone 2.0% Homosalate 4.0% Octisalate 4.0% Octocrylene 2.0%

🧪 Inactive Ingredients ~2 min read ▾

Inactive ingredients Water, Styrene/Acrylates Copolymer, Glycerin, Dimethicone, Isononyl Isononanoate, Trisiloxane, Steareth-21, Pentylene Glycol, Cetyl Alcohol, Phenoxyethanol, Silica, Methyl Methacrylate/Glycol Dimethacrylate Crosspolymer, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Steareth-2, PEG-100 Stearate, Glyceryl Stearate, Polysorbate 20, Dimethicone/Vinyl Dimethicone Crosspolymer, Chlorphenesin, Retinol, Xanthan Gum, BHT, Ethylhexylglycerin, Disodium EDTA, Nylon-12, Sodium Hydroxide, Hydrolyzed Myrtus Communis Leaf Extract, Stearyl Alcohol, Tocopheryl Acetate, Sodium Hyaluronate, Propyl Gallate, Ascorbic Acid, Fragrance beauty 360™ Beauty 360 offers a collection of superior quality products to suit your individual daily needs from head to toe.

Beauty 360: reinventing beauty. Accelerated Wrinkle Repair Moisturizer with Broad Spectrum SPF 30 Sunscreen works quickly for measurable results. Retinol is clinically proven to help: Reduce the appearance of age spots and discolorations Even out skin tone Minimize the visible signs of aging, including fine lines and wrinkles *This product is not manufactured or distributed by Johnson & Johnson Consumer Companies Inc., owner of the registered trademark Neutrogena®.

This product is covered by U.S. Patents 6,500,411 and 6,716,418 Distributed by: CVS Pharmacy, Inc. One CVS Drive, Woonsocket, RI 02895 © 2016 CVS/pharmacy CVS.com® 1-800-SHOP CVS Made in the U.S.A. of U.S. and foreign components V-13649 CVS® Quality Money Back Guarantee What is retinol?

Retinol is a form of Vitamin A that naturally absorbs into your skin. It helps your skin achieve a smoother, more youthful appearance. Rapid retinol SR Combines a potent level of pure retinol with plant-based Phyto-Complex to help skin look and feel younger.

It is a unique combination of the following ingredients: Retinol SR Sustained Release technology contains wrinkle-smoothing retinol and helps reduce the appearance of age spots Hyaluronic Acid Hydrates skin to provide line-plumping moisture for a more rejuvenated appearance Phyto-Complex Helps improve skin tone and reduces the appearance of wrinkles Warnings: You may experience mild tingling and/or redness. This is a sign that the product is working. If discomfort occurs, reduce use to every other day.

Discontinue use if irritation persists. Protect this product from excessive heat and direct sun. Caution: For external use only.

Avoid getting into eyes. If product gets into eyes, rinse thoroughly with water. Keep out of reach of children.

M050891 FP121 ________________________________________________________ end of text 160225 AMCOL Health & Beauty Solutions, Inc. DBA AMCOL Household and Personal Care 301 Laser Lane Lafayette, LA 70507 | www.amcolhpc.com [email protected]

🎯 Purpose 5 words ▾

Purpose Sunscreen Sunscreen Sunscreen Sunscreen

📄 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.

📄 Other Information 14 words ▾

Other information Protect the product in this container from excessive heat and direct sunlight

📄 Package Label / Principal Display Panel 85 words ▾

Principal Display Panel - Carton Label beauty 360™ ACCELERATED WRINKLE REPAIR MOISTURIZER MEASURABLE RESULTS Rapid retinol SR Formulated without parabens UVA/UVB protection BROAD SPECTRUM SPF 30 SUNSCREEN SPF 30 COMPARE TO NEUTROGENA® RAPID WRINKLE REPAIR MOISTURIZER* CVS pharmacy® 1 FL (29 mL) Principal Display Panel - Carton Label

Principal Display Panel - Bottle Label beauty 360™ ACCELERATED WRINKLE REPAIR MOISTURIZER MEASURABLE RESULTS Rapid retinol SR Formulated without parabens BROAD SPECTRUM SPF 30 SUNSCREEN SPF 30 1 FL (29 mL) Principal Display Panel - Bottle Label

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗

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) — Not published for this NDC The labeler did not submit a structured excipient list, or no SPL is 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 Not Final". 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 AMCOL Health & Beauty Solutions, Inc. DBA. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
AMCOL Health & Beauty Solutions, Inc. DBA 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.
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.