SKINVIVE is the product people find when they search for a "skin booster" in the United States, and it is easy to assume it belongs with the DNA and peptide boosters sold in Korean clinics. It does not. It is hyaluronic acid, the material in most fillers, and it is the one product in that category with a US approval. That makes it unusually well documented: an approval file with dates, a manufacturer's label that states the composition, two registered pivotal trials with posted results, and a public adverse-event database. This page reads all four.
The manufacturer does not publish a full ingredient list in the consumer sense; what this page states about composition comes from the SKINVIVE by Juvéderm Directions for Use posted by AbbVie, read 2 October 2026.
What the gel is
The Directions for Use describe a "sterile, biodegradable, non-pyrogenic, viscoelastic, clear, colorless, homogeneous gel implant": hyaluronic acid produced by Streptococcus species of bacteria, crosslinked with 1,4-butanediol diglycidyl ether (BDDE), at 12 mg/mL, with 0.3% w/w lidocaine in a physiologic buffer. Lidocaine is a local anaesthetic, which is why the label lists lidocaine allergy as a contraindication.
Three things follow from that sentence. It is not a peptide, so the peptide evidence on this site does not apply to it. It is not PDRN or polynucleotide, the salmon-DNA material in Rejuran-type boosters and in the PDRN products this site covers. And it is the same class of material as the Juvéderm filler range, placed higher in the skin and in smaller amounts; the difference between this "booster" and a filler is one of placement, amount and stated purpose, not of substance.
The approval record, dated
FDA's premarket approval database lists SKINVIVE as a supplement to Allergan's Juvéderm file, PMA P110033. Read on 2 October 2026, the trade name appears on 20 records. The ones that change what the product is approved for:
| Date | Supplement | What FDA approved |
|---|---|---|
| 11 May 2023 | S059 | Intradermal injection to improve facial skin smoothness of the cheeks in adults over 21 |
| 1 Aug 2023 | S072 | Final revised labelling |
| 1 May 2025 | S097 | Updated postmarket surveillance data in the patient labelling and Directions for Use |
| 11 Jun 2026 | S099 | Adds intradermal and/or subdermal injection to reduce neck lines |
| 11 Aug 2026 | S091 | Sodium hyaluronate from an additional manufacturing line as a raw material |
The other fifteen are manufacturing notices: cleanrooms, mixers, syringe shelf life, carton varnish. They are routine, and they show the product's file is active. The neck indication is new enough that many clinic pages, and some articles about the product, still describe it as a cheek-only treatment.
What the two pivotal trials measured
Both trials were sponsored by the manufacturer, randomized, and blinded for the person scoring the result. Both compared the gel against no treatment, not against another product or a saline injection. That design shows the gel did something compared with leaving skin alone; it cannot show how it compares with any other filler or booster.
Cheeks (NCT03728309, 209 adults). The primary result, posted on ClinicalTrials.gov, is the share of participants who improved by at least one grade on the Allergan Cheek Smoothness Scale on both cheeks at month 1: 57.9% treated (n = 131) against 4.5% untreated (n = 71). The scale is the company's own and runs from 0 (smooth) to 4. In the Directions for Use, the treated group's responder rate was 58.4% at 1 month, 61.7% at 2 months, 59.1% at 4 months and 55.6% at 6 months. Participants' own satisfaction on the FACE-Q skin questionnaire rose by 32.0 points in the treated group against 1.4 in the control.
Neck (NCT05316233, 159 adults). The primary result is the share improving by at least one grade on the Allergan Transverse Neck Lines Scale at month 1: 74.8% treated (n = 105) against 16.1% untreated (n = 54). The Directions for Use report 66.0% (64 of 97) still meeting that bar at six months.
Two caveats are worth stating plainly. Both scales were developed by the company, which is normal for device trials and still worth knowing. And a one-grade change on a five-point scale is the trial's definition of success, not a description of what a reader would see.
Side effects, as the label and the trials record them
The cheek trial asked participants to keep a 30-day diary of injection-site responses. 79.4% (158 of 199) reported at least one. The most common were redness (68.8%), lumps or bumps (63.3%), swelling (61.3%), bruising (57.8%), pain (52.8%), tenderness (52.8%) and firmness (47.2%). Most were mild and lasted a week or less, but 9.5% had some response lasting more than 30 days, and three participants had lumps or bumps that took 12 to 15 months to resolve. The neck trial's diaries show the same pattern, with lumps or bumps reported by 76.2%.
The label's postmarket section, built from reports received worldwide since the product's 2016 launch outside the US, lists in order of frequency: subcutaneous nodule, oedema, inflammatory nodule, erythema, pain, bruising, vascular occlusion, local reaction, rash, unsatisfactory result, discolouration, inflammation, allergic reaction, and further down abscess, infection, necrosis, scarring and vision changes. It notes that no vascular-occlusion event was reported for the neck. Vascular occlusion, when filler blocks a blood vessel, is the serious risk of every injected filler, and the label's warnings section opens with it.
The label also sets limits that were studied: no more than 20 mL of any Juvéderm gel per 60 kg of body weight per year, and volumes above 6.0 mL for the cheeks or 5.0 mL for the neck per treatment course "have not been studied". Safety in pregnancy, breastfeeding and in people under 22 has not been established.
What FDA's adverse-event database holds
On 2 October 2026, FDA's MAUDE database held 376 reports naming SKINVIVE: 374 coded as injury, 1 as malfunction and 1 as death. By year received: 31 in 2023, 90 in 2024, 77 in 2025 and 178 so far in 2026. The most frequent coded problems were obstruction or occlusion (119), nodule (107), subcutaneous nodule (53), inflammation (24), abscess (17) and allergic reaction (15).
How to read those numbers. MAUDE is a reporting system, not a count of how often anything happens: reports are voluntary or manufacturer-filed, one event can be coded several ways, and the database holds no figure for how many treatments were given, so no rate can be calculated from it. The 2026 rise may reflect more treatments after the neck approval, more reporting, or both; the database cannot say which. The single death report, filed by the manufacturer in December 2023, describes a patient who died the day after a 2 mL cheek treatment and states the death was "deemed not device related".
What this record establishes
- SKINVIVE is a crosslinked hyaluronic-acid gel with lidocaine, from the Juvéderm approval file. It is neither a peptide nor a DNA booster.
- It holds two FDA indications, cheek smoothness (2023) and neck lines (2026), each backed by a sponsor-run, evaluator-blinded trial against no treatment.
- The trials show a measured improvement against untreated skin at one month that was still measured in most participants at six months. They do not compare it with any other product.
- Short-lived injection-site reactions were the norm in the trials; lumps lasting a year occurred in a small number, and the label's warnings centre on vascular occlusion.
This is an ingredient analysis, not a review. It does not say whether anyone should have the treatment. That is a conversation for a qualified injector, who can explain the risks for a particular face and neck. For the wider booster category, see our skin boosters guide; for a different kind of injectable that works by provoking collagen rather than by adding gel, see Sculptra.
Sources
- AbbVie, SKINVIVE by Juvéderm Directions for Use (rxabbvie.com/pdf/skinvive_dfu.pdf), read 2026-10-02.
- FDA, Summary of Safety and Effectiveness Data, PMA P110033/S059 (accessdata.fda.gov), read 2026-10-02.
- FDA PMA database via openFDA, all records with trade name SKINVIVE (20), read 2026-10-02.
- FDA MAUDE via openFDA, device brand name SKINVIVE: event-type, year and patient-problem counts, and the death-coded report 3005113652-2023-10055, read 2026-10-02 (database last updated 2026-09-22).
- ClinicalTrials.gov, NCT03728309 (cheek, posted results) and NCT05316233 (neck, posted results), read 2026-10-02.