Key takeaways
- Fillers are approved one product and one area at a time, for adults 22 or older.
- Under-eye filler is on-label only for the four products approved for infraorbital hollowing.
- No US filler is approved for the nose, forehead, glabella, buttocks, hips or breasts.
- The FDA recommends against using any filler for body contouring.
- There is no standard syringe count per area, only trial medians and label maximums.
Which face areas can filler treat?
Fillers are approved one product and one area at a time.
An approval order names the exact area and the age group it covers, and the FDA states that fillers are approved for adults aged 22 or older (over 21), with each product label setting the exact age.
The FDA describes dermal fillers as medical device implants approved to create a smoother and/or fuller appearance in the face, and its overview names the nasolabial folds, cheeks, chin, lips and the back of the hands.
Approvals since then have added more areas, product by product.
For how the product types differ, start with our dermal fillers guide, then find each area below.
Approved filler areas, product by product
| Area | Approved products (year) |
|---|---|
| Lips | Restylane (2011), Restylane-L (2012), Juvéderm Ultra XC (2015), Juvéderm Volbella XC (2016), Restylane Kysse (2020), Revanesse Lips+ (2020), RHA 3 (2023), Belotero Intense (+) Lidocaine (2026) |
| Cheeks | Juvéderm Voluma XC (2013), Restylane Lyft (2015), Restylane Contour (2021), RHA 4 and RHA Dynamic Volume (2025), Belotero Volume (+) Lidocaine (2026) |
| Chin | Juvéderm Voluma XC (2020), Restylane Defyne (2021), Restylane Lyft (2025) |
| Jawline | Radiesse (+) (2021), Juvéderm Volux XC (2022) |
| Under-eyes | Juvéderm Volbella XC (2021), Restylane Eyelight (2023), Belotero Balance (+) (2023), RHA Redensity Eye (2026) |
| Temples | Juvéderm Voluma XC (2023), Restylane Contour (2026) |
| Back of the hands | Radiesse (2015), Restylane Lyft (2018) |
| Neck lines | SKINVIVE by Juvéderm (2026) |
Lips. Lip augmentation has drawn its own product approvals since 2011, when Restylane became the first US filler with a lip indication (Restylane-L followed in 2012).
Approvals have since gone to Juvéderm Ultra XC (2015), Juvéderm Volbella XC (2016), Restylane Kysse (2020), Revanesse Lips+ (2020), RHA 3 (2023) and Belotero Intense (+) Lidocaine (2026).
Several of the same products are approved for the vertical "lip lines" around the mouth: Volbella XC and Kysse carry perioral-line indications, and RHA Redensity was approved for moderate to severe dynamic perioral lines in 2021.
RHA 3 is the only RHA product with a lip approval, so other RHA fillers used in the lips are off-label.
Our guide to lips covers the products, cost and duration.
Cheeks. Cheek augmentation is an approved indication for Juvéderm Voluma XC (2013, age-related midface volume deficit), Restylane Lyft (2015), Restylane Contour (2021), RHA 4 and RHA Dynamic Volume (2025) and Belotero Volume (+) Lidocaine (2026, midface volume).
SKINVIVE by Juvéderm is a different kind of cheek approval: it was approved in 2023 to improve cheek skin smoothness, not to add volume.
Our cheeks guide covers the area in depth.
Chin. Chin approvals have gone to Juvéderm Voluma XC (2020, to improve the chin profile), Restylane Defyne (2021, mild to moderate chin retrusion) and Restylane Lyft (2025, also mild to moderate chin retrusion).
A recessed chin and a double chin are different problems: fullness under the chin has its own approved injectable, Kybella — a prescription drug, not a filler — approved in 2015 to improve the appearance of moderate to severe fullness associated with submental fat in adults.
Our chin guide explains the area.
Jawline. Two approvals cover the jawline: Juvéderm Volux XC (2022), for improvement of jawline definition in adults over 21 with moderate to severe loss of jawline definition, and Radiesse (+) (2021), for moderate to severe loss of jawline contour.
The label language is precise: it speaks of jawline definition and jawline contour, not of jowls.
Ask a licensed provider what an approved jawline product would and would not cover for sag at or below the jaw.
Our jawline guide explains the area in detail.
Under-eyes. Under-eye filler is not automatically off-label: since 2021, four products have gained FDA approvals for infraorbital (under-eye) hollowing — Juvéderm Volbella XC, the first, in 2021; Restylane Eyelight in 2023; Belotero Balance (+) in 2023; and RHA Redensity Eye in 2026.
Any other filler used under the eyes is off-label, meaning it is not on that product's current US label.
The FDA's general filler page lists the periorbital area among uses that are not approved, which is why the product name matters here.
Our under-eyes guide covers the area.
Temples. Temple hollowing became an approved filler area in 2023, when Juvéderm Voluma XC was approved for supraperiosteal injection to augment the temple region in adults over 21 with moderate to severe temple hollowing.
Restylane Contour followed with an approval for correction of temple hollowing in 2026.
Smile lines and marionette lines. The nasolabial fold — the smile line running from the side of the nose to the mouth corner — is the classic filler indication.
It appears in the FDA's overview, and Restylane Lyft, Restylane Defyne (deep nasolabial folds), Restylane Refyne and Radiesse all carry nasolabial-fold approvals; Radiesse's covers "moderate to severe facial wrinkles and folds such as nasolabial folds".
Marionette lines, the folds that continue from the mouth corners toward the jaw, sit just below.
The labels cited here name the nasolabial folds as the example, so ask a licensed provider to show you the indication on the label of any product proposed for the marionette area.
Hands. The back of the hands is a non-facial area that does hold filler approvals, and the approval records show hand rejuvenation is on-label for only two US fillers: Radiesse (2015) and Restylane Lyft (2018), both for correction of volume loss.
Any other filler injected into the hands is off-label.
Neck and chest. The FDA's general filler page lists the neck among areas that are not approved injection sites, but narrow approvals have started to arrive.
SKINVIVE by Juvéderm was approved in 2026 to reduce neck lines for improvement of neck appearance in adults over 21, and Radiesse is approved, diluted 1:2 with saline, for décolleté wrinkles in patients 22 and older as of March 2026.
SKINVIVE's approval covers neck lines, not neck volume.
Earlobes. We could not confirm an FDA-approved filler indication for the earlobes.
If a practice offers earlobe filler, treat it as a question for a licensed provider: ask which product is being used and what the indication on its label covers.
Which areas are off-label or high-risk?
An off-label filler use is one that is not on any current US label for that product.
The FDA's general filler page, last updated February 2024, lists the glabella, nose, periorbital area, forehead and neck among uses that are not approved, and specific products have gained approvals near some of those areas since — which is why this page names the product every time.
As of the FDA's PMA file dated 2026-10-12, no approval order for a face or hand filler mentions the nose, the glabella, the forehead, the buttocks, the hips or the breasts.
Marketing that presents any of these as approved areas does not match those records, and every product injected into them is off-label.
Nose. The non-surgical nose job, or liquid rhinoplasty, reshapes the nose with filler, and no US dermal filler carries an approval that names the nose.
The nose is also a high-scoring site in published case reports of filler-related vision loss: a 2024 review of 365 newly published cases ranked it the highest-risk site, at 40.6%, and it was second in a 2015 review at 25.5% of the 98 cases.
Case reports count what was published, not how often it happens, but they are why this area is treated as high-risk.
Our nose guide explains the technique and its evidence.
Forehead and glabella. No filler is approved for the forehead or the glabella — the area between the eyebrows.
These sites score high in the same case reviews: the glabella led the 2015 review at 38.8% of cases, and in the 2024 review the forehead accounted for 27.7% and the glabella 19.0%.
The FDA's general filler page lists both areas among uses that are not approved.
Highest-risk sites in published vision-loss cases
Share of 365 cases published Sept 2018–Mar 2023
Source: 2024 review of published case reports
Silicone. One more material belongs on this list: the FDA has not approved liquid silicone or silicone gel injection to fill wrinkles or augment tissue anywhere in the body.
FDA calls unintentional injection into a blood vessel the most concerning filler risk: rare, but it can cause tissue death (necrosis), vision problems including blindness, and stroke, and the damage may be permanent. FDA tells patients to seek immediate medical attention for unusual pain, vision changes, a white, gray or blue appearance of skin near the injection site, or signs of stroke.
Body filler (buttocks, hip dips)
As of the FDA's October 2026 PMA file, the buttocks and hips are not filler areas on any US label: the approval orders for face and hand fillers name no product for the buttocks, hips or breasts.
And for body uses the FDA goes beyond "not approved" — it recommends against body-contouring filler.
Sculptra, a poly-L-lactic acid filler, holds three facial approvals: HIV-associated facial fat loss (2004), nasolabial fold contour deficiencies and other facial wrinkles (2009, as Sculptra Aesthetic), and fine lines and wrinkles in the cheek region (2023).
Its label states that safety and effectiveness have not been evaluated when it is injected in larger amounts, at different frequencies or at sites other than its approved uses — which places the buttocks and hips outside the label, and is why an off-label "Sculptra BBL" is not an approved use.
The published evidence behind buttock filler is thin.
A 2020 review in Dermatologic Surgery called the literature sparse, and a 2023 systematic review found only 12 reports on filler buttock augmentation, most judged strongly biased, concluding that "gluteal augmentation with soft tissue fillers is not as simple and innocuous as advertised" and that serious complications may occur. "Hip dip" filling falls under the same body uses: no filler is approved for the hips.
The FDA recommends against using dermal fillers — or any injectable filler — for body contouring and enhancement, including increasing breast size and increasing the size of the buttocks. It also lists implantation into bone, tendon, ligament or muscle among uses that are not approved.
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How many syringes per area
We found no standard number of syringes per face area.
No label, professional-society guidance or peer-reviewed source we checked gives one — none we found says "two syringes for cheeks" — so a typical-sounding count you see online is not a label figure.
What exists are trial medians and label maximums, each tied to one product and one area.
The trial numbers come with their context.
In the Restylane Kysse US pivotal trial, which randomized 273 subjects, the median total volume for initial treatment plus touch-up was 2.50 mL across all areas, including a median of 0.90 mL in the upper lip and 0.80 mL in the lower lip; the median volume at retreatment was 1.30 mL.
A trial median is a midpoint for that study, not an amount to expect for your face.
Labels set maximums instead of typical amounts.
The Restylane Kysse label recommends a maximum of 6 mL per patient per treatment — 3 mL for the lips and 3 mL for the perioral area — and the Sculptra label allows up to 9 mL — one vial in an 8 mL reconstitution — per cheek per session for cheek wrinkles.
Label maximums per session
| Product and area | Label maximum |
|---|---|
| Restylane Kysse, lips | 3 mL |
| Restylane Kysse, perioral area | 3 mL |
| Restylane Kysse, total per patient per treatment | 6 mL |
| Sculptra, cheek wrinkles | 9 mL (one vial, 8 mL reconstitution) per cheek |
The size of a "syringe" is not fixed either.
Revanesse Versa, Versa+ and Lips+ are approved in both 1.0 mL and 1.2 mL syringes, so one syringe does not mean the same volume across brands.
"Facial balancing" — a multi-area filler plan quoted as a single package — is not an FDA-defined indication, and we found no primary source for typical syringe counts or total cost for these plans.
What the approvals support is combining individually approved areas, such as cheeks, chin, jawline, lips and temples, using a product approved for each; the nose, forehead and glabella parts of a "balancing" plan are off-label.
Body areas run to a different scale.
In one retrospective series of 60 women who had Sculptra buttock injections — one to three sessions, four to six weeks apart, with two to 12 vials per session "based on the patient budget" — the authors concluded that visible results required at least 20 vials in total.
It is a single small series of an off-label use, not a recommendation.
Because no table can tell you your number, the syringe question is one for a consultation.
The FDA advises choosing a licensed health care provider with dermatology or plastic-surgery experience who is trained in filler injection, and treating filler injection as a medical procedure rather than a cosmetic treatment.
Frequently asked questions
What is dermal filler used for?
The FDA describes dermal fillers as medical device implants approved to create a smoother and/or fuller appearance in the face.
Its overview names the nasolabial folds, cheeks, chin, lips and the back of the hands, and product approvals add areas such as the jawline, temples, under-eyes and, for one product, neck lines.
Each approval names the exact product, area and age group, so what a filler can be used for always depends on which product is being injected.
Is nose filler FDA-approved?
No. As of the FDA's October 2026 PMA file, no US dermal filler carries an approval that names the nose, so a non-surgical nose job with filler is an off-label use — not on any current US label for the product used.
A 2024 review of 365 published vision-loss cases also ranked the nose the highest-risk site, at 40.6%.
Case reports count what was published, not how often it happens.
Is under-eye filler off-label?
Not always.
Four products hold FDA approvals for infraorbital (under-eye) hollowing: Juvéderm Volbella XC (2021, the first), Restylane Eyelight (2023), Belotero Balance (+) (2023) and RHA Redensity Eye (2026).
Any other filler used under the eyes is off-label — not on that product's current US label.
The product name is what decides, so it is worth asking which filler a provider would use and what its approval covers.
How many syringes of filler does the average face need?
We found no standard number of syringes for any face area: no label, professional society or peer-reviewed study we checked gives one.
The figures that exist are trial medians and label maximums for single products — for example, a median 0.90 mL in the upper lip and 0.80 mL in the lower lip in one Restylane Kysse trial.
What any one person needs depends on the product and the area, which is a question for a licensed provider.
Is Sculptra approved for the buttocks?
No. Sculptra's approvals are facial: HIV-associated facial fat loss (2004), nasolabial fold contour deficiencies and other facial wrinkles (2009) and fine lines and wrinkles in the cheek region (2023).
Its label states that safety and effectiveness have not been evaluated in larger amounts, at different frequencies or at sites other than its approved uses, and the FDA recommends against body-contouring filler, including increasing the size of the buttocks.
A 2023 systematic review found only 12 reports on filler buttock augmentation, most judged strongly biased.
Sources
Every number on this page comes from one of these sources and was checked against it.
- Dermal Fillers (Soft Tissue Fillers) · U.S. Food and Drug Administration
- FDA-Approved Dermal Fillers · U.S. Food and Drug Administration
- accessdata.fda.gov · U.S. Food and Drug Administration
- restylaneusa.com · restylaneusa.com
- sculptrausa.com · sculptrausa.com
- KYBELLA- deoxycholic acid injection, solution · DailyMed, U.S. National Library of Medicine
- Avoiding and Treating Blindness From Fillers: A Review of the World Literature · Beleznay et al., Dermatol Surg, 2015
- Update on Blindness From Filler: Review of Prognostic Factors, Management Approaches, and a Century of Published Cases · Doyon et al., Aesthet Surg J, 2024
- Safety and Efficiency of Minimally Invasive Buttock Augmentation: A Review · Atiyeh et al., Aesthetic Plast Surg, 2023
- Poly-L-Lactic Acid for Gluteal Augmentation found to be Safe and Effective in Retrospective Clinical Review of 60 Patients · Durairaj et al., Dermatol Surg, 2020
Medical disclaimer. MedSpaStandard is for education only and is not medical advice. Talk to a licensed provider about your own health, and check any provider's license with your state board.