FDA-Approved On-Label Uses for Dermal Fillers

FDA approval applies to a specific filler product for a specific purpose. It does not mean every product within a brand collection can be used interchangeably—or that every approved treatment is suitable for every patient.

The following overview highlights selected approved uses for hyaluronic acid injectables, including newer products and indications. It is not an exhaustive list or a substitute for checking the current labeling.

Juvéderm

Products within the Juvéderm collection have different approved uses.

Examples include Volux XC for improving jawline definition, Voluma XC for cheek, chin, and temple augmentation under its specified indications, and Volbella XC for lip augmentation, perioral lines, and infraorbital hollowing.

Ultra XC, Ultra Plus XC, and Vollure XC have their own indications. Approval of one formulation does not extend automatically to another.

Skinvive by Juvéderm

Skinvive is approved to improve cheek skin smoothness and to reduce neck lines for improvement of neck appearance in adults over age 21.

The neck indication was added in June 2026. These skin-quality indications differ from adding facial projection or replacing substantial volume.

Restylane

The Restylane collection includes products with indications involving facial folds, lips, cheeks, chin, under-eye hollowing, and dorsal-hand volume, depending on the formulation.

Examples include Eyelight for infraorbital hollowing, Kysse for lip augmentation and upper perioral lines, and Defyne for certain deep facial folds and chin augmentation.

Restylane Contour is approved for cheek augmentation and correction of midface contour deficiencies. Its indication expanded in March 2026 to include temple hollowing in patients over age 21. Temple treatment has product-specific training requirements.

RHA Collection

RHA 2, RHA 3, and RHA 4 have indications involving moderate to severe dynamic facial wrinkles and folds. RHA 3 also has a lip-augmentation indication, while RHA Redensity is approved for specified dynamic perioral lines.

In September 2025, FDA expanded the indications for RHA 4 and RHA Dynamic Volume to include cheek augmentation and correction of age-related midface contour deficiencies in adults age 22 and older.

The exact formulation and current instructions matter when selecting a product.

Belotero

Belotero Balance products have indications involving selected facial wrinkles and folds. Belotero Balance (+) also has an infraorbital-hollowing indication.

Belotero Intense (+) Lidocaine received FDA approval in July 2026 for lip augmentation in adults over age 21.

Revanesse

Revanesse Versa products have indications for selected moderate to severe facial wrinkles and folds. Revanesse Lips+ is approved for lip augmentation.

The applicable age requirements, placement, and precautions should be checked for the exact product.

Obagi saypha

Saypha MagIQ received FDA approval in September 2025 for correcting moderate to severe facial wrinkles and folds, such as nasolabial folds, in adults over age 21.

Saypha ChIQ received FDA approval in June 2026 for cheek augmentation and restoration of midface volume deficits in adults over age 21.

Evolysse

Evolysse Form and Evolysse Smooth received FDA approval in February 2025 for dermal and subdermal injection to correct moderate to severe dynamic facial wrinkles and folds, such as nasolabial folds, in adults age 22 and older.

Other products discussed internationally should not be assumed to share that US approval.

What does off-label mean?

Using an approved product outside its approved labeling is called off-label use. This may involve a different location or purpose.

An off-label recommendation requires a discussion of the supporting evidence, alternatives, limitations, and risks. It should not be described as FDA-approved for that proposed use.

Approval does not eliminate risk

Filler injections can cause swelling, bruising, tenderness, infection, and other reactions. Uncommon vascular complications can cause tissue injury, blindness, or stroke.

Unusual pain or concerning skin-color changes require immediate contact with your injector. Vision changes or stroke symptoms require emergency medical attention.

At Modern Aesthetics in San Jose, I assess your anatomy, treatment history, and goals before recommending a product. This educational overview includes products beyond those offered at the practice.

Schedule a consultation to discuss an individualized plan.

Updated October 23, 2026.

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Off-Label Dermal Filler: What Patients Should Know

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Understanding Different Dermal Filler Brands