FDA-Approved On-Label Uses for Dermal Fillers

Dermal fillers, also called injectable implants, are medical devices approved by the U.S. Food and Drug Administration (FDA) for specific aesthetic indications. Depending on the individual product, fillers may be used to improve certain facial wrinkles and folds, restore volume, enhance facial contours, augment the lips, improve undereye hollowing, and address age-related volume loss in the hands.

The FDA recommends seeking treatment from a licensed healthcare provider who is experienced with dermal filler injections and knowledgeable about facial anatomy, filler products, and the recognition and management of complications. FDA approval applies to a specific filler product for a specific indication; products within the same brand collection are not automatically FDA-approved for the same treatment areas.

To obtain an FDA-approved indication for a treatment area, a manufacturer must submit clinical and preclinical evidence demonstrating a reasonable assurance of safety and effectiveness for that specific product and use. Many commonly performed filler treatments may be considered off-label. Off-label treatment is not inherently inappropriate, but it means the use is outside that individual product’s FDA-approved labeling.

Below are selected FDA-approved, on-label uses for commonly used hyaluronic acid dermal fillers. Individual treatment plans should always be based on anatomy, tissue quality, medical history, goals, and a qualified provider’s assessment.

Belotero

• Belotero Balance / Belotero Balance (+)

  • FDA-approved for correction of moderate-to-severe facial wrinkles and folds, such as nasolabial folds.

• Belotero Balance (+)

  • Also FDA-approved for improvement of infraorbital hollowing, commonly called undereye hollows, in adults over age 21.

Juvéderm Collection

• Juvéderm Volux XC

  • FDA-approved for improvement of jawline definition in adults over age 21 with moderate-to-severe loss of jawline definition.

• Juvéderm Voluma XC

  • FDA-approved for cheek augmentation to correct age-related volume deficit in the midface; chin augmentation to improve chin profile; and augmentation of the temple region to improve moderate-to-severe temple hollowing.

• Juvéderm Vollure XC

  • FDA-approved for correction of moderate-to-severe facial wrinkles and folds, such as nasolabial folds.

• Juvéderm Volbella XC

  • FDA-approved for lip augmentation, correction of perioral rhytids, and improvement of infraorbital hollowing.

• Juvéderm Ultra XC

  • FDA-approved for lip augmentation and correction of moderate-to-severe facial wrinkles and folds, such as nasolabial folds.

• Juvéderm Ultra Plus XC

  • FDA-approved for correction of moderate-to-severe facial wrinkles and folds, such as nasolabial folds.

Restylane Collection

• Restylane

  • FDA-approved for lip augmentation and correction of moderate-to-severe facial wrinkles and folds, such as nasolabial folds.

• Restylane-L

  • FDA-approved for lip augmentation and correction of moderate-to-severe facial wrinkles and folds, such as nasolabial folds.

• Restylane Lyft with Lidocaine

  • FDA-approved for correction of moderate-to-severe facial wrinkles and folds, such as nasolabial folds; cheek augmentation and correction of age-related midface contour deficiencies; correction of dorsal-hand volume deficit; and chin augmentation to improve chin profile in patients with mild-to-moderate chin retrusion.

• Restylane Silk

  • FDA-approved for lip augmentation and correction of perioral rhytids.

• Restylane Eyelight

  • FDA-approved for improvement of infraorbital hollowing.

• Restylane Contour

  • FDA-approved for cheek augmentation and correction of midface contour deficiencies, as well as correction of temple hollowing.

• Restylane Kysse

  • FDA-approved for lip augmentation and correction of upper perioral rhytids.

• Restylane Defyne

  • FDA-approved for correction of moderate-to-severe deep facial wrinkles and folds, such as nasolabial folds, and chin augmentation to improve chin profile in patients with mild-to-moderate chin retrusion.

• Restylane Refyne

  • FDA-approved for correction of moderate-to-severe facial wrinkles and folds, such as nasolabial folds.

RHA Collection

• RHA 2

  • FDA-approved for correction of moderate-to-severe dynamic facial wrinkles and folds, such as nasolabial folds.

• RHA 3

  • FDA-approved for correction of moderate-to-severe dynamic facial wrinkles and folds, such as nasolabial folds, and for lip augmentation and lip fullness in adults age 22 and older.

• RHA 4

  • FDA-approved for correction of moderate-to-severe dynamic facial wrinkles and folds, such as nasolabial folds.

• RHA Redensity

  • FDA-approved for correction of moderate-to-severe dynamic perioral rhytids.

Revanesse Collection

• Revanesse Versa / Versa+

  • FDA-approved for correction of moderate-to-severe facial wrinkles and folds, such as nasolabial folds.

• Revanesse Lips+

  • FDA-approved for lip augmentation in patients age 22 and older.

Choosing the Right Filler

An FDA-approved indication is one important part of treatment planning, but it does not mean every filler is appropriate for every patient or every concern. Product selection should account for facial anatomy, tissue quality, degree and location of volume loss, facial movement, skin laxity, previous treatments, and your individual goals.

Your aesthetic provider should understand the properties of each filler product as well as the anatomy and safety considerations involved in filler treatment. This allows for an individualized plan focused on balanced, natural-looking results.

Dermal filler injections can cause temporary swelling, bruising, redness, tenderness, or firmness. Rare but serious complications can occur, including accidental injection into a blood vessel, which may lead to tissue injury, vision changes or blindness, or stroke. Seek urgent medical attention for severe or unusual pain, blanching or dusky skin discoloration, vision changes, or neurologic symptoms after filler treatment.

Last medically reviewed: September 2026.