Indications and 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 caused by the sun.
Replenix Lip Therapy
- Manufacturer
- Topiderm, Inc.
- Effective date
- 2023-02-02
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 7
- Source
- full-release
- Hydrated at
- 2026-06-01 01:54:40
Label at a glance#
ProductReplenix Lip Therapy homosalate
Active ingredientHOMOSALATE, OCTINOXATE, OCTISALATE, AVOBENZONE
Label structure7 sections
Dosage and administration
Apply a generous coat to bare lips as often as desired, staying inside the lip line. Visible volume and natural color typically lasts 1-2 hours. Individual results may vary. 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 of 15 or higher and other sunscreen measures including: limit...
Label contents#
Full prescribing information#
SPL UNCLASSIFIED SECTION
Drug Facts
OTC - ACTIVE INGREDIENT SECTION
OTC - PURPOSE SECTION
| Active ingredients | Purpose |
|---|---|
| Homosalate 15.0% | Sunscreen |
| Octinoxate 7.5% | Sunscreen |
| Octisalate 5.0% | Sunscreen |
| Avobenzone 3.0% | Sunscreen |
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 caused by the sun.
Warnings
For lip application only.
This product delivers a temporary tingling sensation to the lips. Only apply product inside the line of your lips.
OTC - WHEN USING SECTION
When using this product keep out of eyes, rinse with water to remove.
OTC - STOP USE SECTION
Stop use if signs of irritation or rash appear. If irritation or rash persists consult a doctor.
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
Keep out of reach of children.
In case of accidental ingestion, seek professional assistance or contact a Poison Control Center immediately.
Directions
Apply a generous coat to bare lips as often as desired, staying inside the lip line. Visible volume and natural color typically lasts 1-2 hours. Individual results may vary.
- 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 of 15 or higher and other sunscreen measures including:
- limit time in the sun, especially from 10a.m.-2 p.m.
- wear long-sleeve shirts, pants, hats, and sunglasses
Inactive ingredients
Hydrogenated Polyisobutene, Ethylene/Propylene/Styrene Copolymer, Butylene/Ethylene/Styrene Copolymer, Octocrylene, Benzyl Nicotinate, Glycerin, Cetearyl Ethylhexanoate, Sorbitan Isostearate, Portulaca Pilosa Extract, Sucrose Cocoate, Pa l m i t o y l Tripeptide-38, Sodium Hyaluronate, Menthone Glycerin Acetal, Stevia Rebaudiana Leaf/Stem Powder, Niacinamide, Tocopheryl Acetate, Hydrolyzed Sodium Hyaluronate, Glutathione, Ergothioneine, Ceramide NP, Ceramide AP, Ceramide EOP, Phytosphingosine, Cholesterol, Sodium Lauroyl Lactylate, Carbomer, Xanthan Gum, Yucca Schidigera Root Extract, Salix Alba (Willow) Bark Extract, Panthenol, Essential Oil of Spearmint (Mentha Viridis), Essential Oil of Peppermint (Mentha Piperita), Flavor.
PRINCIPAL DISPLAY PANEL - 4 ml Bottle Carton
REPLENIX®
PURE HYDRATION
Plumping Lip Treatment
Broad Spectrum SPF 30 Sunscreen
Net 0.14 fl. oz. (4 ml)
Topix Pharmaceuticals, Inc. N. Amityville, NY 11701
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 51326-102-04 | 2025-01-30 | C162847 | 48780-1 | 2cef2736-80c4-d83d-e063-dadaa90ab31f | REPLENIX ® Lip Therapy homosalate |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 51326-102-04 | Replenix Lip Therapyhomosalate | 4 g in 1 BOTTLE | LIPSTICK | 4 | 7 |
Products#
Every source-derived product name is available through these pages.
- Replenix Lip Therapy homosalate
- homosalate
- OCTINOXATE
- OCTISALATE
- AVOBENZONE
- HYDROGENATED POLYISOBUTENE (1300 MW)
- OCTOCRYLENE
- BENZYL NICOTINATE
- GLYCERIN
- CETEARYL ETHYLHEXANOATE
- SORBITAN ISOSTEARATE
- PORTULACA PILOSA WHOLE
- SUCROSE COCOATE
- PALMITOYL TRIPEPTIDE-38
- HYALURONATE SODIUM
- MENTHONE 1,2-GLYCEROL KETAL, (+/-)-
- STEVIA REBAUDIANA LEAF
- NIACINAMIDE
- .ALPHA.-TOCOPHEROL ACETATE
- GLUTATHIONE
- ERGOTHIONEINE
- CERAMIDE NP
- CERAMIDE AP
- CERAMIDE 1
- PHYTOSPHINGOSINE
- CHOLESTEROL
- SODIUM LAUROYL LACTYLATE
- CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE
- XANTHAN GUM
- YUCCA SCHIDIGERA ROOT
- SALIX ALBA BARK
- PANTHENOL
- SPEARMINT OIL
- PEPPERMINT OIL
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 51326-102 | 51326-102-04 |
Ingredients#
Every source-derived ingredient row is available through these pages.
Source Document#
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Replenix Lip Therapy homosalate | HOMOSALATE | Topiderm, Inc. | b60dc004-d713-47bc-a6e9-ea4783aa7019 | 2023-02-02 | Warnings | 51326-102-04 51326-102 51326010204 cda6e73e-8e21-48d6-bd98-282e4a06ff32 b60dc004-d713-47bc-a6e9-ea4783aa7019 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.