Other
Drug Facts
Replenix Lip Therapy Lipstick
FDA Label NDC 51326-102
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Topiderm, Inc. for the product Replenix Lip Therapy (NDC 51326-102). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding other, otc - purpose, uses, warnings, otc - when using, otc - stop use, otc - keep out of reach of children, directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
| 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
When using this product keep out of eyes, rinse with water to remove.
Otc - Stop Use
Stop use if signs of irritation or rash appear. If irritation or rash persists consult a doctor.
Otc - Keep Out Of Reach Of Children
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
Principal Display Panel (4 ml Bottle Carton)
* Please review the disclaimer below.
