FDA Label for Replenix Lip Therapy Homosalate
View Indications, Usage & Precautions
Replenix Lip Therapy Homosalate Product Label
The following document was submitted to the FDA by the labeler of this product Topiderm, Inc.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Other
Drug Facts
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
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