replenix®

replenix®
SPL v5
SPL
SPL Set ID b60dc004-d713-47bc-a6e9-ea4783aa7019
Route
topical
Published
Effective Date 2023-02-07
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
homosalate (150 mg) octinoxate (75 mg) octisalate (50 mg) avobenzone (30 mg)
Inactive Ingredients
hydrogenated polybutene (1300 mw) octocrylene benzyl nicotinate glycerin cetearyl ethylhexanoate sorbitan isostearate portulaca pilosa whole sucrose cocoate palmitoyl lysyldioxymethionyllysine hyaluronate sodium menthone 1,2-glycerol ketal, (+/-)- stevia rebaudiuna 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

Identifiers & Packaging

Marketing Status
otc monograph not final active Since 2022-01-02

Description

Drug Facts


Medication Information

Warnings

For lip application only.

This product delivers a temporary tingling sensation to the lips. Only apply product inside the line of your lips.

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.
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.

Description

Drug Facts

Section 42229-5

Drug Facts

Section 50565-1

Keep out of reach of children.

In case of accidental ingestion, seek professional assistance or contact a Poison Control Center immediately.

Section 50566-9

Stop use if signs of irritation or rash appear. If irritation or rash persists consult a doctor.

Section 50567-7

When using this product keep out of eyes, rinse with water to remove.

Section 55105-1
Active ingredients Purpose
Homosalate 15.0% Sunscreen
Octinoxate 7.5% Sunscreen
Octisalate 5.0% Sunscreen
Avobenzone 3.0% Sunscreen
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


Structured Label Content

Warnings

For lip application only.

This product delivers a temporary tingling sensation to the lips. Only apply product inside the line of your lips.

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.
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 (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.

Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

Keep out of reach of children.

In case of accidental ingestion, seek professional assistance or contact a Poison Control Center immediately.

Section 50566-9 (50566-9)

Stop use if signs of irritation or rash appear. If irritation or rash persists consult a doctor.

Section 50567-7 (50567-7)

When using this product keep out of eyes, rinse with water to remove.

Section 55105-1 (55105-1)
Active ingredients Purpose
Homosalate 15.0% Sunscreen
Octinoxate 7.5% Sunscreen
Octisalate 5.0% Sunscreen
Avobenzone 3.0% Sunscreen
Principal Display Panel 4 Ml Bottle Carton (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


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)