REPLENIX LIP THERAPY HOMOSALATE- homosalate lipstick

Replenix Lip Therapy by

Drug Labeling and Warnings

Replenix Lip Therapy by is a Otc medication manufactured, distributed, or labeled by Topiderm, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

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.

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

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

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

INGREDIENTS AND APPEARANCE

REPLENIX LIP THERAPY   HOMOSALATE
homosalate lipstick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51326-102
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	150 mg  in 1 g
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	75 mg  in 1 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	50 mg  in 1 g
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	30 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
HYDROGENATED POLYBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ)
OCTOCRYLENE (UNII: 5A68WGF6WM)
BENZYL NICOTINATE (UNII: S497LCF9C9)
GLYCERIN (UNII: PDC6A3C0OX)
CETEARYL ETHYLHEXANOATE (UNII: 9M64UO4C25)
SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4)
PORTULACA PILOSA WHOLE (UNII: II29C6E5R3)
SUCROSE COCOATE (UNII: 3H18P0UK73)
PALMITOYL LYSYLDIOXYMETHIONYLLYSINE (UNII: T7A529FB8O)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
MENTHONE 1,2-GLYCEROL KETAL, (+/-)- (UNII: 7QQ1EE6RCP)
STEVIA REBAUDIUNA LEAF (UNII: 6TC6NN0876)
NIACINAMIDE (UNII: 25X51I8RD4)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
GLUTATHIONE (UNII: GAN16C9B8O)
ERGOTHIONEINE (UNII: BDZ3DQM98W)
CERAMIDE NP (UNII: 4370DF050B)
CERAMIDE AP (UNII: F1X8L2B00J)
CERAMIDE 1 (UNII: 5THT33P7X7)
PHYTOSPHINGOSINE (UNII: GIN46U9Q2Q)
CHOLESTEROL (UNII: 97C5T2UQ7J)
SODIUM LAUROYL LACTYLATE (UNII: 7243K85WFO)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
XANTHAN GUM (UNII: TTV12P4NEE)
YUCCA SCHIDIGERA ROOT (UNII: E2H9ET15AT)
SALIX ALBA BARK (UNII: 205MXS71H7)
PANTHENOL (UNII: WV9CM0O67Z)
SPEARMINT OIL (UNII: C3M81465G5)
PEPPERMINT OIL (UNII: AV092KU4JH)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51326-102-04	4 g in 1 BOTTLE; Type 0: Not a Combination Product	01/02/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part352	01/02/2022

Labeler - Topiderm, Inc. (049121643)

Establishment
Name	Address	ID/FEI	Business Operations
Topiderm, Inc.		049121643	MANUFACTURE(51326-102)