REPLENIX LIP THERAPY  HOMOSALATE- homosalate lipstick 
Topiderm, Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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REPLENIX® Lip Therapy
homosalate

Drug Facts

Active ingredientsPurpose
Homosalate 15.0%Sunscreen
Octinoxate 7.5%Sunscreen
Octisalate 5.0%Sunscreen
Avobenzone 3.0%Sunscreen

Uses

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.

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
REPLENIX LIP THERAPY   HOMOSALATE
homosalate lipstick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51326-102
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE150 mg  in 1 g
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE75 mg  in 1 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE50 mg  in 1 g
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE30 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:51326-102-044 g in 1 BOTTLE; Type 0: Not a Combination Product01/02/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart35201/02/2022
Labeler - Topiderm, Inc. (049121643)
Establishment
NameAddressID/FEIBusiness Operations
Topiderm, Inc.049121643MANUFACTURE(51326-102)

Revised: 2/2023
Document Id: f36547fe-d116-479a-8d81-561a6694a25e
Set id: b60dc004-d713-47bc-a6e9-ea4783aa7019
Version: 5
Effective Time: 20230202
 
Topiderm, Inc.