REPLENIX TINTED SUNSCREEN  SPF 50- zinc oxide and octinoxate lotion 
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® Tinted Sunscreen
SPF 50

Drug Facts

Active ingredientPurpose
Zinc Oxide 14.5%Sunscreen
Octinoxate 7.5%Sunscreen

Uses

Warnings

For external use only.

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.

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 10 a.m.-2 p.m.
  • wear long-sleeve shirts, pants, hats, and sunglasses

Directions

Inactive ingredients

Purified Water, Niacinamide, Oleth-3 Phosphate, Neopentyl Glycol Diheptanoate, Polyisobutene, Octyldodecyl Neopentanoate, Butylene Glycol, Sodium Hyaluronate, Tocopheryl Acetate, Caffeine, Dimethicone, Panthenol, Sucrose, Jojoba Esters, Lactic Acid, Glycerin, Ethylhexyl Stearate, Triethoxycaprylylsilane, Xanthan Gum, Lauryl PEG-9 Polydimethylsiloxyethyl Dimethicone, Iron Oxides, PEG-7 Trimethylolpropane Coconut Ether, Hydroxyethyl Acrylate/Sodium Acryloydimethyl Taurate Copolymer, Phenoxyethanol, Disodium EDTA.

PRINCIPAL DISPLAY PANEL - 63 g Bottle Label

REPLENiX®
SUNSCREEN

ESSENTIAL
OIL FREE TINTED
SPF 50

14.5% Micronized Zinc Oxide
Multi-tasking tinted application
Sensitive skin friendly

BROAD SPECTRUM UVA/UVB SPF 50

Net wt. 2.22 oz. (63 g)

TOPIX PHARMACEUTICALS, INC. N. AMITYVILLE, NY 11701

PRINCIPAL DISPLAY PANEL - 63 g Bottle Label
REPLENIX TINTED SUNSCREEN   SPF 50
zinc oxide and octinoxate lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51326-201
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE145 mg  in 1 g
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE75 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
NIACINAMIDE (UNII: 25X51I8RD4)  
OLETH-3 PHOSPHATE (UNII: 8Q0Z18J1VL)  
NEOPENTYL GLYCOL DIHEPTANOATE (UNII: 5LKW3C543X)  
HYDROGENATED POLYBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ)  
OCTYLDODECYL NEOPENTANOATE (UNII: X8725R883T)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
CAFFEINE (UNII: 3G6A5W338E)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
PANTHENOL (UNII: WV9CM0O67Z)  
SUCROSE (UNII: C151H8M554)  
HYDROLYZED JOJOBA ESTERS (ACID FORM) (UNII: UDR641JW8W)  
LACTIC ACID, DL- (UNII: 3B8D35Y7S4)  
GLYCERIN (UNII: PDC6A3C0OX)  
ETHYLHEXYL STEARATE (UNII: EG3PA2K3K5)  
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
XANTHAN GUM (UNII: TTV12P4NEE)  
LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: 25G622K2RA)  
FERROUS OXIDE (UNII: G7036X8B5H)  
PEG-7 TRIMETHYLOLPROPANE COCONUT ETHER (UNII: MVJ3AD73GG)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (100000 MPA.S AT 1.5%) (UNII: 86FQE96TZ4)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:51326-201-0163 g in 1 BOTTLE; Type 0: Not a Combination Product04/22/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart35204/22/2022
Labeler - Topiderm, Inc. (049121643)
Registrant - Topiderm, Inc. (049121643)
Establishment
NameAddressID/FEIBusiness Operations
Topiderm, Inc.049121643MANUFACTURE(51326-201)

Revised: 2/2023
Document Id: e95cd431-e6df-4047-bd6f-0204b0ddf146
Set id: 1fda4a54-e323-4f3c-b659-bded4b1b3dd0
Version: 2
Effective Time: 20230222
 
Topiderm, Inc.