TOPIX MINERAL BRIGHTENING AND CORRECTING EYE MAKE-UP  SPF 50- zinc oxide and titanium dioxide 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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Topix Mineral Brightening and Correcting Eye Make-up
SPF 50

Drug Facts

Active ingredientPurpose
Zinc Oxide 6.5%Sunscreen
Titanium Oxide 6.4%Sunscreen

Uses

Warnings

For external use only.

Do not use on damaged or broken skin.

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

Stop use and ask a doctor if rash occurs.

Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center Immediately.

Directions

Other information

Protect the product in this container from excessive heat and direct sun.

Inactive Ingredients

Purified Water, Caprylyl Methicone, Cetyl Diglyceryl Tris(Trimethylsiloxy)silylethyl Dimethicone, Dimethicone Crosspolymer, Glycerin, Isododecane, Dimethicone, Alumina, Hydrogen Dimethicone, HDI/Trimethylol Hexyllactone Crosspolymer, Iron Oxides, Tin Oxide, Sodium Hyaluronate, Acetyl Hexapeptide-8, Leontopodium Alpinum Callus Culture Extract, Dunaliella Salina Extract, Macrocystis Pyrifera (Kelp) Extract, Panthenol, Tocopheryl Acetate, Palmitoyl Tripeptide-5, Hydrolyzed Vegetable Protein, Ascophyllum Nodosum Extract, Asparagopsis Armata Extract, Sucrose, Xanthan Gum, Mica, Silica, PVP, Triethoxycaprylylsilane, Sorbitol, Phenyl Trimethicone, Sodium Chloride, Phenoxyethanol, Disodium EDTA, Potassium Sorbate.

PRINCIPAL DISPLAY PANEL - 8.5 ml Tube Carton

AGE DEFENSE
FOR THE EYES

5-IN-1

BROAD SPECTRUM UVA/UVB SPF 50+

WATER/SWEAT RESISTANT (80 MIN)

Net 0.29 fl. oz. (8.5 ml)

Principal Display Panel - 8.5 ml Tube Carton
TOPIX MINERAL BRIGHTENING AND CORRECTING EYE MAKE-UP   SPF 50
zinc oxide and titanium dioxide lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51326-121
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE65 mg  in 1 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE64 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL)  
CETYL DIGLYCERYL TRIS(TRIMETHYLSILOXY)SILYLETHYL DIMETHICONE (3500 MM2/S) (UNII: KB7T6C99UP)  
DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII: UF7620L1W6)  
GLYCERIN (UNII: PDC6A3C0OX)  
ISODODECANE (UNII: A8289P68Y2)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
FERROUS OXIDE (UNII: G7036X8B5H)  
STANNOUS OXIDE (UNII: JB2MV9I3LS)  
HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
ACETYL HEXAPEPTIDE-8 (UNII: L4EL31FWIL)  
LEONTOPODIUM NIVALE SUBSP. ALPINUM ROOT (UNII: SDW6SS1K6I)  
DUNALIELLA SALINA (UNII: F4O1DKI9A6)  
MACROCYSTIS PYRIFERA (UNII: K31S3OG5C4)  
PANTHENOL (UNII: WV9CM0O67Z)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
PALMITOYL TRIPEPTIDE-5 (UNII: 2A3916MQHO)  
HYDROLYZED WHEAT PROTEIN (ENZYMATIC; 3000 MW) (UNII: J2S07SB0YL)  
ASCOPHYLLUM NODOSUM (UNII: 168S4EO8YJ)  
ASPARAGOPSIS ARMATA (UNII: 2936KN6I1G)  
SUCROSE (UNII: C151H8M554)  
XANTHAN GUM (UNII: TTV12P4NEE)  
MICA (UNII: V8A1AW0880)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
POLY(4-VINYLPYRIDINE-N-OXIDE) (UNII: 2I40HY84KZ)  
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
SORBITOL (UNII: 506T60A25R)  
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:51326-121-018.5 mL in 1 TUBE; Type 0: Not a Combination Product01/24/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart35201/24/2021
Labeler - Topiderm, Inc. (049121643)
Registrant - Topiderm, Inc. (049121643)
Establishment
NameAddressID/FEIBusiness Operations
Topiderm, Inc.049121643MANUFACTURE(51326-121)

Revised: 3/2023
Document Id: 0455d937-704b-47e1-8ca5-2925ab973f8c
Set id: a0b04863-3054-46d4-be1d-ef2d32906675
Version: 1
Effective Time: 20230317
 
Topiderm, Inc.