TOPIX MINERAL MATTIFYING TINTED SUNSCREEN  SPF 30- zinc oxide cream 
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 Mattifying Tinted Sunscreen
SPF 30

Drug Facts

Active ingredientPurpose
Zinc Oxide 16.5%Sunscreen
Titanium Dioxide 3.2%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 10a.m.-2 p.m.
    • wear long-sleeve shirts, pants, hats, and sunglasses

Directions

Inactive ingredients

Alumina, Ascorbic Acid, Biotin, Butylene Glycol, Butyrospermum Parkii (Shea) Butter, Camellia Sinensis Leaf (Green Tea) Polyphenols, Caprylic/Capric Triglyceride, Centella Asiatica Extract, Ceramide NS, Cyclopentasiloxane, Cyclotetrasiloxane, Dimethicone Crosspolymer, Dimethicone, Hexyl Laurate, Iron Oxides, Isodoecane, Methyl Trimethicone, PEG/PPG-18/18 Dimethicone, PEG-10 Dimethicone, PEG-8 Methyl Ether Triethoxysilane, Phospholipids, Phyllanthus Emblica Fruit Extract, Polyglyceryl-4 Isostearate, Polyhydroxystearic Acid, Polymethylsilsesquiloxane, Polysilicone-11, Purified Water, Resveratrol, Silica Dimethyl Silylate, Silica, Stearic Acid, Tocopherol, Ubiquinone (Co-Enzyme Q10).

PRINCIPAL DISPLAY PANEL - 54 g Bottle Label

COMPLIMENTS OF
TOPIX
PHARMACEUTICALS, INC

MULTI-TASKING

Mineral Mattifying
Tinted Sunscreen
SPF 30

Broad Spectrum SPF 30

Net wt. 1.9 oz. (54 g)

Available
Custom Branded
800.445.2595
c.service@topixpharm.com

Principal Display Panel - 54 g Bottle Label
TOPIX MINERAL MATTIFYING TINTED SUNSCREEN   SPF 30
zinc oxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51326-130
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE162 mg  in 1 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE32 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
ALUMINUM OXIDE (UNII: LMI26O6933)  
ASCORBIC ACID (UNII: PQ6CK8PD0R)  
BIOTIN (UNII: 6SO6U10H04)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
SHEA BUTTER (UNII: K49155WL9Y)  
GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
CENTELLA ASIATICA WHOLE (UNII: 7M867G6T1U)  
CERAMIDE NG (UNII: C04977SRJ5)  
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
CYCLOMETHICONE 4 (UNII: CZ227117JE)  
DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII: UF7620L1W6)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
HEXYL LAURATE (UNII: 4CG9F9W01Q)  
FERROUS OXIDE (UNII: G7036X8B5H)  
ISODODECANE (UNII: A8289P68Y2)  
METHYL TRIMETHICONE (UNII: S73ZQI0GXM)  
PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794)  
PEG-10 DIMETHICONE (220 CST) (UNII: 287GF3Y3WC)  
OMEGA-3 FATTY ACIDS (UNII: 71M78END5S)  
PHYLLANTHUS EMBLICA FRUIT (UNII: YLX4CW2576)  
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)  
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
POLYMETHYLSILSESQUIOXANE (11 MICRONS) (UNII: Z570VEV8XK)  
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)  
WATER (UNII: 059QF0KO0R)  
RESVERATROL (UNII: Q369O8926L)  
SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  
COENZYME Q10, (2Z)- (UNII: U705VLF0VW)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:51326-130-0154 g in 1 BOTTLE; Type 0: Not a Combination Product02/21/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart35202/21/2023
Labeler - Topiderm, Inc. (049121643)
Registrant - Topiderm, Inc. (049121643)
Establishment
NameAddressID/FEIBusiness Operations
Topiderm, Inc.049121643MANUFACTURE(51326-130)

Revised: 2/2023
Document Id: b67367ac-6c9d-424b-9196-27c1c95fe112
Set id: 7220e507-0aea-47de-8cac-ccc69a999395
Version: 1
Effective Time: 20230224
 
Topiderm, Inc.