TOPIX MINERAL MATTIFYING TINTED SUNSCREEN SPF 30- zinc oxide cream

Topix Mineral Mattifying Tinted Sunscreen by

Drug Labeling and Warnings

Topix Mineral Mattifying Tinted Sunscreen 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 ingredient	Purpose
Zinc Oxide 16.5%	Sunscreen
Titanium Dioxide 3.2%	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 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

• Apply liberally and spread evenly by hand 15 minutes before sun exposure
• Re-apply after swimming, excessive perspiring, or anytime after towel drying
• Use a water resistant sunscreen if swimming or sweating
• Use on children under 6 months of age: consult a doctor.

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

INGREDIENTS AND APPEARANCE

TOPIX MINERAL MATTIFYING TINTED SUNSCREEN   SPF 30
zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51326-130
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	162 mg  in 1 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	32 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51326-130-01	54 g in 1 BOTTLE; Type 0: Not a Combination Product	02/21/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part352	02/21/2023

Labeler - Topiderm, Inc. (049121643)

Registrant - Topiderm, Inc. (049121643)

Establishment
Name	Address	ID/FEI	Business Operations
Topiderm, Inc.		049121643	MANUFACTURE(51326-130)