Label: TOPIX MINERAL MATTIFYING TINTED SUNSCREEN SPF 30- zinc oxide cream
- NDC Code(s): 51326-130-01
- Packager: Topiderm, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
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.
Drug Label Information
Updated February 24, 2023
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
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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.
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Warnings
For external use only.
- In case of accidental ingestion, seek professional assistance or contact a Poison Control Center immediately.
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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
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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
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INGREDIENTS AND APPEARANCE
TOPIX MINERAL MATTIFYING TINTED SUNSCREEN SPF 30
zinc oxide creamProduct 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)