Label: MINERAL MATTESCREEN BROAD SPECTRUM SPF 40- zinc oxide, titanium dioxide lotion
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Contains inactivated NDC Code(s)
NDC Code(s): 75936-280-01, 75936-280-02, 75936-280-03 - Packager: Taylor James
- 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 April 26, 2021
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- KEEP OUT OF REACH OF CHILDREN
- WARNINGS
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DOSAGE & ADMINISTRATION
Directions
- apply generously and evenly 15 minutes before sun exposure
- reapply:
- after 40 minutes of swimming or sweating
- immediately after towel drying
- at least 2 hours
- Sun Protection Measures Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk of skin cancer and early skin aging, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including:
- Limit time in the sun, especially from 10 a.m. -2p.m.
- Wear Long-sleeved shirts, pants, hats, and sunglasses
- Children under 6 months: Ask a doctor
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INACTIVE INGREDIENT
Inactive ingredients
Cyclopentasiloxane, Coco-Caprylate, Isododecane, Coco-Caprylate/Caprate, Dimethicone Crosspolymer, Silica Dimethyl Silylate, Dimethicone/Bis-Isobutyl PPG-20 Crosspolymer, Argania Spinosa Kernel Oil, Cyclohexasiloxane, Tocopheryl Acetate, C12-15 Alkyl Benzoate, Polyglyceryl-3 Polyricinoleate, Dimethicone, Iron Oxides (CI 77492), Water (Aqua), Isostearic Acid, Cyclotetrasiloxane, Propanediol, Ethylhexylglycerin, PEG/PPG-18/18 Dimethicone, Bisabolol, Alumina, Hydrogen Dimethicone, Iron Oxides (CI 77491),
Polyhydroxystearic Acid, Iron Oxides (CI 77499), Buddleja Officinalis Flower Extract, Triethoxycaprylylsilance, Tocopherol, Phenoxyethanol, Potassium Sorbate, Hydrangea Aborescens Root Extract, Morus Alba Root Extract, Polysorbate 20, Resveratrol, Scutellaria Lateriflora Extract, Caprylyl Glycol, Hexylene Glycol, Pentapeptide-21
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
MINERAL MATTESCREEN BROAD SPECTRUM SPF 40
zinc oxide, titanium dioxide lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:75936-280 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 0.7 g in 100 mL ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 17 g in 100 mL Inactive Ingredients Ingredient Name Strength LEVOMENOL (UNII: 24WE03BX2T) HYDROGEN DIMETHICONE (13 CST) (UNII: 4QGR4P2YOI) POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F) FERROSOFERRIC OXIDE (UNII: XM0M87F357) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) PHENOXYETHANOL (UNII: HIE492ZZ3T) POTASSIUM SORBATE (UNII: 1VPU26JZZ4) HYDRANGEA ARBORESCENS ROOT (UNII: SFK828Q2DE) MORUS ALBA ROOT (UNII: CST1G9BZGD) POLYSORBATE 20 (UNII: 7T1F30V5YH) CAPRYLYL GLYCOL (UNII: 00YIU5438U) HEXYLENE GLYCOL (UNII: KEH0A3F75J) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794) FERRIC OXIDE RED (UNII: 1K09F3G675) TOCOPHEROL (UNII: R0ZB2556P8) RESVERATROL (UNII: Q369O8926L) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ) CYCLOMETHICONE 6 (UNII: XHK3U310BA) DIMETHICONE/BIS-ISOBUTYL PPG-20 CROSSPOLYMER (UNII: O4I3UFO6ZF) DIMETHICONE (UNII: 92RU3N3Y1O) BUDDLEJA OFFICINALIS FLOWER (UNII: 274707Y672) SCUTELLARIA LATERIFLORA (UNII: 7BP4DH5PDC) ISOSTEARIC ACID (UNII: X33R8U0062) PROPANEDIOL (UNII: 5965N8W85T) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) CYCLOMETHICONE 5 (UNII: 0THT5PCI0R) COCO-CAPRYLATE (UNII: 4828G836N6) COCO-CAPRYLATE/CAPRATE (UNII: 8D9H4QU99H) DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5) SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W) ARGAN OIL (UNII: 4V59G5UW9X) WATER (UNII: 059QF0KO0R) ALUMINUM OXIDE (UNII: LMI26O6933) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:75936-280-01 5 mL in 1 TUBE; Type 0: Not a Combination Product 02/09/2018 2 NDC:75936-280-02 45 mL in 1 BOX; Type 0: Not a Combination Product 02/09/2018 3 NDC:75936-280-03 15 mL in 1 TUBE; Type 0: Not a Combination Product 02/09/2018 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part352 02/09/2018 Labeler - Taylor James (033381850) Establishment Name Address ID/FEI Business Operations Englewood Lab, Inc. 080987545 manufacture(75936-280)
