MINERAL MATTESCREEN BROAD SPECTRUM SPF 40- zinc oxide, titanium dioxide lotion

Mineral Mattescreen Broad Spectrum SPF 40 by

Drug Labeling and Warnings

Mineral Mattescreen Broad Spectrum SPF 40 by is a Otc medication manufactured, distributed, or labeled by Taylor James, Englewood Lab, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredients Purpose

Zinc oxide 17% Sunscreen

Titanium dioxide 0.7% Sunscreen

PURPOSE

Uses

• Helps prevent Sunburn
• If used as directed with other sun protection ( see Directions), decreases the risk of skin cancer and early skin aging caused by the sun.

KEEP OUT OF REACH OF CHILDREN

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

WARNINGS

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.

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

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

Smooth and Poreless

100% mineral Poreless

Broad Spectrum SPF 40

Water & Sweat Resistant (40 minutes)

1.5 fl. oz/ 45 mL

INGREDIENTS AND APPEARANCE

MINERAL MATTESCREEN BROAD SPECTRUM SPF 40 
zinc oxide, titanium dioxide lotion

Product 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
4	NDC: 75936-280-04	1.5 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)