MINERAL MATTESCREEN SPF 40- titanium dioxide, zinc oxide cream

Mineral Mattescreen SPF 40 by

Drug Labeling and Warnings

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

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredients Purpose

Titanium Dioxide 1.3% Sunscreen

Zinc Oxide 17.4% Sunscreen

PURPOSE

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.

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

INDICATIONS & USAGE

• Stop use and ask a doctor if rash occurs.

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.

DOSAGE & ADMINISTRATION

Directions

• Apply generously and evenly 15 minutes before sun exposure
• Reapply at least every 2 hours.
• Use a water-resistant sunscreen if swimming or sweating
• Sun Protection Measures Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use sunscreen with a Broad-Spectrum SPF value of 15 or higher and other sunprotection measures including: limit your time in the sun, especially from 10a.m. – 2 p.m. wear long-sleeved shirts, pants, hats, and sunglasses
• Children under 6 months of age: ask a doctor.

INACTIVE INGREDIENT

Inactive Ingredients

Dimethicone, Dimethicone Copolymer, Caprylic/Capric Triglyceride, Methyl Dihydroabietate, Polyhydroxystearic Acid, C9-12 Alkane, Glycerin, Iron Oxides (CI 77492), Ethylhexylglycerin, Water (Aqua), Coco-Caprylate/Caprate, Silica, Stearic Acid, Iron Oxides (CI 77491), Iron Oxides (CI 77499), Hedychium Coronarium Root Extract, Lactobacillus/Arundinaria Gigantea Leaf Ferment Filtrate, Leuconostoc/Radish Root Ferment Filtrate, Titanium Dioxide (CI 77891)

PRINCIPAL DISPLAY PANEL

Mineral Mattescreen SPF 40

100% Mineral Broad Spectrum Sunscreen SPF 40 PA +++

1.5 fl. oz./45 ml

20 ml packaging

15 ml packaging

10 ml packaging

1.5 ml packette

INGREDIENTS AND APPEARANCE

MINERAL MATTESCREEN SPF 40 
titanium dioxide, zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 75936-281
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	1.3 g  in 100 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	17.4 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
METHYL DIHYDROABIETATE (UNII: 7666FJ0J9F)
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
COCO-CAPRYLATE/CAPRATE (UNII: 8D9H4QU99H)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
STEARIC ACID (UNII: 4ELV7Z65AP)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
HEDYCHIUM CORONARIUM ROOT (UNII: 92A6N0IQN9)
LEUCONOSTOC/RADISH ROOT FERMENT FILTRATE (UNII: D2QHA03458)
DIMETHICONE (UNII: 92RU3N3Y1O)
DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII: UF7620L1W6)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 75936-281-01	5 mL in 1 TUBE; Type 0: Not a Combination Product	05/18/2021
2	NDC: 75936-281-02	10 mL in 1 TUBE; Type 0: Not a Combination Product	05/18/2021
3	NDC: 75936-281-03	45 mL in 1 CARTON; Type 0: Not a Combination Product	05/18/2021
4	NDC: 75936-281-04	20 mL in 1 TUBE; Type 0: Not a Combination Product	09/02/2021
5	NDC: 75936-281-05	1.5 mL in 1 PACKET; Type 0: Not a Combination Product	05/18/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	05/18/2021

Labeler - Supergoop, LLC (117061743)