MAX MINERAL- titanium dioxide, zinc oxide cream

Max Mineral by

Drug Labeling and Warnings

Max Mineral by is a Otc medication manufactured, distributed, or labeled by Peter Thomas Roth Labs, LLC, June Jacobs Labs, LLC, JUNE JACOBS LABS, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Titanium Dioxide I.93%

Zinc Oxide 19.24%

PURPOSE

Active Ingredients.............................................................. Purpose

Titanium Dioxide I.93%................................................... Sunscreen

Zinc Oxide 19.24%..... ................................................... Sunscreen

INDICATIONS & USAGE

Uses

helps prevent sunburn
lf used as directed with other sun protection measures

(see Directions), decreases the risk of skin cancer and early skinaging caused by the sun

DOSAGE & ADMINISTRATION

Directions

apply liberally 15 minutes before sun exposure
reapply at least every 2 hours
use a waterresistant 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 a sunscreen with a broad spectrum SPF of 15 or higher and other sun protection measures including: limit time in the sun, especially from 10 a.m. to 2 p.m.
wear longsleeved shirts, pants, hats, and sunglasses

children under 6 months of age: ask a doctor

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 aska doctor if rash occurs.

Keep out of reach of children.

If product is swallowed, get medical help or contact a Poison Control Center right away.

INACTIVE INGREDIENT

Inactive Ingredients

Water, Butyloctyl Salicylate, C9- 12 Alkane, Carthamus Tinctorius (Safflower) Oleosomes, lsodecyl Neopentanoate, Dicaprylyl Carbonate, Cetyl Alcohol, Coco-Caprylate/ Caprate, Propanediol, Ethylhexyl Olivate, Glyceryl Stearate, PEG-I00 Stearate, Cetearyl Olivate, Stearyl Phosphate, Triethoxycaprylylsilane, Phenoxyethanol, Oleth3 Phosphate, Sorbitan Olivate, HDI/Trimethylol Hexyllactone Crosspolymer, Alumina, Xanthan Gum, Polymethylsilsesquioxane, Polyhydroxystearic Acid, Squalane, Gluconolactone, Sodium Phytate, lsopropyl Titanium Triisostearate, Sodium Benzoate, Hydrogen Dimethicone, Potassium Sorbate, Silica, Tocopheryl Acetate, Ascorbic Acid, Diamond Powder, Iron Oxides, Mica

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children.

QUESTIONS

Question or comments?

Call toll free 1-800-PTR-SKIN (787-7546)

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

MAX MINERAL 
titanium dioxide, zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 54031-020
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	9.271756 g  in 48.19 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	0.9276575 g  in 48.19 g

Inactive Ingredients
Ingredient Name	Strength
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
MICA (UNII: V8A1AW0880)
C9-12 ALKANE (UNII: 7J5R5W72QM)
CARTHAMUS TINCTORIUS SEED OLEOSOMES (UNII: 9S60Q72309)
STEARYL PHOSPHATE (UNII: F3C8G3904Y)
SODIUM BENZOATE (UNII: OJ245FE5EU)
ISOPROPYL TITANIUM TRIISOSTEARATE (UNII: 949E3KBJ1I)
ISODECYL NEOPENTANOATE (UNII: W60VYE24XC)
COCO-CAPRYLATE/CAPRATE (UNII: 8D9H4QU99H)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
CETYL ALCOHOL (UNII: 936JST6JCN)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
HEXAMETHYLENE DIISOCYANATE/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER (UNII: WB5K9Y35Y9)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
DIAMOND (UNII: 6GRV67N0U2)
PHYTATE SODIUM (UNII: 88496G1ERL)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
XANTHAN GUM (UNII: TTV12P4NEE)
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)
FERRIC OXIDE RED (UNII: 1K09F3G675)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
ETHYLHEXYL OLIVATE (UNII: HTC7G3S2PV)
OLETH-3 PHOSPHATE (UNII: 8Q0Z18J1VL)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)
PEG-100 STEARATE (UNII: YD01N1999R)
CETEARYL OLIVATE (UNII: 58B69Q84JO)
PROPANEDIOL (UNII: 5965N8W85T)
WATER (UNII: 059QF0KO0R)
SORBITAN OLIVATE (UNII: MDL271E3GR)
ALUMINUM OXIDE (UNII: LMI26O6933)
SQUALANE (UNII: GW89575KF9)
GLUCONOLACTONE (UNII: WQ29KQ9POT)
HYDROGEN DIMETHICONE (13 CST) (UNII: 4QGR4P2YOI)
ASCORBIC ACID (UNII: PQ6CK8PD0R)

Product Characteristics
Color	brown (TINTED TAN)	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 54031-020-01	48.19 g in 1 TUBE; Type 0: Not a Combination Product	02/15/2021
2	NDC: 54031-020-02	48.19 g in 1 CARTON; Type 0: Not a Combination Product	02/15/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	02/15/2021

Labeler - Peter Thomas Roth Labs, LLC (780458944)

Registrant - June Jacobs Labs, LLC (122610681)

Establishment
Name	Address	ID/FEI	Business Operations
JUNE JACOBS LABS, LLC		122610681	manufacture(54031-020)