Label: MAX MINERAL- titanium dioxide, zinc oxide cream
- NDC Code(s): 54031-020-01, 54031-020-02
- Packager: Peter Thomas Roth Labs, LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated November 14, 2023
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- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
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DOSAGE & ADMINISTRATION
Directions
apply liberally 15 minutes before sun exposure
reapply at least every 2 hours
use a water•resistant sunscreen if swimming or sweatingSun 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 long•sleeved shirts, pants, hats, and sunglasseschildren under 6 months of age: ask a doctor
- WARNINGS
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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, Oleth•3 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
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- QUESTIONS
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
MAX MINERAL
titanium dioxide, zinc oxide creamProduct 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)
