Mattifying Duo by ULTRACEUTICALS PTY LIMITED / Nanophase Technologies Corporation Mattifying Duo

Mattifying Duo by

Drug Labeling and Warnings

Mattifying Duo by is a Otc medication manufactured, distributed, or labeled by ULTRACEUTICALS PTY LIMITED, Nanophase Technologies Corporation. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

MATTIFYING DUO- zinc oxide 
ULTRACEUTICALS PTY LIMITED

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.

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Mattifying Duo

Active Ingredients Purpose

Zinc Oxide 12% w/w Sunscreen

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

Stop use and ask a doctor: if skin rash occurs.

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

Directions

Apply liberally 15 minutes before sun exposure and at least every 2 hours.

Children under 6 months of age: ask a doctor.


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 value of 15 or higher and other sun
protection measures including: limit your time in the sun, especially from 10
a.m. – 2 p.m. wear long-sleeved shirts, pants, hats, and sunglasses
Reapply:
After 40 minutes of swimming or sweating
Immediately after towel drying

Inactive Ingredients

Allantoin, Bisabolol, Butyloctyl Salicylate, C12-15 Alkyl Benzoate, Caffeine, Caprylyl Glycol, Caprylyl Methicone, Carnosine, Dimethicone, Isododecane, Lauryl PEG-10 Tris(Trimethylsiloxy) Silylethyl Dimethicone, Lauryl PEG-8 Dimethicone, Methylpropanediol, Niacinamide, Octyldodecyl Neopentanoate, PEG-10, Phenylpropanol, Polymethylsilsesquioxane, Propanediol, Silica, Sodium Chloride, Sodium Hydroxide, Tetrasodium Glutamate Diacetate, Triceteareth-4 Phosphate, Tridecyl Salicylate, Water

Mattifying Duo

Face Moisturizer 75mL

Sunscreen 100mL

Mattifying Duo 1a

Mattifying Duo 2

MATTIFYING DUO 
zinc oxide kit
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 10028-026
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 10028-026-011 in 1 KIT08/13/202002/01/2022
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 11 BOX 100 mL
Part 21 BOTTLE 75 mL
Part 1 of 2
ULTRA UV PROTECTIVE MINERAL DEFENSE SPF 50 
zinc oxide cream
Product Information
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION12 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
TETRASODIUM GLUTAMATE DIACETATE (UNII: 5EHL50I4MY)  
PROPANEDIOL (UNII: 5965N8W85T)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
ALLANTOIN (UNII: 344S277G0Z)  
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
TRICETETH-4 PHOSPHATE (UNII: 972Z27BS2V)  
TRIDECYL SALICYLATE (UNII: AZQ08K38Z1)  
WATER (UNII: 059QF0KO0R)  
CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL)  
CARNOSINE (UNII: 8HO6PVN24W)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
METHYLPROPANEDIOL (UNII: N8F53B3R4R)  
CAFFEINE (UNII: 3G6A5W338E)  
OCTYLDODECYL NEOPENTANOATE (UNII: X8725R883T)  
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)  
POLYETHYLENE GLYCOL 500 (UNII: 761NX2Q08Y)  
PHENYLPROPANOL (UNII: 0F897O3O4M)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
LEVOMENOL (UNII: 24WE03BX2T)  
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
NIACINAMIDE (UNII: 25X51I8RD4)  
ISODODECANE (UNII: A8289P68Y2)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1100 mL in 1 BOX; Type 1: Convenience Kit of Co-Package
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35208/13/202002/01/2022
Part 2 of 2
ULTRA HYDRATING LOTION 
lotions, oils, powders, and creams lotion
Product Information
Route of AdministrationTOPICAL
Other Ingredients
Ingredient KindIngredient NameQuantity
INGRHYALURONATE SODIUM (UNII: YSE9PPT4TH)  
INGRALOE VERA LEAF (UNII: ZY81Z83H0X)  
INGRCHOLESTEROL (UNII: 97C5T2UQ7J)  
INGRCETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
INGRCETEARETH-12 (UNII: 7V4MR24V5P)  
INGRCETYL PALMITATE (UNII: 5ZA2S6B08X)  
INGRSQUALENE (UNII: 7QWM220FJH)  
INGRWATER (UNII: 059QF0KO0R)  
INGRDECYL OLEATE (UNII: ZGR06DO97T)  
INGRLINOLENIC ACID (UNII: 0RBV727H71)  
INGRLECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
INGRCERAMIDE NP (UNII: 4370DF050B)  
INGRPOLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)  
INGROLIVE OIL DECYL ESTERS (UNII: 3AQ222F18X)  
INGRSODIUM LACTATE (UNII: TU7HW0W0QT)  
INGRLACTIC ACID, UNSPECIFIED FORM (UNII: 33X04XA5AT)  
INGRCITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
INGRSODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)  
INGRGLYCERIN (UNII: PDC6A3C0OX)  
INGRDIMETHICONE (UNII: 92RU3N3Y1O)  
INGRAMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER (UNII: W59H9296ZG)  
INGRSOYBEAN OIL (UNII: 241ATL177A)  
INGRSODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F)  
INGRUREA (UNII: 8W8T17847W)  
INGRTOCOPHEROL (UNII: R0ZB2556P8)  
INGRLINOLEIC ACID (UNII: 9KJL21T0QJ)  
INGRCETEARYL ISONONANOATE (UNII: P5O01U99NI)  
INGRPHENYLPROPANOL (UNII: 0F897O3O4M)  
INGRCAPRYLYL GLYCOL (UNII: 00YIU5438U)  
INGRXANTHAN GUM (UNII: TTV12P4NEE)  
INGRSODIUM HYDROXIDE (UNII: 55X04QC32I)  
INGRDICAPRYLYL CARBONATE (UNII: 609A3V1SUA)  
INGRMALTODEXTRIN (UNII: 7CVR7L4A2D)  
INGRGLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
INGRBENZOIC ACID (UNII: 8SKN0B0MIM)  
INGRTERT-BUTYL ALCOHOL (UNII: MD83SFE959)  
INGRMETHYLPROPANEDIOL (UNII: N8F53B3R4R)  
INGRAMMONIUM ACRYLOYLDIMETHYLTAURATE, DIMETHYLACRYLAMIDE, LAURYL METHACRYLATE AND LAURETH-4 METHACRYLATE COPOLYMER, TRIMETHYLOLPROPANE TRIACRYLATE CROSSLINKED (45000 MPA.S) (UNII: Q7UI015FF9)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
175 mL in 1 BOTTLE; Type 1: Convenience Kit of Co-Package
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
Cosmetic08/14/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35208/13/202002/01/2022
Labeler - ULTRACEUTICALS PTY LIMITED (744068995)
Establishment
NameAddressID/FEIBusiness Operations
Nanophase Technologies Corporation623502044manufacture(10028-026)

Revised: 2/2023