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

Hydrating Duo by

Drug Labeling and Warnings

Hydrating 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]

HYDRATING 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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Hydrating 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

at least every 2 hours

Protect the product in this container from excessive heat and direct sun.

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

Hydrating Duo

Face Moisturizer 75mL

Sunscreen 100mL

HYDRATING DUO 
zinc oxide kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 10028-027

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 10028-027-01	1 in 1 KIT; Type 1: Convenience Kit of Co-Package	08/14/2020	02/01/2022

Quantity of Parts
Part #	Package Quantity	Total Product Quantity
Part 1	1 TUBE	100 mL
Part 2	1 TUBE	75 mL

Part 1 of 2

ULTRA UV PROTECTIVE MINERAL DEFENCE SPF 50 
zinc oxide cream

Product Information
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	12 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
CAFFEINE (UNII: 3G6A5W338E)
CARNOSINE (UNII: 8HO6PVN24W)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
TRIDECYL SALICYLATE (UNII: AZQ08K38Z1)
LEVOMENOL (UNII: 24WE03BX2T)
CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL)
METHYLPROPANEDIOL (UNII: N8F53B3R4R)
OCTYLDODECYL NEOPENTANOATE (UNII: X8725R883T)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)
PHENYLPROPANOL (UNII: 0F897O3O4M)
ALLANTOIN (UNII: 344S277G0Z)
TETRASODIUM GLUTAMATE DIACETATE (UNII: 5EHL50I4MY)
NIACINAMIDE (UNII: 25X51I8RD4)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
WATER (UNII: 059QF0KO0R)
DIMETHICONE (UNII: 92RU3N3Y1O)
ISODODECANE (UNII: A8289P68Y2)
TRICETEARETH-4 PHOSPHATE (UNII: 69534Y66NO)
PROPANEDIOL (UNII: 5965N8W85T)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1		100 mL in 1 TUBE; Type 1: Convenience Kit of Co-Package

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	08/14/2020	02/01/2022

Part 2 of 2

ULTRA MOISTURIZER CREAM 
lotions, oils, powders, and creams cream

Product Information
Route of Administration	TOPICAL

Other Ingredients
Ingredient Kind	Ingredient Name	Quantity
INGR	EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
INGR	CAPRYLYL GLYCOL (UNII: 00YIU5438U)
INGR	LACTIC ACID, UNSPECIFIED FORM (UNII: 33X04XA5AT)
INGR	CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
INGR	LINOLEIC ACID (UNII: 9KJL21T0QJ)
INGR	TOCOPHEROL (UNII: R0ZB2556P8)
INGR	XANTHAN GUM (UNII: TTV12P4NEE)
INGR	CETETH-20 (UNII: I835H2IHHX)
INGR	STEARETH-20 (UNII: L0Q8IK9E08)
INGR	VANILLIN (UNII: CHI530446X)
INGR	SODIUM HYDROXIDE (UNII: 55X04QC32I)
INGR	LINOLENIC ACID (UNII: 0RBV727H71)
INGR	POLYSORBATE 60 (UNII: CAL22UVI4M)
INGR	SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4)
INGR	WATER (UNII: 059QF0KO0R)
INGR	ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
INGR	METHYLPROPANEDIOL (UNII: N8F53B3R4R)
INGR	GLYCERYL MONOBEHENATE (UNII: A626UU0W2A)
INGR	COCONUT OIL (UNII: Q9L0O73W7L)
INGR	PHENYLPROPANOL (UNII: 0F897O3O4M)
INGR	DIMETHICONE (UNII: 92RU3N3Y1O)
INGR	UREA (UNII: 8W8T17847W)
INGR	CERAMIDE NP (UNII: 4370DF050B)
INGR	SHEA BUTTER (UNII: K49155WL9Y)
INGR	CHOLESTEROL (UNII: 97C5T2UQ7J)
INGR	SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)
INGR	GLYCERIN (UNII: PDC6A3C0OX)
INGR	CETYL ALCOHOL (UNII: 936JST6JCN)
INGR	GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
INGR	SODIUM LACTATE (UNII: TU7HW0W0QT)
INGR	HYALURONATE SODIUM (UNII: YSE9PPT4TH)
INGR	PEG-75 STEARATE (UNII: OT38R0N74H)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1		75 mL in 1 TUBE; Type 1: Convenience Kit of Co-Package

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Cosmetic		08/14/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	08/14/2020	02/01/2022

Labeler - ULTRACEUTICALS PTY LIMITED (744068995)

Establishment
Name	Address	ID/FEI	Business Operations
Nanophase Technologies Corporation		623502044	manufacture(10028-027)

Revised: 2/2023

Document Id: f5623a60-9efd-e039-e053-2a95a90abcff

34390-5

Set id: acb1c8be-eb74-702b-e053-2a95a90a935f

Version: 2

Effective Time: 20230223