STARTER SET DRY/NORMAL SKIN- zinc oxide kit

Starter Set Dry/Normal Skin by

Drug Labeling and Warnings

Starter Set Dry/Normal Skin by is a Otc medication manufactured, distributed, or labeled by Ultraceuticals Pty Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredients Purpose

Zinc Oxide 12% w/w 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

Do not use:

on damaged or broken skin

When using this product

keep out of eyes. Rinse with water to remove

For external use only

DOSAGE & ADMINISTRATION

Directions

• Apply liberally 15 minutes before sun exposure and at least every 2 hours
• Children under 6 months
• 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 sunglassesof age: ask a doctor.
• reapply after 40 minutes of swimming or sweating
• immediately after towel drying
• at least every 2 hours

INACTIVE INGREDIENT

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.

PRINCIPAL DISPLAY PANEL

Starter Set Dry/Normal Skin

Ultra Hydrating Milk Cleanser 200ML

Ultra B2 Hydrating Serum 30ML

Ultra Moisturiser Cream 75ML

Ultra UV Protective Mineral Defence SPF 50+ 100ML

INGREDIENTS AND APPEARANCE

STARTER SET DRY/NORMAL SKIN 
zinc oxide kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 10028-022

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 10028-022-01	1 in 1 BOTTLE	03/04/2020

Quantity of Parts
Part #	Package Quantity	Total Product Quantity
Part 1	1 BOTTLE	100 mL  in 100
Part 2	1 BOTTLE	30 mL  in 30
Part 3	1 BOTTLE	75 mL  in 75
Part 4	1 BOTTLE	200 mL  in 200

Part 1 of 4

ULTRA UV PROTECTIVE MINERAL DEFENCE SPF 50 
zinc oxide cream

Product Information
Item Code (Source)	NDC: 10028-023
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
ALLANTOIN (UNII: 344S277G0Z)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
TRIDECYL SALICYLATE (UNII: AZQ08K38Z1)
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)
OCTYLDODECYL NEOPENTANOATE (UNII: X8725R883T)
POLYETHYLENE GLYCOL 500 (UNII: 761NX2Q08Y)
PHENYLPROPANOL (UNII: 0F897O3O4M)
ISODODECANE (UNII: A8289P68Y2)
PROPANEDIOL (UNII: 5965N8W85T)
TRICETEARETH-4 PHOSPHATE (UNII: 69534Y66NO)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
TETRASODIUM GLUTAMATE DIACETATE (UNII: 5EHL50I4MY)
DIMETHICONE (UNII: 92RU3N3Y1O)
METHYLPROPANEDIOL (UNII: N8F53B3R4R)
WATER (UNII: 059QF0KO0R)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL)
CARNOSINE (UNII: 8HO6PVN24W)
LEVOMENOL (UNII: 24WE03BX2T)
CAFFEINE (UNII: 3G6A5W338E)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
NIACINAMIDE (UNII: 25X51I8RD4)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 10028-023-01	100 mL in 1 BOTTLE; Type 9: Other Type of Part 3 Combination Product (e.g., Drug/Device/Biological Product)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	03/04/2020

Part 2 of 4

ULTRA B2 HYDRATING SERUM 
moisturizing cream

Product Information
Route of Administration	TOPICAL

Other Ingredients
Ingredient Kind	Ingredient Name	Quantity
INGR	UREA (UNII: 8W8T17847W)
INGR	GLYCERIN (UNII: PDC6A3C0OX)
INGR	CUCUMBER (UNII: YY7C30VXJT)
INGR	BENZYL ALCOHOL (UNII: LKG8494WBH)
INGR	TREHALOSE (UNII: B8WCK70T7I)
INGR	SALICYLIC ACID (UNII: O414PZ4LPZ)
INGR	SORBIC ACID (UNII: X045WJ989B)
INGR	POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
INGR	NIACINAMIDE (UNII: 25X51I8RD4)
INGR	HYALURONATE SODIUM (UNII: YSE9PPT4TH)
INGR	PANTHENOL (UNII: WV9CM0O67Z)
INGR	SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)
INGR	WATER (UNII: 059QF0KO0R)
INGR	PROPANEDIOL (UNII: 5965N8W85T)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1		30 mL in 1 BOTTLE; Type 1: Convenience Kit of Co-Package

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Cosmetic		03/03/2020

Part 3 of 4

ULTRA MOISTURISER CREAM 
moisturizing cream

Product Information
Route of Administration	TOPICAL

Other Ingredients
Ingredient Kind	Ingredient Name	Quantity
INGR	TOCOPHEROL (UNII: R0ZB2556P8)
INGR	HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (100000 MPA.S AT 1.5%) (UNII: 86FQE96TZ4)
INGR	PEG-75 STEARATE (UNII: OT38R0N74H)
INGR	WATER (UNII: 059QF0KO0R)
INGR	SHEA BUTTER (UNII: K49155WL9Y)
INGR	GLYCERIN (UNII: PDC6A3C0OX)
INGR	CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
INGR	GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
INGR	SODIUM LACTATE (UNII: TU7HW0W0QT)
INGR	HYALURONATE SODIUM (UNII: YSE9PPT4TH)
INGR	SODIUM HYDROXIDE (UNII: 55X04QC32I)
INGR	LACTIC ACID (UNII: 33X04XA5AT)
INGR	ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
INGR	METHYLPROPANEDIOL (UNII: N8F53B3R4R)
INGR	GLYCERYL MONOBEHENATE (UNII: A626UU0W2A)
INGR	CETYL ALCOHOL (UNII: 936JST6JCN)
INGR	PHENYLPROPANOL (UNII: 0F897O3O4M)
INGR	COCONUT OIL (UNII: Q9L0O73W7L)
INGR	VANILLIN (UNII: CHI530446X)
INGR	POLYSORBATE 60 (UNII: CAL22UVI4M)
INGR	LINOLEIC ACID (UNII: 9KJL21T0QJ)
INGR	SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)
INGR	SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4)
INGR	CAPRYLYL GLYCOL (UNII: 00YIU5438U)
INGR	EDETATE DISODIUM (UNII: 7FLD91C86K)
INGR	XANTHAN GUM (UNII: TTV12P4NEE)
INGR	DIMETHICONE (UNII: 92RU3N3Y1O)
INGR	UREA (UNII: 8W8T17847W)
INGR	CERAMIDE NP (UNII: 4370DF050B)
INGR	LINOLENIC ACID (UNII: 0RBV727H71)
INGR	CHOLESTEROL (UNII: 97C5T2UQ7J)
INGR	CETETH-20 (UNII: I835H2IHHX)
INGR	STEARETH-20 (UNII: L0Q8IK9E08)

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

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Cosmetic		03/02/2020

Part 4 of 4

ULTRA HYDRATING MILK CLEANSER 
cleansing (cold creams, cleansing lotions, liquids, and pads) cream

Product Information
Route of Administration	TOPICAL

Other Ingredients
Ingredient Kind	Ingredient Name	Quantity
INGR	LIMONENE, (+)- (UNII: GFD7C86Q1W)
INGR	SOYBEAN OIL (UNII: 241ATL177A)
INGR	SQUALENE (UNII: 7QWM220FJH)
INGR	LACTIC ACID (UNII: 33X04XA5AT)
INGR	CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
INGR	PHENYLPROPANOL (UNII: 0F897O3O4M)
INGR	SODIUM HYDROXIDE (UNII: 55X04QC32I)
INGR	OLIVE OIL DECYL ESTERS (UNII: 3AQ222F18X)
INGR	TOCOPHEROL (UNII: R0ZB2556P8)
INGR	CUCUMBER (UNII: YY7C30VXJT)
INGR	MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
INGR	PANTHENOL (UNII: WV9CM0O67Z)
INGR	SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)
INGR	GLYCERIN (UNII: PDC6A3C0OX)
INGR	METHYLPROPANEDIOL (UNII: N8F53B3R4R)
INGR	PROPANEDIOL (UNII: 5965N8W85T)
INGR	WATER (UNII: 059QF0KO0R)
INGR	GRAPE SEED OIL (UNII: 930MLC8XGG)
INGR	CAPRYLYL GLYCOL (UNII: 00YIU5438U)
INGR	SORBITAN OLIVATE (UNII: MDL271E3GR)
INGR	POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)
INGR	EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
INGR	CITRUS MAXIMA FRUIT RIND OIL (UNII: 8U3877WD44)
INGR	POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
INGR	CETEARYL OLIVATE (UNII: 58B69Q84JO)
INGR	PPG-26-BUTETH-26 (UNII: 2II1K6TZ4P)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1		200 mL in 1 BOTTLE; Type 1: Convenience Kit of Co-Package

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Cosmetic		03/04/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	03/04/2020

Labeler - Ultraceuticals Pty Ltd (744068995)

Establishment
Name	Address	ID/FEI	Business Operations
Nanophase Technologies Corporation		623502044	manufacture(10028-022, 10028-023)