STARTER SET OILY/NORMAL SKIN- zinc oxide kit

Starter Set Oily/Normal Skin by

Drug Labeling and Warnings

Starter Set Oily/Normal Skin by is a Otc medication manufactured, distributed, or labeled by ULTRACEUTICALS PTY LIMITED. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredients Purpose

Zinc Oxide 12% w/w Sunscreen

PURPOSE

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 or irritation develops and lasts.

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 Oil/ Normal Skin

Begin your Journey with Ultraceuticals Starter Packs

Ultra UV Protective Mineral Defence SPF 50+ 100ML

Ultra Balancing Cleanser 200ML

Ultra B2 Hydrating Serum 30ML

Ultra Hydrating Lotion 75ML

INGREDIENTS AND APPEARANCE

STARTER SET OILY/NORMAL SKIN 
zinc oxide kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 10028-020

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 10028-020-01	1 in 1 PACKAGE, COMBINATION; Type 9: Other Type of Part 3 Combination Product (e.g., Drug/Device/Biological Product)	03/01/2020

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

Part 1 of 4

ULTRA B2 HYDRATING SERUM 
lotions, oils, powders, and creams cream

Product Information
Route of Administration	TOPICAL

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

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		03/02/2020

Part 2 of 4

ULTRA PROTECTIVE PROTECTIVE MINERAL DEFENCE SPF 50 
zinc oxide cream

Product Information
Item Code (Source)	NDC: 10028-021
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
TETRASODIUM GLUTAMATE DIACETATE (UNII: 5EHL50I4MY)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
ALLANTOIN (UNII: 344S277G0Z)
DIMETHICONE (UNII: 92RU3N3Y1O)
ISODODECANE (UNII: A8289P68Y2)
CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL)
CARNOSINE (UNII: 8HO6PVN24W)
METHYLPROPANEDIOL (UNII: N8F53B3R4R)
OCTYLDODECYL NEOPENTANOATE (UNII: X8725R883T)
CAFFEINE (UNII: 3G6A5W338E)
POLYMETHYLSILSESQUIOXANE (11 MICRONS) (UNII: Z570VEV8XK)
NIACINAMIDE (UNII: 25X51I8RD4)
PHENYLPROPANOL (UNII: 0F897O3O4M)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
PROPANEDIOL (UNII: 5965N8W85T)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
TRICETEARETH-4 PHOSPHATE (UNII: 69534Y66NO)
TRIDECYL SALICYLATE (UNII: AZQ08K38Z1)
WATER (UNII: 059QF0KO0R)
POLYETHYLENE GLYCOL 500 (UNII: 761NX2Q08Y)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 10028-021-01	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	03/01/2020

Part 3 of 4

ULTRA HYDRATING LOTION 
lotions, oils, powders, and creams lotion

Product Information
Route of Administration	TOPICAL

Other Ingredients
Ingredient Kind	Ingredient Name	Quantity
INGR	SODIUM LACTATE (UNII: TU7HW0W0QT)
INGR	LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
INGR	CERAMIDE NP (UNII: 4370DF050B)
INGR	SODIUM HYDROXIDE (UNII: 55X04QC32I)
INGR	MALTODEXTRIN (UNII: 7CVR7L4A2D)
INGR	POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)
INGR	SOYBEAN OIL (UNII: 241ATL177A)
INGR	CETEARETH-12 (UNII: 7V4MR24V5P)
INGR	CAPRYLYL GLYCOL (UNII: 00YIU5438U)
INGR	SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F)
INGR	PHENYLPROPANOL (UNII: 0F897O3O4M)
INGR	BENZOIC ACID (UNII: 8SKN0B0MIM)
INGR	CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
INGR	XANTHAN GUM (UNII: TTV12P4NEE)
INGR	CHOLESTEROL (UNII: 97C5T2UQ7J)
INGR	DIMETHICONE (UNII: 92RU3N3Y1O)
INGR	AMMONIUM ACRYLOYLDIMETHYLTAURATE, DIMETHYLACRYLAMIDE, LAURYL METHACRYLATE AND LAURETH-4 METHACRYLATE COPOLYMER, TRIMETHYLOLPROPANE TRIACRYLATE CROSSLINKED (45000 MPA.S) (UNII: Q7UI015FF9)
INGR	CETEARYL ISONONANOATE (UNII: P5O01U99NI)
INGR	TOCOPHEROL (UNII: R0ZB2556P8)
INGR	AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER (UNII: W59H9296ZG)
INGR	CETYL PALMITATE (UNII: 5ZA2S6B08X)
INGR	GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
INGR	METHYLPROPANEDIOL (UNII: N8F53B3R4R)
INGR	DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)
INGR	DECYL OLEATE (UNII: ZGR06DO97T)
INGR	TERT-BUTYL ALCOHOL (UNII: MD83SFE959)
INGR	LACTIC ACID (UNII: 33X04XA5AT)
INGR	OLIVE OIL DECYL ESTERS (UNII: 3AQ222F18X)
INGR	SQUALENE (UNII: 7QWM220FJH)
INGR	HYALURONATE SODIUM (UNII: YSE9PPT4TH)
INGR	UREA (UNII: 8W8T17847W)
INGR	LINOLEIC ACID (UNII: 9KJL21T0QJ)
INGR	SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)
INGR	LINOLENIC ACID (UNII: 0RBV727H71)
INGR	ALOE VERA LEAF (UNII: ZY81Z83H0X)
INGR	CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
INGR	WATER (UNII: 059QF0KO0R)
INGR	GLYCERIN (UNII: PDC6A3C0OX)

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		03/01/2020

Part 4 of 4

ULTRA BALANCING GEL CLEANSER 
other skin care preparations gel

Product Information
Route of Administration	TOPICAL

Other Ingredients
Ingredient Kind	Ingredient Name	Quantity
INGR	SORBIC ACID (UNII: X045WJ989B)
INGR	PANTHENOL (UNII: WV9CM0O67Z)
INGR	SALICYLIC ACID (UNII: O414PZ4LPZ)
INGR	SODIUM BENZOATE (UNII: OJ245FE5EU)
INGR	SODIUM CHLORIDE (UNII: 451W47IQ8X)
INGR	.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
INGR	CUCUMBER (UNII: YY7C30VXJT)
INGR	XANTHAN GUM (UNII: TTV12P4NEE)
INGR	CITRUS MAXIMA FRUIT RIND OIL (UNII: 8U3877WD44)
INGR	CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
INGR	EDETATE DISODIUM (UNII: 7FLD91C86K)
INGR	GLYCERIN (UNII: PDC6A3C0OX)
INGR	FORMIC ACID (UNII: 0YIW783RG1)
INGR	MALTODEXTRIN (UNII: 7CVR7L4A2D)
INGR	LAURETH-4 (UNII: 6HQ855798J)
INGR	BENZYL ALCOHOL (UNII: LKG8494WBH)
INGR	ALOE VERA LEAF (UNII: ZY81Z83H0X)
INGR	SODIUM HYDROXIDE (UNII: 55X04QC32I)
INGR	GLYCOL DISTEARATE (UNII: 13W7MDN21W)
INGR	EDETATE SODIUM (UNII: MP1J8420LU)
INGR	POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
INGR	OATMEAL (UNII: 8PI54V663Y)
INGR	PROPANEDIOL (UNII: 5965N8W85T)
INGR	LIMONENE, (+)- (UNII: GFD7C86Q1W)
INGR	COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
INGR	SODIUM LAUROYL SARCOSINATE (UNII: 632GS99618)
INGR	DECYL GLUCOSIDE (UNII: Z17H97EA6Y)
INGR	MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)
INGR	SODIUM LAUROYL LACTYLATE (UNII: 7243K85WFO)
INGR	WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1		200 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
Cosmetic		03/01/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	03/01/2020

Labeler - ULTRACEUTICALS PTY LIMITED (744068995)

Establishment
Name	Address	ID/FEI	Business Operations
Nanophase Technologies Corporation		623502044	manufacture(10028-020, 10028-021)