STARTER SET DRY/NORMAL SKIN- zinc oxide 
Ultraceuticals Pty Ltd

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.

----------

Starter Set Dry/Normal Skin

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 rash occurs

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

Directions

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.

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

Normal Dry Set

STARTER SET DRY/NORMAL SKIN 
zinc oxide kit
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10028-022
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:10028-022-011 in 1 BOTTLE03/04/2020
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 11 BOTTLE 100 mL  in 100 
Part 21 BOTTLE 200 mL  in 200 
Part 31 BOTTLE 30 mL  in 30 
Part 41 BOTTLE 75 mL  in 75 
Part 1 of 4
ULTRA UV PROTECTIVE MINERAL DEFENCE SPF 50 
zinc oxide cream
Product Information
Item Code (Source)NDC:10028-023
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE12 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
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)  
OCTYLDODECYL NEOPENTANOATE (UNII: X8725R883T)  
POLYETHYLENE GLYCOL 500 (UNII: 761NX2Q08Y)  
PHENYLPROPANOL (UNII: 0F897O3O4M)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
TRIDECYL SALICYLATE (UNII: AZQ08K38Z1)  
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)  
ALLANTOIN (UNII: 344S277G0Z)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:10028-023-01100 mL in 1 BOTTLE; Type 9: Other Type of Part 3 Combination Product (e.g., Drug/Device/Biological Product)
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35203/04/2020
Part 2 of 4
ULTRA HYDRATING MILK CLEANSER 
cleansing (cold creams, cleansing lotions, liquids, and pads) cream
Product Information
Route of AdministrationTOPICAL
Other Ingredients
Ingredient KindIngredient NameQuantity
INGROLIVE OIL DECYL ESTERS (UNII: 3AQ222F18X)  
INGRTOCOPHEROL (UNII: R0ZB2556P8)  
INGRCUCUMBER (UNII: YY7C30VXJT)  
INGRMEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
INGRPANTHENOL (UNII: WV9CM0O67Z)  
INGRSODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)  
INGRGLYCERIN (UNII: PDC6A3C0OX)  
INGRMETHYLPROPANEDIOL (UNII: N8F53B3R4R)  
INGRPROPANEDIOL (UNII: 5965N8W85T)  
INGRWATER (UNII: 059QF0KO0R)  
INGRGRAPE SEED OIL (UNII: 930MLC8XGG)  
INGRCAPRYLYL GLYCOL (UNII: 00YIU5438U)  
INGRSORBITAN OLIVATE (UNII: MDL271E3GR)  
INGRPOLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)  
INGREDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
INGRCITRUS MAXIMA FRUIT RIND OIL (UNII: 8U3877WD44)  
INGRPOTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
INGRCETEARYL OLIVATE (UNII: 58B69Q84JO)  
INGRPPG-26-BUTETH-26 (UNII: 2II1K6TZ4P)  
INGRCARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
INGRPHENYLPROPANOL (UNII: 0F897O3O4M)  
INGRSODIUM HYDROXIDE (UNII: 55X04QC32I)  
INGRSOYBEAN OIL (UNII: 241ATL177A)  
INGRSQUALENE (UNII: 7QWM220FJH)  
INGRLACTIC ACID (UNII: 33X04XA5AT)  
INGRLIMONENE, (+)- (UNII: GFD7C86Q1W)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1200 mL in 1 BOTTLE; Type 1: Convenience Kit of Co-Package
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
Cosmetic03/04/2020
Part 3 of 4
ULTRA B2 HYDRATING SERUM 
moisturizing cream
Product Information
Route of AdministrationTOPICAL
Other Ingredients
Ingredient KindIngredient NameQuantity
INGRTREHALOSE (UNII: B8WCK70T7I)  
INGRSALICYLIC ACID (UNII: O414PZ4LPZ)  
INGRSORBIC ACID (UNII: X045WJ989B)  
INGRPOTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
INGRNIACINAMIDE (UNII: 25X51I8RD4)  
INGRHYALURONATE SODIUM (UNII: YSE9PPT4TH)  
INGRPANTHENOL (UNII: WV9CM0O67Z)  
INGRSODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)  
INGRWATER (UNII: 059QF0KO0R)  
INGRPROPANEDIOL (UNII: 5965N8W85T)  
INGRUREA (UNII: 8W8T17847W)  
INGRGLYCERIN (UNII: PDC6A3C0OX)  
INGRCUCUMBER (UNII: YY7C30VXJT)  
INGRBENZYL ALCOHOL (UNII: LKG8494WBH)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
130 mL in 1 BOTTLE; Type 1: Convenience Kit of Co-Package
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
Cosmetic03/03/2020
Part 4 of 4
ULTRA MOISTURISER CREAM 
moisturizing cream
Product Information
Route of AdministrationTOPICAL
Other Ingredients
Ingredient KindIngredient NameQuantity
INGRPHENYLPROPANOL (UNII: 0F897O3O4M)  
INGRCOCONUT OIL (UNII: Q9L0O73W7L)  
INGRVANILLIN (UNII: CHI530446X)  
INGRPOLYSORBATE 60 (UNII: CAL22UVI4M)  
INGRLINOLEIC ACID (UNII: 9KJL21T0QJ)  
INGRSODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)  
INGRSORBITAN ISOSTEARATE (UNII: 01S2G2C1E4)  
INGRCAPRYLYL GLYCOL (UNII: 00YIU5438U)  
INGREDETATE DISODIUM (UNII: 7FLD91C86K)  
INGRXANTHAN GUM (UNII: TTV12P4NEE)  
INGRDIMETHICONE (UNII: 92RU3N3Y1O)  
INGRUREA (UNII: 8W8T17847W)  
INGRCERAMIDE NP (UNII: 4370DF050B)  
INGRLINOLENIC ACID (UNII: 0RBV727H71)  
INGRCHOLESTEROL (UNII: 97C5T2UQ7J)  
INGRCETETH-20 (UNII: I835H2IHHX)  
INGRSTEARETH-20 (UNII: L0Q8IK9E08)  
INGRSODIUM HYDROXIDE (UNII: 55X04QC32I)  
INGRLACTIC ACID (UNII: 33X04XA5AT)  
INGRALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
INGRMETHYLPROPANEDIOL (UNII: N8F53B3R4R)  
INGRGLYCERYL MONOBEHENATE (UNII: A626UU0W2A)  
INGRCETYL ALCOHOL (UNII: 936JST6JCN)  
INGRTOCOPHEROL (UNII: R0ZB2556P8)  
INGRHYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (100000 MPA.S AT 1.5%) (UNII: 86FQE96TZ4)  
INGRPEG-75 STEARATE (UNII: OT38R0N74H)  
INGRWATER (UNII: 059QF0KO0R)  
INGRSHEA BUTTER (UNII: K49155WL9Y)  
INGRGLYCERIN (UNII: PDC6A3C0OX)  
INGRCYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
INGRGLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
INGRSODIUM LACTATE (UNII: TU7HW0W0QT)  
INGRHYALURONATE SODIUM (UNII: YSE9PPT4TH)  
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
Cosmetic03/02/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35203/04/2020
Labeler - Ultraceuticals Pty Ltd (744068995)

Revised: 1/2023
Document Id: f1d8ac07-2c85-0539-e053-2995a90a658d
Set id: a00c4137-77de-6466-e053-2a95a90a4344
Version: 2
Effective Time: 20230109
 
Ultraceuticals Pty Ltd