STARTER SET OILY/NORMAL SKIN- 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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Starter Set Oily/Normal Skin

Active Ingredients Purpose

Zinc Oxide 12% w/w Sunscreen

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

Warnings

Do not use:

When using this product

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 Oil/ Normal Skin

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STARTER SET OILY/NORMAL SKIN 
zinc oxide kit
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10028-020
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:10028-020-011 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 QuantityTotal Product Quantity
Part 11 BOTTLE 100 mL  in 100 
Part 21 BOTTLE 200 mL
Part 31 BOTTLE 30 mL  in 30 
Part 41 BOTTLE 75 mL  in 100 
Part 1 of 4
ULTRA PROTECTIVE PROTECTIVE MINERAL DEFENCE SPF 50 
zinc oxide cream
Product Information
Item Code (Source)NDC:10028-021
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
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)  
TETRASODIUM GLUTAMATE DIACETATE (UNII: 5EHL50I4MY)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:10028-021-01100 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 finalpart35203/01/2020
Part 2 of 4
ULTRA BALANCING GEL CLEANSER 
other skin care preparations gel
Product Information
Route of AdministrationTOPICAL
Other Ingredients
Ingredient KindIngredient NameQuantity
INGRXANTHAN GUM (UNII: TTV12P4NEE)  
INGRCITRUS MAXIMA FRUIT RIND OIL (UNII: 8U3877WD44)  
INGRCITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
INGREDETATE DISODIUM (UNII: 7FLD91C86K)  
INGRGLYCERIN (UNII: PDC6A3C0OX)  
INGRFORMIC ACID (UNII: 0YIW783RG1)  
INGRMALTODEXTRIN (UNII: 7CVR7L4A2D)  
INGRLAURETH-4 (UNII: 6HQ855798J)  
INGRBENZYL ALCOHOL (UNII: LKG8494WBH)  
INGRALOE VERA LEAF (UNII: ZY81Z83H0X)  
INGRSODIUM HYDROXIDE (UNII: 55X04QC32I)  
INGRGLYCOL DISTEARATE (UNII: 13W7MDN21W)  
INGREDETATE SODIUM (UNII: MP1J8420LU)  
INGRPOTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
INGROATMEAL (UNII: 8PI54V663Y)  
INGRPROPANEDIOL (UNII: 5965N8W85T)  
INGRLIMONENE, (+)- (UNII: GFD7C86Q1W)  
INGRCOCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
INGRSODIUM LAUROYL SARCOSINATE (UNII: 632GS99618)  
INGRDECYL GLUCOSIDE (UNII: Z17H97EA6Y)  
INGRMAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)  
INGRSODIUM LAUROYL LACTYLATE (UNII: 7243K85WFO)  
INGRWATER (UNII: 059QF0KO0R)  
INGRSORBIC ACID (UNII: X045WJ989B)  
INGRPANTHENOL (UNII: WV9CM0O67Z)  
INGRSALICYLIC ACID (UNII: O414PZ4LPZ)  
INGRSODIUM BENZOATE (UNII: OJ245FE5EU)  
INGRSODIUM CHLORIDE (UNII: 451W47IQ8X)  
INGR.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
INGRCUCUMBER (UNII: YY7C30VXJT)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1200 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
Cosmetic03/01/2020
Part 3 of 4
ULTRA B2 HYDRATING SERUM 
lotions, oils, powders, and creams cream
Product Information
Route of AdministrationTOPICAL
Other Ingredients
Ingredient KindIngredient NameQuantity
INGRNIACINAMIDE (UNII: 25X51I8RD4)  
INGRHYALURONATE SODIUM (UNII: YSE9PPT4TH)  
INGRPROPANEDIOL (UNII: 5965N8W85T)  
INGRWATER (UNII: 059QF0KO0R)  
INGRPANTHENOL (UNII: WV9CM0O67Z)  
INGRBENZYL ALCOHOL (UNII: LKG8494WBH)  
INGRUREA (UNII: 8W8T17847W)  
INGRSODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)  
INGRGLYCERIN (UNII: PDC6A3C0OX)  
INGRCUCUMBER (UNII: YY7C30VXJT)  
INGRTREHALOSE (UNII: B8WCK70T7I)  
INGRSALICYLIC ACID (UNII: O414PZ4LPZ)  
INGRPOTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
INGRSORBIC ACID (UNII: X045WJ989B)  
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
Cosmetic03/02/2020
Part 4 of 4
ULTRA HYDRATING LOTION 
lotions, oils, powders, and creams lotion
Product Information
Route of AdministrationTOPICAL
Other Ingredients
Ingredient KindIngredient NameQuantity
INGRCHOLESTEROL (UNII: 97C5T2UQ7J)  
INGRDIMETHICONE (UNII: 92RU3N3Y1O)  
INGRAMMONIUM ACRYLOYLDIMETHYLTAURATE, DIMETHYLACRYLAMIDE, LAURYL METHACRYLATE AND LAURETH-4 METHACRYLATE COPOLYMER, TRIMETHYLOLPROPANE TRIACRYLATE CROSSLINKED (45000 MPA.S) (UNII: Q7UI015FF9)  
INGRCETEARYL ISONONANOATE (UNII: P5O01U99NI)  
INGRTOCOPHEROL (UNII: R0ZB2556P8)  
INGRAMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER (UNII: W59H9296ZG)  
INGRCETYL PALMITATE (UNII: 5ZA2S6B08X)  
INGRGLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
INGRMETHYLPROPANEDIOL (UNII: N8F53B3R4R)  
INGRDICAPRYLYL CARBONATE (UNII: 609A3V1SUA)  
INGRDECYL OLEATE (UNII: ZGR06DO97T)  
INGRTERT-BUTYL ALCOHOL (UNII: MD83SFE959)  
INGRLACTIC ACID (UNII: 33X04XA5AT)  
INGROLIVE OIL DECYL ESTERS (UNII: 3AQ222F18X)  
INGRSQUALENE (UNII: 7QWM220FJH)  
INGRHYALURONATE SODIUM (UNII: YSE9PPT4TH)  
INGRUREA (UNII: 8W8T17847W)  
INGRLINOLEIC ACID (UNII: 9KJL21T0QJ)  
INGRSODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)  
INGRLINOLENIC ACID (UNII: 0RBV727H71)  
INGRALOE VERA LEAF (UNII: ZY81Z83H0X)  
INGRCETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
INGRWATER (UNII: 059QF0KO0R)  
INGRGLYCERIN (UNII: PDC6A3C0OX)  
INGRBENZOIC ACID (UNII: 8SKN0B0MIM)  
INGRCITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
INGRXANTHAN GUM (UNII: TTV12P4NEE)  
INGRPOLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)  
INGRSOYBEAN OIL (UNII: 241ATL177A)  
INGRCETEARETH-12 (UNII: 7V4MR24V5P)  
INGRCAPRYLYL GLYCOL (UNII: 00YIU5438U)  
INGRSODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F)  
INGRPHENYLPROPANOL (UNII: 0F897O3O4M)  
INGRSODIUM HYDROXIDE (UNII: 55X04QC32I)  
INGRMALTODEXTRIN (UNII: 7CVR7L4A2D)  
INGRSODIUM LACTATE (UNII: TU7HW0W0QT)  
INGRLECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
INGRCERAMIDE NP (UNII: 4370DF050B)  
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
Cosmetic03/01/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35203/01/2020
Labeler - ULTRACEUTICALS PTY LIMITED (744068995)

Revised: 1/2023
Document Id: f1d8ac07-2c86-0539-e053-2995a90a658d
Set id: 9ff6d6a9-e610-5e0a-e053-2995a90a72d5
Version: 2
Effective Time: 20230109
 
ULTRACEUTICALS PTY LIMITED