Label: STARTER SET DRY/NORMAL SKIN- zinc oxide kit

  • NDC Code(s): 10028-022-01, 10028-023-01
  • Packager: Ultraceuticals Pty Ltd
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

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.

Drug Label Information

Updated January 9, 2023

If you are a consumer or patient please visit this version.

View All Sections
  • 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

    Normal Dry Set

  • INGREDIENTS AND APPEARANCE
    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)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!