Label: STARTER SET OILY/NORMAL SKIN- zinc oxide kit
- NDC Code(s): 10028-020-01, 10028-021-01
- Packager: ULTRACEUTICALS PTY LIMITED
- 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.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- KEEP OUT OF REACH OF CHILDREN
- INDICATIONS & USAGE
- WARNINGS
-
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
-
INGREDIENTS AND APPEARANCE
STARTER SET OILY/NORMAL SKIN
zinc oxide kitProduct 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 100 mL in 100 Part 2 1 BOTTLE 200 mL Part 3 1 BOTTLE 30 mL in 30 Part 4 1 BOTTLE 75 mL in 100 Part 1 of 4 ULTRA PROTECTIVE PROTECTIVE MINERAL DEFENCE SPF 50
zinc oxide creamProduct 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 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 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 2 of 4 ULTRA BALANCING GEL CLEANSER
other skin care preparations gelProduct Information Route of Administration TOPICAL Other Ingredients Ingredient Kind Ingredient Name Quantity 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) 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) 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 Part 3 of 4 ULTRA B2 HYDRATING SERUM
lotions, oils, powders, and creams creamProduct Information Route of Administration TOPICAL Other Ingredients Ingredient Kind Ingredient Name Quantity 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) INGR POTASSIUM SORBATE (UNII: 1VPU26JZZ4) INGR SORBIC ACID (UNII: X045WJ989B) 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 4 of 4 ULTRA HYDRATING LOTION
lotions, oils, powders, and creams lotionProduct Information Route of Administration TOPICAL Other Ingredients Ingredient Kind Ingredient Name Quantity 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) INGR BENZOIC ACID (UNII: 8SKN0B0MIM) INGR CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) INGR XANTHAN GUM (UNII: TTV12P4NEE) 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 SODIUM HYDROXIDE (UNII: 55X04QC32I) INGR MALTODEXTRIN (UNII: 7CVR7L4A2D) INGR SODIUM LACTATE (UNII: TU7HW0W0QT) INGR LECITHIN, SOYBEAN (UNII: 1DI56QDM62) INGR CERAMIDE NP (UNII: 4370DF050B) 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 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)
