Label: LUMINOSITY ACTIVATION DAY EDITION- zinc oxide kit

  • NDC Code(s): 83108-001-13, 83108-100-00
  • Packager: Rationale Group Pty Ltd
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated October 18, 2023

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

  • Drug Facts

  • Active Ingredient

    Zinc Oxide 24%

    Purpose

    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 ageing caused by the sun.
  • Warnings

    For external use only. 

    Do not use

    • On damaged or broken skin.

    When using this product

    • Keep out of eyes. Rinse with water to remove.

    Stop use and ask a doctor if

    • Rash occurs.

    Keep out of reach of children.

    • If swallowed, get medical help or contact a Poison Control Center right away.
  • Directions

    • Apply liberally 15 minutes before sun exposure.
    • Reapply 
    • At least every 2 hours 
    • Use a water resistant sunscreen if swimming or sweating.
    • Sun Protection Measures.Spending time in the sun increases your risk of skin cancer and early skin ageing. 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 time in the sun, especially from 10 a.m -2p.m.
    • Wear long sleeved shirts, pants, hats and sunglasses.
    • Children under 6 months of age: Ask a doctor. 
  • Other Information

    • Protect the product in this container from excessive heat and direct sun.
  • Inactive ingredients

    Trisiloxane, Isoamyl Laurate, C12-15 Alkyl Benzoate, Butyloctyl Salicylate, Cyclopentasiloxane, PEG-10 Dimethicone, Ethylhexyl Methoxycrylene, Lauryl PEG-10 Tris (Trimethylsiloxy) silylethyl Dimethicone, Aqua (Water), Styrene/Acrylates Copolymer, Triacontanyl PVP, Argania Spinosa Kernel Oil, Tocopheryl Acetate, Pentaerhthrityl Tetraisostearate, Methyl Methacrylate Crosspolymer, Propanediol, Isostearic Acid, Glyceryl Caprylate, CI 77891 (Titanium Dioxide), Polyhydroxystearic Acid, Boron Nitride, 1,2-Hexanediol, Mica, Disteardimonium Hectorite, Glycerin, Sodium Chloride, CI 77492 (Iron Oxides), Bisabolol, Propylene Carbonate, Camellia Sinensis Leaf Extract, Hydrolyzed Keratin, Caprylhydroxamic Acid, Sodium Potassium Aluminum Silicate, Limonene, Citrus Aurantium Bergamia (Bergamot) Leaf Oil, Citrus Aurantium Dulcis (Orange) Oil, Juniperus Mexicana Oil, Pelargonium Graveolens Oil, 7-Dehydrocholesterol, Citrus Aurantium Amara (Bitter Orange) Flower Oil, Eugenia Caryophyllus (Clove) Leaf Oil, Maltodextrin, Silica, CI 77491 (Iron Oxides), Anigozanthos Flavidus Flower Extract, Syzygium Luehmannii Fruit Extract, Tin Oxide, Aspalathus Linearis Leaf Extract, Butylene Glycol, Sodium Lactate, Sodium PCA, Melanin, CI 77499 (Iron Oxides), Pentylene Glycol, Ceteareth-25, Linalool, Dimethicone, Magnesium Aspartate, Zinc Gluconate, Cetyl Alcohol, Citronellol, Sodium Hyaluronate, Davidsonia Pruriens Fruit Extract, Sodium Benzoate, Glycine, Ethylhexylglycerin, Potassium Sorbate, Behenic Acid, Ceramide NP, Cholesterol, Copper Gluconate, Fructose, Inositol, Lactic Acid, Niacinamide, Urea, Phenoxyethanol, Citric Acid, Ceramide NS, Serine, Glutamic Acid, Ceramide AP, Ceramide EOP, Ceramide EOS, Asparic Acid, Leucine, Acetyl Tetrapeptide-22, Caprooyl Phytosphingosine, Caprooyl Sphingosine, Alanine, Lysine, Arginine, Tyrosine, Phenylalanine, Propine, Threonine, Valine, Isoleucine, Histidine

  • PRINCIPAL DISPLAY PANEL

    LabelLabel2

  • INGREDIENTS AND APPEARANCE
    LUMINOSITY ACTIVATION DAY EDITION 
    zinc oxide kit
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:83108-100
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:83108-100-001 in 1 KIT11/15/2023
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 11 BOTTLE 3 mL
    Part 1 of 1
    THE TINTED SERUM BROAD SPECTRUM SPF 50 
    zinc oxide emulsion
    Product Information
    Item Code (Source)NDC:83108-001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION240 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    TRISILOXANE (UNII: 9G1ZW13R0G)  
    ISOAMYL LAURATE (UNII: M1SLX00M3M)  
    ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
    BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    ETHYLHEXYL METHOXYCRYLENE (UNII: S3KFG6Q5X8)  
    WATER (UNII: 059QF0KO0R)  
    LYSINE (UNII: K3Z4F929H6)  
    TRICONTANYL POVIDONE (UNII: N0SS3Q238D)  
    ARGAN OIL (UNII: 4V59G5UW9X)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    PENTAERYTHRITYL TETRAISOSTEARATE (UNII: 9D7IK5483F)  
    PROPANEDIOL (UNII: 5965N8W85T)  
    ISOSTEARIC ACID (UNII: X33R8U0062)  
    GLYCERYL CAPRYLATE (UNII: TM2TZD4G4A)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    BORON NITRIDE (UNII: 2U4T60A6YD)  
    1,2-HEXANEDIOL (UNII: TR046Y3K1G)  
    MICA (UNII: V8A1AW0880)  
    DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    LEVOMENOL (UNII: 24WE03BX2T)  
    PROPYLENE CARBONATE (UNII: 8D08K3S51E)  
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W)  
    LIMONENE, (+)- (UNII: GFD7C86Q1W)  
    CITRUS BERGAMIA LEAF OIL (UNII: ZVY8741I1V)  
    ORANGE OIL, COLD PRESSED (UNII: AKN3KSD11B)  
    JUNIPERUS DEPPEANA WOOD OIL (UNII: 4739QA5686)  
    GERANIUM OIL, ALGERIAN TYPE (UNII: 5Q1I94P4WG)  
    7-DEHYDROCHOLESTEROL (UNII: BK1IU07GKF)  
    CITRUS AURANTIUM FLOWER OIL (UNII: D4BGE91OXH)  
    CLOVE LEAF OIL (UNII: VCA5491KVF)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    ANIGOZANTHOS FLAVIDUS FLOWERING TOP (UNII: RP2O43NDZC)  
    SYZYGIUM LUEHMANNII FRUIT (UNII: 47QSB3L4KG)  
    STANNIC OXIDE (UNII: KM7N50LOS6)  
    ASPALATHUS LINEARIS LEAF (UNII: H7UGK1GJCU)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    SODIUM LACTATE (UNII: TU7HW0W0QT)  
    SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    PENTYLENE GLYCOL (UNII: 50C1307PZG)  
    CETEARETH-25 (UNII: 8FA93U5T67)  
    LINALOOL, (+/-)- (UNII: D81QY6I88E)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    MAGNESIUM ASPARTATE (UNII: R17X820ROL)  
    ZINC GLUCONATE (UNII: U6WSN5SQ1Z)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    .BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    DAVIDSONIA PRURIENS FRUIT (UNII: Q0AJF937HY)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    GLYCINE (UNII: TE7660XO1C)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    BEHENIC ACID (UNII: H390488X0A)  
    CERAMIDE NP (UNII: 4370DF050B)  
    CHOLESTEROL (UNII: 97C5T2UQ7J)  
    COPPER GLUCONATE (UNII: RV823G6G67)  
    FRUCTOSE (UNII: 6YSS42VSEV)  
    INOSITOL (UNII: 4L6452S749)  
    LACTIC ACID (UNII: 33X04XA5AT)  
    NIACINAMIDE (UNII: 25X51I8RD4)  
    UREA (UNII: 8W8T17847W)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    CERAMIDE NG (UNII: C04977SRJ5)  
    SERINE (UNII: 452VLY9402)  
    GLUTAMIC ACID (UNII: 3KX376GY7L)  
    CERAMIDE AP (UNII: F1X8L2B00J)  
    3-DEHYDROXY CERAMIDE 1 (UNII: CR0J8RN66K)  
    ASPARTIC ACID (UNII: 30KYC7MIAI)  
    LEUCINE (UNII: GMW67QNF9C)  
    CAPROOYL PHYTOSPHINGOSINE (UNII: 2FD4Y5XL2L)  
    N-HEXANOYLSPHINGOSINE (UNII: 038753E78J)  
    ALANINE (UNII: OF5P57N2ZX)  
    ARGININE (UNII: 94ZLA3W45F)  
    TYROSINE (UNII: 42HK56048U)  
    PHENYLALANINE (UNII: 47E5O17Y3R)  
    DIPIVEFRIN HYDROCHLORIDE (UNII: 5QTH9UHV0K)  
    THREONINE (UNII: 2ZD004190S)  
    VALINE (UNII: HG18B9YRS7)  
    ISOLEUCINE (UNII: 04Y7590D77)  
    HISTIDINE (UNII: 4QD397987E)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:83108-001-133 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02011/15/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02011/15/2023
    Labeler - Rationale Group Pty Ltd (756927393)