Label: THE ENRICHED EYE CREME BROAD SPECTRUM SPF15- zinc oxide emulsion

  • NDC Code(s): 83108-002-00, 83108-002-02
  • Packager: Rationale Group Pty Ltd
  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated November 29, 2023

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  • Drug Facts

  • Active Ingredient

    Zinc Oxide 12%

    Purpose

    Sunscreen

  • Uses

    • Helps prevent sunburn.
    • If used as directed with other sun protection measures ( ), decreases the risk of skin cancer and early skin ageing caused by the sun. see Directions
  • 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.
    • 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:  Sun Protection Measures.
    • 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

    Aqua (Water), Dimethicone, Glycerin, Pentylene Glycol, PEG-10 Dimethicone, Tribehenin PEG-20 Esters, Ethylhexyl Methoxycrylene, Coco-Caprylate, Polyhydroxystearic Acid, Propanediol, Argania Spinosa Kernel Oil, Dimethicone Crosspolymer, Polyurethane-62, Tocopheryl Acetate, CI 77891 (Titanium Dioxide), Polyacrylamide, 1,2-Hexanediol, Silica, C13-14 Isoparaffin, Maltodextrin, Mica, Sodium Potassium Aluminum Silicate, Tocopherol, Butylene Glycol, Limonene, Tocotrienols, Laureth-7, Caprylhydroxamic Acid, Disodium EDTA, Hydrolyzed Keratin, Santalum Spicatum (Sandalwood) Seed Oil, Trideceth-10, Voandzeia Subterranea Seed Extract, Behenyl Alcohol, Bisabolol, Polyglyceryl-10 Pentastearate, Helianthus Annuus (Sunflower) Seed Oil, Citrus Aurantium Dulcis (Orange) Oil, Anigozanthos Flavidus Flower Extract, Davidsonia Jerseyana Fruit Extract, Syzygium Luehmannii Fruit Extract, Tin Oxide, Citric Acid, Ceteareth-25, Citrus Aurantium Bergamia (Bergamot) Fruit Oil, Citrus Grandis (Grapefruit) Peel Oil, Citrus Limon (Lemon) Peel Oil, Fructose, Litsea Cubeba Fruit Oil, Sodium Hydroxide, Urea, Citral, Citrus Aurantium Bergamia (Bergamot) Leaf Oil, Juniperus Mexicana Oil, Pelargonium Graveolens Oil, Citrus Aurantium Amara (Bitter Orange) Flower Oil, Eugenia Caryophyllus (Clove) Leaf Oil, Sodium Stearoyl Lactylate, CI 77491 (Iron Oxides), Ceramide NP, 7-Dehydrocholesterol, Cetyl Alcohol, Elaeis Guineensis (Palm) Oil, Melanin, Allantoin, Maltose, Sodium Chloride, Sodium Lactate, Sodium PCA, Trehalose, Magnesium Aspartate, Zinc Gluconate, Linalool, Behenic Acid, Ceramide AP, Cholesterol, Ceramide NG, Phytosphingosine, Ceramide NS, Sodium Hyaluronate, Glycine, Acetyl Tetrapeptide-22, Phenoxyethanol, Potassium Sorbate, Sodium Benzoate, Serine, Glutamic Acid, Ceramide EOP, Ceramide EOS, Copper Gluconate, Glucose, Aspartic Acid, Leucine, Caprooyl Phytosphingosine, Caprooyl Sphingosine, Alanine, Lysine, Ethylhexylglycerin, Arginine, Tyrosine, Phenylalanine, Proline, Threonine, Valine, Isoleucine, Histidine.

  • Package Labeling:20ml

    Label00

  • Package Labeling:2ml

    SFC

    Eml

    2ml

  • INGREDIENTS AND APPEARANCE
    THE ENRICHED EYE CREME BROAD SPECTRUM SPF15 
    zinc oxide emulsion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:83108-002
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION120 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PENTYLENE GLYCOL (UNII: 50C1307PZG)  
    TRIBEHENIN PEG-20 ESTERS (UNII: 84K9EH29Y9)  
    ETHYLHEXYL METHOXYCRYLENE (UNII: S3KFG6Q5X8)  
    COCO-CAPRYLATE (UNII: 4828G836N6)  
    PROPANEDIOL (UNII: 5965N8W85T)  
    ARGAN OIL (UNII: 4V59G5UW9X)  
    POLYURETHANE-62 (UNII: TBK645J3J8)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    1,2-HEXANEDIOL (UNII: TR046Y3K1G)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    C13-14 ISOPARAFFIN (UNII: E4F12ROE70)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    MICA (UNII: V8A1AW0880)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    LIMONENE, (+)- (UNII: GFD7C86Q1W)  
    TOCOTRIENOLS (UNII: KP2MW85SSQ)  
    LAURETH-7 (UNII: Z95S6G8201)  
    CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W)  
    EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
    SANDALWOOD (UNII: 3641YW25N2)  
    TRIDECETH-10 (UNII: G624N6MSBA)  
    BAMBARA GROUNDNUT (UNII: 4T235SD5XE)  
    DOCOSANOL (UNII: 9G1OE216XY)  
    LEVOMENOL (UNII: 24WE03BX2T)  
    POLYGLYCERYL-10 PENTASTEARATE (UNII: PMX5872701)  
    SUNFLOWER OIL (UNII: 3W1JG795YI)  
    ORANGE OIL, COLD PRESSED (UNII: AKN3KSD11B)  
    ANIGOZANTHOS FLAVIDUS FLOWERING TOP (UNII: RP2O43NDZC)  
    SYZYGIUM LUEHMANNII FRUIT (UNII: 47QSB3L4KG)  
    STANNIC OXIDE (UNII: KM7N50LOS6)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    CETEARETH-25 (UNII: 8FA93U5T67)  
    BERGAMOT OIL (UNII: 39W1PKE3JI)  
    CITRUS MAXIMA FRUIT RIND OIL (UNII: 8U3877WD44)  
    LEMON OIL, COLD PRESSED (UNII: I9GRO824LL)  
    FRUCTOSE (UNII: 6YSS42VSEV)  
    LITSEA OIL (UNII: 2XIW34BN6O)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    UREA (UNII: 8W8T17847W)  
    CITRAL (UNII: T7EU0O9VPP)  
    CITRUS BERGAMIA LEAF OIL (UNII: ZVY8741I1V)  
    JUNIPERUS DEPPEANA WOOD OIL (UNII: 4739QA5686)  
    GERANIUM OIL, ALGERIAN TYPE (UNII: 5Q1I94P4WG)  
    CITRUS AURANTIUM FLOWER OIL (UNII: D4BGE91OXH)  
    CLOVE LEAF OIL (UNII: VCA5491KVF)  
    SODIUM STEAROYL LACTYLATE (UNII: IN99IT31LN)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    CERAMIDE NP (UNII: 4370DF050B)  
    7-DEHYDROCHOLESTEROL (UNII: BK1IU07GKF)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    PALM OIL (UNII: 5QUO05548Z)  
    ALLANTOIN (UNII: 344S277G0Z)  
    MALTOSE (UNII: XJ6S9RV06F)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    SODIUM LACTATE (UNII: TU7HW0W0QT)  
    SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)  
    TREHALOSE (UNII: B8WCK70T7I)  
    MAGNESIUM ASPARTATE (UNII: R17X820ROL)  
    ZINC GLUCONATE (UNII: U6WSN5SQ1Z)  
    LINALOOL, (+/-)- (UNII: D81QY6I88E)  
    BEHENIC ACID (UNII: H390488X0A)  
    CERAMIDE AP (UNII: F1X8L2B00J)  
    CHOLESTEROL (UNII: 97C5T2UQ7J)  
    CERAMIDE NG (UNII: C04977SRJ5)  
    PHYTOSPHINGOSINE (UNII: GIN46U9Q2Q)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    GLYCINE (UNII: TE7660XO1C)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SERINE (UNII: 452VLY9402)  
    GLUTAMIC ACID (UNII: 3KX376GY7L)  
    CERAMIDE EOS (UNII: CR0J8RN66K)  
    COPPER GLUCONATE (UNII: RV823G6G67)  
    ANHYDROUS DEXTROSE (UNII: 5SL0G7R0OK)  
    ASPARTIC ACID (UNII: 30KYC7MIAI)  
    LEUCINE (UNII: GMW67QNF9C)  
    CAPROOYL PHYTOSPHINGOSINE (UNII: 2FD4Y5XL2L)  
    N-HEXANOYLSPHINGOSINE (UNII: 038753E78J)  
    ALANINE (UNII: OF5P57N2ZX)  
    LYSINE (UNII: K3Z4F929H6)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    ARGININE (UNII: 94ZLA3W45F)  
    TYROSINE (UNII: 42HK56048U)  
    PHENYLALANINE (UNII: 47E5O17Y3R)  
    PROLINE (UNII: 9DLQ4CIU6V)  
    THREONINE (UNII: 2ZD004190S)  
    VALINE (UNII: HG18B9YRS7)  
    ISOLEUCINE (UNII: 04Y7590D77)  
    HISTIDINE (UNII: 4QD397987E)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:83108-002-001 in 1 BOX12/08/2022
    120 mL in 1 JAR; Type 0: Not a Combination Product
    2NDC:83108-002-022 mL in 1 JAR; Type 0: Not a Combination Product12/08/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02012/08/2022
    Labeler - Rationale Group Pty Ltd (756927393)