Label: BEAUTIFUL SKIN SUPERFLUID BROAD SPECTRUM SPF30 M6- zinc oxide emulsion

  • NDC Code(s): 83108-060-00, 83108-060-03
  • Packager: Rationale Group Pty Ltd
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated November 29, 2023

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

  • Drug Facts

  • Active Ingredient

    Zinc Oxide 14.4%

    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.

  • DirectionsMM

    • 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

    Undecane, Aqua (Water), Coco-Caprylate, Caprylic/Capric Triglyceride, Tridecane, Butyloctyl Salicylate, Lauryl PEG-10 Tris(Trimethylsiloxy)silylethyl Dimethicone, Polyhydroxystearic Acid, Argania Spinosa Kernel Oil, Tocopheryl Acetate, Triacontanyl PVP, Dipropylene Glycol, Methyl Methacrylate Crosspolymer, Pentylene Glycol, Ethylhexyl Methoxycrylene, Sodium Palmitoyl Proline, Propanediol, CI 77891 (Titanium Dioxide), Silica, Butylene Glycol, Bis-Ethylhexyl Hydroxydimethoxy Benzylmalonate, Boron Nitride, Sodium Chloride, Polyurethane-79, Polyurethane-62, C12-15 Alkyl Benzoate, CI 77492 (Iron Oxides), Isopropyl Palmitate, Mica, Bisabolol, 1,2-Hexanediol, Sodium Potassium Aluminum Silicate, Limonene, Panthenol, Lecithin, Tocopherol, CI 77491 (Iron Oxides), Citrus Aurantium Dulcis (Orange) Oil, CI 77499 (Iron Oxides), Caprylhydroxamic Acid, Trideceth-10, Triethoxycaprylylsilane, Tin Oxide, Citrus Aurantium Bergamia (Bergamot) Leaf Oil, Juniperus Mexicana Oil, Pelargonium Graveolens Oil, Citrus Aurantium Amara (Bitter Orange) Flower Oil, Eugenia Caryophyllus (Clove) Leaf Oil, Ceteareth-25, Helianthus Annuus (Sunflower) Seed Oil, Melanin, Cyclopentasiloxane, Citrus Aurantium Bergamia (Bergamot) Fruit Oil, Citrus Grandis (Grapefruit) Peel Oil, Citrus Limon (Lemon) Peel Oil, Litsea Cubeba Fruit Oil, Citral, Glycerin, PEG/PPG-18/18 Dimethicone, Cetyl Alcohol, Magnesium Aspartate, Zinc Gluconate, Nymphaea Alba Flower Extract, Linalool, Glycine, Behenic Acid, Ceramide NP, Cholesterol, Ceramide NS, Serine, Glutamic Acid, Aspartic Acid, Leucine, Ethylhexylglycerin, Ceramide AP, Ceramide EOP, Ceramide EOS, Copper Gluconate, Alanine, Lysine, Arginine, Tyrosine, Phenylalanine, Proline, Threonine, Valine, Isoleucine, Caprooyl Phytosphingosine, Caprooyl Sphingosine, Phenoxyethanol, Sodium Hyaluronate, Histidine, Acetyl Hexapeptide-1.

  • Package Labeling:30ml

    Label M6

  • Package Labeling:3ml

    Outer Package M6Inner Package6

  • INGREDIENTS AND APPEARANCE
    BEAUTIFUL SKIN SUPERFLUID BROAD SPECTRUM SPF30 M6 
    zinc oxide emulsion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:83108-060
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION141 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    UNDECANE (UNII: JV0QT00NUE)  
    WATER (UNII: 059QF0KO0R)  
    COCO-CAPRYLATE (UNII: 4828G836N6)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    TRIDECANE (UNII: A3LZF0L939)  
    ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
    BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    ARGAN OIL (UNII: 4V59G5UW9X)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    DIPROPYLENE GLYCOL (UNII: E107L85C40)  
    TRICONTANYL POVIDONE (UNII: N0SS3Q238D)  
    SODIUM PALMITOYL PROLINE (UNII: 64L053FRFO)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    PENTYLENE GLYCOL (UNII: 50C1307PZG)  
    ETHYLHEXYL METHOXYCRYLENE (UNII: S3KFG6Q5X8)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    PROPANEDIOL (UNII: 5965N8W85T)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    BIS-ETHYLHEXYL HYDROXYDIMETHOXY BENZYLMALONATE (UNII: 7D4Q5YJ8NV)  
    OCTYLDODECANOL (UNII: 461N1O614Y)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794)  
    BORON NITRIDE (UNII: 2U4T60A6YD)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)  
    POLYURETHANE-62 (UNII: TBK645J3J8)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    MICA (UNII: V8A1AW0880)  
    LEVOMENOL (UNII: 24WE03BX2T)  
    1,2-HEXANEDIOL (UNII: TR046Y3K1G)  
    LIMONENE, (+)- (UNII: GFD7C86Q1W)  
    PANTHENOL (UNII: WV9CM0O67Z)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    ORANGE OIL, COLD PRESSED (UNII: AKN3KSD11B)  
    CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W)  
    TRIDECETH-10 (UNII: G624N6MSBA)  
    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)  
    CETEARETH-25 (UNII: 8FA93U5T67)  
    SUNFLOWER OIL (UNII: 3W1JG795YI)  
    STANNIC OXIDE (UNII: KM7N50LOS6)  
    SORBITAN MONOOLEATE (UNII: 06XEA2VD56)  
    BERGAMOT OIL (UNII: 39W1PKE3JI)  
    CITRUS MAXIMA FRUIT RIND OIL (UNII: 8U3877WD44)  
    LEMON OIL, COLD PRESSED (UNII: I9GRO824LL)  
    LITSEA OIL (UNII: 2XIW34BN6O)  
    CITRAL (UNII: T7EU0O9VPP)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    MAGNESIUM ASPARTATE (UNII: R17X820ROL)  
    ZINC GLUCONATE (UNII: U6WSN5SQ1Z)  
    NYMPHAEA ALBA FLOWER (UNII: 40KQ7Q535O)  
    LINALOOL, (+/-)- (UNII: D81QY6I88E)  
    GLYCINE (UNII: TE7660XO1C)  
    BEHENIC ACID (UNII: H390488X0A)  
    CERAMIDE NP (UNII: 4370DF050B)  
    CHOLESTEROL (UNII: 97C5T2UQ7J)  
    CERAMIDE NG (UNII: C04977SRJ5)  
    SERINE (UNII: 452VLY9402)  
    GLUTAMIC ACID (UNII: 3KX376GY7L)  
    ASPARTIC ACID (UNII: 30KYC7MIAI)  
    LEUCINE (UNII: GMW67QNF9C)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    CERAMIDE AP (UNII: F1X8L2B00J)  
    CERAMIDE EOS (UNII: CR0J8RN66K)  
    COPPER GLUCONATE (UNII: RV823G6G67)  
    ALANINE (UNII: OF5P57N2ZX)  
    LYSINE (UNII: K3Z4F929H6)  
    ARGININE (UNII: 94ZLA3W45F)  
    TYROSINE (UNII: 42HK56048U)  
    PHENYLALANINE (UNII: 47E5O17Y3R)  
    PROLINE (UNII: 9DLQ4CIU6V)  
    THREONINE (UNII: 2ZD004190S)  
    VALINE (UNII: HG18B9YRS7)  
    ISOLEUCINE (UNII: 04Y7590D77)  
    CAPROOYL PHYTOSPHINGOSINE (UNII: 2FD4Y5XL2L)  
    N-HEXANOYLSPHINGOSINE (UNII: 038753E78J)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    HISTIDINE (UNII: 4QD397987E)  
    ACETYL HEXAPEPTIDE-1 (UNII: 49ZWR266MZ)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:83108-060-001 in 1 CARTON01/29/2023
    130 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    2NDC:83108-060-033 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product01/29/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02001/29/2023
    Labeler - Rationale Group Pty Ltd (756927393)