Label: BEAUTIFUL SKIN SUPERFLUID BROAD SPECTRUM SPF30 M2- zinc oxide emulsion

  • NDC Code(s): 83108-020-00, 83108-020-03
  • Packager: Rationale Group Pty Ltd
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not 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 March 7, 2023

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  • Drug Facts

  • Active Ingredient

    Zinc Oxide 16.9%

    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.
    • 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

    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-62, Polyurethane-79, Isopropyl Palmitate, Mica, Bisabolol, 1,2-Hexanediol, CI 77492 (Iron Oxides), C12-15 Alkyl Benzoate, Sodium Potassium Aluminum Silicate, Limonene, Panthenol, Lecithin, Tocopherol, Citrus Aurantium Dulcis (Orange) Oil, Caprylhydroxamic Acid, Trideceth-10, 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, CI 77491 (Iron Oxides), Citrus Aurantium Bergamia (Bergamot) Fruit Oil, Citrus Grandis (Grapefruit) Peel Oil, Citrus Limon (Lemon) Peel Oil, Litsea Cubeba Fruit Oil, Citral, Glycerin, Triethoxycaprylylsilane, CI 77499 (Iron Oxides), Cetyl Alcohol, Cyclopentasiloxane, Magnesium Aspartate, Zinc Gluconate, Nymphaea Alba Flower Extract, Linalool, PEG/PPG-18/18 Dimethicone, 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 M2

  • Package Labeling:3ml

    Outer Package M2Inner Package2

  • INGREDIENTS AND APPEARANCE
    BEAUTIFUL SKIN SUPERFLUID BROAD SPECTRUM SPF30 M2 
    zinc oxide emulsion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:83108-020
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION169 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    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)  
    3-DEHYDROXY CERAMIDE 1 (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)  
    SODIUM PALMITOYL PROLINE (UNII: 64L053FRFO)  
    PROPANEDIOL (UNII: 5965N8W85T)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    BIS-ETHYLHEXYL HYDROXYDIMETHOXY BENZYLMALONATE (UNII: 7D4Q5YJ8NV)  
    BORON NITRIDE (UNII: 2U4T60A6YD)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    POLYURETHANE-62 (UNII: TBK645J3J8)  
    ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)  
    MICA (UNII: V8A1AW0880)  
    LEVOMENOL (UNII: 24WE03BX2T)  
    1,2-HEXANEDIOL (UNII: TR046Y3K1G)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
    LIMONENE, (+)- (UNII: GFD7C86Q1W)  
    PANTHENOL (UNII: WV9CM0O67Z)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    ORANGE OIL, COLD PRESSED (UNII: AKN3KSD11B)  
    CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W)  
    TRIDECETH-10 (UNII: G624N6MSBA)  
    STANNIC OXIDE (UNII: KM7N50LOS6)  
    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)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    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)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    MAGNESIUM ASPARTATE (UNII: R17X820ROL)  
    ZINC GLUCONATE (UNII: U6WSN5SQ1Z)  
    NYMPHAEA ALBA FLOWER (UNII: 40KQ7Q535O)  
    LINALOOL, (+/-)- (UNII: D81QY6I88E)  
    PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794)  
    GLYCINE (UNII: TE7660XO1C)  
    BEHENIC ACID (UNII: H390488X0A)  
    CERAMIDE NP (UNII: 4370DF050B)  
    ACETYL HEXAPEPTIDE-1 (UNII: 49ZWR266MZ)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    HISTIDINE (UNII: 4QD397987E)  
    UNDECANE (UNII: JV0QT00NUE)  
    WATER (UNII: 059QF0KO0R)  
    COCO-CAPRYLATE (UNII: 4828G836N6)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    TRIDECANE (UNII: A3LZF0L939)  
    BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
    ARGAN OIL (UNII: 4V59G5UW9X)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    TRICONTANYL POVIDONE (UNII: N0SS3Q238D)  
    DIPROPYLENE GLYCOL (UNII: E107L85C40)  
    PENTYLENE GLYCOL (UNII: 50C1307PZG)  
    ETHYLHEXYL METHOXYCRYLENE (UNII: S3KFG6Q5X8)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:83108-020-001 in 1 CARTON01/29/2023
    130 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    2NDC:83108-020-033 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 not finalpart35201/29/2023
    Labeler - Rationale Group Pty Ltd (756927393)
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