Label: NOON POST PROCEDURE PROGRAM- allantoin, titanium dioxide, octocrylene, and avobenzone kit

  • NDC Code(s): 78863-1230-2, 78863-1270-2, 78863-2600-1
  • Packager: Noon Aesthetics M.R. Ltd
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated October 12, 2023

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  • SPL UNCLASSIFIED SECTION

    DeFlame + DERMSHIELD™

  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active Ingredient

    Allantoin 0.5%

  • Purpose

    Skin Protectant

  • Uses

    • Temporarily protects minor: skin irritation, cuts, scrapes, burns and helps protect and relieve chafed, chapped or cracked skin.
  • Warnings

    For external use only.

    Do not use on

    • deep or puncture wounds, animal bites, serious burns.

    When using this product

    • avoid contact with eyes. In case of eye contact, flush with water.

    Stop use and ask a doctor if

    • condition worsens.
    • symptoms last more than 7 days or clear up and occur again within a few days.

    Keep out of reach of children.

  • Directions

    • Apply as needed.
  • Inactive Ingredients

    Water, Propylene Glycol, Glycerin, Dimethyl Sulfone, Strontium Chloride Hexahydrate, Dimethicone, Cetyl Alcohol, Glyceryl Stearate, Propanediol, Dipotassium Glycyrrhizate, Polysorbate 20, PEG-40 Stearate, Laureth-4, Porphyridium Cruentum Extract, Arnica Montana Flower Extract, sh-Oligopeptide-1 (EGF), sh-Oligopeptide-2 (IGF-1), sh-Polypeptide-1 (bFGF), sh-Polypeptide-9 (VEGF), sh-Polypeptide-11 (FGF-1), Bacillus/Folic Acid Ferment Filtrate Extract, Octyldodecyl Xyloside, Butylene Glycol, Sodium Hyaluronate, 1,2-Hexanediol, Acetyl Glutamine, Octyldodecanol, PEG-30 Dipolyhydroxystearate, Sorbitan Tristearate, Lecithin, Phenoxyethanol, Benzyl Alcohol, Caprylyl Glycol, Potassium Sorbate, Disodium EDTA, Sodium Benzoate.

  • SPL UNCLASSIFIED SECTION

    Multi-Vit Sun Protector SPF 30

  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active IngredientPurpose
    Titanium Dioxide 9%Sunscreen
    Octocrylene 4.8%Sunscreen
    Butyl Methoxydibenzoylmethane 1.44%Sunscreen
  • Uses

    • Help prevent sunburn.
  • Warnings

    For external use only.

    Do not use

    • on damage or broken skin.

    When using this product

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

    Stop use and ask a doctor

    • if rash or irritation develops and lasts.

    Keep out of reach of children.

    • If product is swallowed, get medical help or contact a poison control center right away.
  • Directions

    • Apply liberally 15 minutes before sun exposure and as needed.
    • Use a water-resistant sunscreen if swimming or sweating.
    • Reapply at least every 2 hours.
    • Children under 6 months: Ask a doctor.
    • 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 time in the sun, especially from 10 a.m.-2 p.m.
    • wear long-sleeved shirts, pants, hats, and sunglasses.
  • Other Information

    • Sun alert: Limiting sun exposure, wearing protective clothing, and using sunscreens may reduce the risks of skin aging, skin cancer, and other harmful effects of the sun.
    • Protect this product from excessive heat and direct sun.
  • Inactive Ingredients

    Water, Isononyl Isononanoate, Cyclopentasiloxane, Isohexadecane, Glyceryl Stearate, PEG 100 Stearate, Glycerin, Silica, Potassium Cetyl Phosphate, Sorbitol, Sorbitan Stearate, Magnesium Aluminum Silicate, Xanthan Gum, Sodium Phytate, Xylitol, Nicotinamide, Butyrospermum Parkii (Shea ) Butter, Tocopheryl Acetate, Ascorbyl Tetraisopalmitate, Ectoin, Phenoxyethanol, Anhydroxylitol, Stearic Acid, Alumina, PPG-3 Benzyl Ether Myristate, PVP, Xylitylglucoside, Citrus Aurantium Bergamia fruit oil, Fragrance, Sodium Polyacrylate, Ethylhexyl Cocoate, Caprylyl Glycol, Alcohol.

  • SPL UNCLASSIFIED SECTION

    Developed + Dist by NOON Aesthetics
    TLV, 62153

  • PRINCIPAL DISPLAY PANEL - Kit Carton

    AESTHETICS

    Post-Procedure Treatment Program

    MicroSoft Cleanser 15 mL / 0.5 Fl. Oz.
    Smart Occlusion System 15 mL / 0.5 Fl. Oz.
    Halo-Ronic Serum 15 mL / 0.5 Fl. Oz.

    Optimal Moisturizing Guardian 15 mL / 0.5 Fl. Oz.
    DeFlame 15 mL / 0.5 Fl. Oz.
    Multi-Vit Sun Protector SPF 30 15 mL / 0.5 Fl. Oz.

    Principal Display Panel - Kit Carton
  • INGREDIENTS AND APPEARANCE
    NOON POST PROCEDURE PROGRAM 
    allantoin, titanium dioxide, octocrylene, and avobenzone kit
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:78863-2600
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:78863-2600-11 in 1 CARTON10/01/2023
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 11 BOTTLE 15 mL
    Part 21 BOTTLE 15 mL
    Part 31 BOTTLE 15 mL
    Part 41 BOTTLE 15 mL
    Part 51 BOTTLE 15 mL
    Part 61 BOTTLE 15 mL
    Part 1 of 6
    MICRO SOFT CLEANSER 
    cleansing (cold creams, cleansing lotions, liquids, and pads) cream
    Product Information
    Route of AdministrationTOPICAL
    Other Ingredients
    Ingredient KindIngredient NameQuantity
    INGRPEG-20 GLYCERYL TRIISOSTEARATE (UNII: 4714JOJ107)  
    INGRCYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    INGRISOHEXADECANE (UNII: 918X1OUF1E)  
    INGRPROPANEDIOL (UNII: 5965N8W85T)  
    INGRWATER (UNII: 059QF0KO0R)  
    INGRMACADAMIA OIL (UNII: 515610SU8C)  
    INGRSQUALANE (UNII: GW89575KF9)  
    INGRISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    INGRPANTHENOL (UNII: WV9CM0O67Z)  
    INGRSTRONTIUM CHLORIDE HEXAHYDRATE (UNII: O09USB7Z44)  
    INGRBUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    INGRDIMETHYL SULFONE (UNII: 9H4PO4Z4FT)  
    INGRNYMPHAEA ALBA ROOT (UNII: 866B05KWBR)  
    INGRGLYCERIN (UNII: PDC6A3C0OX)  
    INGRPROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    INGRCAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    INGRPHENOXYETHANOL (UNII: HIE492ZZ3T)  
    INGRBENZYL ALCOHOL (UNII: LKG8494WBH)  
    INGRSODIUM BENZOATE (UNII: OJ245FE5EU)  
    INGRPOTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    INGRETHYLHEXYL COCOATE (UNII: I1MPW273QS)  
    INGRPHYTATE SODIUM (UNII: 88496G1ERL)  
    INGRCITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    INGRPOLYSORBATE 20 (UNII: 7T1F30V5YH)  
    INGRALCOHOL (UNII: 3K9958V90M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    115 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    COSMETIC10/01/2023
    Part 2 of 6
    SMART OCCLUSION SYSTEM 
    face and neck (excluding shaving preparations) cream
    Product Information
    Route of AdministrationTOPICAL
    Other Ingredients
    Ingredient KindIngredient NameQuantity
    INGRWATER (UNII: 059QF0KO0R)  
    INGRPROPANEDIOL (UNII: 5965N8W85T)  
    INGRCHOLESTEROL (UNII: 97C5T2UQ7J)  
    INGRMEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    INGRMINERAL OIL (UNII: T5L8T28FGP)  
    INGRPOLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)  
    INGRCYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    INGRGLYCERIN (UNII: PDC6A3C0OX)  
    INGRMICROCRYSTALLINE WAX (UNII: XOF597Q3KY)  
    INGRTURMERIC (UNII: 856YO1Z64F)  
    INGRISOSORBIDE DICAPRYLATE (UNII: 0IK29C4889)  
    INGROLEIC ACID (UNII: 2UMI9U37CP)  
    INGRPALMITIC ACID (UNII: 2V16EO95H1)  
    INGRBORON NITRIDE (UNII: 2U4T60A6YD)  
    INGRCERAMIDE NP (UNII: 4370DF050B)  
    INGRMAGNESIUM STEARATE (UNII: 70097M6I30)  
    INGR.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    INGRFERULIC ACID (UNII: AVM951ZWST)  
    INGRCERAMIDE AP (UNII: F1X8L2B00J)  
    INGRCERAMIDE NG (UNII: C04977SRJ5)  
    INGRGLYCYRRHIZINATE DIPOTASSIUM (UNII: CA2Y0FE3FX)  
    INGRBUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    INGRCAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    INGR1,2-HEXANEDIOL (UNII: TR046Y3K1G)  
    INGRPHENOXYETHANOL (UNII: HIE492ZZ3T)  
    INGREDETATE TRISODIUM (UNII: 420IP921MB)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    115 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    COSMETIC10/01/2023
    Part 3 of 6
    HALO-RONIC SERUM 
    face and neck (excluding shaving preparations) cream
    Product Information
    Route of AdministrationTOPICAL
    Other Ingredients
    Ingredient KindIngredient NameQuantity
    INGRWATER (UNII: 059QF0KO0R)  
    INGRBUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    INGRPROPANEDIOL (UNII: 5965N8W85T)  
    INGRTURMERIC (UNII: 856YO1Z64F)  
    INGRAZADIRACHTA INDICA LEAF (UNII: HKY915780T)  
    INGRHYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    INGRSODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)  
    INGRGLYCYRRHIZINATE DIPOTASSIUM (UNII: CA2Y0FE3FX)  
    INGRHISTIDINE (UNII: 4QD397987E)  
    INGRBETAINE (UNII: 3SCV180C9W)  
    INGRSERINE (UNII: 452VLY9402)  
    INGRGLYCERIN (UNII: PDC6A3C0OX)  
    INGRARGININE (UNII: 94ZLA3W45F)  
    INGRALANINE (UNII: OF5P57N2ZX)  
    INGRGLYCINE (UNII: TE7660XO1C)  
    INGRLYSINE HYDROCHLORIDE (UNII: JNJ23Q2COM)  
    INGRTHREONINE (UNII: 2ZD004190S)  
    INGRPROLINE (UNII: 9DLQ4CIU6V)  
    INGRGLUTAMIC ACID (UNII: 3KX376GY7L)  
    INGRCALCIUM LACTATE ANHYDROUS (UNII: 2URQ2N32W3)  
    INGRSODIUM LACTATE (UNII: TU7HW0W0QT)  
    INGRCITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    INGRSODIUM BENZOATE (UNII: OJ245FE5EU)  
    INGRCAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    INGR1,2-HEXANEDIOL (UNII: TR046Y3K1G)  
    INGRPHENOXYETHANOL (UNII: HIE492ZZ3T)  
    INGRALCOHOL (UNII: 3K9958V90M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    115 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    COSMETIC10/01/2023
    Part 4 of 6
    OPTIMAL MOISTURIZING GUARDIAN 
    moisturizing cream
    Product Information
    Route of AdministrationTOPICAL
    Other Ingredients
    Ingredient KindIngredient NameQuantity
    INGRWATER (UNII: 059QF0KO0R)  
    INGRMEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    INGRPROPANEDIOL (UNII: 5965N8W85T)  
    INGRCHOLESTEROL (UNII: 97C5T2UQ7J)  
    INGRSQUALANE (UNII: GW89575KF9)  
    INGRPOLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)  
    INGRCYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    INGRGLYCERIN (UNII: PDC6A3C0OX)  
    INGRMICROCRYSTALLINE WAX (UNII: XOF597Q3KY)  
    INGRTURMERIC (UNII: 856YO1Z64F)  
    INGRISOSORBIDE DICAPRYLATE (UNII: 0IK29C4889)  
    INGROLEIC ACID (UNII: 2UMI9U37CP)  
    INGRPALMITIC ACID (UNII: 2V16EO95H1)  
    INGRBORON NITRIDE (UNII: 2U4T60A6YD)  
    INGRCERAMIDE NP (UNII: 4370DF050B)  
    INGRMAGNESIUM STEARATE (UNII: 70097M6I30)  
    INGR.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    INGRBUCKMINSTERFULLERENE (UNII: NP9U26B839)  
    INGRFERULIC ACID (UNII: AVM951ZWST)  
    INGRCERAMIDE AP (UNII: F1X8L2B00J)  
    INGRCERAMIDE NG (UNII: C04977SRJ5)  
    INGRGLYCYRRHIZINATE DIPOTASSIUM (UNII: CA2Y0FE3FX)  
    INGRBUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    INGRCAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    INGR1,2-HEXANEDIOL (UNII: TR046Y3K1G)  
    INGRPHENOXYETHANOL (UNII: HIE492ZZ3T)  
    INGREDETATE TRISODIUM (UNII: 420IP921MB)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    115 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    COSMETIC10/01/2023
    Part 5 of 6
    DEFLAME 
    allantoin cream
    Product Information
    Item Code (Source)NDC:78863-1270
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALLANTOIN (UNII: 344S277G0Z) (ALLANTOIN - UNII:344S277G0Z) ALLANTOIN5 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)  
    STRONTIUM CHLORIDE HEXAHYDRATE (UNII: O09USB7Z44)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    PROPANEDIOL (UNII: 5965N8W85T)  
    GLYCYRRHIZINATE DIPOTASSIUM (UNII: CA2Y0FE3FX)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    LAURETH-4 (UNII: 6HQ855798J)  
    ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)  
    OCTYLDODECYL XYLOSIDE (UNII: 8Z6VNR46QM)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    1,2-HEXANEDIOL (UNII: TR046Y3K1G)  
    ACEGLUTAMIDE (UNII: 01J18G9G97)  
    OCTYLDODECANOL (UNII: 461N1O614Y)  
    PEG-30 DIPOLYHYDROXYSTEARATE (4000 MW) (UNII: 9713Q0S7FO)  
    SORBITAN TRISTEARATE (UNII: 6LUM696811)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:78863-1270-215 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph drugM02010/01/2023
    Part 6 of 6
    MULTI-VIT SUN PROTECTOR SPF 30 
    titanium dioxide, octocrylene, and avobenzone cream
    Product Information
    Item Code (Source)NDC:78863-1230
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE90 mg  in 1 mL
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE48 mg  in 1 mL
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE14.4 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ISONONYL ISONONANOATE (UNII: S4V5BS6GCX)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    ISOHEXADECANE (UNII: 918X1OUF1E)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)  
    SORBITOL (UNII: 506T60A25R)  
    SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X)  
    MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    PHYTATE SODIUM (UNII: 88496G1ERL)  
    XYLITOL (UNII: VCQ006KQ1E)  
    NIACINAMIDE (UNII: 25X51I8RD4)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    ASCORBYL TETRAISOPALMITATE (UNII: 47143LT58A)  
    ECTOINE (UNII: 7GXZ3858RY)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    ANHYDROXYLITOL (UNII: 8XWR7NN42F)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    PPG-3 BENZYL ETHER MYRISTATE (UNII: 8075L58MKO)  
    POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
    XYLITYLGLUCOSIDE (UNII: O0IEZ166FB)  
    ETHYLHEXYL COCOATE (UNII: I1MPW273QS)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    ALCOHOL (UNII: 3K9958V90M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:78863-1230-215 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph drugM02010/01/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph drugM01610/01/2023
    Labeler - Noon Aesthetics M.R. Ltd (600185560)
    Establishment
    NameAddressID/FEIBusiness Operations
    Noon Aesthetics M.R. Ltd600185560MANUFACTURE(78863-2600)
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