Label: CAY SKIN ISLE LIP BALM SPF 30 CORAL- avobenzone, homosalate, octisalate cream
CAY SKIN ISLE LIP BALM SPF 30 BAD GYAL BERRY- avobenzone, homosalate, octisalate cream
CAY SKIN ISLE LIP BALM SPF 30 NUDE TING- avobenzone, homosalate, octisalate cream
CAY SKIN ISLE LIP BALM SPF 30 COCOA CABANA- avobenzone, homosalate, octisalate cream
CAY SKIN ISLE LIP BALM SPF 30- avobenzone, homosalate, octisalate cream
CAY SKIN ISLE LIP BALM SPF 30 IRIE ROSE- avobenzone, homosalate, octisalate cream

  • NDC Code(s): 82657-001-01, 82657-010-01, 82657-011-01, 82657-012-01, view more
    82657-013-01, 82657-014-01
  • Packager: Cay Skin, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated March 13, 2026

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

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  • Drug Facts

  • Active ingredients (w/w)

    Avobenzone 3%, Homosalate 10%, Octisalate 5%

  • 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 aging 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 consult a doctor

    if skin rash occurs.

    Keep out of reach of children.

    If product is swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    • Adults and children over 6 months of age:
    • Apply liberally 15 minutes before sun exposure.
    • Reapply: at least every 2 hours or after 40 minutes of swimming or sweating.
    • Children under 6 months of age: 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

    Protect this product from excessive heat and direct sun.

  • Inactive ingredients

    Hydrogenated Polyisobutene, C18-38 Alkyl Hydroxystearoyl Stearate, Butyrospermum Parkii (Shea) Oil, Butyloctyl Salicylate, VP/Hexadecene Copolymer, Ozokerite, Cetyl Alcohol, Vanillin, Glyceryl Stearate, Phytosteryl/Octyldodecyl Lauroyl Glutamate, Methyl Dihydroabietate, Trihydroxystearin, Erythritol, Aloe Barbadensis Leaf Juice, Water (Aqua), Chondrus Crispus Extract

    Cocoa Cabana

    Hydrogenated Polyisobutene, C18-38 Alkyl Hydroxystearoyl Stearate, Butyrospermum Parkii (Shea) Oil, Butyloctyl Salicylate, VP/Hexadecene Copolymer, Ozokerite, Cetyl Alcohol, Vanillin, Glyceryl Stearate, Phytosteryl/Octyldodecyl Lauroyl Glutamate, Erythritol, Aqua (Water, Eau), Aloe Barbadensis Leaf Juice, Chondrus Crispus Extract, Tocopherol, Citric Acid, Methyl Dihydroabietate, Trihydroxystearin, Potassium Sorbate, Sodium Benzoate, Vanillin, CI 77891 (Titanium Dioxide), CI 77491/CI 77492/CI 77499 (Iron Oxides), CI 15850 (Red 7 Lake)

    Coral

    Hydrogenated Polyisobutene, C18-38 Alkyl Hydroxystearoyl Stearate, Butyrospermum Parkii (Shea) Oil, Butyloctyl Salicylate, VP/Hexadecene Copolymer, Ozokerite, Cetyl Alcohol, Vanillin, Glyceryl Stearate, Phytosteryl/Octyldodecyl Lauroyl Glutamate, Erythritol, Aqua (Water, Eau), Aloe Barbadensis Leaf Juice, Chondrus Crispus Extract, Tocopherol, Citric Acid, Methyl Dihydroabietate, Trihydroxystearin, Potassium Sorbate, Sodium Benzoate, Vanillin, CI 77891 (Titanium Dioxide), CI 77491/CI 77492

    Nude Ting

    Hydrogenated Polyisobutene, C18-38 Alkyl Hydroxystearoyl Stearate, Butyrospermum Parkii (Shea) Oil, Butyloctyl Salicylate, VP/Hexadecene Copolymer, Ozokerite, Cetyl Alcohol, Vanillin, Glyceryl Stearate, Phytosteryl/Octyldodecyl Lauroyl Glutamate, Erythritol, Aqua (Water, Eau), Aloe Barbadensis Leaf Juice, Chondrus Crispus Extract, Tocopherol, Methyl Dihydroabietate, Trihydroxystearin, Citric Acid, Potassium Sorbate, Sodium Benzoate, CI 77891 (Titanium Dioxide), CI 77491/CI 77492/CI 77499 (Iron Oxides)

    Irie Rose

    Hydrogenated Polyisobutene, C18-38 Alkyl Hydroxystearoyl Stearate, Butyrospermum Parkii (Shea) Oil, Butyloctyl Salicylate, VP/Hexadecene Copolymer, Ozokerite, Cetyl Alcohol, Vanillin, Glyceryl Stearate, Phytosteryl/Octyldodecyl Lauroyl Glutamate, Erythritol, Aqua (Water, Eau), Aloe Barbadensis Leaf Juice, Chondrus Crispus Extract, Tocopherol, Methyl Dihydroabietate, Trihydroxystearin, Citric Acid, Potassium Sorbate, Sodium Benzoate. May Contain +/-: CI 77891 (Titanium Dioxide), CI 77491/CI 77492/CI 77499 (Iron Oxides), CI 15850 (Red 7 Lake)

    Bad Gyal Berry

    Hydrogenated Polyisobutene, C18-38 Alkyl Hydroxystearoyl Stearate, Butyrospermum Parkii (Shea) Oil, Butyloctyl Salicylate, VP/Hexadecene Copolymer, Ozokerite, Cetyl Alcohol, Vanillin, Glyceryl Stearate, Phytosteryl/Octyldodecyl Lauroyl Glutamate, Erythritol, Aqua (Water, Eau), Aloe Barbadensis Leaf Juice, Chondrus Crispus Extract, Tocopherol, Methyl Dihydroabietate, Trihydroxystearin, Citric Acid, Potassium Sorbate, Sodium Benzoate. May Contain +/-: CI 77891 (Titanium Dioxide), CI 77491/CI 77492/CI 77499 (Iron Oxides), CI 15850 (Red 7 Lake)

  • Questions or comments?

    cayskin.com (256) 396-8268

  • Product Packaging

    isle lip balm

  • Product Packaging - Cocoa Cabana

    1

  • Product Packaging - Coral

    1

  • Product Packaging - Nude Ting

    1

  • Product Packaging - Irie Rose

    1

  • Product Packaging - Bad Gyal Berry

    1

  • INGREDIENTS AND APPEARANCE
    CAY SKIN ISLE LIP BALM SPF 30 CORAL 
    avobenzone, homosalate, octisalate cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:82657-011
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE30 mg  in 1 g
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE50 mg  in 1 g
    HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE100 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    CI 77492 (UNII: EX438O2MRT)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SHEANUT OIL (UNII: O88E196QRF)  
    BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    ERYTHRITOL (UNII: RA96B954X6)  
    CHONDRUS CRISPUS (UNII: OQS23HUA1X)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    CERESIN (UNII: Q1LS2UJO3A)  
    HYDROGENATED POLYBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ)  
    PHYTOSTERYL/OCTYLDODECYL LAUROYL GLUTAMATE (UNII: 65954KGO9Q)  
    METHYL DIHYDROABIETATE (UNII: 7666FJ0J9F)  
    TRIHYDROXYSTEARIN (UNII: 06YD7896S3)  
    WATER (UNII: 059QF0KO0R)  
    C18-38 ALKYL HYDROXYSTEAROYL STEARATE (UNII: WW4FVB2PEM)  
    VINYLPYRROLIDONE/HEXADECENE COPOLYMER (UNII: KFR5QEN0N9)  
    VANILLIN (UNII: CHI530446X)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    CI 77491 (UNII: 1K09F3G675)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:82657-011-011 in 1 CARTON01/01/2025
    110 g in 1 TUBE, WITH APPLICATOR; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02001/01/2025
    CAY SKIN ISLE LIP BALM SPF 30 BAD GYAL BERRY 
    avobenzone, homosalate, octisalate cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:82657-014
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE30 mg  in 1 g
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE50 mg  in 1 g
    HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE100 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    CI 15850 (UNII: 481744AI4O)  
    CI 77492 (UNII: EX438O2MRT)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SHEANUT OIL (UNII: O88E196QRF)  
    BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    ERYTHRITOL (UNII: RA96B954X6)  
    CHONDRUS CRISPUS (UNII: OQS23HUA1X)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    CERESIN (UNII: Q1LS2UJO3A)  
    HYDROGENATED POLYBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ)  
    PHYTOSTERYL/OCTYLDODECYL LAUROYL GLUTAMATE (UNII: 65954KGO9Q)  
    METHYL DIHYDROABIETATE (UNII: 7666FJ0J9F)  
    TRIHYDROXYSTEARIN (UNII: 06YD7896S3)  
    WATER (UNII: 059QF0KO0R)  
    C18-38 ALKYL HYDROXYSTEAROYL STEARATE (UNII: WW4FVB2PEM)  
    VINYLPYRROLIDONE/HEXADECENE COPOLYMER (UNII: KFR5QEN0N9)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    CI 77491 (UNII: 1K09F3G675)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    CI 77499 (UNII: XM0M87F357)  
    VANILLIN (UNII: CHI530446X)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:82657-014-011 in 1 CARTON01/01/2023
    110 g in 1 TUBE, WITH APPLICATOR; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02001/01/2023
    CAY SKIN ISLE LIP BALM SPF 30 NUDE TING 
    avobenzone, homosalate, octisalate cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:82657-012
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE30 mg  in 1 g
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE50 mg  in 1 g
    HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE100 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    CI 77492 (UNII: EX438O2MRT)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SHEANUT OIL (UNII: O88E196QRF)  
    BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    ERYTHRITOL (UNII: RA96B954X6)  
    CHONDRUS CRISPUS (UNII: OQS23HUA1X)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    CERESIN (UNII: Q1LS2UJO3A)  
    HYDROGENATED POLYBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ)  
    PHYTOSTERYL/OCTYLDODECYL LAUROYL GLUTAMATE (UNII: 65954KGO9Q)  
    METHYL DIHYDROABIETATE (UNII: 7666FJ0J9F)  
    TRIHYDROXYSTEARIN (UNII: 06YD7896S3)  
    WATER (UNII: 059QF0KO0R)  
    C18-38 ALKYL HYDROXYSTEAROYL STEARATE (UNII: WW4FVB2PEM)  
    VINYLPYRROLIDONE/HEXADECENE COPOLYMER (UNII: KFR5QEN0N9)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    CI 77491 (UNII: 1K09F3G675)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    CI 77499 (UNII: XM0M87F357)  
    VANILLIN (UNII: CHI530446X)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:82657-012-011 in 1 CARTON01/01/2024
    110 g in 1 TUBE, WITH APPLICATOR; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02001/01/2024
    CAY SKIN ISLE LIP BALM SPF 30 COCOA CABANA 
    avobenzone, homosalate, octisalate cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:82657-010
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE30 mg  in 1 g
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE50 mg  in 1 g
    HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE100 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    CI 77499 (UNII: XM0M87F357)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    CI 77492 (UNII: EX438O2MRT)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SHEANUT OIL (UNII: O88E196QRF)  
    BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    ERYTHRITOL (UNII: RA96B954X6)  
    CHONDRUS CRISPUS (UNII: OQS23HUA1X)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    CERESIN (UNII: Q1LS2UJO3A)  
    HYDROGENATED POLYBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ)  
    PHYTOSTERYL/OCTYLDODECYL LAUROYL GLUTAMATE (UNII: 65954KGO9Q)  
    METHYL DIHYDROABIETATE (UNII: 7666FJ0J9F)  
    TRIHYDROXYSTEARIN (UNII: 06YD7896S3)  
    WATER (UNII: 059QF0KO0R)  
    C18-38 ALKYL HYDROXYSTEAROYL STEARATE (UNII: WW4FVB2PEM)  
    VINYLPYRROLIDONE/HEXADECENE COPOLYMER (UNII: KFR5QEN0N9)  
    VANILLIN (UNII: CHI530446X)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    CI 15850 (UNII: 481744AI4O)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    CI 77491 (UNII: 1K09F3G675)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:82657-010-011 in 1 CARTON09/13/2024
    110 g in 1 TUBE, WITH APPLICATOR; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02009/13/2024
    CAY SKIN ISLE LIP BALM SPF 30 
    avobenzone, homosalate, octisalate cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:82657-001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE30 mg  in 1 g
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE50 mg  in 1 g
    HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE100 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    SHEANUT OIL (UNII: O88E196QRF)  
    BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    ERYTHRITOL (UNII: RA96B954X6)  
    CHONDRUS CRISPUS (UNII: OQS23HUA1X)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    CERESIN (UNII: Q1LS2UJO3A)  
    HYDROGENATED POLYBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ)  
    PHYTOSTERYL/OCTYLDODECYL LAUROYL GLUTAMATE (UNII: 65954KGO9Q)  
    METHYL DIHYDROABIETATE (UNII: 7666FJ0J9F)  
    TRIHYDROXYSTEARIN (UNII: 06YD7896S3)  
    WATER (UNII: 059QF0KO0R)  
    C18-38 ALKYL HYDROXYSTEAROYL STEARATE (UNII: WW4FVB2PEM)  
    VINYLPYRROLIDONE/HEXADECENE COPOLYMER (UNII: KFR5QEN0N9)  
    VANILLIN (UNII: CHI530446X)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:82657-001-011 in 1 CARTON03/29/2022
    110 g in 1 TUBE, WITH APPLICATOR; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02003/29/2022
    CAY SKIN ISLE LIP BALM SPF 30 IRIE ROSE 
    avobenzone, homosalate, octisalate cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:82657-013
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE30 mg  in 1 g
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE50 mg  in 1 g
    HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE100 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    CI 15850 (UNII: 481744AI4O)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    CI 77492 (UNII: EX438O2MRT)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SHEANUT OIL (UNII: O88E196QRF)  
    BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    ERYTHRITOL (UNII: RA96B954X6)  
    CHONDRUS CRISPUS (UNII: OQS23HUA1X)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    CERESIN (UNII: Q1LS2UJO3A)  
    HYDROGENATED POLYBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ)  
    PHYTOSTERYL/OCTYLDODECYL LAUROYL GLUTAMATE (UNII: 65954KGO9Q)  
    METHYL DIHYDROABIETATE (UNII: 7666FJ0J9F)  
    TRIHYDROXYSTEARIN (UNII: 06YD7896S3)  
    WATER (UNII: 059QF0KO0R)  
    C18-38 ALKYL HYDROXYSTEAROYL STEARATE (UNII: WW4FVB2PEM)  
    VINYLPYRROLIDONE/HEXADECENE COPOLYMER (UNII: KFR5QEN0N9)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    CI 77491 (UNII: 1K09F3G675)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    CI 77499 (UNII: XM0M87F357)  
    VANILLIN (UNII: CHI530446X)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:82657-013-011 in 1 CARTON01/01/2023
    110 g in 1 TUBE, WITH APPLICATOR; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02001/01/2023
    Labeler - Cay Skin, Inc. (118574309)
    Establishment
    NameAddressID/FEIBusiness Operations
    Atlantis Laboratories, Inc.194673984manufacture(82657-011, 82657-014, 82657-012, 82657-010, 82657-001, 82657-013)
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