Label: HYDRATING SHEER LIP BALM SPF 30 -CRYSTAL BROAD SPECTRUM SPF 30 UVA-UVB SUNSCREEN- avobenzone, octisalate, and homosalate lipstick
HYDRATING SHEER LIP BALM SPF 30 - BARE BROAD SPECTRUM SPF 30 UVA-UVB SUNSCREEN- avobenzone, octisalate, and homosalate lipstick
HYDRATING SHEER LIP BALM SPF 30 - BLUSH BROAD SPECTRUM SPF 30 UVA-UVB SUNSCREEN- avobenzone, octisalate, and homosalate lipstick
HYDRATING SHEER LIP BALM SPF 30 - RUBY BROAD SPECTRUM SPF 30 UVA-UVB SUNSCREEN- avobenzone, octisalate, and homosalate lipstick
HYDRATING SHEER LIP BALM SPF 30 - SHIMMER BROAD SPECTRUM SPF 30 UVA-UVB SUNSCREEN- avobenzone, octisalate, and homosalate lipstick
HYDRATING SHEER LIP BALM SPF 30 - SPICE BROAD SPECTRUM SPF 30 UVA-UVB SUNSCREEN- avobenzone, octisalate, and homosalate lipstick
HYDRATING SHEER LIP BALM SPF 30 - DREAM BROAD SPECTRUM SPF 30 UVA-UVB SUNSCREEN- avobenzone, octisalate, and homosalate lipstick

  • NDC Code(s): 49358-600-01, 49358-601-01, 49358-602-01, 49358-603-01, view more
    49358-604-01, 49358-605-01, 49358-606-01
  • Packager: MDSolarSciences
  • Category: HUMAN OTC DRUG LABEL

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 September 20, 2023

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredientsPurpose
    Avobenzone 3%Sunscreen
    Octisalate 5%Sunscreen
    Homosalate 10%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

    • 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:
      • use a water resistant sunscreen if swimming or sweating
      • 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 the risk, regularly use a sunscreen with Broad Spectrum SPF of 15 or higher and other sun protection measures including:
      • Limit time in the sun, especially from 10a.m.- 2p.m.
      • Wear long-sleeved shirts, pants, hats and sunglasses
  • Other Information

    • Protect the product in this container from excessive heat and direct sunlight
    • You may report serious adverse reactions to: Report Reaction, LLC., PO Box 22, Plainsboro, NJ 08536-0222
  • Inactive Ingredients

    Persea Gratissima (Avocado) Oil, Butyrospermum Parkii (Shea) Butter, Hydrogenated Soybean Oil, Paraffin, Ricinus Communis (Castor) Seed Oil, Olea Europaea (Olive) Fruit Oil, Octyldodecanol, Butyloctyl Salicylate, Hydrogenated Vegetable Oil, Jojoba Esters, Microcrystalline Wax, Stearic Acid, Helianthus Annuus (Sunflower) Seed Wax, Squalene, Polyglycerin-3, Tetrahexyldecyl Ascorbate (Vitamin C), Tocopheryl Acetate (Vitamin E), Ascorbyl Palmitate (Vitamin C), Tocopherol (Vitamin E), Rhus Verniciflua Peel Wax, Acacia Decurrens Flower Wax, Sorbitan Oleate, Synthetic Fluorphlogopite, May contain: CI 77891, CI 77491, CI 77492, CI 77499, CI 15850, CI 42090, CI 77861, CI 45410, CI 19140

  • SPL UNCLASSIFIED SECTION

    DISTRIBUTED BY
    MDSOLARSCIENCES CORP.
    GREENS FARMS, CT 06838

  • PRINCIPAL DISPLAY PANEL - 4.2 G Applicator Carton - Crystal

    MDSOLARSCIENCES®

    HYDRATING
    SHEER
    LIP BALM

    Broad Spectrum SPF 30

    SPF 30

    CRYSTAL

    DERMATOLOGIST
    DEVELOPED

    SHEA
    BUTTER
    VITAMIN E

    AVOCADO
    OIL
    VITAMIN C

    .15 OZ / 4.2 G

    PRINCIPAL DISPLAY PANEL - 4.2 G Applicator Carton - Crystal
  • PRINCIPAL DISPLAY PANEL - 4.2 G Applicator Carton - Bare

    MDSOLARSCIENCES®

    PROTECT & NOURISH

    HYDRATING
    SHEER
    LIP BALM

    Broad Spectrum SPF 30

    SPF 30

    BARE

    SHEA
    BUTTER
    VITAMIN E

    AVOCADO
    OIL
    VITAMIN C

    .15 OZ / 4.2 G

    PRINCIPAL DISPLAY PANEL - 4.2 G Applicator Carton - Bare
  • PRINCIPAL DISPLAY PANEL - 4.2 G Applicator Carton - Blush

    MDSOLARSCIENCES®

    PROTECT & NOURISH

    HYDRATING
    SHEER
    LIP BALM

    Broad Spectrum SPF 30

    SPF 30

    BLUSH

    SHEA
    BUTTER
    VITAMIN E

    AVOCADO
    OIL
    VITAMIN C

    .15 OZ / 4.2 G

    PRINCIPAL DISPLAY PANEL - 4.2 G Applicator Carton - Blush
  • PRINCIPAL DISPLAY PANEL - 4.2 G Applicator Carton - Ruby

    MDSOLARSCIENCES®

    PROTECT & NOURISH

    HYDRATING
    SHEER
    LIP BALM

    Broad Spectrum SPF 30

    SPF 30

    RUBY

    SHEA
    BUTTER
    VITAMIN E

    AVOCADO
    OIL
    VITAMIN C

    .15 OZ / 4.2 G

    PRINCIPAL DISPLAY PANEL - 4.2 G Applicator Carton - Ruby
  • PRINCIPAL DISPLAY PANEL - 4.2 G Applicator Carton - Shimmer

    MDSOLARSCIENCES®

    PROTECT & NOURISH

    HYDRATING
    SHEER
    LIP BALM

    Broad Spectrum SPF 30

    SPF 30

    SHIMMER

    SHEA
    BUTTER
    VITAMIN E

    AVOCADO
    OIL
    VITAMIN C

    .15 OZ / 4.2 G

    PRINCIPAL DISPLAY PANEL - 4.2 G Applicator Carton - Shimmer
  • PRINCIPAL DISPLAY PANEL - 4.2 G Applicator Carton - Spice

    MDSOLARSCIENCES®

    PROTECT & NOURISH

    HYDRATING
    SHEER
    LIP BALM

    Broad Spectrum SPF 30

    SPF 30

    SPICE

    SHEA
    BUTTER
    VITAMIN E

    AVOCADO
    OIL
    VITAMIN C

    .15 OZ / 4.2 G

    PRINCIPAL DISPLAY PANEL - 4.2 G Applicator Carton - Spice
  • PRINCIPAL DISPLAY PANEL - 4.2 G Applicator Carton - Dream

    MDSOLARSCIENCES®

    PROTECT & NOURISH

    HYDRATING
    SHEER
    LIP BALM

    Broad Spectrum SPF 30

    SPF 30

    DREAM

    SHEA
    BUTTER
    VITAMIN E

    AVOCADO
    OIL
    VITAMIN C

    .15 OZ / 4.2 G

    PRINCIPAL DISPLAY PANEL - 4.2 G Applicator Carton - Dream
  • INGREDIENTS AND APPEARANCE
    HYDRATING SHEER LIP BALM SPF 30 -CRYSTAL   BROAD SPECTRUM SPF 30 UVA-UVB SUNSCREEN
    avobenzone, octisalate, and homosalate lipstick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49358-600
    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
    AVOCADO OIL (UNII: 6VNO72PFC1)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    HYDROGENATED SOYBEAN OIL (UNII: A2M91M918C)  
    Paraffin (UNII: I9O0E3H2ZE)  
    OCTYLDODECANOL (UNII: 461N1O614Y)  
    CASTOR OIL (UNII: D5340Y2I9G)  
    OLIVE OIL (UNII: 6UYK2W1W1E)  
    BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
    CORN OIL (UNII: 8470G57WFM)  
    HYDROGENATED JOJOBA OIL, RANDOMIZED (UNII: Q47ST02F58)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)  
    HELIANTHUS ANNUUS SEED WAX (UNII: 42DG15CHXV)  
    SQUALANE (UNII: GW89575KF9)  
    TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    TOXICODENDRON VERNICIFLUUM FRUIT RIND WAX (UNII: 6RG2461FCH)  
    ACACIA DECURRENS FLOWER WAX (UNII: AU6XZE9IY9)  
    POLYGLYCERIN-3 (UNII: 4A0NCJ6RD6)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49358-600-011 in 1 CARTON07/01/2023
    14.2 g in 1 APPLICATOR; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35207/01/2023
    HYDRATING SHEER LIP BALM SPF 30 - BARE   BROAD SPECTRUM SPF 30 UVA-UVB SUNSCREEN
    avobenzone, octisalate, and homosalate lipstick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49358-601
    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
    AVOCADO OIL (UNII: 6VNO72PFC1)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    HYDROGENATED SOYBEAN OIL (UNII: A2M91M918C)  
    Paraffin (UNII: I9O0E3H2ZE)  
    CASTOR OIL (UNII: D5340Y2I9G)  
    OLIVE OIL (UNII: 6UYK2W1W1E)  
    BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
    CORN OIL (UNII: 8470G57WFM)  
    HYDROGENATED JOJOBA OIL, RANDOMIZED (UNII: Q47ST02F58)  
    MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    HELIANTHUS ANNUUS SEED WAX (UNII: 42DG15CHXV)  
    SQUALANE (UNII: GW89575KF9)  
    POLYGLYCERIN-3 (UNII: 4A0NCJ6RD6)  
    TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    TOXICODENDRON VERNICIFLUUM FRUIT RIND WAX (UNII: 6RG2461FCH)  
    ACACIA DECURRENS FLOWER WAX (UNII: AU6XZE9IY9)  
    SORBITAN MONOOLEATE (UNII: 06XEA2VD56)  
    Other Ingredients
    Ingredient KindIngredient NameQuantity
    May containTITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    May containFERRIC OXIDE RED (UNII: 1K09F3G675)  
    May containFERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    May containFERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    May containD&C RED NO. 6 (UNII: 481744AI4O)  
    May containFD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    May containSTANNIC OXIDE (UNII: KM7N50LOS6)  
    May containD&C RED NO. 28 (UNII: 767IP0Y5NH)  
    May containFD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    Product Characteristics
    ColorBROWNScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49358-601-011 in 1 CARTON07/01/2023
    14.2 g in 1 APPLICATOR; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35207/01/2023
    HYDRATING SHEER LIP BALM SPF 30 - BLUSH   BROAD SPECTRUM SPF 30 UVA-UVB SUNSCREEN
    avobenzone, octisalate, and homosalate lipstick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49358-602
    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
    AVOCADO OIL (UNII: 6VNO72PFC1)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    HYDROGENATED SOYBEAN OIL (UNII: A2M91M918C)  
    Paraffin (UNII: I9O0E3H2ZE)  
    CASTOR OIL (UNII: D5340Y2I9G)  
    OLIVE OIL (UNII: 6UYK2W1W1E)  
    BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
    CORN OIL (UNII: 8470G57WFM)  
    HYDROGENATED JOJOBA OIL, RANDOMIZED (UNII: Q47ST02F58)  
    MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    HELIANTHUS ANNUUS SEED WAX (UNII: 42DG15CHXV)  
    SQUALANE (UNII: GW89575KF9)  
    POLYGLYCERIN-3 (UNII: 4A0NCJ6RD6)  
    TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    TOXICODENDRON VERNICIFLUUM FRUIT RIND WAX (UNII: 6RG2461FCH)  
    ACACIA DECURRENS FLOWER WAX (UNII: AU6XZE9IY9)  
    SORBITAN MONOOLEATE (UNII: 06XEA2VD56)  
    Other Ingredients
    Ingredient KindIngredient NameQuantity
    May containTITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    May containFERRIC OXIDE RED (UNII: 1K09F3G675)  
    May containFERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    May containFERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    May containD&C RED NO. 6 (UNII: 481744AI4O)  
    May containFD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    May containSTANNIC OXIDE (UNII: KM7N50LOS6)  
    May containD&C RED NO. 28 (UNII: 767IP0Y5NH)  
    May containFD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    Product Characteristics
    ColorPINKScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49358-602-011 in 1 CARTON07/01/2023
    14.2 g in 1 APPLICATOR; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35207/01/2023
    HYDRATING SHEER LIP BALM SPF 30 - RUBY   BROAD SPECTRUM SPF 30 UVA-UVB SUNSCREEN
    avobenzone, octisalate, and homosalate lipstick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49358-603
    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
    AVOCADO OIL (UNII: 6VNO72PFC1)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    HYDROGENATED SOYBEAN OIL (UNII: A2M91M918C)  
    Paraffin (UNII: I9O0E3H2ZE)  
    CASTOR OIL (UNII: D5340Y2I9G)  
    OLIVE OIL (UNII: 6UYK2W1W1E)  
    BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
    CORN OIL (UNII: 8470G57WFM)  
    HYDROGENATED JOJOBA OIL, RANDOMIZED (UNII: Q47ST02F58)  
    MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    HELIANTHUS ANNUUS SEED WAX (UNII: 42DG15CHXV)  
    SQUALANE (UNII: GW89575KF9)  
    POLYGLYCERIN-3 (UNII: 4A0NCJ6RD6)  
    TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    TOXICODENDRON VERNICIFLUUM FRUIT RIND WAX (UNII: 6RG2461FCH)  
    ACACIA DECURRENS FLOWER WAX (UNII: AU6XZE9IY9)  
    SORBITAN MONOOLEATE (UNII: 06XEA2VD56)  
    Other Ingredients
    Ingredient KindIngredient NameQuantity
    May containTITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    May containFERRIC OXIDE RED (UNII: 1K09F3G675)  
    May containFERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    May containFERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    May containD&C RED NO. 6 (UNII: 481744AI4O)  
    May containFD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    May containSTANNIC OXIDE (UNII: KM7N50LOS6)  
    May containD&C RED NO. 28 (UNII: 767IP0Y5NH)  
    May containFD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    Product Characteristics
    ColorREDScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49358-603-011 in 1 CARTON07/01/2023
    14.2 g in 1 APPLICATOR; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35207/01/2023
    HYDRATING SHEER LIP BALM SPF 30 - SHIMMER   BROAD SPECTRUM SPF 30 UVA-UVB SUNSCREEN
    avobenzone, octisalate, and homosalate lipstick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49358-604
    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
    AVOCADO OIL (UNII: 6VNO72PFC1)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    HYDROGENATED SOYBEAN OIL (UNII: A2M91M918C)  
    Paraffin (UNII: I9O0E3H2ZE)  
    CASTOR OIL (UNII: D5340Y2I9G)  
    OLIVE OIL (UNII: 6UYK2W1W1E)  
    BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
    CORN OIL (UNII: 8470G57WFM)  
    HYDROGENATED JOJOBA OIL, RANDOMIZED (UNII: Q47ST02F58)  
    MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    HELIANTHUS ANNUUS SEED WAX (UNII: 42DG15CHXV)  
    SQUALANE (UNII: GW89575KF9)  
    POLYGLYCERIN-3 (UNII: 4A0NCJ6RD6)  
    TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    TOXICODENDRON VERNICIFLUUM FRUIT RIND WAX (UNII: 6RG2461FCH)  
    ACACIA DECURRENS FLOWER WAX (UNII: AU6XZE9IY9)  
    SORBITAN MONOOLEATE (UNII: 06XEA2VD56)  
    Other Ingredients
    Ingredient KindIngredient NameQuantity
    May containTITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    May containFERRIC OXIDE RED (UNII: 1K09F3G675)  
    May containFERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    May containFERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    May containD&C RED NO. 6 (UNII: 481744AI4O)  
    May containFD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    May containSTANNIC OXIDE (UNII: KM7N50LOS6)  
    May containD&C RED NO. 28 (UNII: 767IP0Y5NH)  
    May containFD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    Product Characteristics
    ColorPINKScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49358-604-011 in 1 CARTON07/01/2023
    14.2 g in 1 APPLICATOR; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35207/01/2023
    HYDRATING SHEER LIP BALM SPF 30 - SPICE   BROAD SPECTRUM SPF 30 UVA-UVB SUNSCREEN
    avobenzone, octisalate, and homosalate lipstick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49358-605
    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
    AVOCADO OIL (UNII: 6VNO72PFC1)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    HYDROGENATED SOYBEAN OIL (UNII: A2M91M918C)  
    Paraffin (UNII: I9O0E3H2ZE)  
    CASTOR OIL (UNII: D5340Y2I9G)  
    OLIVE OIL (UNII: 6UYK2W1W1E)  
    BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
    CORN OIL (UNII: 8470G57WFM)  
    HYDROGENATED JOJOBA OIL, RANDOMIZED (UNII: Q47ST02F58)  
    MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    HELIANTHUS ANNUUS SEED WAX (UNII: 42DG15CHXV)  
    SQUALANE (UNII: GW89575KF9)  
    POLYGLYCERIN-3 (UNII: 4A0NCJ6RD6)  
    TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    ASCORBYL PALMITATE (UNII: QN83US2B0N)  
    TOXICODENDRON VERNICIFLUUM FRUIT RIND WAX (UNII: 6RG2461FCH)  
    ACACIA DECURRENS FLOWER WAX (UNII: AU6XZE9IY9)  
    SORBITAN MONOOLEATE (UNII: 06XEA2VD56)  
    MAGNESIUM POTASSIUM ALUMINOSILICATE FLUORIDE (UNII: YK3DC63Y5M)  
    Other Ingredients
    Ingredient KindIngredient NameQuantity
    May containTITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    May containFERRIC OXIDE RED (UNII: 1K09F3G675)  
    May containFERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    May containFERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    May containD&C RED NO. 6 (UNII: 481744AI4O)  
    May containFD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    May containSTANNIC OXIDE (UNII: KM7N50LOS6)  
    May containD&C RED NO. 28 (UNII: 767IP0Y5NH)  
    May containFD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    Product Characteristics
    ColorREDScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49358-605-011 in 1 CARTON07/01/2023
    14.2 g in 1 APPLICATOR; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35207/01/2023
    HYDRATING SHEER LIP BALM SPF 30 - DREAM   BROAD SPECTRUM SPF 30 UVA-UVB SUNSCREEN
    avobenzone, octisalate, and homosalate lipstick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49358-606
    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
    AVOCADO OIL (UNII: 6VNO72PFC1)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    HYDROGENATED SOYBEAN OIL (UNII: A2M91M918C)  
    Paraffin (UNII: I9O0E3H2ZE)  
    CASTOR OIL (UNII: D5340Y2I9G)  
    OLIVE OIL (UNII: 6UYK2W1W1E)  
    BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
    CORN OIL (UNII: 8470G57WFM)  
    HYDROGENATED JOJOBA OIL, RANDOMIZED (UNII: Q47ST02F58)  
    MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    HELIANTHUS ANNUUS SEED WAX (UNII: 42DG15CHXV)  
    SQUALANE (UNII: GW89575KF9)  
    POLYGLYCERIN-3 (UNII: 4A0NCJ6RD6)  
    TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    ASCORBYL PALMITATE (UNII: QN83US2B0N)  
    TOXICODENDRON VERNICIFLUUM FRUIT RIND WAX (UNII: 6RG2461FCH)  
    ACACIA DECURRENS FLOWER WAX (UNII: AU6XZE9IY9)  
    SORBITAN MONOOLEATE (UNII: 06XEA2VD56)  
    MAGNESIUM POTASSIUM ALUMINOSILICATE FLUORIDE (UNII: YK3DC63Y5M)  
    Other Ingredients
    Ingredient KindIngredient NameQuantity
    May containTITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    May containFERRIC OXIDE RED (UNII: 1K09F3G675)  
    May containFERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    May containFERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    May containD&C RED NO. 6 (UNII: 481744AI4O)  
    May containFD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    May containSTANNIC OXIDE (UNII: KM7N50LOS6)  
    May containD&C RED NO. 28 (UNII: 767IP0Y5NH)  
    May containFD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    Product Characteristics
    ColorPINKScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49358-606-011 in 1 CARTON07/01/2023
    14.2 g in 1 APPLICATOR; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35207/01/2023
    Labeler - MDSolarSciences (013647301)