Label: HYDRATING SHEER LIP BALM SPF 30 - RED BROAD SPECTRUM SPF 30 UVA-UVB SUNSCREEN- avobenzone, octisalate, and homosalate lipstick
HYDRATING SHEER LIP BALM SPF 30 - PINK BROAD SPECTRUM SPF 30 UVA-UVB SUNSCREEN- avobenzone, octisalate, and homosalate lipstick
HYDRATING SHEER LIP BALM SPF 30 - NUDE BROAD SPECTRUM SPF 30 UVA-UVB SUNSCREEN- avobenzone, octisalate, and homosalate lipstick

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph 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 August 6, 2019

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active IngredientsPurpose
    Avobenzone 2%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.

    Stop use and ask a doctor if rash occurs.

    When using this product keep out of eyes. Rinse with water to remove.

    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 & again after swimming or sweating.
    • Reapply at least every 2 hours.
    • Children under 6 months: Ask a doctor
    • Sun Protection Measures: To decrease your risk of skin cancer and early skin aging, regularly use a sunscreen of SPF15 or higher and other sun protective 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, Paraffin Wax, Hydrogenated Soybean Oil, Ricinus Communis (Castor) Seed Oil, Octyldodecanol, Olea Europaea (Olive) Fruit Oil, Jojoba Esters, Hydrogenated Vegetable Oil, Microcrystalline Wax, Stearic Acid, Helianthus Annuus (Sunflower) Seed Oil, Squalane, Acacia Decurrens Flower Wax, Polyglycerin-3, Rhus Verniciflua Peel Wax, Sorbitan Oleate, Tetrahexyldecyl Ascorbate, Tocopheryl Acetate, Ascorbyl Palmitate, Tocopherol. May contain: Titanium Dioxide (CI 77891), Iron Oxides (CI 77491- Red), Iron Oxides (CI 77492 - Yellow), Iron Oxides (CI 77499 - Black) CI 19140 - Yellow 5, Red 28 Lake (CI 45410)

  • SPL UNCLASSIFIED SECTION

    Distributed by: MDSolarSciences Corp, Stamford, CT 06902

  • PRINCIPAL DISPLAY PANEL - 4.2 g Applicator Carton - Nude

    NUDE

    MDSolarSciences™

    HYDRATING
    SHEER
    LIP BALM

    30

    BROAD SPECTRUM
    SPF 30
    UVA-UVB SUNSCREEN

    sun repair

    Net Wt. 4.2 g -.15Oz

    PRINCIPAL DISPLAY PANEL - 4.2 g Applicator Carton - Nude
  • PRINCIPAL DISPLAY PANEL - 4.2 g Applicator Carton - Pink

    PINK

    MDSolarSciences™

    HYDRATING
    SHEER
    LIP BALM

    30

    BROAD SPECTRUM
    SPF 30
    UVA-UVB SUNSCREEN

    sun repair

    Net Wt. 4.2 g -.15Oz

    PRINCIPAL DISPLAY PANEL - 4.2 g Applicator Carton - Pink
  • PRINCIPAL DISPLAY PANEL - 4.2 g Applicator Carton - Red

    RED

    MDSolarSciences™

    HYDRATING
    SHEER
    LIP BALM

    30

    BROAD SPECTRUM
    SPF 30
    UVA-UVB SUNSCREEN

    sun repair

    Net Wt. 4.2 g -.15Oz

    PRINCIPAL DISPLAY PANEL - 4.2 g Applicator Carton - Red
  • INGREDIENTS AND APPEARANCE
    HYDRATING SHEER LIP BALM SPF 30 - RED   BROAD SPECTRUM SPF 30 UVA-UVB SUNSCREEN
    avobenzone, octisalate, and homosalate lipstick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49358-564
    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)  
    PARAFFIN (UNII: I9O0E3H2ZE)  
    HYDROGENATED SOYBEAN OIL (UNII: A2M91M918C)  
    Castor Oil (UNII: D5340Y2I9G)  
    OCTYLDODECANOL (UNII: 461N1O614Y)  
    OLIVE OIL (UNII: 6UYK2W1W1E)  
    HYDROGENATED JOJOBA OIL, RANDOMIZED (UNII: Q47ST02F58)  
    CORN OIL (UNII: 8470G57WFM)  
    MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    SUNFLOWER OIL (UNII: 3W1JG795YI)  
    SQUALANE (UNII: GW89575KF9)  
    ACACIA DECURRENS FLOWER WAX (UNII: AU6XZE9IY9)  
    POLYGLYCERIN-3 (UNII: 4A0NCJ6RD6)  
    TOXICODENDRON VERNICIFLUUM FRUIT RIND WAX (UNII: 6RG2461FCH)  
    SORBITAN MONOOLEATE (UNII: 06XEA2VD56)  
    TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    ASCORBYL PALMITATE (UNII: QN83US2B0N)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    D&C RED NO. 28 (UNII: 767IP0Y5NH)  
    Product Characteristics
    ColorREDScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49358-564-011 in 1 CARTON10/01/2019
    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 FINALpart35210/01/2019
    HYDRATING SHEER LIP BALM SPF 30 - PINK   BROAD SPECTRUM SPF 30 UVA-UVB SUNSCREEN
    avobenzone, octisalate, and homosalate lipstick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49358-565
    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)  
    PARAFFIN (UNII: I9O0E3H2ZE)  
    HYDROGENATED SOYBEAN OIL (UNII: A2M91M918C)  
    Castor Oil (UNII: D5340Y2I9G)  
    OCTYLDODECANOL (UNII: 461N1O614Y)  
    OLIVE OIL (UNII: 6UYK2W1W1E)  
    HYDROGENATED JOJOBA OIL, RANDOMIZED (UNII: Q47ST02F58)  
    CORN OIL (UNII: 8470G57WFM)  
    MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    SUNFLOWER OIL (UNII: 3W1JG795YI)  
    SQUALANE (UNII: GW89575KF9)  
    ACACIA DECURRENS FLOWER WAX (UNII: AU6XZE9IY9)  
    POLYGLYCERIN-3 (UNII: 4A0NCJ6RD6)  
    TOXICODENDRON VERNICIFLUUM FRUIT RIND WAX (UNII: 6RG2461FCH)  
    SORBITAN MONOOLEATE (UNII: 06XEA2VD56)  
    TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    ASCORBYL PALMITATE (UNII: QN83US2B0N)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    D&C RED NO. 28 (UNII: 767IP0Y5NH)  
    Product Characteristics
    ColorPINKScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49358-565-011 in 1 CARTON10/01/2019
    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 FINALpart35210/01/2019
    HYDRATING SHEER LIP BALM SPF 30 - NUDE   BROAD SPECTRUM SPF 30 UVA-UVB SUNSCREEN
    avobenzone, octisalate, and homosalate lipstick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49358-566
    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)  
    PARAFFIN (UNII: I9O0E3H2ZE)  
    HYDROGENATED SOYBEAN OIL (UNII: A2M91M918C)  
    Castor Oil (UNII: D5340Y2I9G)  
    OCTYLDODECANOL (UNII: 461N1O614Y)  
    OLIVE OIL (UNII: 6UYK2W1W1E)  
    HYDROGENATED JOJOBA OIL, RANDOMIZED (UNII: Q47ST02F58)  
    CORN OIL (UNII: 8470G57WFM)  
    MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    SUNFLOWER OIL (UNII: 3W1JG795YI)  
    SQUALANE (UNII: GW89575KF9)  
    ACACIA DECURRENS FLOWER WAX (UNII: AU6XZE9IY9)  
    POLYGLYCERIN-3 (UNII: 4A0NCJ6RD6)  
    TOXICODENDRON VERNICIFLUUM FRUIT RIND WAX (UNII: 6RG2461FCH)  
    SORBITAN MONOOLEATE (UNII: 06XEA2VD56)  
    TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    ASCORBYL PALMITATE (UNII: QN83US2B0N)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    D&C RED NO. 28 (UNII: 767IP0Y5NH)  
    Product Characteristics
    ColorBROWNScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49358-566-011 in 1 CARTON10/01/2019
    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 FINALpart35210/01/2019
    Labeler - MDSolarSciences (013647301)
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