Label: INDUSTRIAL LIP BALM SPF 15- octinoxate and oxybenzone lipstick
CLEANROOM LIP BALM SPF 15- octinoxate and oxybenzone lipstick
DESERT SPIRIT LIP BALM SPF 15- octinoxate and oxybenzone lipstick

  • 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 October 20, 2020

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  • SPL UNCLASSIFIED SECTION

    DRUG FACTS

  • Active Ingredients

    Benzophenone-3 (Oxybenzone) 3%
    Ethylhexyl Methoxycinnamate (Octinoxate) 7.5%

  • Purpose

    Sunscreen

  • Uses

    Helps prevent sunburn

  • Warnings

    • Skin Cancer/Skin Aging Alert: Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to help prevent sunburn, not skin cancer or early skin aging.
    • 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
    • Use a water resistant sunscreen if swimming or sweating
    • Reapply at least every 2 hours
    • Children under 6 months: Ask a doctor
  • Inactive Ingredients

    Aloe Barbadensis (Aloe Vera) Leaf Extract, Copernicia Cerifera (Carnauba) Wax, Flavor, Mineral Oil, Paraffin, Petrolatum, Retinyl Palmitate, Simmondsia Chinensis (Jojoba) Seed Oil, Theobroma Cacao (Cocoa) Seed Butter, Tocopherol (Vitamin E), Zea Mays (Corn) Oil (and) BHA (and) Propyl Gallate (and) Citric Acid.

  • Other Information

    Protect this product from excessive heat and direct sun

  • Questions or comments?

    Call 1-262-268-2720

  • SPL UNCLASSIFIED SECTION

    Manufactured by: Alliance Packaging Group, Inc. Saukville, WI 53080

  • PRINCIPAL DISPLAY PANEL - 4.2 g Applicator Label - Industrial

    INDUSTRIAL
    LIPBALM
    SPF 15

    LIME BURST
    LIP BALM

    PN# ISLB

    Net Wt. : 0.15 oz / 4.2 g

    Peel label
    for drug
    facts info.

    PRINCIPAL DISPLAY PANEL - 4.2 g Applicator Label - Industrial
  • PRINCIPAL DISPLAY PANEL - 4.2 g Applicator Label - Clean Balm

    Peel label
    for drug
    facts info.

    R&R
    LOTION®
    I.C. CLEAN BALM SPF 15 ™

    LIME BURST
    LIP BALM

    PN# ISLB

    Net Wt. : 0.15 oz / 4.2 g

    PRINCIPAL DISPLAY PANEL - 4.2 g Applicator Label - Clean Balm
  • PRINCIPAL DISPLAY PANEL - 4.2 g Applicator Label - Desert Spirit

    DESERT SPIRIT

    SPF 15
    Lip Protection

    Net Wt. : 0.15 oz / 4.2 g

    Peel label
    for drug
    facts info.

    PRINCIPAL DISPLAY PANEL - 4.2 g Applicator Label - Desert Spirit
  • INGREDIENTS AND APPEARANCE
    INDUSTRIAL LIP BALM SPF 15 
    octinoxate and oxybenzone lipstick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59555-111
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate75 mg  in 1 g
    Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y) Oxybenzone30 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    Carnauba Wax (UNII: R12CBM0EIZ)  
    Mineral Oil (UNII: T5L8T28FGP)  
    Paraffin (UNII: I9O0E3H2ZE)  
    Petrolatum (UNII: 4T6H12BN9U)  
    Vitamin A Palmitate (UNII: 1D1K0N0VVC)  
    Jojoba Oil (UNII: 724GKU717M)  
    Cocoa Butter (UNII: 512OYT1CRR)  
    Corn Oil (UNII: 8470G57WFM)  
    Propyl Gallate (UNII: 8D4SNN7V92)  
    Citric Acid Monohydrate (UNII: 2968PHW8QP)  
    BUTYLATED HYDROXYANISOLE (UNII: REK4960K2U)  
    Product Characteristics
    ColorYELLOWScore    
    ShapeSize
    FlavorLIME (Lime Burst) Imprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59555-111-204.2 g in 1 APPLICATOR; Type 0: Not a Combination Product01/01/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart35201/01/2020
    CLEANROOM LIP BALM SPF 15 
    octinoxate and oxybenzone lipstick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59555-112
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate75 mg  in 1 g
    Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y) Oxybenzone30 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    Carnauba Wax (UNII: R12CBM0EIZ)  
    Mineral Oil (UNII: T5L8T28FGP)  
    Paraffin (UNII: I9O0E3H2ZE)  
    Petrolatum (UNII: 4T6H12BN9U)  
    Vitamin A Palmitate (UNII: 1D1K0N0VVC)  
    Jojoba Oil (UNII: 724GKU717M)  
    Cocoa Butter (UNII: 512OYT1CRR)  
    Corn Oil (UNII: 8470G57WFM)  
    Propyl Gallate (UNII: 8D4SNN7V92)  
    Citric Acid Monohydrate (UNII: 2968PHW8QP)  
    BUTYLATED HYDROXYANISOLE (UNII: REK4960K2U)  
    Product Characteristics
    ColorYELLOWScore    
    ShapeSize
    FlavorLIME (Lime Burst) Imprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59555-112-204.2 g in 1 APPLICATOR; Type 0: Not a Combination Product01/01/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart35201/01/2020
    DESERT SPIRIT LIP BALM SPF 15 
    octinoxate and oxybenzone lipstick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59555-113
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate75 mg  in 1 g
    Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y) Oxybenzone30 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    Carnauba Wax (UNII: R12CBM0EIZ)  
    Mineral Oil (UNII: T5L8T28FGP)  
    Paraffin (UNII: I9O0E3H2ZE)  
    Petrolatum (UNII: 4T6H12BN9U)  
    Vitamin A Palmitate (UNII: 1D1K0N0VVC)  
    Jojoba Oil (UNII: 724GKU717M)  
    Cocoa Butter (UNII: 512OYT1CRR)  
    Corn Oil (UNII: 8470G57WFM)  
    Propyl Gallate (UNII: 8D4SNN7V92)  
    Citric Acid Monohydrate (UNII: 2968PHW8QP)  
    BUTYLATED HYDROXYANISOLE (UNII: REK4960K2U)  
    Product Characteristics
    ColorYELLOWScore    
    ShapeSize
    FlavorLIME (Lime Burst) Imprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59555-113-204.2 g in 1 APPLICATOR; Type 0: Not a Combination Product01/01/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart35201/01/2020
    Labeler - R & R Lotion, Inc (062979000)
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